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Meet Us at DIA Europe 2023

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 2023 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.

Organizations

Speakers

  • 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 recently joined MSD to lead regulatory policy efforts for innovation that will lead to better treatment for patients in Europe, the Middle East, Africa and Asia. In particular, she is supporting work on science policy, regulatory innovation and integrated evidence generation. Before joining MSD, Ginny was the senior spokesman for the industry in the UK for research, medical and innovation policy. She was responsible for ABPI’s work on BREXIT for the life sciences sector. Previously, Ginny worked for Amgen and Pfizer.

  • Peter Richard Arlett, MD, FFPM, FRCP

    Peter Richard Arlett, MD, FFPM, FRCP

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

    Dr Peter Arlett - Head, Data Analytics and Methods Task Force, European Medicines Agency. Education: Medical Degree, University College London 1991; Member, Royal College of Physicians (MRCP) of London 1994; Fellow of the Faculty of Pharmaceutical Medicine (FFPM) of the Royal College of Physicians of London 2007; Fellow of the Royal College of Physicians of Edinburg 2017; Honorary Professor, London School of Hygiene and Tropic Medicine (2020). Career to date: Head of Pharmacovigilance and Epidemiology Department, EMA 2008 – 2020; Principal Administrator, Pharmaceuticals Unit, European Commission 2003-2008; UK MHRA 1996-2003; Hospital Physician, Oxford and London, UK NHS 1991-1996.

  • 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 numerous discussions within Roche and EFPIA, e.g. EU Clinical Trial Regulation, adaptive pathways, incentives, real world data. To that end, she has been seconded to EFPIA from 2015-2016. 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. Earlier roles included head of the coordination unit for drugs for the German Länder at ZLG and head of unit at the regional Ministry of Health in Hesse

  • Corey Michael Benedum, PhD, MPH

    Corey Michael Benedum, PhD, MPH

    • Quantitative Scientist
    • Flatiron Health, United States

  • Lourens  Bloem, PharmD, PhD, MSc

    Lourens Bloem, PharmD, PhD, MSc

    • Assistant Professor Clinical Therapeutics
    • Utrecht University, Netherlands

    Lourens Bloem (PharmD, PhD) is assistant professor at Utrecht University, The Netherlands. He was trained as a pharmacist and holds a PhD from the Utrecht Institute for Pharmaceutical Sciences (UIPS). Next to his doctoral studies, he worked as pharmacovigilance assessor at the Dutch Medicines Evaluation Board. His research focuses on Drug Regulatory Science, especially on aspects of evidence generation for regulatory decision-making and their effects on downstream decision-making, for example on reimbursement or in clinical practice. In addition, he is Programme Manager Drug Regulatory Science for the Utrecht Science Park, drawing on his research experience as well as previous work experience at the Dutch Medicines Evaluation Board.

  • 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, and her previous role at Johnson & Johnson, 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.

  • Thomas  Brookland, MSc

    Thomas Brookland, MSc

    • EU Data 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.

  • Ursula  Busse, PhD, MBA

    Ursula Busse, PhD, MBA

    • Head of Regulatory Affairs
    • Tigen Pharma SA, Switzerland

    Ursula is the Head of Regulatory Intelligence and Policy at Boehringer Ingelheim (BI) and in charge of global regulatory intelligence and regulatory policy activities. Prior to her current role, Ursula held leadership roles in Quality Intelligence and External Affairs, Biopharmaceutical Operations and CMC Regulatory Affairs at Novartis. Before joining Novartis in 2006, she worked for startup biotechnology companies in Canada for 10 years, in research, development, Quality Assurance and CMC Regulatory Affairs. Ursula holds a Master’s degree in Biology from Tübingen University (Germany) and a PhD in Cellular and Molecular Biology from Laval University (Québec, Canada), coupled with an MBA she earned with honors.

  • Claudia  Cabrera

    Claudia Cabrera

    • Senior Director Epidemiology & Evidence Excellence, AstraZeneca AB
    • Adj Researcher Karolinska Institute, Dept Epidemiology and Biostatistics, Sweden

    Claudia Cabrera graduated from Tulane University School of Public Health with a master’s degree in international public health and a concentration in Epidemiology and Biostatistics. She completed her doctorate degree in Epidemiology, and she also holds a Licentiate in Medical Science, from 2005. Claudia has worked in Industry for 17 years across all therapy areas and patient safety, of late she has focused on the build of large global studies related to respiratory disease. In her most recent position, she leads studies in Patient Safety, China RWE development as part of the Global Evidence Hub, as well as leading Clinical Trial Diversity research.

