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Meet Us at DIA Europe 2024

Get to know some of the organizations and speakers that will take a part at this yearly landmark in life-science events.

Join us at DIA Europe 2024 conference for a unique chance to meet with and hear directly from representatives of national regulators, HTA bodies, patient advocacy groups, and other critical stakeholders.

Meet the Keynote Speakers

Meet Speakers from the European Commission

Meet Speakers from the European Medicines Agency

Speakers

  • Barbara E Bierer, MD

    Barbara E Bierer, MD

    • Faculty Director, MRCT Center; Professor of Medicine
    • Harvard Medical School, United States

    Barbara Bierer, M.D., a hematologist-oncologist, is Professor of Medicine at Harvard Medical School and the Brigham and Women’s Hospital (BWH). Dr. Bierer co-founded and now leads the Multi-Regional Clinical Trials Center of BWH and Harvard (MRCT Center, www.mrctcenter.org), a collaborative effort to improve standards for the planning, conduct, and regulatory environment of international clinical trials. She is the Director of the Regulatory Foundations, Ethics, and the Law at the Harvard Catalyst (https://catalyst.harvard.edu) and Director of Regulatory Policy for SMART IRB (www.SMARTIRB.org). She currently serves on the BODs of Management Sciences for Health, Edward P. Evans Foundation, and Vivli.

  • Gabriele  Breda, PhD

    Gabriele Breda, PhD

    • Research and Innovation Director
    • ProductLife Group, France

    Gabrièle Breda is the Director of Research & Innovation at ProductLife Group (PLG). Graduated from Ecole Normale Supérieure of Paris, with a PhD in Neurosciences, Gabrièle has been managing collaborative Research & Innovation in Healthcare Engineering at Altran and Capgemini Engineering for 12 years. Since 2022 she is developing Research & Innovation at PLG to address the main Life Sciences evolutions and challenges brought by digital transformation and technological innovation, with perspectives to regulatory science and shared value.

  • Magda  Chlebus, MA

    Magda Chlebus, MA

    • Executive Director, Science Policy & Regulatory Affairs
    • EFPIA - European Federation of Pharmaceutical Industries and Associations, Belgium

    Magda Chlebus is Executive Director Scientific & Regulatory Affairs at the European Federation of Pharmaceutical Industries and Associations (EFPIA), representing the R&D-based pharmaceutical industry in Europe. Magda and her team are in charge of following policy and legislative developments that influence the research and regulatory environments for the healthcare industry in Europe. She joined EFPIA in 1995. Her experience covers public and government affairs mainly at EU level, on a range of legislative and non-legislative files in the area of research, development and access to medicines and enabling technologies. Magda, a Polish national, holds a Master Degree in Applied Linguistics from the University of Warsaw.

  • Tamara  Di Carlantonio, MA

    Tamara Di Carlantonio, MA

    • Regulatory Policy Lead
    • Roche, Switzerland

    Tamara is a Regulatory Policy Lead at Roche in Switzerland, focusing on EU policy topics, in particular Drug Repurposing, Orphan Medicines and the General Pharmaceutical Legislation. She joined Roche in 2013 and has held roles of increasing responsibility across different business areas. Additionally, she was a project manager and policy advisor at EFPIA (on secondment) from 2021 until 2023. She holds a MA in International Relations and is currently completing an MBA at Warwick Business School.

  • Fengyun(Vicky)  Han

    Fengyun(Vicky) Han

    • Senior Director, Head of Regulatory Policy for Asia Pacific
    • Johnson & Johnson Pte. Ltd., Singapore

    Vicky Han is Senior Director at Janssen Pharmaceuticals and head up the Asia Pacific Regulatory Policy since 2016. Her experiences span Asia & Europe and cross pharmaceutical, biological, vaccines, and generics. She dedicated 18 years of her career to GSK where she held several positions in various countries. She led the RA team in pharmaceuticals and vaccines in GSK China before moving to GSK vaccines headquarters in Belgium in 2008. In GSK Vaccine, she led the cross-product regulatory affairs team to deal directly with the European Medicines Agency (EMA) regarding vaccine registration. In 2011, she relocated to GSK Pharmaceuticals headquarters in London as the Senior Director to oversee the regulatory strategies in China/Asia.

  • Kristina  Larsson, MS

    Kristina Larsson, MS

    • Head of Orphan Medicines, Division for Human Medicines Evidence Generation
    • European Medicines Agency, Netherlands

    Kristina Larsson joined the orphan team of the EMA as the Head of Office in July 2014. Before that she spent 8 years as a scientific officer in the scientific advice team of the EMA in charge of the Scientific Advice Working Party secretariat. Before joining the agency she worked three years in clinical research for AstraZeneca in Mölndal, Sweden. Kristina has a master of Medicine in Pharmaceutical Bioscience from the University of Gothenburg.

  • David  Lewis, PhD

    David Lewis, PhD

    • Head QPPV PRRC Office, Chief Medical Office & Patient Safety
    • Novartis Pharma AG, Switzerland

    Dr Dave Lewis joined Novartis in March 2007 following 20 years’ pharmacovigilance at GSK and at Shire. He has worked in country affiliates and in a variety of global safety & risk management functions with both investigational & marketed products, as well as in roles involving systems and processes. Dr Lewis is the author of papers on the safety of medicines as well as research papers on neuropharmacology. He is Senior Visiting Research Fellow, Department of Clinical, Pharmaceutical and Biological Sciences, School of Life and Medical Sciences, University of Hertfordshire, a member of the ICH E2D(R1) Expert Working Group, Project Coordinator for the IMI WEB-RADR 2 consortium, and Work Package Co-Leader for IMI ConcePTION.

  • Thomas W. Moller, MBA, MSc

    Thomas W. Moller, MBA, MSc

    • Director Global Regulatory Affairs - Devices
    • Novo Nordisk, Denmark

    Thomas is the Senior Director of Regulatory Affairs for Devices at Novo Nordisk and is responsible for devices and combination products and has extensive experience with regulating medical devices. As a former Director of Medical Devices in the DKMA and an MDCG member, he has worked with the public sector, MedTech-Industry and Patient-organisations to secure patient safety. He has been elected Chair of the Competent Authorities for Medical Devices and has experience in national and international arenas. Thomas holds a master’s degree in political science from the University of Copenhagen. He has undertaken several courses and continuing education in project management and leadership and has several years of practical management experience.

  • Remco  Munnik

    Remco Munnik

    • President
    • IRISS Forum, Spain

    Remco Munnik is a Director at Iperion, a Deloitte company. He has more than 20 years’ experience in Life Science and Regulatory Affairs, including more than a decade providing consultancy around Regulatory Information Management (RIM) and electronic submissions. He is a respected subject matter expert in RIM, eCTD, xEVMPD and ISO IDMP. Remco is Chair of Medicines for Europe Telematics group; and President of the IRISS Forum, a global, open, multidisciplinary, non-profit networking organisation for life science professionals by life science professionals.

  • Jan  Petracek, MD, MSc

    Jan Petracek, MD, MSc

    • CEO
    • Ivigee, Czech Republic

    Jan is a passionate and visionary leader in the field of pharmacovigilance, with over 20 years of experience in the industry. He is the CEO of iVigee, a company that provides innovative and sustainable solutions for drug safety and risk management. He is also a Fellow of the International Society of Pharmacovigilance (FISoP), a Global Fellow in Medicines Development (GFMD), and a Qualified Person for Pharmacovigilance (QPPV). Jan has a proven track record of establishing, growing, and selling successful organizations, both for-profit and non-profit, in the pharmacovigilance sector. He has received multiple awards and recognitions, including the DIA Excellence in Service Award in 2018 and HM Queen's Award for International Trade in 2019.

  • Francesco  Pignatti, MD

    Francesco Pignatti, MD

    • Scientific Adviser for Oncology
    • European Medicines Agency, Netherlands

    Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In 1999 he joined the European Medicines Agency (EMA) in London, UK. Since 2009, he has held the position of Head of Oncology, Haematology and Diagnostics in the Human Medicines Evaluation Division. In 2023 he was appointed as Scientific adviser for oncology. His main regulatory science interests include cancer clinical trial methodology, benefit-risk analysis, and stated preference studies.

  • Mitali  Purohit, PhD, MS

    Mitali Purohit, PhD, MS

    • Associate Director, Immunology TA Lead
    • CSL Behring, United States

  • Kirsty  Reid, PhD, MSc

    Kirsty Reid, PhD, MSc

    • Director Science Policy
    • EFPIA - European Federation of Pharmaceutical Industries and Associations, Belgium

    Kirsty Reid is the Director for Science Policy at EFPIA – the European Federation of pharmaceutical industry and associations. She is team leader and Science Policy topic lead. She has over 17 years experience in EU public and regulatory affairs covering various EU legislation and policy areas, working specifically on animal experimentation; alternatives to animal testing, and environment, health and safety issues. She obtained her PhD in Biology in South Africa in 2003.

  • Pär  Tellner, MPharm, MSc, RPh

    Pär Tellner, MPharm, MSc, RPh

    • Director, Regulatory, Drug development and Manufacturing
    • EFPIA - European Federation of Pharmaceutical Industries and Associations, Belgium

    Pär Tellner is Director EFPIA since 2012 and member of ICH Management Committee and Assembly since 2016. Pär has previously been working as Compliance officer (marketing ethics) and Director of Veterinary Medicine, LIF Sweden and as Head of regulatory affairs for several pharmaceutical companies, e.g Octapharma, Biovitrum, Pharmacia Plasma Products and Novartis. Pär has also been working as Senior Pharm. Officer for the Swedish Medical Products Agency. Pär graduated as a pharmacist at Uppsala university in 1986.

  • Virginia  Acha, PhD, MSc

    Virginia Acha, PhD, MSc

    • AVP, Global Regulatory Policy
    • Merck Sharp & Dohme LLC, United Kingdom

    Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She joined MSD in 2017 and since January 2020 she leads the talented and experienced Global Regulatory Policy and Intelligence team for MSD. Ginny spearheaded regulatory policy initiatives within industry and in MSD to address the COVID-19 imperatives, and to explore how this experience may prove a watershed for development and regulation of medicines for the future. She also Chairs the Advanced Therapeutics working group at IFPMA, and her work has resulted in a number of peer-reviewed publications and invited presentations globally.

  • Sarah  Adam

    Sarah Adam

    • Associate Director, Regulatory Affairs
    • IFPMA, Switzerland

    Sarah Adam coordinates IFPMA activities in the Regulatory field focussing on policy, regulatory system strengthening and harmonisation. She also leads Regulatory Science Policy for Africa. Prior, Sarah worked for many years, for ICH, supporting the harmonisation of ICH technical Guidelines and requirements for pharmaceutical product registration. She also dedicated over 10 years of research in academia in the field of pulmonary disease preclinical drug testing and vaccine development. Sarah was an appointed lecturer at the School of Pharmacy at the University of Geneva, she holds a PhD degree in Molecular Biology and an Engineering degree in Biotechnology.

  • Fiona  Adshead, DrMed, DrPH, MD, MPH, MSc, FRCP

    Fiona Adshead, DrMed, DrPH, MD, MPH, MSc, FRCP

    • Chair of the Sustainable Healthcare Coalition
    • Sustainable Healthcare Coalition, United Kingdom

    Fiona chairs the Sustainable Healthcare Coalition that inspires partnerships and action on sustainable healthcare and is an independent expert advisor and board member for national and global organisations on wellbeing and sustainability. A high-profile public health leader with a track record of reframing thinking and developing innovative strategy and programmes at the heart of business and government, her previous roles include Deputy Chief Medical Officer and Director General in the UK Government, Director of Chronic Disease and Health Promotion at the World Health Organisation and Bupa’s Chief Wellbeing Officer. Fiona is a visiting Professor at UCL and is a Senior Associate at Cambridge Institute for Sustainability Leadership.

  • Peter Richard Arlett, MD, FFPM, FRCP

    Peter Richard Arlett, MD, FFPM, FRCP

    • Head Data Analytics and Methods Task Force
    • European Medicines Agency, Netherlands

    Peter Arlett is Head of the Data Analytics and Methods Taskforce at the European Medicines Agency. In this role he leads on operations and transformation on clinical evidence at the EMA including clinical trials, real world evidence, safety reporting and data science including AI. He is Chair of the EMA Data Board, Co-Chair of the HMA-EMA Big Data Steering Group, Co-chair of the EMA AI Coordination Group, Co-chair of the Vaccine Monitoring Platform Steering Group and Member of the ACT EU Steering Group In addition to his role at EMA, Peter is Honorary Professor at the London School of Hygiene and Tropical Medicine. He is also a Fellow of the Royal College of Physicians of Edinburgh and of the Faculty of Pharmaceutical Medicines of London

  • Susanne  Ausborn, PhD

    Susanne Ausborn, PhD

    • Global Head International Regulatory Policy
    • Roche, Switzerland

    Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global convergence of regulatory requirements and has been engaged in many international conferences, workshops and meetings with regulators from various emerging markets over the last decade. Currently, she is the Vice Chair of the EFPIA IREG, Chair of the EFPIA Russia reg network, and member of EFPIA Middle East network and several IFPMA expert groups.

  • Samvel  Azatyan, MD, PhD

    Samvel Azatyan, MD, PhD

    • Team Lead, Regulatory Convergence and Networks (RCN/REG)
    • World Health Organization (WHO), Switzerland

    Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 24 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration, convergence and harmonization, as well as regulatory capacity building and facilitation of products introduction in the countries. Dr Azatyan has also led various projects aiming at development of national regulatory systems, as well as the development and implementation of the concept of reliance in regulation of medical products. Dr Azatyan is currently leading the Regulatory Convergence and Networks Team at the WHO's Headquarters in Geneva, Switzerland.

  • James  Bell

    James Bell

    • Associate Director, Global PVQA
    • AbbVie, United Kingdom

  • Michael  Berntgen, PhD

    Michael Berntgen, PhD

    • Head of Scientific Evidence Generation
    • European Medicines Agency, Netherlands

    Michael Berntgen, Head of Scientific Evidence Generation at the EMA, Amsterdam, oversees robust medicine development. Collaborating with stakeholders, the department provides scientific advice, supports pediatric and orphan diseases, and manages the PRIME scheme. Michael, a pharmacist with a PhD, worked in pharmaceutical regulatory affairs in Germany and the UK from 1999 to 2006. Joining BfArM in 2006, he moved to EMA in 2007, holding various positions until becoming Head of the department in March 2020.

  • Niklas  Blomberg

    Niklas Blomberg

    • Executive Director
    • IHI, Belgium

    Dr. Niklas Blomberg, IHI's Executive Director since January 16, 2024, has vast experience in life sciences research and leadership. With a background in chemistry and a PhD in structural biology and bioinformatics, he worked at AstraZeneca for 14 years, leading data-driven drug discovery. As industry co-lead of Open PHACTS, he contributed to IMI. As ELIXIR's founding director, he facilitated its establishment and growth to 23 member states, securing funding from the EU.

  • Ane Sofie  Böhm Nielsen

    Ane Sofie Böhm Nielsen

    • Director, Head of Regulatory Policy
    • Novo Nordisk A/S, Denmark

    Ane Sofie Böhm Nielsen, VP of Global Regulatory Affairs Policy and Intelligence at Novo Nordisk A/S, has been driving policy functions there since 2013, transitioning to Global Regulatory Affairs in 2015. Committed to ensuring compliance with new regulatory requirements, she engages in meaningful dialogues with external stakeholders on regulatory science trends. Currently focused on the EU General Pharmaceutical Legislation revision, Ane Sofie previously led the health policy department at Burson-Marsteller Public Affairs in Brussels and served as a Public Policy Manager at Roche in Basel. She holds an M.Sc. in Public Administration from Aalborg University and an M.A. in International Relations from the University of Kent at Canterbury.

  • Thomas  Brookland, MSc

    Thomas Brookland, MSc

    • EU Data and AI Policy Lead
    • F. Hoffmann-La Roche Ltd, Switzerland

    Thomas (Tom) Brookland has worked in the Pharma industry for the last 15 years, combining interests in regulatory science, health technology and policy research. He joined Hoffmann La Roche in 2008 and in this time has held multiple roles within regulatory product development across molecules and therapeutic areas, in addition to globally and regionally focused policy lead roles in the emerging areas of RWD/RWE, big data, digital health and AI/ML. His current work and passion is focused on strategy and external engagement in the European policy landscape for data, digital and AI, supporting the development of new policy options as the convergence of medical knowledge, technology and data science is revolutionising patient care.

  • Melanie  Carr

    Melanie Carr

    • Head of Stakeholders and Communication Division
    • European Medicines Agency, Netherlands

    Melanie Carr is Head of the Stakeholders and Communication Division and a member of the Executive Board at the European Medicines Agency (EMA). She joined EMA in 1996 and has held various roles in pharmacovigilance, the centralised procedure for marketing authorisation, orphan medicines, the SME office and corporate stakeholders department. In her current role she is responsible for stakeholder relations management and communication. She has a degree in Pharmacy from the University of Nottingham in the UK and worked as a regulatory professional in the pharmaceutical industry prior to joining EMA.

  • Alison  Cave, PhD

    Alison Cave, PhD

    • Chief Safety Officer
    • Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

    Dr Cave joined the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2021 as the Chief Safety Officer with responsibility for the safety of medicines and devices in the UK. She holds a BSc Honours degree and PhD from the University of London and has significant academic research and regulatory experience, the latter at both the European Medicines Agency (EMA) and MHRA. Previously she was Head of Cellular, Developmental and Physiological Sciences at the Wellcome Trust and most recently an Industrial Strategy Challenge Fund Director at UK Research and Innovation.

  • Aude  Clement

    Aude Clement

    • Regulatory Senior Program Director
    • F. Hoffmann-La Roche Ltd, Switzerland

    Aude Clement is a Senior Director in the Pharma Development Regulatory team at Roche. She currently contributes to building the organizational capability for digital technology based drug development tools and personalized healthcare digital solutions. Aude has two decades of experience in the Pharma industry, as a global regulatory lead and regional strategist for innovative medicines across modalities and therapeutic areas at Roche, Novartis, Sanofi and Pfizer. She holds a French Doctorate in Pharmacy and Master’s degree in International Drug Development & Registration. She recently completed the Quantic School of Business & Technology Executive MBA.

  • Helena  Corte-Real Correia, PhD

    Helena Corte-Real Correia, PhD

    • Regulatory Portfolio Data and Content Lead
    • F. Hoffmann-La Roche Ltd, Switzerland

    Helena Corte-Real Correia is the VP, Regulatory Portfolio Data and Content Lead within Product Development at Roche. With a PhD in Marine Genetics from the University of Liverpool and over 10 years of research in molecular genetics at Oxford University, the Portuguese National Institute of Health, and Basel University, she transitioned to the pharmaceutical industry to apply her scientific knowledge and skills to advance healthcare. She joined the Regulatory Affairs group at Roche in 2003 and has had various roles of increasing responsibility as Late Stage Head for Regulatory Documentation, Global Head of Regulatory Operations and Regulatory Portfolio Data and Content Leader.

  • Natashia  De Casamassimi

    Natashia De Casamassimi

    • Head of Regulatory Affairs
    • Product Life Group, Italy

    Natashia De Casamassimi is a molecular biologist by training and is currently Head of Regulatory Affairs at ProductLife Group. In her role, Natashia leads a group of 150+ people, is a permanent member of the PLG operating committee, and provides leading Strategy Advice Management. She is also responsible for Solution Management from both Sales and Operations perspectives, managing mid- to big-sized portfolios. With over 24 years of expertise in the Pharmaceutical sector, she has extensive experience with international and local consultancy and know-how in international, EU, and local regulatory requirements.

  • Vera  Dinis, RPh

    Vera Dinis, RPh

    • Director, Regulatory Affairs
    • IQVIA, Portugal

    Regulatory Affairs Director at IQVIA with more than 20 years regulatory experience, including both CRO and pharmaceutical industries. Oversight Regulatory Affairs Lead for long-term lifecycle management projects. Mentor for IQVIA Project Leads.

  • Claudia  Dollins, PhD, RAC

    Claudia Dollins, PhD, RAC

    • Vice President, Precision Medicines, Global Regulatory Affairs
    • GlaxoSmithKline, United States

    A geneticist by training, Claudia Dollins served in regulatory leadership roles located both in the USA and Europe. She held multiple roles of increasing responsibility in US FDA’s CDRH/Office of In Vitro Diagnostics and Radiological Health before transitioning to the pharmaceutical industry. In prior pharmaceutical industry roles, she has built global Digital Health, Companion Diagnostics, Medical Devices, and Combination Product Regulatory organizations within Merck Healthcare KGaA and Bristol-Myers Squibb. She is currently the VP, Precision Medicines, Global Regulatory Affairs at GSK.

  • Falk  Ehmann, MD, PhD, MS

    Falk Ehmann, MD, PhD, MS

    • Head of Innovation and Development Accelerator – ad interim,
    • Regulatory Science and Innovation Task Force, European Medicines Agency, Netherlands

    Falk Ehmann is a medical doctor with a PhD in Experimental Medicine and expertise in European and International law. He is currently chairing the EMA’s Innovation Task Force (ITF). His main areas of expertise include Pharmacogenomics, Nanomedicines and Borderline and Combined Medicinal Products and other -omics especially in connection with Personalized Medicine. Falk worked for the EMA since 2004 including manager of Scientific Advice teams and working as Product Team Leader in the Oncology and Anti-Invectives therapeutic areas.

  • Zaide  Frias, PharmD

    Zaide Frias, PharmD

    • Head of Digital Business Transformation Task Force
    • European Medicines Agency, Netherlands

    Zaïde Frias has degrees in Pharmacy and Business Administration. Prior to joining the European Medicines Agency she worked in Pharmaceutical Industry. She joined the EMA in 1999; she was appointed Head of Human Medicines Research & Development Support Division in 2013 and Head of Head of Human Medicines Evaluation Division in 2016. In 2020, she took the position of Head of Digital Business Transformation Task Force. The Digital Business Transformation Task Force was created to drive complex, disruptive change initiatives that have a profound impact on the strategy of EMA, its operational structure and operation in relation to the EU medicines regulatory network, its partners and stakeholders.

  • Michela  Gabaldo, PharmD, MSc

    Michela Gabaldo, PharmD, MSc

    • VP ATMP Global Regulatory Affairs
    • Evotec, Italy

    Dr Gabaldo has more than 20 years of experience in drug development spanning from chemicals up to ATMP. Currently Head of Alliance Management & Regulatory Affairs at Fondazione Telethon where she joined in 2011. Her team manages gene therapy projects at different stage of development ranging from early development up to clinical translation, registration and patient access developed both internally & in partnership with relevant pharmaceutical industries. Degree in Pharmacy and Master in Regulatory Affairs & Market Access. Winner of 2017 edition of TopRA Award in the Future category, Michela offers up to date knowledge of the most recent regulations in ATMPs and Orphans. Currently member of the IRDIRC Therapies Scientific Committee.

  • Alberto  Ganan Jimenez, PhD

    Alberto Ganan Jimenez, PhD

    • Head of Committees and Quality Assurance
    • European Medicines Agency, Netherlands

    Alberto Ganan Jimenez is a Pharmacist and a Biochemist and holds a PhD on Molecular and Cell Biology from University of Zaragoza (Spain). After working in Pharmaceutical Industry in Business Intelligence positions, Alberto joined the EMA in 2006 as a Product Lead in the Quality of Medicines Office. In 2013, he was appointed Head of Procedures office and since 2022 he is leading the Committees and Quality Assurance Department. This department hosts the secretariat of the Scientific Committees and Working Parties and the Expert panels on Medical devices, provides quality assurance on regulatory and labelling aspects of medicines and is responsible for the procedural management of minor variations and validation of initial MAAs.

  • David  Haerry

    David Haerry

    • Co-Chair Advisory Committee
    • EUPATI Foundation,European AIDS Treatment Group, Belgium

    David has been involved with providing input to R&D from a patient perspective for more than 20 years. He has played an active role in the European Patients’ Academy on Therapeutic Innovation (EUPATI), and currently co-leads their external Advisory Committee. He is a past co-chair of the Patient and Consumer Working Party at the European Medicines Agency.Currently, is involved with Swissmedic’s Patients and Consumer Working Group, and he is a member of the PFMD Executive Committee, of the Zurich Cantonal Ethics Committee and the Impact Council for Gilde Healthcare. As a past member of the DIA Regional Advisory Council for EMEA, he was awarded the Outstanding Contribution to Global Health award in 2019.

  • Francois  Hebraud, PharmD

    Francois Hebraud, PharmD

    • EU Regulatory Policy Lead
    • Roche, Switzerland

  • Marie-Laure  Hecquet, MSc

    Marie-Laure Hecquet, MSc

    • Policy Advisor
    • EDQM Council of Europe, France

  • Heidrun  Hildebrand

    Heidrun Hildebrand

    • Paediatric Development Alliance Manager, Paediatric Medicine; Research and De
    • BAYER, Germany

    Heidrun Hildebrand has 30 plus years’ experience in drug development. Heidrun started her carrier in the Pharmaceutical industry as Quality Manager within Clinical Development and held different positions with increasing responsibility. Since 2017 Heidrun is part of the new Therapeutic Area Pediatric Development at Bayer. Heidrun is one of he co-leads of the EFPIA Consortium driving the IMI2 initiative to create a pan-European Paediatric Clinical Trials. Network.

  • Martin  Keller

    Martin Keller

    • CEO
    • Acodis, Switzerland

    Martin Keller is Co-Founder and CEO of Acodis, a Swiss-based AI company with the mission to turn documents into business value. Martin has a background in strategy consulting and a passion to deliver high-value solutions for customers. He holds a MBA from IESE in Barcelona and Master's in International Relations from the Graduate Institute in Geneva.

  • Hannes  Kulovits

    Hannes Kulovits

    • Senior Customer Portfolio Lead, Value Stream Manager Product Lifecycle Managemen
    • EMA - European Medicines Agency, Netherlands

  • Florian  Lasch

    Florian Lasch

    • Biostatistics Specialist, Data Analytics and Methods Task Force
    • European Medicines Agency, Netherlands

    Florian is a Biostatistician with a degree in mathematics and a PhD from Hannover Medical School. Florian works as a Biostatistics Specialist at the European Medicines Agency, providing scientific support to development and evaluation throughout all stages of marketing authorisation assessments of medicinal products, and leads the ACT EU Priority Action on Clinical Trial Methodologies.

  • Melly  Lin

    Melly Lin

    • CMC Regulatory Policy Lead, Pharma Technical Regulatory
    • F. Hoffmann-La Roche Ltd, Switzerland

    Melly Lin is working at F. Hoffmann-La Roche Ltd. as CMC Regulatory Policy Lead. She is responsible for identifying policy priorities and supporting regulatory policy advocacy efforts for South East Europe, Central Asia and Egypt. She has over 20 years of experience in Regulatory Affairs, within that 13 years in CMC Regulatory Policy. She joined Roche China in 2004. There she held different positions with increasing experience and responsibility in regulatory filing. She took the responsibility as China Policy Lead from 2011 to 2019. She is now taking an active role in the middle east region by leading the EFPIA MERN LCM team. She is also chairing an industry network for South East Europe.

  • Lenita  Lindström, LLM

    Lenita Lindström, LLM

    • ICH Assembly Chair and Senior Expert, European Commission
    • European Commission, Belgium

    Mrs Lindström is the Chair of the ICH Assembly. She is working as a Senior Expert in the Directorate General for Health and Food Safety (DG SANTE) in the European Commission where she is in charge of international relations in the field of pharmaceuticals. Mrs Lindström has over 20 years experience in the European Commission, including over 10 years in the field of pharmaceuticals. She holds a Master of Laws degree from the University of Helsinki, Finland.

  • Marianne  Lunzer, DrMed

    Marianne Lunzer, DrMed

    • Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care
    • AGES, Austria

    Marianne is a medical doctor by training and joined AGES in 2008 as a pharmacovigilance assessor. She was an alternate PRAC member between 2015 and 2017. In 2017, she joined the clinical trial unit at AGES as a safety assessor and has since been part of the Clinical Trials Facilitation and Coordination Group (CTFG) group. Since 2022 she is chairing the group now called Clinical trials coordination group (CTCG). Marianne contributed to the CTFG best practice guidelines for safety assessors for clinical trials and is a member of the drafting team for the Commission implementing regulation for the cooperation in safety assessment of clinical trials.

  • Ania   Mitan

    Ania Mitan

    • Senior Vice President & Managing Director, EMEA and India
    • DIA, Switzerland

    Ania Mitan serves as the Senior Vice President & Managing Director, EMEA and India. She is former Executive Director of the commercial organization at Celgene, where she built the oncology business in the EMEA region with healthcare partners to shape quality delivery systems and new commercialization models in personalized medicine, specifically with novel cell and gene therapies. She began her career at Eli Lilly and Company, serving as Head of Commercial Development for EU mid-size countries, Head of Primary Care Business Unit for the UK and Ireland, and Head of Marketing for the Critical Care Unit. Ania earned her MBA from Simmons College and MSc in Pharmacy from Silesian Medical Academy (Poland).

  • Mireille  Muller, DrSc, PhD, MSc

    Mireille Muller, DrSc, PhD, MSc

    • Regulatory Policy & Intelligence Director
    • Novartis Pharma AG, Switzerland

    Mireille Muller Ph.D. has over 25 years of experience in regulatory affairs at the global level, including policy, benefit-risk research, drug development focused in clinical research. Special interest in early development, scientific advice, expedited regulatory pathways, and innovative clinical trials such as innovative clinical trial designs, decentralised trials and digital health systems. Involved in several public private partnerships IHI/IMI programs and pre-competitive collaboration.

  • Alexander  Natz, JD

    Alexander Natz, JD

    • Secretary General
    • European Confederation of Pharmaceutical Entrepreneurs, Belgium

    Alexander Natz is the Secretary General of the European Confederation of Pharmaceutical Entrepreneurs in Brussels and advises innovative pharmaceutical and biotech companies, including start-ups, in regulatory and pricing & reimbursement matters from the EU law and German law perspective. From 2008 to 2013, he was Head of the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. Before, he has been a lawyer at Sträter Law Firm in Germany with a special focus on managed entry agreements & licensing of pharmaceuticals. He has also worked in the field of competition law with the EC & in the pharma industry. His doctorate was supervised by the former judge at the European Court of Justice, Prof. Dr. Dr. Ulrich Everling.

  • Koen  Nauwelaerts, PharmD, PhD, MBA

    Koen Nauwelaerts, PharmD, PhD, MBA

    • Regulatory Policy and Innovation Lead
    • Bayer AG, Belgium

    Koen Nauwelaerts holds a Master’s degree in Pharmacy from Leuven University, Belgium and a PhD in Drug Development from the same university. Further he obtained an MBA degree from Vlerick Business School and completed the technology immersion program at MIT. Koen is currently working at Bayer as RA Policy and Innovation Lead. He joined Bayer as head of regulatory affairs and quality for the Belgium/Luxemburg region and previously has been active within MSD and Medicines for Europe in different roles in Regulatory Affairs and Quality. Within his current role as RA Policy and Innovation Lead, Koen leads the internal global e-labeling initiatives at Bayer and is vice-chair of the Inter Association TaskForce (IATF) for ePI.

  • Julie  O'Brien, PhD

    Julie O'Brien, PhD

    • EFPIA; Senior Director, Head Europe and International Regulatory Policy
    • Pfizer Inc, Ireland

    Julie is a regulatory affairs professional specialising in European and International regulatory policy with impact to innovative medicines. She focuses on advancing science-based regulatory policy, including in the area of global regulatory system strengthening. In her role, she implements strategic regulatory policy initiatives and develops recommendations to address regional regulatory policy challenges. She has over eighteen years industry experience and is a member of the Regulatory Science Committee of EFPIA and is a member of the Regulatory Science Committee of IFPMA. She holds a Ph.D. in the area of immunology and vaccine development from Trinity College Dublin.

  • Cécile Mathilde Ollivier, MS

    Cécile Mathilde Ollivier, MS

    • Managing Director Europe
    • Critical Path Institute, Netherlands

    Senior health engineer with 15 years of global drug development experience in children & rare diseases. Cecile joined C-Path as scientific director, prior to C-Path, she was with a medtech company for 2 years and scientific officer in the Paediatric division of Science & Innovation at EMA for 12 years where Cecile has been leading the EMA extrapolation strategy and was an expert for the ICH E11(R)1 guideline.

  • Rodrigo  Palacios, MBA

    Rodrigo Palacios, MBA

    • Regulatory Policy Lead
    • F. Hoffmann-La Roche, Switzerland

    Rodrigo Palacios is an Associate Director in Regulatory Policy at Roche. He is responsible for advancing global policy on data and technology in the regulatory domain. These topics include Cloud Submissions, Data Standardisation (e.g. IDMP), structured data submissions, eCTD and Regulatory Information Management. Rodrigo represents Roche in EFPIA and PhRMA Regulatory Technology expert groups. He has over 25 years of experience in data and technology strategy, Information Technology management, software development and consulting.

  • Chrissi  Pallidis, DrMed

    Chrissi Pallidis, DrMed

    • Senior Scientific Specialist, Paediatric Medicines
    • Scientific Evidence Generation Department, European Medicines Agency, Netherlands

    Chrissi Pallidis, MD, graduated in Greece in 1995, and trained in pediatrics at UK hospitals, including University Hospital Wales and King’s College Hospital London. She worked as a general pediatrician in the UK and Greece. From 2005 to 2012, Dr. Pallidis was a senior medical assessor at the UK's Medicines and Healthcare products Regulatory Agency, specializing in clinical assessments. In 2012, she joined the European Medicines Agency, focusing on pediatric investigation plans and specializing in pediatric gastroenterology and hepatology. She also serves as the scientific lead for the Pediatric Committee (PDCO).

  • Mark  Perrott, PhD

    Mark Perrott, PhD

    • Axian Consulting Limited, United Kingdom

    Mark is a founder and managing partner at Axian Consulting, where he focuses on improving benefit:risk balance and outcomes for patients through improving communication and adding value using digital approaches. He has a >20 year pharma career which has included industry (Wellcome, GW, GSK and AZ) and consultancy roles (WCI, Foresight, PopeWoodhead, Huron and now is a founder and managing partner of Axian Consulting). He is now focusing on the opportunities presented by improved benefit-risk management approaches to enhance risk management decision-making in development and on adding value to the interactions of industry and customers to maximise B-R balance and improve outcomes in REMS and aRMM programmes.

  • David  Pilarek

    David Pilarek

    • Managing Director
    • MSU Consulting GmbH, Germany

    David Pilarek is Managing Director of MSU Consulting GmbH – a consultancy dedicated to future-proofing pharmaceutical R&D and commercial operations. David has over 20 years of international experience in the industry in advisory as well as operational roles. The focus of his consulting work is the enhancement of R&D productivity by digital technologies.

  • Helena  Pontes Pedrosa, PharmD, PhD

    Helena Pontes Pedrosa, PharmD, PhD

    • Associate Director, Global Case Processing, Pharmacovigilance
    • UBC, United States

    Helena Pedrosa, with 11 years' pharmaceutical industry experience, joined UBC in Oct 2012. She's served as Safety Data Associate, Scientist, & Team Manager. Dr. Pedrosa excels in end-to-end case processing, regulatory compliance, & scientific literature monitoring for PV. Currently managing operational teams for case processing, expedited reporting, literature monitoring, safety database configurations, reconciliation activities, & local PV. Holds a Pharm D & PhD in Toxicology from University of Porto.

  • Matt  Popkin, PhD

    Matt Popkin, PhD

    • Senior Director, CMC Excellence, Global Regulatory Affairs
    • GlaxoSmithKline, United Kingdom

    Matt Popkin has a degree in Chemistry from the University of Bristol and a PhD from University College London. Following postdoctoral research, he joined GSK to work as synthetic chemist in 2000. Since then, he has worked in a number of roles in the CMC development and registration of novel medicines. In his current role he is responsible for CMC Policy, Devices and vaccines facilities. Matt is vice-chair of Manufacturing and Quality Expert Group of the European Federation of Pharmaceutical Industries and Associations (EFPIA). Amongst his roles for EFPIA, he leads the CMC PRIME/COVID task force, has been a member of the ICH Q11 Implementation Working Group, and currently represents EFPIA on the ICH Quality Discussion Group.

  • Daniel  Reed, PhD

    Daniel Reed, PhD

    • Senior Regulatory Intelligence Director
    • AstraZeneca, United Kingdom

    Daniel Reed holds a PhD and has a global publication record in cardiovascular pharmacology and cell therapy from Imperial College London. With a diverse background, he's been a biomarker specialist, worked in patient advocacy, and collaborated with regulators on stem-cell-based screening tools. In the past decade, he has worked as an expert intelligence professional, serving as an analyst, consultant, insights lead, and business leader across various therapeutic areas. Currently leading the Intelligence and Policy group for Cardiovascular-Renal-Metabolic at AstraZeneca, he collaborates with leadership and regulatory teams, providing strategic direction on intelligence and policy matters.

  • Sofia  Ribeiro

    Sofia Ribeiro

    • Head Regulatory Affairs CMC
    • Bayer US LLC, United States

    Sofia holds a Chemical Engineering degree from the Instituto Superior Tecnico, Lisboa, Portugal and a PhD in Biochemistry from the Universität Bayreuth, Germany. She has over 25 years industry experience in various companies in Biotech as well as Pharmaceuticals working in varied areas of basic research, early- and late-stage development as well as lifecycle of small molecules, mRNA, biologics, and combination products. For the past 10 years she has been working at Bayer in the global organization in Quality and more recently she took the lead for Global Regulatory Affairs CMC responsible for global CMC strategy for Bayer Pharma.

  • Sophie  Schmitz

    Sophie Schmitz

    • Managing Partner
    • P4A Partners for Access, Netherlands

    Sophie is Managing Partner at Partners4Access (P4A), a global consultancy 100% focused on orphan drug access. P4A support the biotechnology and pharmaceutical industry along their launch journey to help secure successful price, reimbursement and access for orphan drugs. The company has solid partnerships with clients supporting their strategy and operations to effectively ensure launch success. Sophie has worked in a range of disease therapy areas and has industry experience in both medical device and pharmaceutical industries, as such she has developed a solid appreciation of strategic challenges and opportunities facing companies.

  • Leonardo  Semprun, RPh

    Leonardo Semprun, RPh

    • Global Regulatory Policy Lead-LatAm
    • MSD, Panama

    Leonardo Semprún is currently Senior Director, Global Regulatory Policy at MSD. In this role, Leonardo is responsible to define and execute a regional regulatory policy plan that addresses current and future needs, while also advocating for and anticipating regulatory change with LATAM-based regulators and multilateral organizations. He has worked with governments, regulators, trade bodies and other external stakeholders to shape regional regulatory policy. Leonardo' work in the industry spans over 20 years, across regulatory, quality, intellectual property and policy functions

  • Álmath  Spooner, PhD

    Álmath Spooner, PhD

    • Head of Europe Regulatory Policy
    • AbbVie, Ireland

    Álmath is Head of Europe Regulatory Policy at AbbVie. Álmath dually qualified as a pharmacist and a barrister-at-law with a PhD from Trinity College Dublin and postgraduate qualifications in statistics and pharmaceutical medicine. Álmath has extensive experience in regulation and policy having held management and assessment roles at the Irish HPRA (2007-2019) and at EMA's PRAC (Vice Chair 2012-2018). Álmath was called to the Bar of Ireland in 2018 and practiced in Commercial Law prior to joining AbbVie in 2020. At EFPIA, Álmath chairs the Integrated Evidence Generation Working Group. She has prior experience in various global initiatives including at ICH. She is a member of the DIA Regional Advisory Council.

  • Rabia  Sucu

    Rabia Sucu

    • Senior Technical Advisor
    • Management Sciences for Health, Ukraine

    Rabia Kahveci is the Vice President of HTAi and Senior Technical Advisor for Pharmaceutical Policy and Governance in the SAFEMed project, in Kyiv Ukraine. Prior to her position with SAFEMed, she was the director of a hospital-based HTA center in Turkiye and a professor of family medicine. She has dedicated almost 20 years to integrate HTA into health care reforms including Turkiye, Ukraine and other countries through her different roles, such as chairing developing countries interest group of HTAi or chairing the Eurasian HTA Initiative that had members from 9 countries from Balkans and Central Asia.

  • Daisuke  Tanaka, PhD

    Daisuke Tanaka, PhD

    • Office Director
    • PMDA, Japan

    Dr. Tanaka joined the Ministry of Health, Labour and Welfare (MHLW) in April 2001 and was involved in orphan drug designation and new drug approval as well as amendment of the Pharmaceutical Affairs Law. Subsequently, he worked in several organisations including European Medicines Agency and World Health Organization, in addition to MHLW. He has a wide range of experience in pharmaceutical regulation such as marketing authorisation, pharmacovigilance, supply chain and drug pricing. He joined PMDA in June 2022 and worked to develop its next 5-years mid-term plan. Since July 2023 he has been in current position. He is a pharmacist by education and holds a Ph.D. in Pharmaceutical Science from the University of Tokyo.

  • Tina  Taube

    Tina Taube

    • Director Market Access & Orphan Drug Policy Lead
    • EFPIA, Belgium

  • Charlotte  Thibault

    Charlotte Thibault

    • Vice-President of European Affairs at EPSA, EFPIA intern in Science Policy
    • EFPIA and EPSA, Belgium

    Charlotte is the Vice President of European Affairs at EPSA (European Pharmaceutical Students Association) and a Trainee at EFPIA (European Federation of Pharmaceutical Industries and Associations) in the Science Policy and Regulatory Team. With a pharmaceutical background, Charlotte is currently based in Brussels as a young advocate for pharmaceutical students.

  • Steffen  Thirstrup, MD, PhD

    Steffen Thirstrup, MD, PhD

    • Chief Medical Officer
    • European Medicines Agency, Netherlands

    Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen. From 2004-9 ST worked at the Danish Medicines Agency acting as member of CHMP and additionally CAT at the European Medicines Agency. Following a short period involved in developing best practice guidelines for primary care ST rejoined the DKMA as Head of the Licensing. From 2013-22, Prof Thirstrup worked asdirector and strategic consultant for NDA Group AB. From June 2022 Prof Thistrup is the Chief Medical Officer of the European Medicines Agency.

  • Michal  Timler

    Michal Timler

    • Director of the eCValidation Department
    • eConsulting Ltd, Poland

    Michal Timler, Director of the eCValidation Department at eConsulting Ltd. Associated with the pharmaceutical industry for more than 18 years. He has led activities related to validation processes and the design, installation and operational qualification of installations, facilities, equipment. For nearly 10 years involved in the subject of validation of computer systems. Long-time member of ISPE (International Society for Pharmaceutical Engineering) -conducted training courses in the areas of Treated Water and HVAC, among others. Currently, as Director of Validation, he manages a team of several dozen people, which carries out a variety of projects in the areas of validation, qualification, audits and implementation (GMP, MDR, IVDR).

  • Sara  Torgal, MPharm

    Sara Torgal, MPharm

    • Senior Manager, Scientific Programs
    • DIA, Switzerland

    Sara is currently Senior Manager, Scientific Programmes at DIA. In the EMEA region, she is responsible for engaging with external stakeholders and advancing the scientific content strategy by creating opportunities to integrate scientific and regulatory changes of interest in DIA initiatives. Additionally, she is responsible for the regional patient engagement and learning design initiatives, being the liason for the Middle East and SEE regions. Previously, she was Public Health Promotion Projects Manager at the Portuguese Pharmaceutical Society. Sara is a Master of Pharmacy since 2015 and a Soft skills Trainer since 2012, having delivered over 300h of Training internationally primarily focused on creating impactful interactions.

  • Katherine  Tyner, PhD

    Katherine Tyner, PhD

    • FDA Liaison to the EMA, Office of Global Policy and Strategy, OC
    • FDA, United States

    Dr. Katherine Tyner is the FDA liaison to the EMA. Dr. Tyner joined FDA in 2007 and has held numerous positions within CDER to advance the quality, safety, and efficacy of complex drug products. In her most recent role as the Associate Director for Science in the Office of Pharmaceutical Quality (OPQ), Dr. Tyner led the OPQ Science Staff in coordinating the intersection between science, review, and policy as well as facilitating interactions among FDA Centers and Offices. Prior to her appointment as liaison, Dr. Tyner was in the Office of Science and Technology Policy within the Executive Office of the President working on efforts to increase technology transfer across the research, development, and deployment continuum.

  • Emmanuel  Walckenaer, MS

    Emmanuel Walckenaer, MS

    • CEO
    • Yseop, United States

    Emmanuel joined Yseop as CEO in 2017, leading the company’s growth and vision to bring the benefits of automation and NLG to enterprise companies globally. He brings over 25 years of international experience in high-tech service and business development. He joined from Sierra Wireless, where he was General Manager and Senior Vice President of the Cloud & Connectivity Services business unit. He led the growth of this unit across Europe and North America through strategic acquisitions and the development of a bespoke cloud and connectivity offering for the expanding Internet of Things (IOT) market.

  • James  Whitehead, MBA, MSc

    James Whitehead, MBA, MSc

    • Senior Director, Device & Digital Safety
    • AstraZeneca, United Kingdom

    James Whitehead is the Senior Director, Device & Digital Safety at AstraZeneca working within Global Patient Safety, having started his career with AZ as a Pharmacovigilance Scientist in Oncology. Since graduating with a BSc in Psychology from the University of Leicester, James has held positions at CROs, Pharmaceutical Companies and Consulting Practises with a focus on Signal and Risk Management. That passion for Signal and Risk Management culminated in a MSc in Pharmacovigilance from the University of Hertfordshire, James is now a Visiting Lecturer on the course. Recently, James studied for an MBA and focused this project on innovation and digital transformation within Patient Safety.

  • Amira Deia Younes

    Amira Deia Younes

    • Director, Eastern Europe, Middle East & Africa (EEMEA) Global Regulatory Policy
    • MSD, United Arab Emirates

    Amira is currently Associate Director, Regulatory Policy and Intelligence for Middle East, Africa, Russia and Central Eastern Europe at AbbVie, supporting regulatory policy advocacy efforts for the region. She has over 13 years of experience in Policy and Regulatory Affairs, being the Chair of EFPIA Middle East Regulatory Network (MERN) since June 2021, where she was previously Vice chair. Amira is also an active member of several trade associations including IFPMA Africa Regulatory Network (ARN), EFPIA India regulatory network, PhRMA Regulatory Middle East & Africa network, and PhRMA Gulf Regulatory Affairs Working Group (RAWG). She holds of bachelor’s degree of Pharmacy and Biotechnology from the German University in Cairo.

  • Monique  Al, PhD

    Monique Al, PhD

    • Special advisor CCMO
    • Central Committee on Research Involving Human Subjects (CCMO), Netherlands

    Monique Al is currently special advisor at the Central Committee on Research Involving Human Subjects (CCMO) in The Netherlands. Since May 2023 she is the vice-chair of the Clinical Trial Coordination Group. She is the lead of the CTCG ethics advisory group. Her background is Clinical Nutrition with a PhD in Human Biology. She has worked for several nutritional and pharmaceutical companies in the field of clinical research before she started in 2001 as a scientific staff member at the CCMO.

  • Elina  Asikanius

    Elina Asikanius

    • Biostatistician
    • Finnish Medecines Agency Fimea, Finland

    Elina Asikanius is a statistician at the Finnish Medicines Agency. She is also a member of the EMA Methodology Working Party and the EMA Scientific Advice Working Party. She joined FIMEA 2020 and before becoming a regulator she worked over 10 years in the pharmaceutical industry with broad responsibilities.

  • Priya  Bahri, PhD, RPh

    Priya Bahri, PhD, RPh

    • Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy)
    • European Medicines Agency, Netherlands

    Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation of risk minimisation in healthcare. Pro bono, she is active in the learned societies ISoP and ISPE and as associated researcher at Utrecht University. She is the editor of the Springer textbook "Communicating about Risks and Safe Use of Medicines - Real Life and Applied Research", published in 2020.