  • 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.

  • Michelle  Crouthamel, PhD

    Michelle Crouthamel, PhD

    • Managing Director, Digital Health Strategy
    • AbbVie, Inc., United States

    Michelle Crouthamel is a recognized industry leader who integrates digital health in pharmaceutical development and collaborates broadly with academics, tech, consortia, and health authorities to create impacts. As the Head of Digital Science at AbbVie, Michelle leads digital strategy and implementation in RCT and RWE. Prior to joining AbbVie, Michelle led many successful R&D programs at Merck and GSK. She is a scientific advisor to many tech companies, an inventor who holds multiple patents, and an author who published extensively in Neuroscience, Oncology, and Digital Health.

  • Juan  Garcia-Burgos, MD, PhD

    Juan Garcia-Burgos, MD, PhD

    • Head of Public and Stakeholders Engagement
    • 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.

  • Markus  Goese

    Markus Goese

    • Head EU CMC Regulatory Policy
    • F. Hoffmann-La Roche Ltd, Switzerland

    Markus Goese holds a Ph.D. in Biochemistry/ Organic Chemistry from the Technische Universität München (Munich), Germany. He has over 20 years industry experience in various companies (Roche, DSM, Novartis) in Pharmaceuticals and Fine Chemicals Research, Development and Commercialization. For the last 15 years he has been working in CMC Regulatory Affairs, initially on Biopharmaceutical Products in early- and late-stage development, and in 2011 he then took on the responsibility as EU Lead CMC Regulatory Policy for Roche Pharma Global Technical Operations. Markus is based in Basel, Switzerland. He is currently Chair of EFPIA's Manufacturing and Quality Expert Group (MQEG) and Co-Lead of EFPIA's PRIME CMC team.

  • Vicky (Fengyun)  Han

    Vicky (Fengyun) 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 spans in 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 has led the RA team in pharmaceuticals and vaccines’ in GSK China before moving to GSK vaccines headquarters in Belgium in 2018. In GSK Bio Global, 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.

  • Shahid  Hanif, PhD, MSc

    Shahid Hanif, PhD, MSc

    • Managing Director
    • GetReal Institute, Canada

  • Helena  Harnik

    Helena Harnik

    • Program Director
    • The Synergist ASBL, Belgium

  • Martin  Harvey Allchurch, LLM

    Martin Harvey Allchurch, LLM

    • Head of International Affairs
    • European Medicines Agency, Netherlands

    Martin Harvey Allchurch 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 earned Law degrees from the University of Dundee (UK) and Vrije Universiteit Brussels (Belgium).

  • Inka  Heikkinen, MBA, MS, MSc

    Inka Heikkinen, MBA, MS, MSc

    • Director, Global Regulatory Policy
    • MSD, Denmark

  • Anne-Sophie  Henry-Eude, PharmD

    Anne-Sophie Henry-Eude, PharmD

    • Head of Access to Documents Department
    • European Medicines Agency, Netherlands

    Anne-Sophie Henry-Eude is a doctor in pharmacy with post-graduate degrees in Regulatory Affairs and Pharmacovigilance & Pharmacoepidemiology. She worked in the pharma industry then joined EMA as product team leader for anti-infectives. She then worked on paediatric investigation plans in the HIV field. In 2013 she became Head of the new Access to Documents Service and with the implementation of the policy on Clinical Data Publication, she is now Head of Documents Access & Publication at EMA.

  • Esteban  Herrero-Martinez, PhD

    Esteban Herrero-Martinez, PhD

    • Director Regulatory Policy and Intelligence
    • Abbvie Ltd, 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

  • Milou  Hogervorst, PharmD, MSc

    Milou Hogervorst, PharmD, MSc

    • PhD Candidate
    • Utrecht University, Netherlands

    I studied Pharmacy between 2012-2019 at Utrecht University and added a Master’s in Health Economics Policy and Law from Erasmus University between 2016-2018. Currently I am doing a PhD at the UU within the H2020 HTx project. My interest for research was sparked during an internship on US pharmaceutical pricing policies at the University of California San Francisco where I lived in 2018.

  • Tony  Humphreys, MPharm

    Tony Humphreys, MPharm

    • Head of the Regulatory Science and Innovation Task Force
    • European Medicines Agency, Netherlands

    He is the Head of the Regulatory Science and Innovation Task Force (TRS). He is responsible for providing leadership in the taskforce and the Agency to enable it’s continuous future proofing through operation of a regulatory science observatory, addressing key scientific and technological trends and their translation through the development of regulatory science strategy, planning and governance.