  • Gesine  Bejeuhr, PharmD

    Gesine Bejeuhr, PharmD

    • Pediatric Regulatory Leader
    • Bayer AG, Germany

    Gesine Bejeuhr, PharmD, PhD, is responsible for generating and implementing global pediatric regulatory strategies and for pediatric regulatory science innovation within Bayer AG. She also provides advice to pediatric development teams. Gesine represents Bayer in the Pediatric WGs of EFPIA, PhRMA, and BIO. In her previous role at the German trade association vfa she was responsible for Regulatory Affairs, Production, Quality and Environment and in addition coordinated and co-chaired the Inter-Association-Task Force of EFPIA, Medicines for Europe and AESGP on eProductInformation (ePI) and a German pilot project on ePI.

  • Tim  Chesworth

    Tim Chesworth

    • Senior Director Regulatory Affairs
    • AstraZeneca, United Kingdom

    Tim joined AstraZeneca in 2007 to lead a team responsible for developing delivery devices for AZ’s new drug portfolio. This encompassed all dosage forms and had a significant focus on inhalation and injection devices. Tim’s current role is to lead the Medical Devices & Combination Products group within AstraZeneca Regulatory Affairs. The group is responsible for developing and implementing regulatory strategies and processes for both new and existing medical devices and combination products. This encompasses conventional pharmaceuticals, biologics and AZ’s activities in Digital Health. Tim is a leading member of a number of medical device & combination product industry groups and associations.

  • Marwan  Fathallah, MBA, MSc

    Marwan Fathallah, MBA, MSc

    • President & Global Chief Executive
    • DIA, United States

    Prior to joining DIA in 2023, Fathallah was the Operating Officer and EVP at Ortho Clinical Diagnostics, accountable for Operations, Post Market Product Science and Engineering, Regulatory, Quality, Medical, Clinical, Scientific Affairs, and Process Excellence. Before joining Ortho, he held Executive and Senior Leadership roles in Research and Development, Operations, and Regulatory Medical and Clinical Affairs at Avantor, Danaher, Pfizer, Hospira, and Abbott Laboratories. Fathallah holds a Master’s and Bachelor of Science degrees in Mechanical Engineering from the Univ. of Wisconsin-Madison and an MBA from the Kellogg School of Management at Northwestern University.

  • Ivana  Ferber, MPharm, MS

    Ivana Ferber, MPharm, MS

    • Associate Director Regulatory Affairs; Regulatory Affairs Lead Croatia/Bosnia an
    • MSD, Croatia (Hrvatska)

    Regulatory Affairs Professional with over 20 years of experience in the innovative pharmaceutical industry. Leading Regulatory Affairs teams Croatia & Bosnia and Herzegovina at Merck Sharp & Dohme. Prior joining industry spent 8 years in academic settings at the Department of Pharmacology, Medical Faculty, University of Zagreb, Croatia. By profession, I am a pharmacist, and I have also completed post-graduate studies in the field of Natural Sciences. As Regulatory Affairs professional I feel privileged to contribute to bringing innovative medicines to patients and to follow the product throughout life cycle. As Regulatory Affairs Policy Manager I am excited to be actively engaged in the development of new pharmaceutical regulation.

  • Maria I. Florez, MA

    Maria I. Florez, MA

    • Research Consultant
    • Tufts Center for the Study of Drug Development, United States

    Maria Florez is a research consultant affiliated with the Tufts Center for the Study of Drug Development. Her research looks at the impact of digital transformation in clinical research, and at practices, strategies and incentives driving improvements and innovation in the pharmaceutical R&D process. Maria has been a researcher and strategist in the healthcare sector for more than a decade. She has held strategy positions at Cleveland Clinic and New York-Presbyterian Hospital of Columbia and Cornell Universities. She has published in peer-reviewed in a trade journals. Maria holds a bachelor’s degree in economics and master’s degree from The Fletcher School of Law and Diplomacy at Tufts University.

  • Juan  Garcia-Burgos, MD, PhD

    Juan Garcia-Burgos, MD, PhD

    • Head of Public and Stakeholders Engagement Department
    • European Medicines Agency, Netherlands

    Juan García Burgos is a Qualified Medical Doctor from Autonoma University in Madrid, specialised in urology. Juan worked as a urologist surgeon at the Maranon hospital in Madrid. He joined the European Medicines Agency in 2002 and was responsible for coordinating the preparation of EU clinical guidelines for drug development. In 2005 he was appointed Head of Medical and Health Information, being directly involved in the interaction with Patients, Consumers and Healthcare Professionals' Organisations and the preparation of information on benefit-risk of medicines for lay audiences. In 2017, he was appointed Head of Public and Stakeholders Engagement Department and is Co-chair of the EMA patients’ and healthcare professionals’ working party.

  • Martin  Harvey Allchurch, LLM

    Martin Harvey Allchurch, LLM

    • Head of International Affairs
    • European Medicines Agency, Netherlands

    Martin Harvey is Head of International Affairs at the European Medicines Agency (EMA), EU. He first joined the EMA legal team after serving as a European affairs consultant in Brussels. He headed the Office of the Executive Director, served as Head of Communication, and then moved to the Agency's International Affairs team. He took an 18-month career break with Unitaid, the WHO-hosted partnership dedicated to innovation in global health from 2019-2020. Martin has served on the DIA Advisory Council for EMEA; and as program advisor for DIA's EuroMeeting and Global Annual Meeting. He holds law degrees from the University of Dundee (UK) and the Vrije Universiteit Brussels (Belgium). He is a Fellow of DIA since 2018.

  • Niklas  Hedberg, MPharm

    Niklas Hedberg, MPharm

    • HTACG Co-Chair & Chief Pharmacist
    • Dental and Pharmaceutical Benefits Agency, TLV, Sweden

    Niklas Hedberg is the Chief Pharmacist at the Swedish national governmental authority, the Dental and Pharmaceuticals Benefits Agency (TLV). He is the Chair of the EUnetHTA Executive Board and the TLV lead partner in EUnetHTA WP 3 Evaluation. Niklas has been working with pricing and reimbursement since 2001. Niklas started as a medical assessor and project leader in the agency, he was the Head of the Department for New Submissions between 2009 and 2014 and is since in his current position. Niklas has a broad experience of different aspects of value based evaluation and over time has seen the increasing importance for health technology assessment (HTA) both across health care systems and on local level to prepare accurate decision making.

  • Isabelle  Huys

    Isabelle Huys

    • Professor
    • KU Leuven, Belgium

    Isabelle Huys has a PhD in pharmaceutical sciences from KU Leuven (Belgium) and an LLM in IPR and regulatory sciences from the Max-Planck-Institute (Munich, Germany). Since 2010, she is a full-time professor in regulatory sciences at the Faculty of Pharmaceutical Sciences and a member of the Center for IT & Intellectual Property IT law (CiTiP) of KU Leuven. Isabelle Huys has been Advisor for European Projects, Intellectual Property Officer and Regional Development officer at the KU Leuven R&D department. She did post-doctoral research at the Law Faculty of KU Leuven on patents and biomedical inventions. Isabelle Huys is deputy co-ordinator of PREFER and also academic leader for the work package on recommendations.

  • Olga  Kholmanskikh Van Criekingen, MD, PhD

    Olga Kholmanskikh Van Criekingen, MD, PhD

    • Clinical assessor
    • Federal Agency for Medicines and Health Products, Belgium

    Olga Kholmanskikh is a clinical assessor at the Federal Agency for Medicines and Health Products (FAMHP), a Belgian National Competent Authority, since 2012. She is an MD by training and holds PhD in Biomedical and Pharmaceutical Sciences. She leads the Complex Clinical Trials (CCTs) working subgroup at Clinical Trials Coordination Group (CTCG) of the Heads of Medicines Agencies (HMA).

  • Evdokia  Korakianiti, PhD, MSc

    Evdokia Korakianiti, PhD, MSc

    • Head of Quality and Safety of Medicines
    • European Medicines Agency, Netherlands

    Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s strategic priority to facilitate the uptake of advanced manufacturing approaches in EU and is part of the ICMRA PQKMS group. She has trained as a pharmacist in the School of Pharmacy of the University of Athens and has received a M.Sc. and a Ph.D. in Pharm. Technology from the same Faculty.

  • Fadila  Lakkis

    Fadila Lakkis

    • Regulatory Affairs, Intelligence & Communications Manager, Gulf
    • GSK, United Arab Emirates

    Fadilla has over 12 years of experience in Pharma Industry transitioning from Sales, to Global Policy and Intelligence till reaching Regional Regulatory Affairs. She is the Vice Chair of EFPIA Middle East Regulatory Network (MERN) since end 2021 and an active member in PhRMA Gulf Regulatory Affairs Working Group (RAWG). She holds bachelor’s degree of Pharmacy from the Lebanese International University & MBA degree from the American University of Science & Technology in Lebanon.

  • Hubert  Leufkens, PharmD, PhD

    Hubert Leufkens, PharmD, PhD

    • Professor, Pharmaceutical Policy and Regulatory Science
    • Utrecht University, Netherlands

    Hubert (Bert) G. Leufkens is emeritus professor of Pharmaceutical Policy and Regulatory Science at Utrecht University, the Netherlands. He is research and policy-wise active at several (inter)national platforms on regulatory science, innovation, drug safety, and pharmaceutical policy (e.g., past-member EMA Pharmacovigilance Working Party, chair of Dutch Medicines Evaluation Board (MEB), past-member of the EMA CHMP, past-President of ISPE, former Scientific Director of the Utrecht WHO Collaborating Centre for Pharmaceutical Policy and Regulation. He is vice-president of the European Federation for Pharmaceutical Sciences (EUFEPS), and (co) author of >600 papers in peer reviewed journals, book chapters and research reports.

  • Thomas  Metcalfe, MBA

    Thomas Metcalfe, MBA

    • Personalised Healthcare Ecosystems
    • F. Hoffmann-La Roche, Switzerland

    Tom Metcalfe graduated in Biochemisty from King's in London and has an MBA from the Open University. He currently works in the Ecosystems team in Roche Pharma's Personalised Healthcare Centre of Excellence. He also represents Roche Pharma in the EFPIA Innovation Board Sponsored Committee. Prior to that he worked for Roche as a Strategic Innovation Leader in Global Development from 2015 to 2018. He served as CEO of Oncotest GmbH, a CRO providing preclinical profiling services in Oncology from 2011 to 2104 and worked for Roche Pharma and Diagnostics in a variety of roles from 1993 to 2011 including as Head of the Personalised Healthcare Portfolio and the Roche Biomarker Program.

  • Ronnie Harprit Mundair

    Ronnie Harprit Mundair

    • Regional Labelling Head - AfME, Canada and LATAM - Senior Director
    • Pfizer, United Kingdom

    +20 years’ of experience working in both the public & private sector of Regulatory Affairs (RA). Her career started at the MHRA - the UK RA & then moved into UK & EU regulatory strategy roles at both AZ & then Pfizer. In each of these roles she gained valuable experience across multidisciplinary aspects of RA ranging from Strategy, Labelling, CMC, Submissions, Artwork to Clinical Trials. In 2009, Ronnie moved into Labeling, managing diverse roles within Global & Regional functions at Pfizer. Ronnie’s responsibilities have included projects spanning labeling activities across EUCANZ, EME, AfME, Canada &LATAM. Currently a key focus for Ronnie is internally & externally leading on the topics of health literacy and ePI across LATAM, AFME, EU.

  • Martin  O'Kane, PhD, RPh

    Martin O'Kane, PhD, RPh

    • Regional Head RA EU Policy & Liaison
    • Novartis Pharmaceuticals, United Kingdom

    Dr Martin O'Kane, MRPharmS, studied pharmacy at University of Aston and after completing a PhD and a post-doctorate research project at the University of Glasgow, he moved to Japan to work within the pharmaceutical industry. He joined the MHRA in 2005 as a Pharmacopoeial Scientist with the British Pharmacopoeia and was a member of the European Pharmacopoeia Commission’s Working Party on Cell Therapy Products. He moved to the Clinical Trials Unit as a Pharmaceutical Assessor in 2007 and was involved in the assessment of chemical and biological CTA applications for all phases of study. In 2023, becoming the Regional Head RA EU Policy & Liaison at Novartis.

  • Claudia  Percivalle, PhD, MSc

    Claudia Percivalle, PhD, MSc

    • Regulatory Affairs Director
    • AstraZeneca, United Kingdom

    Claudia Percivalle is a global regulatory affairs professional with broad experience across various regulatory fields and therapeutic areas including cardiovascular, rare diseases, and neurology. Claudia successfully led global teams in early development (CTA/IND) and late development/product lifecycle (MAA/NDA/ANDA/sNDA) projects for EU, North America, MENA, and APAC markets. As Regulatory Affairs Director at AstraZeneca since 2022, she provides strategic directions to project teams within AZ CVRM portfolio. Previously, she served as Head of Regulatory Affairs & Clinical Development at Cycle Pharmaceuticals Ltd. Claudia holds a PhD in organic chemistry and has published her research in prestigious chemistry peer-reviewed journals.

  • Luis  Pinhero

    Luis Pinhero

    • Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce
    • European Medicines Agency, Netherlands

    Luis Pinheiro, PharmD, MEpi, is responsible for developing and running real-world data analytics studies and is tasked with methods development and learning within the team. Luis is also a co-chair of the AI Technical Group at EMA. Before moving to the Data Analytics Workstream, he worked 8 years in drug safety. Prior to joining the EMA, he was the Head of the Signal Detection Unit at Infarmed and the Portuguese representative at the PV Working Party at EMA. Before that, he worked in the PV Unit of the Faculty of Pharmacy of Lisbon for 8 years where he assisted in the teaching of Pharmacoepidemiology and Public health in undergraduate and postgraduate courses.

  • Aimad  Torqui

    Aimad Torqui

    • Head of Division Medicines Evaluation Board
    • MEB, Netherlands

    Aimad Torqui is Director of Global Regulatory Policy at MSD. Previous employment. He has worked with governments, regulators, trade bodies and other external stakeholders to shape robust science-based regulatory policy.

  • Esther  De Vries, MSc

    Esther De Vries, MSc

    • Pharmacovigilance Assessor
    • CBG-MEB, Netherlands

    Esther de Vries is a pharmacovigilance assessor at the Dutch national agency (MEB), while finishing her PhD at the University Medical Center Groningen in the Netherlands. Her PhD centres around the Direct Healthcare Professional Communication (DHPC) in the hospital setting in the Netherlands. In addition to these activities, she is involved in digitalising the DHPC in the Netherlands.

  • Michael  Rosenblatt, MD

    Michael Rosenblatt, MD

    • Chief Medical Officer
    • Flagship Pioneering, United States

    Michael Rosenblatt, MD, Senior Partner at Flagship Pioneering, has advanced academic and biopharmaceutical research and development throughout his career. He was previously Chief Medical Officer for Merck, after serving as Dean of Tufts Medical School. Formerly, he was Ebert Professor of Molecular Medicine and Minot Professor at Harvard. He served as President of Beth Israel Deaconess Medical Center and as Director of the Harvard-MIT Division of Health Sciences & Technology. He is on the board of several life sciences companies, and on the Harvard Medical School Board of Fellows and research advisory committees of the Massachusetts General, Brigham and Women’s, and Boston Children’s Hospitals. He earned his MD from Harvard Medical School.

  • Marcus  Droege

    Marcus Droege

    • Senior Advisor
    • Eucope, Belgium

  • Barbara  Briggs, PhD

    Barbara Briggs, PhD

    • Global Strategic Labelling Lead
    • UCB Biopharma UK, United Kingdom

    Barbara Briggs, PhD, has over 40 years of research and development (R&D) experience. Her journey began with research at Charing Cross Medical School, followed by a 9-years at Bayer Pharmaceuticals. She then transitioned into Development and Regulatory Affairs, accumulating over 9 years at GSK, followed by 8 years at Biogen, and currently, is a part of UCB. She has specialised in Labelling both at a Global and Regional level.

  • Momir  Radulovic

    Momir Radulovic

    • Executive Director
    • Slovenian Medicines and Medical Devices Agency (JAZMP), Slovenia

    Momir Radulovic leads the Slovenian Medicines and Medical Devices Agency since December 2018. He is a member of EMA Management Board, a member of EC Pharmaceutical Committee, HMA Management Group, Chair of EURIPID Board of Participants and member of EU Network Training Centre Steering Group. His previous work experience includes Hospital and Community Pharmacy and Pharma industry, focused on oncology medicines, HIV and vaccines. By living and working in countries with diverse Health systems and cultural environments he has learned to adapt swiftly to changes and to seize the opportunities that those can offer. He has track record of strong results, enjoy prioritizing, simplifying complex ideas and acting on them with high levels of energy.

  • Chimwemwe  Chamdimba

    Chimwemwe Chamdimba

    • African Medicines Regulation Harmonization Programme Head
    • African Union Development Agency-NEPAD, South Africa

    Chimwemwe Chamdimba heads the African Medicines Regulatory Harmonization Initiative at AUDA-NEPAD. She manages the AMRH Programme, supports AMA operationalization, and drives policy reforms connecting regulatory strengthening to local medical product manufacturing. A health policy expert, she leads reforms, harmonization, and partner coordination, contributing to vital continental policies including the AU Model Law on Medical Product Regulation; the Treaty for the establishment of the African Medicines Agency (AMA); and the AU Private Sector Engagement in Health Framework.

  • Neil  Mackillop

    Neil Mackillop

    • Exec Director
    • AstraZeneca, United Kingdom

    Neil Mackillop has worked all phases of Clinical Development across many different disease areas. He also has a long-standing interest in Environmental Protection with a focus in recent years in quantifying and reducing the carbon emissions from clinical trials. The Sustainable Healthcare Coalition of pharma, academics and healthcare systems is co-ordinating a workstream of the Sustainable Markets Initiative that is producing guidance and tools that will deliver in 2024 and enable all pharma and academics to run low-carbon clinical trials. Get ready now!

  • Vedran   Raguž

    Vedran Raguž

    • Scientific Programs Specialist
    • DIA, Switzerland

    Experienced student with a demonstrated history of working in the non-profit organization management industry. Skilled in Team Motivation, Health Advocacy, Communication, Supervisory Skills, and Teamwork. Aiming to become a strong business development professional with a Master of Pharmacy - MPharm focused in research, pharmaceuticals industry, regulatory affairs and health advocacy - from University of Mostar - Faculty of Pharmacy.

  • Agnes  Dangy-Caye, DrSc

    Agnes Dangy-Caye, DrSc

    • Regulatory Science & Policy Manager
    • Sanofi, France

    Agnès is a member of the Regulatory Science & Policy EU/AMEE team at Sanofi. She is a member of EFPIA sub-team on dynamic regulatory assessment (DRA) but also in IFPMA ATWG, ARM EU Regulatory groups and EFPIA IREG. Agnès has a PhD in Genetics, Molecular Biology and Toxicology at the University of Paris Saclay. She started her pharmaceutical industry career in Regulatory Affairs 25 years ago at Amersham/GE HealthCare, then at CIS Bio international/IBA, and at Sanofi from Sept 2015. She has a very large experience in GRA (Global, EU & International region, French affiliate, initial submissions, Life Cycle Management, CMC expert, Labelling, Regulatory operation, Science & Policy) and global quality.

  • Tyler  Ludlow, MBA

    Tyler Ludlow, MBA

    • Founder and Chief Decision Scientist
    • Decision Skills Institute, United States

    As a decision scientist, Tyler helps people turn decision burdens into opportunities for growth. After earning a degree in applied math and an MBA, Tyler studied decision science at Stanford. He then spent a decade helping leaders at global 500 firms (including top pharma companies), make large, complex, and strategic decisions. Seeing the human benefits of decision science, he founded the Decision Skills Institute, whose mission is to make the world more deciderate by impacting 10 million decisions in 10 years. Professionally, he now helps employees, entrepreneurs, small business owners, patients, and caregivers learn better decision skills. Personally, he and his wife endeavor to do the same with their ten children.

  • Eishita  Agarwal, MSc

    Eishita Agarwal, MSc

    • Digital Innovation Manager, Medical Writing
    • GlaxoSmithKline Pharmaceuticals Limited, India

    Eishita, a Biochemistry Master’s graduate, brings 12 years of experience in pharmaceuticals, specializing in Clinical and Regulatory medical writing at GSK for 9 years. Transitioning to Digital Innovation Lead in 2021, she drives collaboration to integrate cutting-edge tech into medical writing. Passionate about improvement, she identifies best practices, develops new platforms, and fosters change within the organization. Prior to GSK, she was a Bio-Modeling Scientist at Cellworks Research Limited. Outside work, Eishita enjoys reading, painting, and spending time with loved ones.

  • Amalia  Alexe

    Amalia Alexe

    • Policy and Liaison Lead, QPPV Office
    • Advanced Accelerator Applications, A Novartis Company, Switzerland

    Amalia is a Clinical Pharmacist, with ten years`experience in PV, with a passion for safety in pregnancy. She has completed her second MSc under EU2P program, with the Thesis: ‘Is my treatment harming my baby?`- a critical appraisal of a patient`s journey through pregnancy safety data available publicly. Amalia is currently enrolled in a PhD in PV, focusing her research on safety in pregnancy. Amalia is a member of IMI ConcePTION and is co-leading the development of the ConcePTION pregnancy & breastfeeding information exchange app. She is also the TransCelerate Topic Lead for the IGR PV Topic: Regulations Governing the Use of Medicines in Pregnancy & Breastfeeding. Amalia is currently a Policy & Liaison Lead in the QPPV Office of Novartis

  • Sabine  Atzor, MPharm, RPh

    Sabine Atzor, MPharm, RPh

    • Head of EU Regulatory Policies
    • F. Hoffmann-La Roche Ltd, Switzerland

    Sabine Atzor joined F. Hoffmann-La Roche Ltd in Basel as Head of EU Regulatory Policy in 2010. In this function she has been leading or contributing to numerous discussions within Roche and EFPIA, e.g. EU Clinical Trial Regulation and recently the revision of the EU Pharma Legislation. This included an advisory role to EFPIA as part of a secondment. Prior to joining Roche she worked for about 14 years in the public sector, of which almost 6 years in the Pharmaceuticals Unit of the European Commission, DG ENTR and later at DG SANCO with a focus on the Falsified Medicines Directive. Before that she held different roles in regional health authorities in Germany.

  • Phillipe  Botteron

    Phillipe Botteron

    • Senior Safety/Project Physician, Pharmacovigilance
    • UBC, United States

    Dr. Botteron has 8 years of experience in the pharmaceutical industry. He serves as a Senior Safety/Project Physician. In this role, he performs medical review of individual cases or safety reports, participates in writing periodic safety reports, performs signal detection and management, and writes company documents (e.g. CCDS) and regulatory documents (e.g. RMP). His fields of expertise are Oncology, Immunology, and Infectious diseases. He received his medical degree from the University of Geneva.

  • Helerin  Eiche

    Helerin Eiche

    • Quality Assessor
    • State Agency of Medicines, Estonia, Estonia

    Helerin Eiche obtained her PhD degree in Cell Biology in 2016 and since then she has been working as a quality assessor for biotechnological medicinal products at the State Agency of Medicines (Estonia). She is mainly involved in the assessment of the quality part of clinical trial and centralised marketing authorisation applications. In addition, she is a member of the EMA Biologics Working Party (BWP). Helerin is interested in the development and life-cycle management of biopharmaceutical medicinal products with focus on monoclonal antibodies. Her other possession is the emerging field of phage therapy. She also aims to enhance awareness of environmental/sustainability issues in CMC within the EU regulatory network.

  • Pedro  Franco, PharmD, PhD, MS, MSc

    Pedro Franco, PharmD, PhD, MS, MSc

    • Senior Director for Global Regulatory & Scientific Policy (GRASP)
    • Merck Serono Limited, United Kingdom

    Pedro holds a degree in Pharmaceutical Science (PharmD), a Master in Organic Chemistry from the University of Lisbon in collaboration with Imperial College in London and a PhD in Orphan drugs and Rare diseases from the University of Sheffield. Currently, he is working as a Director for Global Regulatory & Scientific Policy at Merck, mainly focus on regulatory intelligence, strategy and policy. He is the liaison for the China and Latam region concerning regulatory and policy topics. Previously, he worked at EMA for 12 years in different departments (regulatory affairs, assessment, authorisation of medicines, veterinary, orphan drugs, paediatrics, peer review and quality). Beforehand, he was working at INFARMED as a pharmaceutical assessor.

  • Iñaki  Gutierrez

    Iñaki Gutierrez

    • Head Of Knowledge Management and Evaluation
    • BIOEF, Spain

  • Kowid  Ho, PharmD

    Kowid Ho, PharmD

    • Pharma Technical Regulatory Policy
    • F. Hoffmann-La Roche Ltd, Switzerland

    Kowid Ho has been working at F. Hoffmann-La Roche Ltd.’s Global Pharma Technical (CMC) Regulatory Policy in Basel, Switzerland for >10 years. He was previously a quality assessor for biological products at Agence nationale de sécurité du médicament et des produits santé (ANSM, formely AFSSaPS) for 13 years. He has authored many European assessment reports and scientific advices on biotech, vaccines, blood and advanced therapy products, and has participated to several product related inspections. He was a member of European Medicines Agency (EMA) Biologics Working Party (BWP), Biosimilar Working Party (BMWP), and PAT/QbD team.

  • Julian  Isla

    Julian Isla

    • Chairman and Founder, Foundation 29; Scientific Director
    • Dravet Syndrome European Federation, Spain

    Julian is the father of Sergio, a young boy fourteen years old who has Dravet Syndrome Founder the European Dravet Syndrome Federation and Dravet Syndrome Foundation in Spain Dravet Syndrome is an epileptic encephalopathy having long lasting seizures refractory to treatment as severe developmental delay as main symptoms. Julian is software engineer by training, and he works for Microsoft as full time employee on Artificial Intelligence projects. Julian is also founder of Foundation 29, a NPO doing research on AI to improve life of patients: Julian is also member of the Orphan Drug Committee at European Medicines Agency and member of different NPO boards.

  • Filip  Josephson

    Filip Josephson

    • Swedish Medical Products Agency, Sweden

    I'm an M.D., Ph.D. in Clinical Pharmacology based in Sweden. Since 2008, I've worked at the Swedish Medical Products Agency (MPA), leading Scientific and Regulatory Development. Since 2014, I've represented MPA at the European Medicines Agency's Committee for Human Medicinal Products (CHMP), acting as rapporteur for products in infectious diseases, oncology, and onco-hematology. Notably, I've worked on drugs like Sovaldi, Imbruvica, and Vitrakvi. I was in the CHMP's Scientific Advice Working Party from 2016-2020 and joined the EMA's Emergency Task Force for public-health emergencies in 2020.

  • Dominik  Karres

    Dominik Karres

    • Scientific Officer
    • European Medecines Agency, Netherlands

    Dominik Karres has a medical degree and a MD in paediatric drug development. He held a training post in paediatric haematology/ oncology, last working in the UK as clinical fellow in paediatric oncology drug development. He works in drug regulation since over 10 years, with various roles at the MHRA, currently at EMA as Senior Scientific Specialist in the Paediatric Medicines Office and most recently also supporting technical regulatory/ HTA collaboration across the agency as HTA/ payer engagement specialist.

  • Alireza  Khadem Broojerdia

    Alireza Khadem Broojerdia

    • Team Lead, Regulatory System Strenghtening
    • WHO, Switzerland

    Dr Alireza KHADEM is currently a scientist of the WHO working in the Regulatory Systems Strengthening team. His work is aimed to support WHO Member States to build their national capacity for regulating medical products. During his career in WHO, he has been involved in developing WHO guidelines, as well as benchmarking tools for regulatory systems and organizing and conducting numerous NRA assessments. He has planned and performed many in country trainings during mentioned period.

  • Oliver  Koeth

    Oliver Koeth

    • Chief Technology Officer (CTO)
    • NTT Data Dach, Germany

    Oliver Koeth is Chief Technology Officer (CTO) for the DACH Region (Germany, Austria, Switzerland) at NTT DATA. Oliver joined NTT DATA in 2002 as Software Architect and was working in international system integration projects in NTT DATA's global automotive practice. As CTO Oliver advises clients on issues relating to new technologies in the areas of cloud, internet of things, customer experience, artificial intelligence, cyber security, and quantum computing and brings in the expertise of NTT DATA's global technology and innovation portfolio. He is also responsible for the global Agile/DevOps centre of excellence. Co-founded Enso, won BMW Quantum Challenge. Founded GenAI Office, developed Good GPT chatbot.

  • Jason  LaRoche, MSc

    Jason LaRoche, MSc

    • Director | Focus Area Lead
    • Janssen Pharmaceuticals, United States

    Jason has over 19 years of experience working in Pharma, 15 years of which have been with Johnson & Johnson Innovative Medicines. For the last 7 years, he has been a member of their Innovative Health team where he applies his strong technical and collaboration skills and global project leadership in delivering transformational innovation projects that have the goal to shape the future of clinical trial operations at Johnson & Johnson. Jason is Director of Innovative Health, he Focus Area Leader for Environmental Sustainability in Clinical Research, and he is leading the transformation of Johnson & Johnson Innovative Medicines’ global clinical operations towards sustainability.

  • Marie  Manley

    Marie Manley

    • Partner, Head of EU and UK Life Sciences (UK)
    • Sidley Austin LLP, United Kingdom

    Marie Manley leads is Partner and Head of Sidley’s UK life sciences practice. She is a distinguished thought leader and adviser on EU and UK regulatory law and acts as Chairperson of the DIA Legal Affairs Community. Marie advises clients before both national and European courts and the regulatory agencies in the UK and across Europe. She represents leading pharmaceutical and life sciences companies in litigation before the EU and English Courts, as well as before the national and EU regulatory authorities. Marie features prominently in leading bar publications. She earned a LLM from Columbia University School of Law and from Lausanne University; and a Postgraduate Diploma on EU Competition Law from King’s College.

  • Mic  McGoldrick, MT

    Mic McGoldrick, MT

    • CMC Technical Advocacy and Policy
    • MSD, United States

    Mic currently is an Associate Director of Global CMC Policy at Merck. He has over 32 years of experience with Vaccine and Biologics. For 15 years Mic worked in Regulatory Affairs on INDs, new product filings, post approval submissions globally, and evaluation of worldwide guidance's. For the last seven years Mic has been working on CMC Policy for Vaccines and Biologics, advocating for harmonization and greater access of medicines to patients.

  • Peter  Mol, PharmD, PhD

    Peter Mol, PharmD, PhD

    • European representative (alternate),
    • MEB, Netherlands

    Peter Mol is a principal assessor at the Dutch Medicines Evaluation Board and a member (vice chair) of EMA’s Scientific Advice Working Party. He is chair of the EMA Cross-Committee Task force on Registries. He is also a professor of drug regulatory science at the University Medical Center Groningen. His research interest is in the area of regulatory science; from new tools to optimize regulatory decision-making (especially impact of personalised medicine and real world evidence), to improve knowledge transfer and with a specific interest in safety communication.

  • Ana  Palma, PharmD

    Ana Palma, PharmD

    • Senior Director Global Head Patient Access & Policy
    • Sobi, Belgium

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  • Raffaella  Pandini

    Raffaella Pandini

    • Senior RA Project Manager
    • Pharmaceutical Development & Services, Italy

    Rafaella Pandini has extensive experience in Regulatory Affairs, Project Management, Pharmaceutical Consultancy, Licensing, QA Inspections, and Training. She holds a degree in Pharmaceutical Chemistry and Technologies from the University of Milan, and is currently the Regulatory Affairs Director at Pharma D&S a ProductLife Group Company. She is also involved in training activities within the Pharma Education Center.

  • Ana  Pedro Jesuíno

    Ana Pedro Jesuíno

    • Marketed Product Safety Ass. Director
    • IQVIA, Portugal

    Marketed Product Safety Ass. Director at IQVIA, with more than 10 years pharmacovigilance experience, including both CRO and Pharmaceutical industries. Oversight of Local QPPV Global Network.

  • Mark  Pellett, PhD, MSc, RPh

    Mark Pellett, PhD, MSc, RPh

    • Senior Director and Group Manager
    • AstraZeneca, United Kingdom

    Mark is a registered UK Pharmacist and was awarded his PhD in Pharmaceutical Sciences at University of Wales College of Cardiff and then completed his post-doctoral studies at both Cardiff and the University of Queensland, Australia. He started his industrial career in pharmaceutical product development for Wyeth and then moved into CMC Regulatory Affairs at Pfizer, GSK, Shire, Biogen and AstraZeneca, working across small molecules, biologicals and vaccines supporting pre-Phase 1 CMC strategies through to post-approval life cycle management. Mark is currently Sr Director and Group Manager at AstraZeneca, and was a regional lead for Vaxzevria, AstraZeneca’s COVID-19 vaccine.

  • Lauren  Pilling

    Lauren Pilling

    • Senior PV Process Director
    • F. Hoffmann-La Roche Ltd, Switzerland

  • Claudia  Popp

    Claudia Popp

    • Head EU Regulatory Science and EMA Liaison
    • F. Hoffmann-La Roche Ltd / EFPIA , Switzerland

    Claudia Popp is the Head EU Regulatory Science & EMA Liaison at Roche. As a senior leader, Claudia has worked for the pharmaceutical industry for more than 20 years and joined Hoffmann La Roche in 2008. She has substantial experience in global regulatory affairs and has held multiple roles within regulatory product development across molecules and therapeutic areas. She combines substantial experience of EMA and FDA processes with a deep knowledge of Health Authority interactions at national level, having held the role of Head Drug Regulatory Affairs at the Roche German Affiliate. The scope of her work includes complex drug/device interfaces.

  • Franz  Schaefer

    Franz Schaefer

    • Professor of Pediatrics and Chief of the Pediatric Nephrology Division
    • Heidelberg University Children's Hospital, Germany

    Dr. Franz Schaefer, Pediatric Nephrology Chief at Heidelberg University Hospital, MD from Würzburg Uni. President of IPNA, his research covers genetic kidney diseases, disease progression, and renal replacement therapy. Leads ESCAPE and IPDN. Coordinates ERKNet, PodoNet, Global Registry, CompCure, EJP RD, ERICA. 700+ publications, H-Index 97. Edited 'Pediatric Kidney Disease' and 'Pediatric Dialysis'.

  • Gabriele  Schwarz, MPharm

    Gabriele Schwarz, MPharm

    • GCP Strategy Expert
    • Federal Institute for Drugs and Medical Devices (BfArM), Germany

    Gabriele Schwarz, a registered pharmacist, joined the Federal Institute for Drugs and Medical Devices (BfArM) in 2001. She is currently BfArM’s GCP Strategy Expert and represents the EU in the ICH E6(R3) EWG, which is working on a revision of the GCP guideline. She is also contributing to a number of activities of the EMA ACT-EU project. Until the end of 2022, she was Head of BfArM’s GCP Inspectorate. In parallel, she has contributed to the development of a number of European guidelines e.g. for Risk-Based Quality Management, eSource, (e)TMF and Clinical Trials with Decentralised Elements, and also to international guidelines such as the OECD Recommendation on the Governance of Clinical Trials, the ICH E6(R2) and the ICH E19 Guideline.

  • Andrej  Segec, MPharm, MS

    Andrej Segec, MPharm, MS

    • Scientific administrator
    • European Medicines Agency, Netherlands

    Andrej Segec is originally from Slovakia and a pharmacist by training (Comenius University, Bratislava, Slovakia) with an MSc in Epidemiology (London School of Hygiene and Tropical Medicine, London, UK). He has worked for the European Medicines Agency (EMA) since 2008, holding a number of roles in pharmacovigilance, from signal detection and signal management, monitoring of the performance of the EMA pharmacovigilance system, in surveillance and epidemiology, as committee manager for the operations of the Pharmacovigilance Risk Assessment Committee (PRAC) and as a risk management specialist for anti-infective therapies and vaccines during the COVID-19 pandemic. In the current role, Andrej’s focus is on the generation of RWE and DARWIN EU.

  • Nathalie  Seigneuret

    Nathalie Seigneuret

    • Senior Scientific Project Manager
    • Innovative Health Initiative (IHI), Belgium

    Nathalie Seigneuret is a Senior Scientific Project Manager at Innovative Health Initiative (IHI). She joined the Innovative Medicines Initiative the public private partnership predecessor of IHI in 2011. Prior to that Nathalie, who is doctor in pharmacy, worked for 16 years at EMA where she held various positions.

  • Kim  Sherwood, MPharm

    Kim Sherwood, MPharm

    • Senior Expert Product Information Assessor
    • Läkemedelsverket, Sweden

    Kim Sherwood, Pharmacist and Senior expert assessor with more than 20 years of experience in Product Information and regulatory knowledge at the Swedish Medical Products Agency. Swedish delegate of the QRD group EMA since 2006. Project manager for the national ePI project since 2020 (electronic structured product information). Elected as one of the 4 ePI SMEs at EMA since 2022. International experience and network from EU National Competent Authorities and European Medicines Agency. Special interest in user testing and leadership in creative and agile teams.

  • Olga  Solomon

    Olga Solomon

    • Head of Unit B5 - Medicines: Policy, Authorisation and Monitoring
    • European Commission - DG SANTE, Belgium

    Olga Solomon studied Chemistry at the Aristotle University of Thessaloniki, Greece and holds an MSc in Food Science from the Gothenburg University, Sweden. Before joining the European Commission she worked for 5 years for a beverage producing company in Greece. Solomon joined DG SANCO in 2000 and worked for 10 years in the field of Food Safety in particular dealing with legislation on Food Contact Materials, Food Additives and Enzymes. In 2010, she moved to the Directorate 'Health Systems and Products' where she worked in the field of substances of human origin before taking up a post in the pharmaceutical sector in 2011. She is currently the Head of the DG SANTE Unit responsible for Medicines: policy, authorisation and monitoring.

  • Jens-Ulrich  Stegmann, MD, RN

    Jens-Ulrich Stegmann, MD, RN

    • Senior Vice President, Head Clinical Safety and Pharmacovigilance and EU QPPV
    • GSK , Belgium

    A trained registered nurse with an M.D degree in nursing from the University of Essen Germany and a PhD in Physiology from Christian-Albrechts University in Kiel Germany, Jens worked as an anaesthesiologist and emergency doctor at the University of Dusseldorf. At Grünenthal he contributed to the development of several acting analgesics as clinical lead before moving into Safety in 2008.He joined GSK Vaccines in 2012 as Head of Safety Evaluation and Risk Management in Safety and was appointed Deputy EU-QPPV before becoming Head of Clinical Safety and Pharmacovigilance for the business unit. In 2019, he took on the role as EU-QPPV for GSK and ViiV Healthcare and later became Head Clinical Safety and Pharmacovigilance for GSK in 2020.

  • Pieter  Stolk

    Pieter Stolk

    • Co-Founder & Partner
    • Exon Consultancy, Netherlands

  • Iain  Todd

    Iain Todd

    • Regulatory Policy & Intelligence Executive
    • GlaxoSmithKline Res/ Dev, United Kingdom

    Iain has an educational background in both law and science and holds a Master's degree in Pharmaceutical Medicine. He started his career at Pfizer before joining GSK in 2011, where he is now a member of the Regulatory Policy and Intelligence team. Iain is currently Co-Chair of the EU Regulatory Intelligence Networking Group (EU RING).

  • Shinobu  Uzu, PhD

    Shinobu Uzu, PhD

    • Senior Executive Director
    • Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    Dr. Shinobu Uzu is the Senior Executive Director, PMDA and in charge of the Safety offices, Office of International Programs, and Regulatory Science Center since April 2020. He took Ph.D. in Pharmacy from the graduate school of the University of Tokyo and has over thirty years of experience in MHLW, PMDA. He worked for new drug review as Director of the Office of New Drug I and Associate Executive Director for new drug review, PMDA and safety management for drugs and medical devices as Chief Safety Officer, PMDA and Director of Safety Management, MHLW. He also worked for international affairs as ICH steering committee member on behalf of MHLW and 1st Secretary of the Embassy of Japan in Indonesia.

  • Maren  von Fritschen, PharmD

    Maren von Fritschen, PharmD

    • Head EU Regulatory Policy
    • Moderna, Netherlands

    Maren von Fritschen, PhD has been working for a variety of pharmaceutical/MedTech companies SMEs /Start-ups and global entities for 20+ years. She recently joint Moderna as Head Regulatory Policy EU. In addition, she is Professor at the University of Applied Sciences, Berlin (International Master’s Life Science Management program). She has been leading the Regulatory division at the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and developed PharmaLex in the early phases. Maren is a passionate and dedicated networker, stimulating debate between all stakeholders and Health Authorities. She used to be chair of DIA's Regional Advisor Council EMEA.

  • Glenn  Wells

    Glenn Wells

    • Chief Partnerships Officer
    • MHRA, United Kingdom

    Glenn Wells, MHRA’s Chief Partnerships Officer, is skilled in activating inter-institutional partnerships for patient solutions. He joined MHRA in 2021 after working as the Director of Strategy at the UK Medical Research Council (MRC). At MRC, he developed national partnerships with academia, industry, and government and also established international relationships. Prior to MRC, Glenn built partnerships while working for the Oxford Academic Health Science Centre and the Wellcome Trust. The MHRA aims to achieve a Net Zero Healthcare system, and Glenn's keynote address will demonstrate how regulatory agencies can contribute to environmental sustainability through collaboration with industry.

  • Io  Wens, MSc

    Io Wens, MSc

    • PhD Researcher
    • KU Leuven, Belgium

  • Charles  Alessi

    Charles Alessi

    • Independent Expert
    • FT3, Belgium

  • David Montal Armengou

    David Montal Armengou

    • Co-Lead for Pharma and LifeScience Industry EMEAL
    • NTT Data, Germany

    David Montal, Co-Head of Pharma and Life Sciences at NTT DATA Europe and Latin America, holds a business administration degree from IESE. He completed a double degree in Telecommunications Engineering at ETSETB and Télécom Paris, with a research project at SRC College Park on supercomputing. With 25+ years of consulting experience, his focus shifted to life sciences in 2009. His mission: aid major life sciences firms in reaching strategic goals via innovative IT solutions. Passionate about applying AI and disruptive tech to R&D, he fosters collaboration, innovation, and growth within teams and with tech partners.

  • Sonja  Beken, PhD, MSc

    Sonja Beken, PhD, MSc

    • Chair 3Rs Working Party, EMA; Coordinator Non Clinical Evaluators
    • Federal Agency for Medicines and Health Products, Belgium

    Sonja Beken is the Coordinator of the Unit of non-clinical evaluators at the Belgian Federal Agency for Medicines and Health Products. This Unit is responsible for the evaluation of non-clinical data submitted to support all phases of drug development. She is Chair of the 3Rs Working Party and member of the Non-clinical Working party at the European Medicines Agency. Over the years, Sonja Beken contributed to the direct identification of opportunities for regulatory implementation of 3R testing paradigms through her active involvement in large-scale international initiatives (e.g. ILSI HESI). Her main areas of expertise relate to regulatory science, non-clinical drug development, (in vitro) toxicology and metabolism and 3Rs.

  • Maria Ester  Bernardo

    Maria Ester Bernardo

    • Group Leader/Physician Scientist
    • IRCCS Ospedale SAN RAFFAELE, Italy

    Dr Bernardo is Responsible for the Pediatric Transplant Unit and Pediatric Allogeneic Transplant Coordinator of the Pediatric Immunohematology Unit, San Raffaele Scientific Institute. At SR-TIGET, she is Group Leader and Clinical Coordinator of the Pediatric Clinical Research Unit. She is Associate Professor of Pediatrics at Vita-Salute San Raffaele University Medical School, Milan. She is PI of the Phase I/II clinical trial of ex-vivo gene therapy for the treatment of patients affected by Hurler Syndrome. She is Co-author of >100 peer-reviewed articles published in international journals; H index (Scopus) = 45.

  • Dorina  Bischof

    Dorina Bischof

    • SVP Global Head, Patient Safety and Pharmacovigilance
    • Novartis, Switzerland

  • Alison  Bond, PhD

    Alison Bond, PhD

    • Director, Global Regulatory and R&D Policy
    • Amgen, United Kingdom

    Alison is currently part of the Global Regulatory and R&D Policy group at Amgen, with responsibility to advance regulatory policy strategic goals on key topics in Europe, Latin America, Middle East & Africa and Canada (ELMAC). In this role, Alison leads in external advocacy and engaging in multi-stakeholder groups and initiatives, such as through EFPIA, IMI and TransCelerate. For TransCelerate, Alison currently holds the position of Liaison to the European Medicines Agency, leading engagement across the TransCelerate portfolio. Alison is a post-doctoral scientist with broad ranging R&D experience, gained within the CRO and biopharmaceutical industry environments.

  • Christina  Bucci-Rechtweg, MD

    Christina Bucci-Rechtweg, MD

    • Global Head, Maternal Health and Pediatric Regulatory Policy
    • Novartis , United States

    Christina is Global Head of Pediatric & Maternal Health Policy at Novartis. She graduated from the U Rochester Sch of Medicine & Dentistry and trained in Peds/Pediatric Critical Care Medicine at SUNY Buffalo. She has 20+ yrs of experience in Clinical Development and Regulatory Policy. Her activities advancing the environment for pediatric and maternal health include: ICH E11A Expert Work Group, C-Path International Neonatal Consortium, EFGCP Children's Medicines WP, IQ Consortia Clin Pharm Leadership Group Pediatric WG & NIH/NICHD National Advisory Council on Child Health & Human Development. In her career, Christina has over 40 peer-review published articles and 100 invited lectures.

  • Magda  Bujar, PhD, MSc

    Magda Bujar, PhD, MSc

    • Senior Manager, Regulatory Programme and Strategic Partnerships
    • Centre for Innovation in Regulatory Science (CIRS), United Kingdom

    Dr Magda Bujar is Senior Manager, Regulatory Programme and Strategic Partnerships and has over 8 years’ experience working in Regulatory Policy and Science. She has co-authored a number of publications and has presented and chaired at major scientific meetings including those of DIA, TOPRA and ICH. Prior to joining CIRS, Magda carried out research spanning scientific, engineering and policy issues regarding the development of medicines. She received her Master of Science in Biochemical Engineering from University College London (UCL) and a Doctor of Philosophy from the University of Hertfordshire.

  • Catherine  Cohet, PhD

    Catherine Cohet, PhD

    • Senior Pharmacoepidemiologist, Data Analytics and Methods Task Force
    • European Medicines Agency, Netherlands

    Catherine is a senior pharmacoepidemiologist in the RWE Workstream, Data Analytics & Methods Task Force, at EMA. She previously held various pharma positions, generating and evaluating RWE across all phases of medicine development, including vaccines. She also worked as an epidemiologist at the Centre for Public Health Research and the Malaghan Institute for Medical Research in Wellington, New Zealand, and the WHO International Agency for Research on Cancer in Lyon, France. Her work at EMA focuses on international guidance on RWE, and on public health emergency preparedness as Steering Group member of the EU Vaccine Monitoring Platform. She is co-chair of the ENCePP Steering Group and represents EMA in various RWE-related ICH initiatives.

  • Emer  Cooke, MBA, MSc

    Emer Cooke, MBA, MSc

    • Executive Director, Chair, ICMRA
    • European Medicines Agency, Netherlands

    Ms Cooke is Executive Director of the EMA and Chair of ICMRA. Starting her mandate as ED in June 2020 amid a public health crisis of unprecedented scale she announced “My number one priority will be to drive forward EMA’s response to the pandemic and the work already ongoing to support the development and approval of safe and effective COVID-19 vaccines and treatments.” Doing precisely that has since earned her various accolades including an Honorary Doctorate for outstanding contribution to healthcare (RCSI - 2023) and the ‘European of the Year 2022’ title by European Movement Ireland. Ms Cooke obtained a degree in pharmacy and master’s degrees in both Science and Business Administration from Trinity College in Dublin, Ireland.