  • Judith Catherine Macdonald

    Judith Catherine Macdonald

    • Senior Director, Global Policy Development
    • Pfizer, United Kingdom

    Judith is responsible for global regulatory policy development at Pfizer. She has more than 30 years’ experience in regulatory affairs, where she was responsible for registration of small molecule and biological products across the entire development cycle. Judith joined Pfizer in 2007 working in regulatory strategy, public affairs and regulatory policy. In 2016 she moved into a dedicated regulatory policy role heading up the policy team for Pfizer’s essential health products. In January 2019 she became responsible for global policy development on the innovative product portfolio focusing on regulatory science advocacy. Judith serves on IFPMA’s RSC/ICH Management Committee and works with Accumulus on Global regulatory Policy.

  • Marina Alexandra Malikova, PhD, MS, RAC

    Marina Alexandra Malikova, PhD, MS, RAC

    • Executive Director, Translational Research, Assistant Professor of Surgery
    • Boston University School of Medicine, United States

    Dr. Malikova has over 15 years of experience in the clinical research field, with 8 years’ experience on executive level. She has managed Phase I – IV studies involving investigational drugs, devices, biologics and combination products. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.

  • Michael  Meighu, PhD, MS

    Michael Meighu, PhD, MS

    • Director of Consulting - Expert, Artificial Intelligence
    • CGI, United States

    Dr. Meighu is a specialist in Artificial Intelligence and how it relates to Knowledge Science and Innovation. With 20+ years in the Life Science industry, he has an acute perspective in its data pain points, use cases, and paths for resolutions, in order to create more robust innovation ecosystems. His AI and related experiences includes building complex Ontology systems to make data inter-operable and improve search, Natural Language Processing, and Classification.

  • 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).

  • Mireille  Muller, DrSc, PhD, MSc

    Mireille Muller, DrSc, PhD, MSc

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

    Mireille Muller Ph.D. has over 20 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, and technology-enabled clinical trials and digital systems. Involved in several public private partnership IMI programs such as PREFER.

  • Koen  Nauwelaerts, PharmD, PhD, MBA

    Koen Nauwelaerts, PharmD, PhD, MBA

    • Regulatory Policy and Innovation Lead
    • Bayer AG, Belgium

    Dr. Koen Nauwelaerts is Head Regulatory Affairs and Quality Belgium and Luxembourg at Bayer. Before joining Bayer he worked in various Regulatory Affairs and Quality positions in the pharmaceutical industry. Koen Nauwelaerts holds a PhD and Master Degree in Pharmacy as well as an MBA degree.

  • Lars Rugholm  Nielsen, MSc

    Lars Rugholm Nielsen, MSc

    • Special Adviser
    • Danish Medicines Agency, Denmark

  • Chelsea  O'Connell, MSc

    Chelsea O'Connell, MSc

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

    Chelsea O’Connell, MS, RAC, joined Amgen in 2011 and is currently a Global Regulatory and R&D Policy Director, where she advances strategic regulatory policy goals by engaging with regulatory authorities, industry, professional associations, and other stakeholders across various policy topics. Prior to joining Policy, she was a Regulatory Lead and developed and executed filing strategies across various therapeutic areas and product presentations. Previous to Amgen, she worked for several medical device companies in ophthalmology and cardiology. She earned a B.S./M.S. from California Polytechnic State University, San Luis Obispo in Biomedical Engineering.

  • Marc  Philipp

    Marc Philipp

    • Partner & Managing Director
    • Kearney, Germany

  • Francesco  Pignatti, MD

    Francesco Pignatti, MD

    • Head of Oncology and Hematology
    • 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. His main regulatory science interests include cancer clinical trial methodology, benefit-risk analysis, and stated preference studies.

  • Matt  Popkin, PhD

    Matt Popkin, PhD

    • Director, CMC Strategy
    • GlaxoSmithKline, United Kingdom

    Matt Popkin achieved a degree in Chemistry from the University of Bristol & 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 several roles in the CMC development and registration of novel medicines. Currently Director, CMC Strategy and Advocacy for CMC Regulatory Affairs. Matt represents GSK on the Manufacturing & Quality Expert Group of EFPIA, where he was a member of the ICH Q11 Implementation Working Group, who developed the Q&A on API Stating Materials completed in 2017. Since its inception in 2019, he has represented EFPIA on the new ICH Informal Quality Discussion Group.