  • Gracy G Crane, PhD, MS

    Gracy G Crane, PhD, MS

    • Policy Lead
    • Roche, United Kingdom

    Gracy holds a Ph.D. in Molecular Oncology from King’s College Hospital, an M.Sc. in Biomedical Research from King’s College. She did her postdoctoral training at Oxford (UK) and at MIT (USA). Gracy brings broad experience in clinical research, medical affairs and health outcomes within the pharmaceutical industry. She currently works as a Regulatory Policy Lead at Roche Pharmaceuticals, focusing on RWD Policy.

  • Anna  Czwarno

    Anna Czwarno

    • Director, Regulatory & Science, Vaccine Europe
    • EFPIA, Belgium

  • Paul  De Boissieu

    Paul De Boissieu

    • Scientific Project Manager
    • HAS, France

    Paul de Boissieu is the Chair of the Joint Clinical Assessments subgroup. He is a senior assessor in solid oncology and haemato-oncology at the Drug Assessment Division of the French National Authority for Health (HAS). He is a medical doctor with a PhD in pharmacovigilance and pharmacoepidemiology.

  • Nikos  Dedes

    Nikos Dedes

    • Representative, European AIDS Treatment Group (EATG)
    • European AIDS Treatment Group (EATG), Greece

    Nikos Dedes is chair of the ‘European AIDS Treatment Group’, founder and chair of ‘Positive Voice’, and vice-chair of ‘Prometheus’, and past member of the Management Board of the European Medicines Agency. Nikos participates on the Steering Committees of NEATid, and the “HIV Outcomes – Beyond Viral Suppression” initiatives. He is a member of the HIV Treatment Guidelines Panel of the European AIDS Clinical Society and member of the Coordinating Team of the HIV, Hepatitis & TB Civil Society Forum, an advisory group to DG SANTE. He is also member of National Clinical Trials Ethics Committee and member of the Board of Directors of the European Forum for Good Clinical Practice.

  • Laurent  Desqueper

    Laurent Desqueper

    • IDMP Business Data Lead
    • -, Belgium

    Laurent has over 20 years experience in Pharmaceutical Regulatory Affairs, including 10 years at MSD Europe and 10 years of consultancy for the European Medicines Agency. At MSD, Laurent has been focused on the business IDMP implementation. Laurent has also been externally focused, as IDMP/SPOR Task Force Industry Co-Chair until Jan-2023, one of the 4 PMS SMEs and EFPIA’s European Regulatory Affairs & Operations (ERAO) IDMP Subgroup co-chair since January 2022.

  • William  Dunlop

    William Dunlop

    • Health Economics and Payer Evidence Director
    • AstraZeneca, United Kingdom

  • Matthieu  Hammer, DrSc, MSc

    Matthieu Hammer, DrSc, MSc

    • Head Safety Data Processing and Compliance Management
    • Merck Healthcare Kgaa, Germany

    Matthieu Hammer has been serving as the Head of Case Processing and Quality in Global Patient Safety Operations at Merck Healthcare KGaA since 2018. He has a strong focus on managing individual safety case reports (ICSRs), which has allowed him to develop expertise in case processing and monitoring ICSR submissions.

  • Claire  Harrison

    Claire Harrison

    • Chief Digital and Technology Officer
    • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

  • Megan  Heath, PhD

    Megan Heath, PhD

    • Head of Clinical Study Units Europe Region
    • Sanofi, United Kingdom

    Megan Heath is Efpia Lead in the PILOT study within IMI Trials@Home project. Megan has 25 years of operational experience managing all phases of the drug development process. Megan started her career as a phase I research associate at Inveresk Clinical Research, UK before moving through various clinical operations positions in the industry. Megan joined Sanofi in Medical Affairs Clinical Operations and is currently the Head of Clinical Studies Units European Region. Megan graduated with a Bachelor’s degree in Pharmacology from Glasgow University before completing a PhD in Asthma Pharmacology at University of Manchester.

  • Esteban  Herrero-Martinez, PhD

    Esteban Herrero-Martinez, PhD

    • Director Regulatory Policy and Intelligence
    • AbbVie, United Kingdom

    Esteban has worked in both academia and industry in a range of roles including academic research, drug discovery, pharmacovigilance and regulatory policy. Before joining AbbVie, Esteban was Director of Regulatory Intelligence and Policy at Daiichi Sankyo Development Ltd, lead for Pharmacovigilance & Regulatory Affairs at the Association of the British Pharmaceutical Industry (ABPI) as well as working in pharmacovigilance for P&G Pharmaceuticals and drug discovery for Novartis. He holds a Biochemistry BSc from Warwick University, PhD in virology from University College London, and has worked as a postdoctoral researcher at Imperial College London

  • Niklas  Jaenich, PhD, RPh

    Niklas Jaenich, PhD, RPh

    • Head of Global Labeling Operations and Digitization
    • Boehringer Ingelheim, Germany

    Dr. Niklas Jänich is Head of Global Labeling Operations & Digitization at Boehringer Ingelheim. In this position Dr. Jänich is responsible for Labeling process, systems, compliance and digitization as well as for driving the implementation of structured content management in the GxP-regulated Labeling process. Dr. Jänich is a certified pharmacist and holds a PhD in medicinal chemistry and a Master of Drug Regulatory Affairs.

  • Lina  Koufokotsiou

    Lina Koufokotsiou

    • Policy Officer
    • European Commission - DG SANTE, Belgium

  • Anna  Litsiou, PhD, MBA, MSc

    Anna Litsiou, PhD, MBA, MSc

    • Director - Regulatory Policy
    • AstraZeneca, United Kingdom

    Anna Litsiou is a Regulatory Policy and Intelligence Director with focus on International and China in AstraZeneca with more than 15-year experience in International Regulatory Affairs in different roles of strategy across therapeutic areas. Anna holds a PhD in Development Developmental Neurobiology from King’s College, London and an Executive MBA from Columbia Business School, London School Business and Hong Kong Business School.

  • Lilia  Luchianov, LLM, MBA

    Lilia Luchianov, LLM, MBA

    • Policy Officer at DG Santé
    • European Commission, Belgium

    Lilia Luchianov, of the European Commission's DG SANTE, has extensive experience in pharmaceuticals, previously in DG COMP. Currently, she focuses on revising pharmaceutical legislation and is involved in the legislative procedure. Lilia co-authored a handbook on EU Law of Competition and Trade in the Pharmaceutical Sector (2019), lectured on Competition Law and IP Law at the University of Strasbourg, and delivered numerous speeches on pharmaceutical, competition, and IP law. She holds an LLM in European Law from the College of Europe, Bruges, and a Master in Business Law from the University of Strasbourg.

  • Ferenc  Marofka

    Ferenc Marofka

    • Policy Officer Health Medecines
    • European Commission, Belgium

  • Patrick  Middag, MBA, MSc

    Patrick Middag, MBA, MSc

    • Principal, R&D Business Consulting
    • Veeva Systems, Belgium

    Patrick Middag, M.Sc., MBA, currently works at Veeva Systems where he focuses on helping life sciences organisations to derive business value & benefits and on all aspects revolving around Regulatory processes, data and organisation. In particular, how customers can get their data strategies, governance and business processes in order to be fully prepared as global requirements are forming. Before being a consultant, Patrick was leading the EU alignment of Global Regulatory IT initiatives at Bristol-Myers Squibb. He was the vice chair of EFPIA’s ERAO and an active member of EMA's SPOR Task Force. He has been working for mid-size pharma companies since 2001, in Enterprise Architecture, business-IT strategic alignment and process improvement.

  • Christian  Muehlendyck

    Christian Muehlendyck

    • Strategic Partnerships Lead Europe, Middle East & Africa
    • UN, Germany

    Christian Muehlendyck, MD, MBA, is Johnson & Johnson MedTech's Scientific Partnerships Lead for EMEA. He drives IHI activities, notably IDERHA establishment, and co-chairs MedTech Europe's Research & Innovation Committee. Beginning as a physician, he earned his MD/PhD while co-leading innovative medical device development, transitioning to MedTech industry to fuel his passion for innovation. With roles spanning medical training, commercial, and health economics, he's a key player in healthcare innovation and research, including value-based healthcare and digitalization like robotic surgery.

  • Laura  Pastor Sanz, PhD, MSc

    Laura Pastor Sanz, PhD, MSc

    • Digital Health Policy Lead
    • Novo Nordisk, Denmark

    Laura Pastor Sanz holds a position as Digital Health Policy Lead at Novo Nordisk, where she contributes to shaping the external regulatory environment for connected devices and software as a medical device, including the use of digital health technologies to derive digital endpoints. She is a member of the EFPIA subteam on Medical Device Software/Digital Health Technologies, and the EFPIA subgroup on Digital Endpoints. Previously, she has been working as researcher, project manager and fundraiser in collaborative EU-funded projects dealing with chronic conditions and technological innovation for a better health and quality of life. She holds a MSc. degree in Telecommunication Engineering and a PhD. in Biomedical Engineering.

  • Mónica  Perea-Vélez, PhD, MSc

    Mónica Perea-Vélez, PhD, MSc

    • CMC Advocacy and Policy Director
    • GSK, Belgium

    Mónica works as Advocacy and Policy Director at GSK’s CMC Global Regulatory Affairs (GRA). She is a medical biologist by training and holds a Masters in Molecular Biology and a PhD in Bioscience Engineering. Mónica has over 17 years’ experience in the pharmaceutical sector where she has held different CMC positions within Regulatory Affairs and Quality Assurance. She has a deep expertise in vaccines product development, clinical trial applications and MAA globally. In her current role, she is responsible for leading GSK’s global LCM and China CMC advocacy and policy activities. Mónica is currently member of EFPIA, IFPMA and VE trade associations working teams with focus on LCM activities globally and in China.

  • Douwe  Postmus, PhD, MSc

    Douwe Postmus, PhD, MSc

    • Assistant Professor & Seconded National Expert
    • University Medical Center Groningen & EMA, Netherlands

    Dr Douwe Postmus is employed as an assistant professor at the Department of Epidemiology of the University Medical Center Groningen, The Netherlands. His research focuses on applying quantitative modeling techniques to decision making problems in health care, including regulatory, reimbursement, and shared decision making problems.

  • Kyle Jacques  Rose

    Kyle Jacques Rose

    • Patient
    • United States

    Kyle Jacques, a diabetes advocate, amplifies the voices of those with diabetes, enhances awareness, and broadens access to care. He's been pivotal in mission-driven startups like mySugr (as its first employee), Bigfoot Biomedical, and TheraSense, as well as in NGOs like IDF and Diabetes Education and Camping Association. Notably, his ventures have led to major acquisitions or global agreements: Bigfoot Biomedical by Abbott Labs (2023), mySugr by Roche (2017), Team Type 1 with Novo Nordisk (2011), and TheraSense by Abbott Labs (2004). Living with Type 1 Diabetes for over 25 years, Kyle is deeply committed to transforming the landscape of diabetes management.

  • Paul-Etienne  Schaeffer, PharmD

    Paul-Etienne Schaeffer, PharmD

    • Life Sciences Regulatory Affairs Manager
    • AESGP, Belgium

    Paul-Etienne Schaeffer worked as Global Regulatory Science & Policy Associate within Sanofi in France. His tasks were focused on regulatory aspects regarding electronic Product Information, big data, artificial intelligence, digital therapeutics, apps and wearables. He has been working since October 2019 as Life Sciences Regulatory Affairs Manager at AESGP (Brussels), where he is involved in digital, medicines and medical devices topic. He has been a member of the Inter-Association task force on electronic Product Information steering group since 2019 and actively participated to the recent Pharma Law review discussions.

  • Katherine Marie Serrano

    Katherine Marie Serrano

    • Director, Latin America, Office of Global Policy and Strategy
    • FDA, United States

    Katherine (Katie) Serrano is the Director of the Latin America Office in FDA’s Office of Global Policy and Strategy (OGPS). Before assuming this role in 2017, Ms. Serrano served nine years in the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health’s Office of In Vitro Diagnostics and Radiological Health (CDRH). While at CDRH, Katie worked as a scientific reviewer, as the Diabetes Diagnostic Branch Chief and the Deputy Director of FDA's Division of Chemistry and Toxicology Devices. She also served as the technical and policy lead for the Agency’s efforts related to Laboratory Developed Tests.

  • Khushboo  Sharma, MBA

    Khushboo Sharma, MBA

    • Chief Regulatory Innovation Officer
    • Accumulus Synergy, United States

    Khushboo Sharma is the Chief Regulatory Innovation Officer for Accumulus. Sharma joined Accumulus Synergy in 2022 from BIO, where she focused on major regulatory policy initiatives to build the appropriate regulatory framework. Prior to BIO, Sharma spent 11 years in various roles at the FDA, including Deputy Director of Operations in the Office of New Drugs. While at the FDA, Sharma oversaw business, regulatory, and programmatic operations, supported regulatory review for the New Drugs Regulatory Program through the New Drugs Modernization effort, and served as an FDA negotiator during PDUFA negotiations. She earned her bachelor’s degree in biotechnology and MBA Biotechnology and Healthcare Industry Management from Penn State University.

  • Rebecca  Stanbrook, RPh

    Rebecca Stanbrook, RPh

    • Executive Director, Regulatory and Development Policy, Regulatory Affairs
    • Novartis Pharma AG, Switzerland

    In her current role, Rebecca Stanbrook focuses on clinical trials policy with specific interests in modernising clinical trial conduct and the application of digital tools. She is the EFPIA Topic lead for ICH E6 R3 and sits on the TransCelerate Regulatory Council. Prior to Novartis, she was Group Manager, Inspections (GLP/GCP/PV) at the MHRA. Since she joined the Agency in 2003, Rebecca held a number of positions within the fields of GCP and Pharmacovigilance; helped shape the GCP & PV statutory programmes in their early stages & was a member of one of the teams conducting the first statutory GCP inspections in the UK. Rebecca’s group at the Agency wrote the Good Clinical Practice Guide and the Good Pharmacovigilance Guide.

  • Kenichi  Tamiya, MSc, RPh

    Kenichi Tamiya, MSc, RPh

    • Associate Executive Director, Office of New Drug
    • Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    Mr. Kenichi Tamiya is the Associate Executive Director for New Drug Evaluation at PMDA and is in charge of supervising the review of new drugs except for vaccines and regenerative medical products. Before assuming his current position in 2020, Mr. Tamiya was the Pharmaceutical Management Director, Medical Economics Division at MHLW and was responsible for Reform of Drug Pricing System. Mr. Tamiya has over 25 years' experience in MHLW, including new drug review at the Pharmaceuticals and Medical Devices Evaluation Center, National Institute of Health Sciences, post-marketing safety measures and promotion of R&D for innovative medical products. Mr. Tamiya holds a Master's degree in Pharmaceutical Sciences form the University of Tokyo.

  • Sabina  Uzeirbegovic, MPharm

    Sabina Uzeirbegovic, MPharm

    • Croatian CMDh Member
    • Agency For Medicinal Products and Medical Devices, Croatia (Hrvatska)

    Sabina joined the Croatian Agency for Medicinal Products and Medical Devices (HALMED) in 2006, where she currently holds the position of Principal Regulatory Advisor. Her main responsibilities include coordination and overseeing regulatory procedures within the MRP/DCP in HALMED. She has been Croatian representative to the Coordination Group for Mutual Recognition and Decentralised Procedures – human (CMDh) since the accession of Croatia to the EU, as well as representative to the NtA. She is also a member of several WG within the CMDh. She is a pharmacist with a postgraduate speciality study in clinical pharmacy.

  • Marie  Valentin, PharmD

    Marie Valentin, PharmD

    • Team Lead, Facilitated Product Introduction
    • WHO, Switzerland

    At WHO, Marie works in the Regulatory Convergence and Network Team towards convergence, harmonization, reliance and system strengthening activities, supporting different regional regulatory networks and supporting Member States to strengthen their regulatory systems, with a part. Before joining the WHO in May 2019, Marie worked for 8.5 years at the European Medicines Agency in London as a Regulatory Affairs Officer where she was in charge of providing regulatory and procedural advice in relation to the development, evaluation and surveillance of medicinal products in the European Union. Before that, she worked in the pharmaceutical industry, contract research organization and consultancies in the United Kingdom, Spain and France.

  • Peter  Van Ven, PhD

    Peter Van Ven, PhD

    • Methodology assessor and Associate Professor in Clinical Trial Methodology
    • Dutch Medicines Evaluation Board (CBG-MEB) and University Medical Center Utrecht, Netherlands

    Peter van de Ven is a Biostatistician affiliated to both the Dutch Medicines Evaluation Board (CBG-MEB) and the University Medical Center Utrecht (UMCU). At the CBG-MEB, he works as a Methodology Assessor. At UMCU, he is an Associate Professor and Head of the Clinical Trial Methodology group within the Department of Data Science and Biostatistics. From 2009 to 2021, he was an Assistant Professor in Biostatistics at the Amsterdam University Medical Centers, location VUmc. He has been involved in design and analysis of trials across a wide range of medical disciplines, including oncology, cardiology and psychiatry. His methodological research focuses on innovations in clinical trial methodology, including adaptive and Bayesian methods.

  • Jorien  Veldwijk

    Jorien Veldwijk

    • Erasmus University Rotterdam, Netherlands

  • Shruthi  Vidyasagar, MS

    Shruthi Vidyasagar, MS

    • Associate Director
    • Novo Nordisk, India

    Shruthi is an experienced leader in medical devices and combination products. She has experience across multiple platforms - combination products, electromechanical devices, consumables and digital health products and held roles within Device R&D as well as Regulatory Affairs. She is currently an Associate Director in RA Digital Health and IVD at Novo Nordisk. Prior to this, she worked at GSK, Pfizer and Hospira in various roles within Device Development. Shruthi has degrees in Electrical Engineering- (VTU, India) and an MS in Biomedical Engineering (University of Michigan, Ann Arbor).

  • Hannah-Marie  Weller

    Hannah-Marie Weller

    • Directorate-General Communications Networks, Content and Technology
    • European Commission, Luxembourg

  • Gabriela  Zenhaeusern, PhD

    Gabriela Zenhaeusern, PhD

    • Deputy Head Stakeholder Engagement
    • Swissmedic, Switzerland

    Gabriela Zenhäusern, a pharmacist with a PhD in biomedical research, joined the Stakeholder Engagement Division at Swissmedic, Switzerland in 2019. In her current position, she is responsible for the coordination of international collaboration, acts as Vice-Chair of the Assembly of the International Council of Harmonisation (ICH) and represents Swissmedic at the International Pharmaceutical Regulators Programme (IPRP) Management Committee and the Access Consortium (Australia-Canada-Singapore-Switzerland-United Kingdom). In addition, she is leading the patient organisation working party at Swissmedic. Gabriela Zenhäusern used to work in the sector authorization at Swissmedic from 2010 to 2015 before joining WHO from 2015 to 2019.

  • Bandar  Al Hammad

    Bandar Al Hammad

    • Chief Pharmacist, Regulatory Affairs Department
    • Saudi Food and Drug Authority (SFDA), Saudi Arabia

    Bandar is Chief Pharmacist at the Executive Department of Regulatory Affairs in Saudi FDA since October 2018. Before this, he was in charge of clinical assessment at SFDA, working as Director of Risk-Benefit Assessment Department from Jan 2015 - Oct 2018. He joined Saudi FDA in 2005 as a pharmacist and worked on the establishment of the Pharmacovigilance Center, later working as a Clinical Assessor, at the National Drug Information Center at SFDA 2009-2015. He got his Master’s degree in clinical pharmacy from Curtin University, Western Australia in 2009. His bachelor’s from King Saud university in 2004.

  • Julian  Beach

    Julian Beach

    • Interim Executive Director of Healthcare Quality and Access (HQA)
    • MHRA, United Kingdom

  • Rainer  Becker

    Rainer Becker

    • Director
    • European Commission, DG Health & Food Safety, Belgium

    Rainer Becker is director in the European Commission’s Directorate-General for Health and Food Safety. He heads the directorate for Medical Products and Innovation, responsible amongst others for Europe’s Pharmaceutical Strategy and its follow-up initiatives such as the revision of pharmaceutical EU legislation and policy initiatives on availability of medicines. His directorate also leads the Commission’s policy work on medical devices and veterinary medicines. Prior to his current position, Rainer was for several years in charge of antitrust enforcement for pharmaceuticals and health in the Commission's Directorate-General for Competition. Before joining the Commission in 2004, Rainer was a senior lawyer in an international law firm.

  • Maria Eugenia (Xenia)  Beltran

    Maria Eugenia (Xenia) Beltran

    • Head of Big Data LifeSTech & PharmaLedger Project Coordinator
    • Universidad Politécnica de Madrid, Spain

    Xenia, Senior R&D Project Manager at UPM-LifeSTech, heads Big Data projects and coordinated the PharmaLedger Project. With an Information Systems Engineering background, an MBA in International Management, and a PhD in Biomedical Engineering, she brings over 15 years of experience in Project & Innovation Management. She leads innovative projects, validating digitalization ecosystems and implementing changes across various sectors. She's coordinated large EU co-funded projects, overseeing 50+ innovative pilots in areas such as Digital Trusted Ecosystems, Big Data, IoT, Health & Wellbeing, Manufacturing, and Education.

  • Jayanthi  Boobalan, MBA, MPharm, RPh

    Jayanthi Boobalan, MBA, MPharm, RPh

    • Head of Regional Regulatory Hub
    • Pfizer (Malaysia) Sdn. Bhd., Malaysia

    Jayanthi Boobalan is Head of Emerging Market Regulatory Strategist Hub in Pfizer. Possessing over 17 years of experience in Regulatory Affairs, she has been an avid contributor in promoting regulatory convergence and has been actively involved in a number of environment shaping initiatives within the Asia Region. She is an active member of the EFPIA ASEAN Network and is a certified Good Registration Management (Good Submission Practice) trainer. She is a Registered Pharmacist and also holds an MBA in Global Business.

  • Anne  Bourrelly, MBA, MSc

    Anne Bourrelly, MBA, MSc

    • Regulatory Innovation & Sustainment Leader
    • F Hoffmann-La Roche Ltd , Switzerland

    Anne has over 30 years experience in drug development, the past 18 years with F. Hoffmann-La Roche PD Regulatory, covering Labeling, Program Management and Regulatory Operations. She joined Roche´s IDMP/SPOR program in 2018 as master data process alignment lead and in 2023 became SPOR lead. Anne is also externally focussed, serving as EFPIA’s European Regulatory Affairs & Operations (ERAO) IDMP Subgroup co-chair in 2022 and as their chair since 2023. She has been PMS Focus Group Data Industry lead and is member of the PMS Industry Support Team since 2023.

  • Karl  Broich, DrMed

    Karl Broich, DrMed

    • President
    • Federal Institute for Drugs and Medical Devices (BfArM), Germany

    Prof. Broich is a physician and has been President of the Federal Institute for Drugs and Medical Devices in Bonn since 2014. His current activities in the European network of regulatory authorities are Member of the Management Board of the European Medicines Agency, Chair of the Network Portfolio Advisory Group. He is a member of the HMA Management Group and is currently its Chair. He is also co-chair of the EMA's Darwin EU Advisory Board. His scientific focus is on clinical psychopharmacology, imaging of neurodegenerative diseases and other potential biomarkers and dementia, and clinical trial methodology, among others. Prof. Broich is author and co-author of more than 220 papers (original scientific papers, reviews, book contributions).

  • Antonella  Cardone

    Antonella Cardone

    • Director
    • Cancer Patients Europe, Belgium

    Antonella Cardone is the CEO of Cancer Patients Europe, a pan-European all-cancer patient association. She's a Patient Advocacy Expert and Advisor to the Board of Pancreatic Cancer Europe (PCE), uniting physicians, patients, politicians, journalists, academia, and industry, and she is a member of Inspire2Live. Antonella led the European Cancer Patient Coalition and served as Executive Director of the Fit for Work Global Alliance. With 25 years of nonprofit experience in health, social, and employment sectors, she also directed the Global Smoke-free Partnership of the American Cancer Society. Antonella holds Master's degrees in Science and Business Administration. She has been on the Boards of All.Can and PCE, where she was vice-chair.

  • Xiao Yuan  Chen, PhD

    Xiao Yuan Chen, PhD

    • Office Director
    • Tsinghua University, China

  • Cathelijne  De Gram, PharmD, RAC

    Cathelijne De Gram, PharmD, RAC

    • EMEA Regulatory Policy Lead
    • J&J Innovative Medicine, Netherlands

    Cathelijne de Gram obtained her PharmD degree in 2000 from Groningen University, The Netherlands and since then she has been working in regulatory affairs both in the EU as well as USA. Cathelijne joined the global regulatory affairs department at Johnson & Johnson Innovative Medicine in 2012. Currently she is an EU regulatory policy leader in the Global Regulatory Policy and Intelligence department at Johnson & Johnson Innovative Medicine.

  • Michel  De Ridder, MS

    Michel De Ridder, MS

    • Partner
    • Deloitte, Belgium

  • Harald  Enzmann, DrMed, MD, MS, MSc

    Harald Enzmann, DrMed, MD, MS, MSc

    • Chair, CHMP; Section Head of European and International Affairs;
    • Federal Institute for Drugs and Medical Devices (BfArM), Germany

    Harald Enzmann is chairperson of EMA’s Committee for Medicinal Products for Human Use (CHMP). A physician by training, Harald held positions at the German Cancer Research Center (dkfz), at the Intitute of Pharmacology and Toxicology at the University of Erlangen, at R&D at Bayer and at the American Health Foundation in Valhalla, NY, USA. He received the dkfz award for outstanding research and the Animal Welfare Research Award of the German Ministry of Health. In 2002, Harald joined the Federal Institute for Drugs and Medical Devices (BfArM) and is currently head of European and International Affairs.

  • Maurille  Feudjo Tepie

    Maurille Feudjo Tepie

    • VP & Head, GLobal RWE and Digital Sciences
    • UCB, United Kingdom

  • Christopher  Golds

    Christopher Golds

    • Safety Process Lead
    • GSK, United Kingdom

  • Katja  Hakkarainen, DrMed, MPharm

    Katja Hakkarainen, DrMed, MPharm

    • VP Epidemiology; Epidemiology & Real-World Science; RWE Scientific Affairs
    • Parexel International, Sweden

    Katja is Vice President in Epidemiology at Parexel’s Epidemiology & Real-World Science team. She has over 15 years of experience in RWE, epidemiology, and pharmacoepidemiology in a variety of therapeutic areas, such as neurology, oncology, and endocrinology. Katja has conducted and lead numerous RWE studies globally using a range of data sources, including national health and demographic registers, pregnancy and disease registers, claims, chart reviews, and prospectively collected data from sites. Numerous of Katja’s studies have had a regulatory demand, and have been submitted to regulators. Katja has MScPharm and PhD in public health and epidemiology, and is a registered pharmacist in Finland and Sweden. Katja is based in Sweden.

  • Matthias  Heyn, MA

    Matthias Heyn, MA

    • Vice President Language Technologies
    • RWS, Belgium

    Matthias Heyn holds the position of VP Language Technologies at RWS Trados and is a pioneer of language technologies focusing on multilingual processes and related technologies in a wide range of industries. Working across product engineering and business development positions from start-up to large scale organizations, he has focused on public-sector organizations in the EU and particularly in multilingual regulatory processes with a focus on the EU CP. Currently he is involved with combining translation technologies with AI and large language models (LLMs) in Cloud facilitated deployments.

  • Virginie  Hivert, PharmD, PhD

    Virginie Hivert, PharmD, PhD

    • Therapeutic Development Director
    • Eurordis-Rare Diseases Europe, France

    Virginie Hivert joined EURORDIS in 2014 as Therapeutic Development Director.Virginie is responsible for following the development of orphan drugs as an observer on the Committee for Orphan Medicinal Products at the European Medicines Agency.She coordinates the group of high-level EURORDIS representatives/volunteers who sit on the various scientific committees/working parties at the EMA, known as the Therapeutic Action Group (TAG).

  • François  Houyez

    François Houyez

    • Treatment Information and Access Director, Health Policy Advisor
    • European Organisation for Rare Diseases (EURORDIS), France

    François is a patient and works at the European Organisation for Rare Diseases as Director of Treatment Information and Access since 2003. He's been involved in EUnetHTA since the first Joint Action back in 2010, and supervises Eurordis policy and advocacy on HTA. François also represents Eurordis at the European Medicines Agency.

  • Stéphanie   Kromar

    Stéphanie Kromar

    • Senior Regulatory Affairs Manager
    • European Organisation for Research and Treatment of Cancer (EORTC) , Belgium

    Stéphanie Kromar joined the EORTC in 2013. In 2014, she joined the Regulatory Affairs Department. As Senior Regulatory Affairs Manager, she is responsible for the preparation, submission and follow-up of Clinical Trials Applications from development until the end of trial. She has experience on VHP and recent pilot phases and provides regulatory advice. She is one of the Sponsor Product Owners under the new CTIS delivery model and has been involved in the implementation of the new clinical trials regulation from the firsts UATs till the recent on-site portal testing at EMA.

  • Maria  Lamas Diaz

    Maria Lamas Diaz

    • Evecutive Director
    • AEMPS, Spain

    María Lamas is the Director of the Spanish Agency of Medicines and Medical Devices. PhD in Pharmacy from the University of Santiago, she is a specialist in hospital pharmacy and she is accredited as a clinical pharmacist in Oncology by the Board of Pharmaceutical Specialties (BPS) and the American Pharmaceutical Association (APhA). Before leading the AEMPS, she directed the Pharmacy Service of the Hospital of Santiago, while coordinating the Area of Platforms and Methodology of the Health Research Institute of Santiago (IDIS - ISCIII). In addition, she was the Research Director of the Spanish Society of Hospital Pharmacy from 2012 to 2016. She is currently coordinator of the Master of Pharmaceutical Oncology at the University of Valencia.

  • Nick  Lee, PhD

    Nick Lee, PhD

    • Executive Pharmaceutical Assessor
    • Health Products Regulatory Authority (HPRA), Ireland

    Nick Lee has a PhD in Physico-organic Chemistry. He started his career implementing NIR applications in primary and secondary manufacturing. Since then, Nick has been involved in a number of organisations in different sectors (originator-generics-CRO; medical device-combination products-medicinals), in increasingly senior roles, culminating in Director of R&D for a small biotechnology company in Ireland. In his role at the HPRA, he has responsibility for assessment of many procedure types including CAPs, CTAs and EMA/national Scientific Advice. As well as being HPRA lead for Continuous Manufacturing and departmental lead for Drug-Device Combination products, Nick is currently the Irish delegate to the QWP and a member of the EMA PAT team.

  • Lada  Leyens, PhD, MSc

    Lada Leyens, PhD, MSc

    • Senior Director, EUCAN regulatory head GI
    • Takeda, Switzerland

    Lada Leyens has a background in human genetics, health economics and personalised medicine. She has worked at Health Authorities for over 8 years, mainly in the approval of clinical trials and as a GCP inspector at Swissmedic. At EMA she was in the specialised disciplines office working in the centralised procedure and with the PKWP and PGWP. At Roche, Lada is the Regulatory Lead for digital health programs and the Regulatory Shaping Lead on Clinical Trial Innovation. In this role she is working to increase the use of innovations in our drug development programs and their acceptance by HAs. Lada is passionate about leveraging innovative technologies to make drug development more efficient and bringing innovative drugs faster to patients.

  • Claudia  Louati, MA, MSc

    Claudia Louati, MA, MSc

    • Head of Policy
    • European Patients' Forum, Belgium

    Claudia Louati joined the European Patients Forum (EPF) as Head of Policy in May 2023. She leads EPF’s policy and advocacy work and steers EPF’s engagement with EU and international stakeholders on relevant health policy topics. Before joining EPF, she worked for almost seven years at the Europe Office of the U.S. Food and Drug Administration, based at the U.S. Mission to the EU in Brussels, where she promoted EU-U.S. regulatory collaboration on medical products. She started her career as a communications and public affairs consultant in Brussels. Claudia holds two master’s degrees in European Affairs from SciencesPo Paris and the London School of Economics.

  • Klaudija  Marijanovic Barac, MD

    Klaudija Marijanovic Barac, MD

    • Senior Director, Teva Periodic Reports and Risk Management Centre
    • Teva, Croatia (Hrvatska)

    Klaudija is a physician with more than 20 years of experience in different pharmacovigilance fields. At present, she is Head of TPC – unit responsible for Company Core Safety Information, aggregate reports and risk management worldwide, supporting marketing authorizations and safety strategy for generics, biosimilar and innovative Teva products. Klaudija led in-house development of additional risk minimisation (ARM) implementation tracking tool and ARM digitalisation. Klaudija is Co-Chair of the Pharmacovigilance Working Group in Medicines for Europe.

  • Vasee  Moorthy

    Vasee Moorthy

    • Senior Advisor, Science Division
    • WHO, Switzerland

    Dr Vasee Moorthy is a Physician with a PhD in malaria immunology, and a background as a Clinical Trials PI and funder. His current main activity at WHO is coordination of development of guidance on best practices for CTs for improving the quality of evidence. In his 14 years at WHO, he has led policy development for the 1st malaria vaccine, set up the horizon scanning process for vaccine R&D, coordinated large CTs consortia for Ebola vaccines and COVID-19 therapeutics (the global solidarity trial), and led the creation of R&D processes at WHO including Target Product Profiles and Coordinated Scientific Advice. He has a medical degree and PhD from the Univ of Oxford and a first class degree in Natural Sciences from the Univ of Cambridge.

  • Henrik K.  Nielsen, PhD, MBA, MSc

    Henrik K. Nielsen, PhD, MBA, MSc

    • Vice President
    • Novo Nordisk A/S, Denmark

    Henrik K. Nielsen has a background as M.Sc. Chemical Engineering, Ph.D. in Biochemistry and MBA. He joined Novo Nordisk in 1983 and has held several positions in Research, Product Development and Manufacturing in Denmark and the USA. Since 2004 he has served in several leadership positions in regulatory affairs and is currently Vice President for Global Regulatory Sciences. He represents Novo Nordisk as regulatory and biotechnology expert in a number of trade associations such as PhRMA, IFPMA and EFPIA where he is chair of the International Regulatory Expert Group.

  • Lars Bo  Nielsen, MSc

    Lars Bo Nielsen, MSc

    • Director General
    • Danish Medicines Agency (DKMA), Denmark

  • Lorraine  Nolan, PhD

    Lorraine Nolan, PhD

    • Chief Executive
    • Health Products Regulatory Authority , Ireland

    Dr Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming the role of Chief Executive Dr Nolan was Director of Human Products Authorisation & Registration. Dr Nolan is a member of the Management Board of the European Medicines Agency (EMA) and as Chair of the Management Board of the EMA since March 2022.

  • Philippe  Page, DrSc

    Philippe Page, DrSc

    • Head of Research Council, Trustee
    • The Human Colossus Foundation, Switzerland

    Dr Philippe Page is a physicist with a PhD in particle physics and 20 years of experience in international finance, including COO of a swiss private bank. His dual technical/managerial expertise lies in information management and governance. He is currently CEO of MeDDEa Solutions AG and Chair of the Board of Trustees of the Human Colossus Foundation, where he develops an alternative, user-centric governance model and tooling for digital interactions: DDE-Dynamic Data Economy. Philippe applies his expertise to the digital transformation of public and private organisations. In healthcare, his work is on distributed governance, allowing patients engagement in a multi-stakeholders environment, including regulators.

  • Caroline  Pothet, PharmD, RPh, RAC

    Caroline Pothet, PharmD, RPh, RAC

    • Scientific Administrator, Regulatory Affairs
    • European Medicines Agency, Netherlands

    Caroline Pothet is head of the office for advanced therapies and haematological diseases at the European Medicines Agency. Caroline joined EMA in 2020; prior to this, Caroline worked in the Industry for 20 years in a variety of sectors such as regulatory policy, regulatory science and drug development, including 10 years in oncology; During these years, Caroline was privileged to be involved in the development and registration of several drugs (e.g. cervical cancer, melanoma, T-ALL/LBL). Caroline is also a member of the Regulatory Scientific Committee in the International Rare Disease Research Consortium.

  • Daniel  Rosenberg, PhD

    Daniel Rosenberg, PhD

    • Senior Director Global Epidemiology
    • Johnson & Johnson, Switzerland

    Daniel is head of the Cross-Therapy area team in the Global Epidemiology Innovative Medicines department at Johnson and Johnson. In his current role, Daniel leads the strategy and manages teams of epidemiologists, analysts and project scientists; to develop and implement epidemiology studies on the benefit risk of medicines (incl. PASS). Daniel previously held various industry roles, working in infectious and rare diseases. Prior to his career in industry, Daniel worked for the Louisiana State public health department focused on the prevention of sexually transmitted diseases. Daniel is a member of Efpia and the lead representative to the ICH M14 EWG to develop guidance on the pharmacoepidemiology for safety assessment.

  • Yury  Rozenman

    Yury Rozenman

    • Senior Vice President, Pharmaceutical and Life Sciences
    • Ada Health, United States

    Yury Rozenman is the Senior Vice President of Business Development at Ada Health. In this role, he leads the company's strategy, vision and oversees execution of all global business development activities. Prior to joining Propeller, Yury was the head of healthcare and life sciences industry partnerships at AWS where he was responsible for the development of life sciences vertical solutions, marketing programs, joint GTM strategy and execution on the global basis. Yury has over 25 years of experience within the industry in pharmaceutical research and development both as a team leader and group research manager. He has worked in diagnostics and medical devices, and has been involved in the development and launch of world-class drugs an

  • Sinan  Sarac, MD

    Sinan Sarac, MD

    • Vice President, Regulatory Strategy
    • Parexel, Denmark

    Dr Sarac has worked for more than a decade at the heart of medicines regulation in the EU. He is an experienced regulator, and an expert in regulatory decision-making, regulatory pathways, and clinical trial design. Dr Sarac served as member of the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA), Committee for Advanced Therapies (CAT) and Scientific Advice Working Party (SAWP). He also chaired EMA’s Oncology Working Party (ONCWP). Dr Sarac has attended +100 plenary meetings in CHMP, CAT, and SAWP. His main expertise is in oncology/hematology. At Parexel, he is responsible for providing strategic regulatory advice to sponsors before and during major submissions to the FDA and EMA.

  • Rebecca  Spencer

    Rebecca Spencer

    • NIHR Clinical Lecturer and Subspecialty Trainee in Maternal and Fetal Medicine
    • University of Leeds, United Kingdom

  • Shannon  Thor, PharmD, MS

    Shannon Thor, PharmD, MS

    • Deputy Director, Office of Global Policy & Strategy, Europe Office
    • FDA, United States

    Lt. Cmdr. Shannon Thor is the Deputy Director of the FDA Europe Office (EO), located in Brussels, Belgium, assuming the role in August 2022. Lt. Cmdr. Thor brings 17 years of experience as a pharmacist and public health leader, with more than nine years in senior policy advisor roles at the FDA. She is responsible for providing leadership and technical expertise on international public health initiatives and U.S.-European Union relations, with a particular focus on maternal health projects such as improving information on the safe use of medicines in pregnancy and during breastfeeding. Her previous FDA experience included policy advisor roles in the Office of Health and Constituent Affairs and in the Office of New Drugs.

  • Véronique  Toully

    Véronique Toully

    • Global Head of Sustainability, Corporate Affairs and Risks
    • UCB, Belgium

    Veronique Toully currently serves as Senior VP and Global Head of Sustainability, Corporate Affairs and Risks at UCB. She integrates sustainability and risk management into UCB’s strategy, championing positive impact for key stakeholders. With 30 years of experience in the healthcare industry, Veronique has honed her expertise in various roles including global market access and general management positions across Europe and Asia-Pacific. Veronique holds a Doctorate in Veterinary Medicine, an MBA from HEC Paris, and a Health Economics diploma from the University of York. She recently studied Sustainability Leadership at the University of Cambridge.

  • Atsushi  Tsukamoto, PhD, MSc

    Atsushi Tsukamoto, PhD, MSc

    • Corporate Officer, Head is Therapeutic Area Strategies
    • Daiichi Sankyo, United States

    Atsushi is VP of New Drug Regulatory Affairs (RA) at Daiichi Sankyo. He is also Head of Specialty Medicine RA in R&D division, to lead gobal specialty medicine regulatory strategies. As Head of Japan New Drug RA, he is responsible for leading new drug RA activities for all projects (RA strategy & operation). He has been global project manager for nearly 20 years (in JPN & US) and the head of PM office in Daiichi Sankyo Japan for 3 years. He has been an active volunteer to both DIA global and Japan, playing session chair roles in global annual meeting more than 10 times, and was the vice-chair for 13th DIA Japan Annnual Meeting 2016. He holds PhD in Drug Development from Kitasato Univ and is the receipent of DIA outstanding award in 2014.

  • Veerle  Vanhuyse

    Veerle Vanhuyse

    • Communication Representative INNODIA, Belgium

    Veerle, diagnosed with Type 1 Diabetes in 1987, transitioned from event planning to a diabetes-related career, fueled by fundraising for Life For a Child. Since 2018, she's been a Communication Representative for INNODIA, a European consortium advancing T1D understanding and addressing tool deficiencies. Veerle is instrumental in both the INNODIA project and its non-profit arm, INNODIA iVZW, bridging therapy developers and tool providers. Additionally, she's a member of the PAC and INPACT, advocating for the T1D community.

  • Alice  Vanneste, MS, MSc

    Alice Vanneste, MS, MSc

    • PhD Student
    • KU Leuven, Belgium

  • Bert  Verstappen

    Bert Verstappen

    • Manager Environmental Sustainability Belgium
    • Janssen Pharmaceutica NV, Belgium

    Bert Verstappen is Manager Environmental Sustainability at Johnson&Johnson Innovative Medicine. Bert is a chemist and environmental scientist by education and has spent his professional life working on environmental sustainability topics in research institutes, consultancy and the industry. Advancing environmental health is key to our vision for a sustainable future because we know that healthy people need a healthy planet.

  • Siri  Wang, PhD

    Siri Wang, PhD

    • Scientific Director; PDCO Member
    • Norwegian Medicines Agency, Norway

    Siri Wang is pharmacist by education and holds a PhD in pharmacology from the University of Oslo. She has been working for 15 years in hospital pharmacy; as head of the production unit, as assistant chief pharmacist, and for 10 years as counseling pharmacist and clinical pharmacist, specifically involved in paediatric and geriatric medicine. In 2005 Siri was appointed to EMA’s Paediatric Working Group (PEG), and has been delegate to the Paediatric Committee (PDCO) since 2007. She was chair of PDCO’s Formulation Working Group from 2008 until 2013. Siri has been at the Norwegian Medicines Agency (NOMA) since 2007 and is currently holding a position as Scientific Director at NOMA, with particular focus on paediatric medicine.

  • Natasa  Zamurovic, DrSc

    Natasa Zamurovic, DrSc

    • TA Head Immunology Preclinical Safety
    • Novartis, Switzerland

    Obtained PhD in Biochemistry at University of Basel, Switzerland and Master of Science in Molecular Biology at University of Belgrade, Serbia. Broad experience in drug discovery and development and translational safety assessment strategies. After a postdoc in mouse genetics research, joined Preclinical Safety Department in Novartis Pharma, Basel, Switzerland, where she held various roles of increasing responsibilities. Current role: Immunology Therapeutic Area Head, responsible for non-clinical safety programs of Novartis Immunology portfolio across modalities.

  • Reem  Al-Naimat

    Reem Al-Naimat

    • Consultant Pharmacist, Head of Manufacturing Sites Accreditation Unit
    • Jordan Food and Drug Administration (JFDA) , Jordan

    Reem Eaid Alnaimat, head of manufacturing site accreditation at Jordan Food and Drug Administration, is a regulatory affairs consultant with a Master's in Pharmaceutical Science and an MBA. With over 14 years of experience, she represents JFDA nationally and internationally at conferences on regulatory topics. Reem leads the Generics Evaluation and JFDA Manufacturing Site Accreditation committees and participates in various others. Previously, she served as a regulatory affairs consultant in Qatar and head of the pharmacy department at Eman Hospital in Jordan's Ministry of Health.

  • Marc  Bailey

    Marc Bailey

    • Chief Science and Innovation Officer
    • MHRA, United Kingdom

    Marc is a molecular biologist with a PhD in Pathology. Marc has had a varied career starting with academic research on infectious diseases before establishing a team developing physical standards for biotechnology at the National Physical Laboratory and then leading research into Digital Health for a multinational corporation. Marc joined the Agency in 2017 at the South Mimms Laboratory initially as a Head of Division and then as interim Director of NIBSC.

  • Kasper  Bendix Johnsen

    Kasper Bendix Johnsen

    • Head of Section
    • Danish National Center For Ethics, Denmark

  • Manuela  Braun

    Manuela Braun

    • Senior Scientific Expert - Preclinical Development of Gene & Cell Therapy Produc
    • Bayer AG, Germany

  • Isabelle  Colmagne-Poulard, PharmD, MBA, MSc

    Isabelle Colmagne-Poulard, PharmD, MBA, MSc

    • Head, International Global Regulatory & Scientific Policy
    • Merck KGaA, Switzerland

    Isabelle has joined Merck KGaA since 2005 where she has held growing managerial roles in RA and RA CMC as Head of Department. She currently is Head of International Global Regulatory & Scientific policy at Merck and as such actively engaged in international regulatory policy as member of IFPMA since 2014, representative at ICH TrSC, EFPIA and PhRMA ICH WG. Prior to joining Merck, she has worked for several Companies in areas of small and large molecules including in Clinical Development for Servier Laboratories, and assumed various manufacturing site managerial responsibilities within Sanofi GMP QA & RA. Isabelle holds a MSc and a Pharm. D from Lyon (France) coupled with an MBA from Paris (EAP) High Business School.

  • Sneha  Dave

    Sneha Dave

    • Executive Director
    • Generation Patient, United States

    Sneha graduated from Indiana University in May 2020, majoring in chronic illness advocacy and journalism. She founded Generation Patient to support young adults with chronic conditions nationwide and internationally, maintaining independence from private healthcare funding. Sneha's advocacy includes Capitol Hill speeches, C-SPAN features, and contributions to U.S. News and World Report. She joined ICER's Comparative Effectiveness Public Advisory Council and served on the FDA Patient Engagement Collaborative and in various grantmaking committees. Sneha received two academic fellowships from the Association of Health Care Journalists.

  • Corinne  de Vries, PhD, MA, MSc

    Corinne de Vries, PhD, MA, MSc

    • Head of Translational Sciences Office
    • European Medicines Agency, Netherlands

    Corinne is a pharmacist and an epidemiologist (PhD) and has an MA in medical ethics and law. She has gained 20 years’ research experience in academia before making the move to the regulatory environment. Throughout her career, she has worked in multinational and multicultural environments, acquired scientific and regulatory expertise, communication, education and presentation skills, as well as a thorough understanding of project and budget management. She is an active member of the International Society for Pharmacoepidemiology with previous roles as Board member, VP Finance, and various committees. She is visiting professor of pharmacoepidemiology at the University of Bath in the UK.

  • Monica  Dias, PharmD, PhD, MPharm, RPh

    Monica Dias, PharmD, PhD, MPharm, RPh

    • Head of Supply and Availability of Medicines and Devices, a.i.
    • European Medicines Agency, Netherlands

    Dr. Dias, Head of Supply and Availability at EMA since 2021, leads key initiatives including co-chairing the HMA/EMA Task Force and chairing the Medicine Shortages SPOC Working Party. With a pharmacy degree from Lisbon and a PhD from Cardiff, she joined EMA in 2004, specializing in quality for 10 years before leading policy and crisis coordination. Her expertise includes Brexit preparedness and managing COVID-19-related shortages. Dr. Dias now oversees EMA's extended mandate on shortages under Regulation 2022/123.