  • Claudia  Popp

    Claudia Popp

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

  • Valerie  Powell, MS

    Valerie Powell, MS

    • Chief Patient Officer, CorEvitas and EVP, Patient Experience
    • Corevitas, LLC, United States

    Valerie Powell has over 35 years of experience in the pharmaceutical space and an advanced degree in Instructional and Performance Technology. She is the Chief Patient Officer of CorEvitas, ensuring the organization's services center on and address the needs of patients worldwide. As EVP, Valerie also oversees business growth and delivery for Patient Experience Team of CorEvitas, where research teams use a range of methodologies to uncover insights into the patient lived experience. Ms. Powell is passionate about learning what matters most to patients and finding the most effective ways to motivate and engage them across the product lifecycle.

  • Tina (Ting)  Wang, MSc

    Tina (Ting) Wang, MSc

    • Senior Manager, HTA programme and strategic partnership
    • CIRS- Centre For Innovation In Regulatory Science, United Kingdom

  • Amira Deia Younes

    Amira Deia Younes

    • Associate Director, Regulatory Policy and Intelligence, MEA, Russia & CEE
    • Abbvie, United Arab Emirates

    Amira is currently Associate Director, Regulatory Policy and Intelligence for Eastern Europe, Middle East, and Africa at AbbVie, supporting regulatory policy advocacy efforts for the region. She has over 10 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.

  • Martine  Zimmermann, PharmD

    Martine Zimmermann, PharmD

    • Senior Vice President, Head of Global Regulatory Affairs, R&D Quality
    • Ipsen Innovation, France

    Martine Zimmermann is Senior Vice President and Head of Regulatory & Quality Affairs at Alexion, AstraZeneca Rare Disease. Dr Zimmermann has over 25 years of combined R&D and global regulatory strategy experience. She joined Alexion Pharmaceuticals (part of AstraZeneca since 2021) in 2009 and has since then been dedicated to the registration of several orphan medicinal products across the globe, as well as to the shaping of the regulatory environment for medicines under development for rare diseases. Prior to Alexion Pharmaceuticals, Dr Zimmermann held numerous R&D and regulatory roles in companies such as Aventis (now Sanofi), Servier and H. Lundbeck A/S. Dr Zimmermann also serves currently as a Director in the Board of Inventiva Pharma.

  • Susana  Almeida, PhD

    Susana Almeida, PhD

    • Clinical Development and Safety Director
    • Medicines for Europe, Belgium

    Dr. Susana Almeida is Clinical Development and Safety Director at Medicines for Europe. Before joining Medicines for Europe, Susana was the Chair of the Association’s Bioequivalence Working Group for almost 15 years. She has worked in clinical development in Europe and in North America, and her experience includes the pharmaceutical industry and clinical research organizations. At Medicines for Europe, Susana is responsible for the coordination of multiple working groups involving policy and regulatory science. She is a Topic Leader in the drafting committee of the ICH’s M09 topic. She holds a PhD from the Faculty of Medicine, Universidad Autònoma de Barcelona and has authored numerous publications.

  • 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.

  • Susan  Bhatti, PhD

    Susan Bhatti, PhD

    • Director EU Global Regulatory and Scientific Policy, Global Regulatory Affairs
    • Merck Healthcare, Netherlands

    Dr Bhatti has over 25 years of experience working in Regulatory Affairs and Medical Writing in both pharmaceutical and CRO companies. She has been working in the regulatory scientific policy area for the past 6 years and has a particular interest in patient engagement and patient focused drug development.

  • Helena  Corte-Real Correia, PhD

    Helena Corte-Real Correia, PhD

    • Global Head of Regulatory Operations
    • F. Hoffmann-La Roche Ltd, Switzerland

    Helena Corte-Real Correia is the Global Head of Regulatory Operations 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. Joined the Regulatory Affairs group at Roche in 2003 and is currently leading the Operations group through digital transformation. Helena is passionate about using science and technology to improve people’s lives.

  • Annick  De Bruin, MBA

    Annick De Bruin, MBA

    • Senior Director, Research Services
    • CISCRP, United States

    Annick de Bruin is the Senior Director of Research Services at the Center for Information and Study on Clinical Research Participation (CISCRP). She is responsible for the design, implementation, analysis and reporting of a variety of CISCRP research studies including the Perceptions & Insights studies and numerous Patient Advisory Boards. She has more than 20 years of experience conducting primary and secondary research studies in the healthcare, life sciences and consumer goods industries. She holds an MBA from the Graduate School of Management at Boston University and a Bachelor of Science degree from Bryant University.