  • Sebastian  Fischer

    Sebastian Fischer

    • Regulatory Strategy Principal
    • Tüv Süd Product Service Gmbh, Germany

    Sebastian is Regulatory Strategist at TÜV SÜD in Munich. Before joining the notified body, he spent eight years as Regulatory Intelligence and Policy expert in pharmaceutical industry at Merck KGaA, Darmstadt. He is Biomedical Scientist by training (M.Sc.) and holds a master’s degree in Drug Regulatory Affairs. His key interests are regulation of combination products as well as digital medical devices and Artificial Intelligence.

  • Valentina  Geisseler-Homann

    Valentina Geisseler-Homann

    • Senior Clinical Trial Regulatory Lead
    • F. Hoffmann-La Roche Ltd, Switzerland

    Valentina is a Senior Clinical Trial Regulatory Lead at Roche and has over 15 years’ experience in regulatory and clinical trial development. As a process owner she is providing critical expertise to the End-to-End Clinical Trial Application (CTA) process to ensure compliance and is also contributing to cross-functional initiatives, industry forums and health-authority interactions. Valentina is the Clinical Trial Regulation (CTR) process lead and together with a cross functional team of experts, has developed and implemented new procedures and supporting solutions, including automation-driven solutions to support the successful implementation of the EU CTR at Roche.

  • Michiel  Hendrix

    Michiel Hendrix

    • Senior Advisor European and Global Regulatory Policy and Intelligence
    • EMA, Netherlands

  • Speaker  Invited

    Speaker Invited

    • Switzerland

  • Yves  Jacob

    Yves Jacob

    • Regulatory Affairs Officer
    • sanofi-aventis Recherche & Developpment, France

  • Chitkala  Kalidas

    Chitkala Kalidas

    • VP and Head Oncology Regulatory Affairs
    • Bayer, United States

    Chitkala Kalidas, PhD, is the Vice President & Global Head of Oncology Regulatory Affairs and Oncology Sustainability at Bayer. Dr. Kalidas and her team of global regulatory affairs professionals are responsible for developing global regulatory strategies for Oncology drugs and diagnostics across all stages of development and in over 70 countries. Dr. Kalidas is active in the area of regulatory science and innovation to expedite availability of innovative cancer therapies to patients as well as multi-stakeholder collaboration to enhance access to cancer clinical trials. Dr. Kalidas also leads the Oncology Sustainability/Health Equity Initiative at Bayer.

  • Christophe  Lahorte

    Christophe Lahorte

    • Head of National Innovation Office and Scientific-Technical Advice Unit
    • Federal Agency for Medicines and Health Products, Belgium

    Dr. Christophe Lahorte, PhD. performed academic research for 6 years at the Gent University. Since 2004 he has been actively involved within the R&D department of Belgian agency for medicines and health products (FAMHP) in the quality assessment of CTA’s and PIP’s. In 2009, Dr. Lahorte was appointed as head of the FAMHP’s Unit for National Scientific-Technical Advice & Knowledge Management. In 2017, he became the Head of the FAMHP’s National Innovation Office which aims to support and guide all types of innovators developing new innovative drug products and medical technologies in Belgium and Europe. In addition, he is actively involved in several European projects coordinated by the EMA and European Commission including the ACT EU.

  • Carmen  Laplaza-Santos

    Carmen Laplaza-Santos

    • Head of Unit of Health Innovations & Ecosystems
    • European Commission DG SANTE, Belgium

  • Zili  Li

    Zili Li

    • DIA Global Fellow, Belgium

  • Nicole  Mahoney, PhD

    Nicole Mahoney, PhD

    • Executive Director US Regulatory Policy & Intelligence
    • Novartis Pharmaceuticals Corporation, United States

    Nicole Mahoney is an Executive Director for Regulatory Policy at Novartis, and global regulatory policy lead for data and digital technologies, including real-world evidence and artificial intelligence. Prior to Novartis, she led Regulatory Policy at Flatiron Health, helping support the acceptance of real-world evidence for regulatory decision making in oncology. Nicole developed and advanced anti-infectives policies as a Director of Global Regulatory Policy at Merck, senior officer for the Pew Charitable Trusts' antibiotics and innovation project, and FDA Commissioner’s Fellow. She earned a doctorate in biochemistry from the Albert Einstein College of Medicine and was a postdoctoral fellow at the University of California, San Francisco.

  • Noemie  Manent, PharmD

    Noemie Manent, PharmD

    • TDA-CTT Operations Workstream Lead
    • European Medicines Agency, Netherlands

    Noémie Manent is the Operations Lead in the Clinical Trial Transformation team at the European Medicines Agency, facilitating change management for member states and sponsors with the implementation of the clinical trial Regulation. She has played an essential role in the set up of structured summary results for clinical trials. Also, she has experience in the coordination of inspections for marketing authorisation application. Noemie has more than 15 years experience working in clinical R&D for small and medium enterprises in industry and academia mainly in France and the United Kingdom.

  • Christine  Mayer-Nicolai, PharmD

    Christine Mayer-Nicolai, PharmD

    • VP, Regulatory & Scientific Policy
    • Merck Healtcare KGaA, Germany

    Dr. Christine Mayer-Nicolai, VP, Regulatory & Scientific Policy at Merck Healthcare KGaA, Germany is based in Darmstadt and Washington, DC. She is leading the development of Merck Healthcare regulatory policy priorities, identifying, and responding to global regulatory and legislative issues that impact research, development or lifecycle management with her team. She is personally driving the regulatory policy advocacy agenda through participation on critical US and EU-based external committees and coalitions. Christine headed the section Regulatory Affairs at the German Association of Pharmaceutical Industry (BPI), driving development of industry positions on new regulations for CP, MRP and national MAs for 8 years before joining Merck

  • Lamine  Messaoudi, DVM

    Lamine Messaoudi, DVM

    • Head Of EUCAN Regulatory Policy And Innovation
    • Takeda Pharmaceuticals International Gmbh, Switzerland

  • Anne  Moen, PhD, MSc, RN

    Anne Moen, PhD, MSc, RN

    • Professor, Faculty of Medicine, Coordinator, Gravitate-Health
    • University of Oslo, Norway

    Prof. Anne Moen, is at the Faculty of Medicine at the University of Oslo, Oslo, Norway, and Norwegian Center for eHealth Research, Tromsø, Norway. In her 25 years of research she combines health, nursing and informatics for design and deployment of citizen centered digital tools and services, emphasizing empowerment, digital health literacy and engagement for health and wellness. She is Coordinator of “Gravitate – Health”, IMI project with 39 partners in 15 countries, 2020-2025. She is a Registered Nurse, holds a PhD in Social Sciences with specialization in health informatics, elected Fellow of the American college of Medical Informatics and honorary fellow of EFMI (European Federation for Medical Informatics).

  • Raluca  Negricea, MPharm, MSc, RPh

    Raluca Negricea, MPharm, MSc, RPh

    • Associate Safety Director
    • Roche, United Kingdom

  • Katharina  Nothelfer

    Katharina Nothelfer

    • Director, Strategic Communications
    • AiCuris, Germany

  • Jean Pierre  Nyemazi, MD, MS

    Jean Pierre Nyemazi, MD, MS

    • Unit Head, Governance and Strategic Initiative, AMR Division
    • WHO, Switzerland

    Dr Jean Pierre Nyemazi works at the World Health Organization (WHO), where he coordinates a Quadripartite Joint Secretariat team focusing on multisectoral activities against AMR, including the development of integrated surveillance systems for AMR/AMU, estimating the burden and economic impact of AMR and supporting the Global Governance Structures. Before joining WHO, he was the Permanent Secretary of the Ministry of Health of Rwanda.

  • Marjon  Pasmooij, PhD

    Marjon Pasmooij, PhD

    • Head Science Department
    • MEB, Netherlands

  • Laura  Pioppo

    Laura Pioppo

    • Scientific Administrator, CTIS expert
    • European Medicines Agency, Netherlands

    Pharmacist with a Master degree in Pharmacovigilance, working experience at EMA in the Compliance and Inspection department, since 2016 working on the development CTIS and leading on CTIS transparency aspects, EMA liaison at the Clinical Trials Coordination Group (CTCG) and from October 2023 Programme Manager for the ACT EU initiative.

  • Kelly  Robinson, MSc

    Kelly Robinson, MSc

    • Director General, Marketed Health Products Directorate
    • Health Canada, Canada

    Kelly joined Health Canada in 2001 and has experience in both the pre-market and post-market review and regulation of biologics and pharmaceuticals. Kelly has been involved in initiatives such as international work sharing, HTA alignment and policy related to submissions relying on third party data. Kelly has recently rejoined the Marketed Health Products Directorate as the Director General.

  • Hamada  Sherief

    Hamada Sherief

    • Director of the General Administration of Registration of Pharmaceutical
    • EDA, Egypt

  • Margi  Sheth

    Margi Sheth

    • Director, Data & AI Policy
    • Astrazeneca, United Kingdom

  • Julie  Spony, MA

    Julie Spony, MA

    • Policy Officer
    • European Patients' Forum, Belgium

    Julie Spony is Policy Officer at the European Patients' Forum (EPF), the voice of patient organisations in Europe. In this role, she contributes to EPF's policy and advocacy work, including leading EPF's activities on the revision of EU pharmaceutical legislation. Julie has a multidisciplinary background in Law, Economics and Political Science and holds a Master's degree in European Affairs from Sciences Po Lyon (France). Prior to joining EPF, Julie worked at the European Commission and the European Parliament, focusing on rule of law and human rights.

  • Jonathan  Sutch, PhD

    Jonathan Sutch, PhD

    • Principal Medicinal Technical Specialist
    • BSI Group, United Kingdom

    Dr Jonathan Sutch is a Principal Medicinal Specialist at the Notified Body BSI Group, working with medical devices containing medicinal substances and drug/device combinations. Jon trained as a Pharmacist at the London School of Pharmacy prior to completing a PhD in Pharmaceutical Sciences at Nottingham University. He has 15 years of experience in the pharmaceutical industry as a formulation scientist and manager before moving to BSI 5 years ago.

  • Olga  Tkachenko, PhD

    Olga Tkachenko, PhD

    • Policy Officer
    • European Commission, Belgium

  • Lidewij Eva Vat, DrSc, MS

    Lidewij Eva Vat, DrSc, MS

    • Program Director
    • The Synergist, Netherlands

  • Cathie  Vielle, PharmD

    Cathie Vielle, PharmD

    • Head of the European Pharmacopoeia Department
    • EDQM/Council of Europe, France

    Mrs Cathie Vielle graduated in Pharmacy in 1996 from the University of Strasbourg. Since 1996 she has held several positions in QA compliance and in supply chain departments in an international pharmaceutical company. In September 2005, she became Head of Quality Department at a manufacturing site for worldwide markets (e.g. Europe, USA, Japan). She joined the EDQM in May 2009, as Head of the European Pharmacopoeia Department.

  • Gabriel  Westman

    Gabriel Westman

    • Head of Artificial Intelligence
    • Swedish Medical Products Agency, Sweden

    GW is an infectious disease specialist and associate professor (MD, PhD), member of EMA/HMA Big Data Steering Group and EMA Methodology Working Party. He also has an MSc in Engineering with experience in bioinformatics, AI and big data applications within medicine and pharmaceutics and is currently building regulatory AI/data science capacity and competence at the Swedish Medical Products Agency, exploring use of real-world data, and hoping for a better and data-driven world.

  • Ditte Zerlang Andersen, PhD, MSc

    Ditte Zerlang Andersen, PhD, MSc

    • EU Project Manager
    • Danish Medicines Agency (DKMA), Denmark

    Ditte Zerlang Andersen joined the clinical trial department at the Danish Medicines Agency (DKMA) in 2015. Starting as a clinical trial assessor, she now works as a project manager, leading European alignments in the regulatory clinical trial landscape and is chair for the ‘project and portfolio management’ sub-group of the Clinical Trial Coordination Group (CTCG). Ditte has been responsible for project management in the EMRN DCT project, which has delivered the EU harmonized recommendation paper on decentralized elements in clinical trials from the European medicines regulatory network (EMRN) in Dec 2022. Prior joining DKMA, Ditte worked 5 years in the pharmaceutical industry and have a PhD in neuroscience.

  • Gunilla  Andrew-Nielsen

    Gunilla Andrew-Nielsen

    • Head of Clinical Trials
    • Swedish Medical Products Agency (läkemedelsverket), Sweden

  • Brian  Aylward

    Brian Aylward

    • Clinical Assessor & Chair of the PDCO FWG, EMA
    • Health Products Regularity Authority, United Kingdom

  • Ahmed Hussein  Babiker

    Ahmed Hussein Babiker

    • Head, Drug Registration & Pricing Section
    • Ministry of Public Health, Qatar

    Mr. Babiker has more than 25 years of experience in different fields of pharmacy practice including hospital, community and clinical pharmacy, drug information, patient safety, quality and risk management. By training, he is a pharmacist with an additional Master program from Queens University Belfast in the UK. His research interests are in the areas of patient safety and pharmacy practice. Mr. Babiker has worked as drug information pharmacist at Hamad Medical Corporation, the principal health institute in Qatar. Through his work for the Ministry of Public Health, especially the Community Pharmacies Steering Group and as vaccine registration supervisor, he also has experience with the development of policies.

  • Richard  Ballerand

    Richard Ballerand

    • Patient Advocate/Expert Advisor
    • AXOLOTL/NICE/NHSE/UKABIF/EUPATI, United Kingdom

  • Kate  Bendall

    Kate Bendall

    • Head of Implementation
    • Axian Consulting Limited, United Kingdom

  • Jan  Bertels

    Jan Bertels

    • Chief of Cabinet of the Belgian Deputy Prime Minister and
    • Minister of Social Affairs and Public Health, Belgium

    Jan Bertels is chief of cabinet of the Belgian Deputy Prime Minister and Minister of Social Affairs and Public Health, Frank Vandenbroucke. He is a lawyer by training. Prior to becoming chief of cabinet, he has been an active politician as Member of Parliament and Mayor of the town of Herentals. He was Director General in the federal administration social security for more than ten years.

  • Laurence  Brihaye, MA

    Laurence Brihaye, MA

    • Industry representative
    • Industry, Belgium

    Laurence Brihaye has +20 years of Labelling and Regulatory Affairs experience. Since the beginning of her career at Bristol-Myers Squibb, in addition to her European regulatory procedural expertise, she managed all the EU labelling activities (from PIM to ePI, from translation management to packaging development). She was the Business Lead for the PI translation outsourcing project and actively contributed to the End-to-End labelling transformation of the company. For a few years she has also been a member of the EFPIA's ERAO PI content group and of the IATF Content, Readability, Layout group.

  • Ursula  Busse, PhD, MBA

    Ursula Busse, PhD, MBA

    • Head of Regulatory Affairs
    • Tigen Pharma SA, Switzerland

    Ursula is the Head of Regulatory Affairs at Tigen Pharma, a clinical stage biotech company focused on cell-based cancer therapies. She has over 20 years of experience in Regulatory Affairs, Quality Assurance, Manufacturing and R&D thanks to global leadership roles in both large Pharma (Novartis, Boehringer Ingelheim) and small Biotech companies. She is a long time active member of several non-for profit organizations (namely DIA) and speaks four languages fluently. Ursula holds a PhD in cell and molecular biology and an MBA she earned with honors.

  • Irina  Cleemput, PhD

    Irina Cleemput, PhD

    • Scientific Programme Director
    • Belgian Health Care Knowledge Centre (KCE), Belgium

    Irina Cleemput is scientific programme director at the Belgian Health Care Knowledge Centre (KCE). She holds a PhD in health economics from the KU Leuven, was visiting professor at KU Leuven and UHasselt for several years and director of INAHTA from 2009 to 2015. Her current work focuses on methodologies for Health Technology Assessment, drug reimbursement decision making, patient and public preferences, identification of unmet medical needs and patient involvement in health policy research. Irina is involved in PREFER as chair of the HTA and Payers’ stakeholder advisory group and co-lead partner of the work package responsible for the recommendations resulting from PREFER.

  • John  Concato, MD, MPH, MS

    John Concato, MD, MPH, MS

    • Associate Director for Real-World Evidence Analytics, OMP, CDER
    • FDA, United States

    Dr. John Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research, FDA. As an internist and epidemiologist, his responsibilities related to real-world evidence (RWE) include developing internal Agency processes, interacting with external stakeholders, and coordinating demonstration projects as well as guidance development. Dr. Concato joined FDA from Yale School of Medicine and the U.S. Department of Veterans Affairs, where he was a clinician, educator, independent investigator, research center director, and Professor of Medicine. He has a BE degree from The Cooper Union, MD & MS degrees from New York University, and an MPH degree from Yale University.

  • Solange  Corriol-Rohou, DrMed, MD, PhD

    Solange Corriol-Rohou, DrMed, MD, PhD

    • Senior Director, Global Regulatory Affairs & Policy, R&D, Europe
    • AstraZeneca , France

    Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French Medicines Agency/EMA and academia to the pharmaceutical industry, she has gained strategic experience in drug development. She is quite active within EFPIA, ICH and IMI, and passionate about paediatric drug development.

  • Anette  Hjelmsmark, MS

    Anette Hjelmsmark, MS

    • Senior Regulatory Intelligence Manager
    • Novo Nordisk A/S, Denmark

    Ms. Anette Hjelmsmark holds a position as Senior Regulatory Intelligence Manager at Novo Nordisk A/S headquarters. In her current capacity she leads Novo Nordisk Regulatory Affairs’ efforts on regulatory intelligence and advocacy in China. Before this she spearheaded similar activities in the EU. ATMPs as well as siRNAs are new areas of involvement. She currently chairs the EFPIA China Regulatory Network, is a member of the EFPIA International Regulatory Expert Group covering various regions and countries as well as a member of the EFPIA ATMP SG. Anette is a faculty member at the University of Copenhagen Master of Industrial Drug Development and holds a MSc. from the Royal Veterinary and Agricultural University in Copenhagen, Denmark

  • Veronika  Jekerle, PhD, RPh

    Veronika Jekerle, PhD, RPh

    • Head of Pharmaceutical Quality
    • European Medicines Agency, Netherlands

    Veronika Jekerle joined the European Medicines Agency in 2006 as a Product Team Leader for Recombinant proteins, Vaccines, ATMPs and Biosimilar applications. She held various positions including Quality Specialist and Scientific secretary for the Biologics working party and coordinated numerous guidelines in the area of Biologicals, ATMPs and vaccines as well as initiatives such as interested parties meetings, PRIME toolbox guidance and prior knowledge. Since 2020 she is Head of Office for EMA’s Pharmaceutical Quality Office in the Human medicines Division.

  • Dominique  Lagrave, PharmD

    Dominique Lagrave, PharmD

    • Senior Vice President of Regulatory Innovation
    • Accumulus Synergy, United States

    Dominique has over 25 years of International Regulatory Affairs experience with the last 20 years spent in Global Regulatory Operations leadership role. Past experiences include work at Galderma, Novo Nordisk, Liquent-Parexel and Dendreon. Dominique joined Accumulus as VP of Regulatory Innovation in early 2022 coming from Amgen where he was heading Global Regulatory Operations. As part of his role at Accumulus, Dominique is supporting global Accumulus platform adoption from Health Authorities and Biopharmaceutical organizations. Dominique is also a Board Member of IRISS Forum since 2021 Dominique holds a Pharm D and a master’s in International Regulatory Affairs from the University of Paris.

  • Rogier  Landman, PhD

    Rogier Landman, PhD

    • Associate Director Data Science
    • Pfizer, United States

    Rogier is Associate Director Data Science at Pfizer. He is passionate about using machine learning to build tools a healthy life. He has experience developing machine learning solutions involving natural language processing, generative AI, genomics and proteomics, computer vision and voice analysis. At Pfizer he has worked on anomaly detection in clinical trial data, detection of Covid based on voice, prediction of medication response using multi-omics, and automated generation of regulatory documents. Prior to Pfizer, he worked as a neuroscientist at NIMH, MIT and the Broad Institute, and in data science consulting. He has a PhD in Neuroscience from University of Amsterdam, Netherlands.

  • Antoine  Manson, PharmD, MPharm

    Antoine Manson, PharmD, MPharm

    • Regulatory Policy and Innovation Specialist
    • Bayer AG, France

  • Sylvie  Meillerais, MSc

    Sylvie Meillerais, MSc

    • Director Global CMC Policy
    • MSD Belgium, Belgium

    Sylvie has been engaged in regulatory policy activities for 20 years, through positions in Brussels trade associations, including EFPIA. She joined MSD as Director Global Regulatory Policy in June 2015, where she is now Global CMC Policy Director. Sylvie’s expertise and knowledge of the European pharmaceutical environment serves to drive regulatory policy activities in the areas of CMC and Quality in the EU and globally. She is an active member of the EFPIA Manufacturing and Quality Experts Group and is leading the IFPMA CMC & Quality policy activities. Sylvie holds a Maîtrise in Biochemistry from the University of Bordeaux II.

  • Estelle  Michael

    Estelle Michael

    • RWE Policy & External Engagement Lead
    • UCB, Belgium

    Estelle Michael majored in science and law, and is a recognized global industry policy leader who aims to positively impact people’s lives and to develop sustainable ecosystems, that facilitates patient access to health care solutions. She has partnered with DIA for over twenty years and in collaboration with patient groups, policy makers, academia and industry delivered thought provoking and forward looking panel discussions and workshops. She strives for excellence as a leader, and strongly believes that we need to continuously learn and improve, failing fast and succeeding slow and long

  • Simone Andrea Mohrs, MSc

    Simone Andrea Mohrs, MSc

    • Manager AI and New Digital Technologies
    • MedTech Europe, Belgium

    Simone Mohrs is the AI and New Digital Technologies Manager at MedTech Europe. She is responsible for Artificial Intelligence and emerging digital technologies, leads the AI Working Group, and supports the Digital Health Committee. In her role, Simone aims to facilitate trust between stakeholders when integrating and adopting artificial intelligence and new emerging digital technologies into healthcare systems.

  • Susanna  Palkonen

    Susanna Palkonen

    • Director
    • EFA (European Federation of Allergy and Airways Diseases Patients' Associations), Belgium

  • Leda  Stott

    Leda Stott

    • Specialist Partnerships and Sustainable Development
    • Universidad Politécnica de Madrid, Spain

    Dr. Leda Stott, Senior Research Fellow at Madrid's Technical University, specializes in partnership projects. With 25 years of experience, she's engaged with intergovernmental bodies like the European Commission, United Nations, and World Bank. A seasoned expert, Dr. Stott collaborates with bilateral development agencies, foundations, businesses, and NGOs. Holding a PhD in partnership studies from the University of Edinburgh, she imparts knowledge on the subject in postgraduate programs across the UK, Spain, Norway, and South Africa. She serves as a partnership expert for the European Community of Practice and is an Associate of the Partnership Brokers Association.

  • Valentina  Strammiello, MA

    Valentina Strammiello, MA

    • Director of Programmes
    • European Patients' Forum, Belgium

    Valentina Strammiello is currently the Director of Programmes at the European Patients Forum where she has been working for the past ten years. She oversees the EPF project portfolio and represents EPF in HTA and health data related activities.Before joining EPF, Valentina worked as freelance OSINT analyst on Security and Energy issues. Self-trained in website management and web 2.0 applications, she is among the founders of ecpa2.0 (European Centre for Public Affairs 2.0), a forum of young professionals in Public Affairs. She holds a BA in International Relations and a Master’s Degree in European Studies.

  • Pamela  Tenaerts, MD, MBA

    Pamela Tenaerts, MD, MBA

    • Chief Scientific Officer
    • Medable, United States

    Dr. Pamela Tenaerts, currently serving as Medable's Chief Scientific Officer, is a respected advocate for clinical trial innovation. At Duke University, she previously led the Clinical Trials Transformation Initiative, improving efficiency and the quality of trials. With over three decades in conducting and researching clinical trials, her focus on patient engagement and evidence-based approaches has been notable. A board member at MedStar Research Institute, and an active member of the Drug Forum of the National Academies of Science, she holds an MD from the Catholic University of Leuven and an MBA from the University of South Florida.

  • Ioana  Ulea

    Ioana Ulea

    • Senior Policy Advisor
    • FDA, Belgium

  • Hilde  Vanaken, PhD, MSc

    Hilde Vanaken, PhD, MSc

    • Head, European Forum GCP (EFGCP) eConsent Initiative, Head TCS Industry Leaders
    • EFGCP, TCS, Belgium

    Hilde is a passionate industry leader with +29 years expertise in various drug development domains. She has a track record of turning large and complex programs into realization through collaboration, such as J&J’s Integrated Smart Trial & Engagement program, J&J Expanded Access Programs and Transcelerate eConsent Project. Partnership is part of Hilde’s DNA. Hilde is currently heading up the non-profit multistakeholder European Forum GCP (EFGCP) eConsent initiative, next to her role as Head TCS Industry leaders Life Sciences. Hilde is a PhD in Medical Sciences, Engineer in Microbiology, and Master in Environmental Sciences, all obtained from the University of Leuven in Belgium.

  • Jeevan  Virk

    Jeevan Virk

    • Radioligand Therapy (RLT) Therapeutic Area Strategy Head
    • Novartis, Switzerland

    Jeevan Virk is Therapeutic Area Strategy Head for Radioligand Therapy (RLT) at Novartis. He has previously been involved in commercial and general management roles at Novartis. His background is in biotech, working with Advanced Accelerator Applications, the first company to gain regulatory approval for an RLT with FDA and EMA. Advanced Accelerator Applications was based in Europe and acquired by Novartis in 2018 for $3.9b.

  • Xiaojun (wendy)  Yan, MD, MBA

    Xiaojun (wendy) Yan, MD, MBA

    • Senior Vice President, Chief Regulatory Officer
    • BeiGene (Beijing) Co., Ltd., China

    Wendy is a pharmacist by training, having graduated from Beijing Traditional Chinese Medicine University (China) and received an MBA from Staffordshire University (UK).  She began her career in Beijing Drug Control Institute, subordinate organization of China NMPA in 1988. Since 1996, she had held multiple leading Regulatory Affairs positions at several multinational pharmaceutical companies for 18 years. Wendy joined BeiGene as the Senior Vice President, Global Head of Regulatory Affairs in August 2014. She was appointed as Senior Vice President, Chief Regulatory Officer since 2021.  Wendy has been former Member of DIA Advisory Council of China (ACC). Wendy is Professor of YEEHONG Business School. She is DIA board members as observer.

  • Jasper-Hugo  Brouwers

    Jasper-Hugo Brouwers

    • Head of corporate affairs, stakeholders engagement and medicines use
    • MEB, Netherlands

    Jasper-Hugo Brouwers has been working at the Medicines Evaluation Board in the Netherlands for over 10 years in several roles. Currently he is the head of corporate and stakeholder affairs, including the medicines use team responsible for electronic product information (ePI). He is also chair of the Dutch Network of Patient Information. Before his time at the MEB Jasper-Hugo worked as a consultant for several medical technology and pharmaceutical companies, and holds degrees in business administration and media & communications.

  • Patrick  Brown, PhD, MA

    Patrick Brown, PhD, MA

    • Associate professor
    • University of Amsterdam, Netherlands

    I am a researcher, studying how health care organisations, professionals and patients handle uncertainty and complexity. In particular I am study how organisations and individuals work with risk and uncertainty, and how trust and hope shape this relationship. I have worked at the University of Amsterdam since 2010 where I am an associate professor and research programme leader within the Amsterdam Institute of Social Science Research. Among other professional roles, I am Editor of the journal Health, Risk and Society and am Chair of the research network on the Sociology of Risk and Uncertainty within the European Sociological Association.

  • Nélio Cézar  de Aquino, MSc

    Nélio Cézar de Aquino, MSc

    • General Manager of Medicines
    • ANVISA, Brazil

    Nélio Cézar de Aquino is the General Manager of Medicines at the Brazilian Health Regulatory Agency (Anvisa). He has held various positions at Anvisa, including General Manager of Information Technology, Ports, Airports, Borders, and Customs Warehouses, Public Quality Control Laboratories, Food Registration, and GMP Inspection. He started his career at Anvisa in 2007 as an Inspector of Good Manufacturing Practices. Aquino holds a Bachelor's degree in Pharmacy and Biochemistry and a Master's degree in Pharmaceutical Sciences from the University of São Paulo. He also has specializations in Health Surveillance from the Oswaldo Cruz Foundation and in Micropolitics of Management and Work in Health from the Federal University of Fluminense.

  • Sheila  Dickinson, MSc

    Sheila Dickinson, MSc

    • Global Benefit-Risk Lead
    • Novartis Pharma AG, Switzerland

    Sheila has an in-depth understanding of the topic of patient preferences through several leadership roles and key contributions to the 5.5-year IMI PREFER project which addressed the question of why, when and how to assess and use patient preferences in medical product decision-making. She has been instrumental in developing the PREFER framework for patient preference studies as industry lead. In addition, Sheila has deep expertise in structured benefit-risk and was recognized with a Novartis Leading Scientist Award for her work in this area. She spearheaded the implementation of structured benefit-risk at Novartis to address regulatory expectations and to ensure alignment with the ICHM4E(R2) guidance.

  • Sini  Eskola, MPharm, MSc

    Sini Eskola, MPharm, MSc

    • PhD Candidate
    • University of Utrecht, Netherlands

  • Malin Kristina Fladvad, PhD, MSc

    Malin Kristina Fladvad, PhD, MSc

    • Head of WHODrug Product Portfolio
    • Uppsala Monitoring Centre, Sweden

    Malin Fladvad is a Portfolio officer at Uppsala Monitoring Centre (UMC). In this position she is responsible for the WHODrug Product Portfolio which dictionaries and applications are used in clinical trials and safety monitoring worldwide. Malin is also engaged in various efforts for global implementation of the ISO standard for Medicinal Product Information (IDMP) such as ISO TC 215 WG6 and UNICOM and co-chair the Global IDMP Working Group (GIDWG). She has a master’s in Molecular Biotechnology Engineering and a PhD in Medical Biophysics from Karolinska Institute, Sweden.

  • Jan  Geissler, MBA

    Jan Geissler, MBA

    • Managing Director
    • Patvocates, Germany

    Jan Geissler is the founder and CEO of Patvocates. He also was the Director of EUPATI. As a patient advocate, he co-founded the patient organisations LeukaNET, WECAN, CML Advocates Network, Acute Leukemia Advocates Network and ECPC. Jan represents patients in committees of EU projects and medical societies and is a member of an ethics committee.

  • Mario  Jendrossek

    Mario Jendrossek

    • Health Data Hub, France

  • Lyne  Le Palaire, MSc

    Lyne Le Palaire, MSc

    • Quality Advocacy Leader
    • Sanofi, France

    Lyne Le Palaire is Quality Advocacy Leader, member of Sanofi Global Quality External Liaison department. She is based in Lyon / France. She graduated in 2003 with Master Sciences degree (MSc) in Strategy, Development & Production in Bio-industries obtained in a French University. She has a 19-years experience in pharmaceutical industry within Quality (both Policy & Manufacturing), Supply Chain & Manufacturing Technology. As Quality Advocacy Leader, She is in charge of developing Sanofi Quality Advocacy position, coordinating Quality Advocacy activities and connecting with external stakeholders. She is also involved in cross-functional activities such as the launch of a worldwide regulatory reliance pilot on Post Approval Changes.

  • Mariska  Mulder

    Mariska Mulder

    • Head of Regulatory Affairs, EMEA, LATAM & Marketed Products
    • Ultragenyx Netherlands BV, Netherlands

  • Laurence  O'Dwyer, RPh

    Laurence O'Dwyer, RPh

    • Scientific Affairs Manager
    • Health Products Regulatory Authority, Ireland

    Laurence is a qualified pharmacist. He joined the Health Products Regulatory Authority in 2004 and worked as a quality assessor for almost 12 years before being appointed to his current role of Scientific Affairs Manager in April 2016. Laurence is actively involved in the implementation of a number of initiatives related to the HPRA’s strategic goal to support health product innovation, including the HPRA’s Innovation Office. He is also co-chair of the EU Innovation Network (EU-IN), which has a joint mandate from the European Medicines Agency and the Heads of Medicines Agencies.The EU-IN brings together representatives from innovation offices across the EU medicines regulatory network to facilitate the development of innovative medicines.

  • Katelyn  Rivas, PhD

    Katelyn Rivas, PhD

    • Regulatory Medical Writer
    • Synterex, Inc., United States

  • Elizabeth  Scanlan, PhD, MSc

    Elizabeth Scanlan, PhD, MSc

    • ePI Product Owner
    • European Medicines Agency, Netherlands

    Elizabeth Scanlan joined the European Medicines Agency in 2016 where she is currently Product Owner for electronic product information (ePI). Prior to joining EMA, she worked in communication roles in the biotechnology industry and not-for-profit sector. Elizabeth holds a PhD in molecular biology from Trinity College Dublin.

  • Isabelle  Stoeckert, PharmD

    Isabelle Stoeckert, PharmD

    • VP. Head Regulatory Affairs Europe Middle East Africa PH
    • Bayer, Germany

    Dr. Isabelle Stoeckert is Vice President and Head Regulatory Affairs Europe Middle East Africa at Bayer AG. With more than 20 years of experience in Regulatory Affairs she held several leading positions in a wide area of Regulatory and Scientific Affairs matters. Such as Vice President, Head of Global Strategy and Director, Head of Regulatory Affairs International at Bayer HealthCare AG. She is member of several EFPIA committees.

  • Gert  Thurau, DrSc, PhD

    Gert Thurau, DrSc, PhD

    • Head of Manufacturing Technology Innovation in CMC Regulatory Policy
    • F. Hoffmann-La Roche Ltd., Switzerland

    Dr. Gert Thurau leads Manufacturing Technology and Innovation Advocacy at Hoffmann-La Roche, Basel, Switzerland. He advocates for advanced technology adoption in GMP manufacturing, including continuous processing, process models, robotics, and AI. Recently, he represented EFPIA and Roche in EMA Quality Innovation Group sessions, participated in FDA workshops on innovative manufacturing approaches, and spoke on AI's life cycle management at FDA PQRI workshops in 2023.

  • Milana  Trucl

    Milana Trucl

    • European Patients' Forum, Belgium

  • Jose Francisco  Vallejo Carrera

    Jose Francisco Vallejo Carrera

    • Global Head of Environment & Sustainability
    • Sanofi, France

    Chemical Engineer & Executive MBA, officially certified in Safety & Industrial Hygiene and proficient in Environment, Risk and Sustainability. Passionate by protecting people & planet, leveraging my operational & corporate experience acquired from exposure to culture diversity, international and global teams. Driving the change on the front line and developing people during this journey from vision & strategy to successful implementation with passion and positivism leadership. Sectors: Biopharma, chemical, glass, mining.

  • Gerard  van Westen

    Gerard van Westen

    • Professor Artificial Intelligence & Medicinal Chemistry
    • Leiden Academic Centre for Drug Research, Leiden University, Netherlands

    Gerard van Westen is a full professor in the Division of Drug Discovery and Safety at the Leiden Academic Centre for Drug Research. He is a member of the interdisciplinary research programme Society, Artificial Intelligence and Life Sciences (SAILS). His main area of research is leveraging artificial intelligence with diverse and large-scale public data (‘big data’) for precision medicine.

  • Cammilla  Gomes

    Cammilla Gomes

    • European Federation of the Pharmaceutical Industry - Regulatory LATAM Network , Belgium

    Specialist in Global Health and Health Regulation, with a Master’s Degree in Development and International Cooperation. Broad experience in regulatory policy, both as government and industry. Specialized knowledge and activities in liaising with government agencies, international and regional organizations, industry and other stakeholders in the area of health regulation. Current role in Roche as Regulatory Policy Lead for Latin America, with special focus on Brazil. Other current roles include - Latin America Editor of the DIA Global Forum, Chair of the Latin America Network in EFPIA, member of the scientific committee of the CASSS CMC Forum Latam, and Latin America Advisor to the program committee of the DIA Global Annual Meeting.

  • Tomasz  Grybek

    Tomasz Grybek

    • Patient Representative
    • Fundacja Bohatera Borysa, Poland

    Member of the Board of Directors of EURORDIS – Rare Diseases Europe. CEO of a patient organization called Foundation of Borys the Hero focused on strategic advisory for public entities. Member representing patients' organizations nominated by the European Commission to the Paediatric Committee of the European Medicines Agency (EMA PDCO). Patient Advocate involved as an e-PAG Member of ERN-ITHACA and Patient Board Member of MetabERN. Cooperates closely with the Rare Disease Centre of Medical University in Gdansk. He is a father of a child living with rare neurological disease called metachromatic leukodystrophy.

  • Saima  Khakwani, MPH, MSc

    Saima Khakwani, MPH, MSc

    • Clinical Science Associate
    • Clario, United Kingdom

    Saima Khakwani is a Clinical Science Associate at Clario. Her focus in the team includes diary design best practice such as impact of use of paper and free text in eCOA, patient safety and minimizing risks for commonly implemented PROs and ClinROs and building databases. In her current role, Saima analyzes how our approach to implementing PROs and ClinROs can be tailored to decrease patient burden and increase patient engagement across various therapeutic areas and indications, and builds knowledge databases. She continues to work on research for improving quality of clinical trial delivery and has authored and co-authored numerous works and publications as a result.

  • Sau L Lee, PhD

    Sau L Lee, PhD

    • Deputy Director of Science, OPQ, CDER
    • FDA, United States

    Sau (Larry) Lee is a Senior Biomedical Research Scientist (SBRS). He is a Deputy Director of the Office of Testing and Research in the Office of Pharmaceutical Quality (OPQ), and the chair of the OPQ Emerging Technology Team. He is leading the effort in advancing OPQ research and in manufacturing science, complex drug substances and products, as well as in developing the regulatory policy, scientific standards as well as computational and modeling tools supporting quality review and inspection in OPQ. In early 2013, Larry was promoted to Expert Regulatory Scientist in recognition of his expertise in evaluation of complex drug substances and products.

  • David  Mukanga, PhD, MPH

    David Mukanga, PhD, MPH

    • Deputy Director, Africa Regulatory Systems
    • Bill and Melinda Gates Foundation, United States

    Dr. David Mukanga is Deputy Director Africa Regulatory Systems at the Bill & Melinda Gates Foundation, where he leads the foundation’s Africa regulatory systems optimization portfolio, and the linkage between regulatory systems and health care services. In this role, David supports the development of harmonized, transparent, and predictable regulatory systems covering the lifecycle of medical products in Africa across the national, regional, and continental levels of the ecosystem. His work also involves support for regulatory emergency preparedness. In this role he works side by side with partners on the African continent to facilitate development of new medical products, as well as patient access to quality essential medicines.

  • Georgios  Paliouras

    Georgios Paliouras

    • Chairman of the Board
    • Duchenne Data Foundation, Netherlands

  • Simon  Piatek

    Simon Piatek

    • Digital Analytics Lead
    • London School of Hygiene and Tropical Medicine U. of London, United Kingdom

  • Stephan  Roenninger, DrSc

    Stephan Roenninger, DrSc

    • Director, Quality External Affairs
    • Amgen (Europe) GmbH, Switzerland

    Stephan works in Quality External Affairs at Amgen on Operations/CMC since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. He represents Amgen in EFPIA MQEG and represents EFPIA on GMPs/inspections, in ICH training and ICH-QDG and before on ICHQ9, ICH Q-IWG and ICHQ7-IWG. In PDA he was at the board and chaired RAQAB.

  • Sabine  Straus, MD, PhD, MSc

    Sabine Straus, MD, PhD, MSc

    • PRAC Chair, Staff Member
    • Medicines Evaluation Board (MEB), Netherlands

    Dr. Sabine Straus has been with the Medicines Evaluation Board (MEB) in the Netherlands since 1997, where she started as an Assessor Pharmacovigilance. Prior to working at the MEB she held different positions in the pharmaceutical industry, her last job as Medical Director at Searle Monsanto in the Netherlands. As of July 2012 she is the Dutch member in the Pharmacovigilance Risk Assessment Committee (PRAC). In addition to her work at the MEB she holds a position as associate professor at the Erasmus Medical Center, department of Medical Informatics in Rotterdam. Her main research focus is on additional risk minimisation, pregnancy prevention programs, biologicals, signal detection and signal management.

  • Max  Wegner, PharmD, RPh

    Max Wegner, PharmD, RPh

    • Head Regulatory Affairs
    • Bayer AG, Germany

    After studying pharmacy at the University of Bonn, Max Wegner commenced his PhD in pharmacology at Bayer and started in Regulatory Affairs as a Dossier Manager in 1996 in Wuppertal. Since then, Max has been employed in various functions within Product Development at Bayer and also spent some time in China and the USA. Max Wegner led the Therapeutic Areas organization in Pharmaceuticals Development for four years before re-joining Regulatory Affairs in 2018 as Head of Regulatory Affairs. As a special Pharmacist for Drug Information, he is a member of the examination board of the Pharmacy Association Nordrhein-Westfalen and a college lecturer and speaker for various regulatory topics.

  • Beatrice   Credi

    Beatrice Credi

    • Head of Brussels Office
    • European Lver Patients' Association, Belgium

    After graduating in Political Science and International Relations at the University of Bologna, she started her career as a journalist reporting on EU social policies and policies on disability in Brussels. She completed an Advanced Master's in European Studies at the UCLouvain Saint-Louis University in Brussels and a Master's in International Patient Advocacy Management at the Cattolica University in Rome. She has been working at the European Liver Patients’ Association since 2019, focusing primarily on patient engagement in a multistakeholder environment at the national and international levels. She is currently the head of the ELPA Brussels office.

  • Christine  Dehn

    Christine Dehn

    • Manager Patient Representation & EU Affairs
    • Deutsche Herzstiftung e.V., Germany

    Christine Dehn joined the German Heart Foundation more than 20 years ago. As a patient representative she strongly advocates for patient needs, concerns and thoughts in national, as well as international contexts. She currently is the EHN member in the Patient and Consumer Working Party (PCWP), established by the EMA, where she represents the CVD patient view. Her mission within the German Heart Foundation is to ensure that the patient’s voice is heard whenever it’s about the patient – be it in political discussions, research projects or clinical settings.

  • Lisa  Ensign, PhD, MSc

    Lisa Ensign, PhD, MSc

    • VP, Data Science
    • Medidata AI, United States

    Lisa Ensign is a VP of Data Science at Medidata AI. Her current work in the Integrated Evidence team is focused on creating analytical approaches to improve and transform the efficiency and rigor of clinical trials, centered on the use of external controls. Dr. Ensign began her career at MD Anderson Cancer Center and has over 30 years experience in the life sciences sector. She received her MS in biostatistics from Harvard University and her PhD in clinical science from the University of Colorado, where she is also an instructor on ethics and the responsible conduct of research.

  • Roberto  Frontini

    Roberto Frontini

    • Director of Pharmacy
    • Centre for Patient Safety Leipzig, Germany

  • Inka  Heikkinen, MBA, MS, MSc

    Inka Heikkinen, MBA, MS, MSc

    • Director, Global Regulatory Policy
    • MSD, Denmark

    Generalist with a broad understanding of policies across value chain in pharmaceutical and health sector. Stakeholder, alliance and project management expertise.

  • Carolyn  Hynes, PhD

    Carolyn Hynes, PhD

    • Senior Director Regulatory Intelligence
    • AstraZeneca, United Kingdom

    Carolyn Hynes is a Senior Director leading the regulatory intelligence team in Oncology Regulatory Science, Strategy & Excellence at AstraZeneca. She has more than 20 years of experience working in large pharmaceutical companies in regulatory intelligence and policy roles. Carolyn holds a PhD in cardiovascular pharmacology from Queen Mary College, University of London.

  • Nathalie  Moll

    Nathalie Moll

    • Director General
    • European Federation of Pharmaceutical Industries and Associations (EFPIA), Belgium

    Nathalie Moll is Director General at the European Federation of Pharmaceutical Industries and Associations (EFPIA). EFPIA represents the pharmaceutical industry operating in Europe. Together with its direct membership 40 leading pharmaceutical companies, 33 national associations representing over 1,900 companies and in collaboration with health and research players, EFPIA's mission is to create an environment that enables members to innovate, discover, develop and deliver new therapies and vaccines for people across Europe, as well as contribute to the European economy.

  • Rita  Purcell, LLM

    Rita Purcell, LLM

    • Deputy Chief Executive
    • Health Products Regulatory Authority (HPRA), Ireland

    Rita Purcell is the Deputy Chief Executive at the Health Products Regulatory Authority where she has responsibility for international affairs, finance, legal, regulatory affairs, corporate governance and infrastructure. She has lead on a number of international initiatives and is an active participant in the International Coalition of Medicines Regulatory Authorities (ICMRA). Rita is a member of the Board of the European Medicines Agency and has experience on other Boards and audit committees. She read law at University College Dublin and is qualified as a Chartered accountant. She previously worked for Price Waterhouse in Dublin and San Francisco and also has worked in the construction and food industries in the areas of finance

  • Barbara  Stubbe

    Barbara Stubbe

    • GMP/GDP Inspector
    • FAGG-AFMPS, Belgium

  • Andrew  Warrington

    Andrew Warrington

    • Life sciences & tech advisor
    • Microsoft, Switzerland

  • J. Rubin  Abrams, PhD

    J. Rubin Abrams, PhD

    • Quantitative Medicine Scientist
    • Critical Path Institute, United States

  • Sevengul  Car, MS, MSc

    Sevengul Car, MS, MSc

    • PhD researcher
    • KU Leuven, Belgium

  • Remi  Savage

    Remi Savage

    • ESG Analyst
    • Candriam, Belgium

  • Adrian  van den Hoven

    Adrian van den Hoven

    • Director General
    • Medicines for Europe, Belgium

    Adrian van den Hoven joined Medicines for Europe as a Director General in September 2013. His priorities at Medicines for Europe are to stimulate competition in off-patent medicine markets, to foster market access for generic, biosimilar and value added medicines, to support policy measures for sustainable pricing, to promote high regulatory standards while ensuring that the associated costs can be integrated into market dynamics and to develop a coherent EU industrial strategy to support the long-term viability of the generic, biosimilar and value added medicines industries.

  • Guenter  Waxenecker

    Guenter Waxenecker

    • Head of the Austrian Medicines and Medical Devices Agency
    • Austrian Medicines and Medical Devices Agency (AGES), Austria

    Günter Waxenecker, with a Master's in drug regulatory affairs, boasts 20+ years in drug development. Recognized for innovation and efficiency, he leads the Austrian Medicines and Medical Devices Agency since 2023, following key roles at Vienna SMEs and the Austrian Federal Office for Safety in Health Care. His expertise spans interdisciplinary know-how, cross-functional collaboration, change management, and international experience. As a lecturer at FH Campus Tulln, FH Joanneum Graz, and Vetmed Vienna, he shares his wealth of knowledge.

  • Marco  Greco, PhD

    Marco Greco, PhD

    • President
    • European Patients' Forum, Belgium

    Dr Marco Greco is the President of the European Patients' Forum (EPF).He currently sits on the Management Board of the European Medicines Agency (EMA) and acts as an observer on the Patients and Consumers Working Party,on behalf of the Board.He works as an attorney at his law firm,focusing on litigation,commerce and consumers' protection legislation.He has been chairman of the European Federation of Crohn's and Ulcerative Colitis Association (EFCCA) and the founder of the EFCCA Youth Group.After an LL.MM in Law, he earned a PhD in Law and Religion, religious freedom and discrimination and canon law at the Universita Cattolica del Sacro Cuore in Milan,where he still collaborates with the Chair of History and Systems of Church-State relations

  • Emma  Du Four, MBA

    Emma Du Four, MBA

    • Regulatory and R&D Policy Professional
    • -, United Kingdom

    Regulatory and R&D professional with extensive experience across a network of industry, government, academic and healthcare system partners and stakeholders. Broad range of expertise in all aspects of medicines and device research and development including evidence generation, licensing, manufacturing, market access and on-market support. Specific areas of expertise include clinical trials, biologics, real world evidence, paediatric drug development, medical devices, pharmacovigilance, CMC and regulatory policy and strategy development.

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