  • Jelena   Duza

    Jelena Duza

    • Junior Manager
    • Novartis, Switzerland

  • Theo  Favard

    Theo Favard

    • Vice President of External Relations
    • European Pharmaceutical Students' Association (EPSA), Belgium

    Theo is a 5th year pharmaceutical student from Montpellier, in the south of France. He is currently an intern at EFPIA in the Science Policy and Regulatory Affairs team and Vice President of External Relations in EPSA. He is responsible for sponsorships and partnerships of EPSA, in charge of taking care of the EPSA interests in European organisations based in Brussels and also to carry out tasks as EPSA Permanent Officer. Theo is also responsible for the following Coordinators: Mobility and Professional Affairs and in charge of ensuring that they are well performing and fulfilling their tasks and in the absence of any of them take over their responsibilities.

  • Mick  Foy

    Mick Foy

    • Deputy Director of Patient Safety Monitoring
    • Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

    Mick Foy has been with the MHRA for more than 30 years, he is a member of the MHRA’s Senior Leadership team and has recently been appointed Deputy Director of Patient Safety Monitoring . Amongst his responsibilities is to lead MHRA efforts to build PV capabilities in other countries particularly low and middle income countries as part of a global initiative with the Bill and Melinda Gates Foundation. Mick continues to have responsibility for the UK Yellow Card scheme with regard to the vigilance of medicines, medical devices and blood. Mick is Chair of the MedDRA Management Committee.

  • Jan  Geissler, MBA

    Jan Geissler, MBA

    • Managing Director
    • Patvocates, Germany

    Founder and Managing Director of Patvocates. Former Director of the European Patients' Academy (EUPATI). Cancer survivor and co-founder of the CML Advocates Network, the Leukemia Patient Advocates Foundation, LeukaNET, Leukämie-Online and the European Cancer Patient Coalition.

  • Sabine  Haubenreisser, PhD, MSc

    Sabine Haubenreisser, PhD, MSc

    • Principal Scientific Administrator, Stakeholders and Communication Division
    • European Medicines Agency, Netherlands

    Sabine Haubenreisser is a pharmacologist with special interest in scientific cooperation and regulatory convergence to the benefit of public health, through engagement with external stakeholders, the European network of experts and international partners and regulators. She has held positions at EMA in scientific divisions, international affairs and (currently) stakeholder engagement. She served 5 years as EMA Liaison Official at the US FDA, where she facilitated cooperation between the European Regulatory Network and the FDA. During this time, she oversaw completion of the EU/US Mutual Recognition Agreement on GMP inspections and development of new platforms for cooperation such as on patient engagement, rare diseases and pharmacometrics.

  • Claudia  Hey, DrSc, PharmD

    Claudia Hey, DrSc, PharmD

    • Senior Director, Head Europe Global Regulatory & Scientific Policy
    • Merck Healthcare KGaA, Germany

    Claudia has extensive regulatory affairs expertise (> 20 years) including clinical and pediatric development, registration, and life-cycle management of medicinal products in oncology, immunology and general medicines. At EFPIA Claudia is chairing the Scientific Dialogue WG which compiled the EFPIA Reflection paper on integrated R&D product support along the product lifecycle. The group currently works on Qualifications providing recommendations for improving this important development tool. She is also a member in the EFPIA Expedited Pathways WG and the Pediatrics WG. Claudia holds a Doctorate in Pharmacy from the University of Frankfurt.

  • Katrin  Manlik

    Katrin Manlik

    • Data Scientist
    • Bayer AG, Global Pharmacovigilance, Germany

  • 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 in Regulatory Technology expert groups. He is a member of the Accumulus Consortium Leadership Team and co-chairs its EU subcommittee. He has over 25 years of experience in data and technology strategy, Information Technology management, software development and consulting.

  • Magdalini  Papadaki, PhD, MBA, MSc

    Magdalini Papadaki, PhD, MBA, MSc

    • Director, Regulatory Affairs International
    • United Kingdom

    A cell and gene therapy scientist with over a decade regulatory and business experience in the EU and US. She joined MSD from the ABPI as Head of Product & Process Innovation. Magda’s experience includes Innovate UK, the MIT Center for Biomedical Innovation and Regulatory Affairs Director at Novartis Greece and Cyprus. Specialises on the development of partnerships to reshape the HA and HTA assessment of novel treatments and was member of the global consortium developing the Adaptive Pathway paradigm in MIT. She holds a PhD in Gene Therapy from the Un. of Athens, an MPhil in Bioscience Enterprise from the University of Cambridge, UK and MSc in Pharmacology from the University of Oxford.

  • Nikos  Paragios

    Nikos Paragios

    • President & Chief Executive Officer
    • TheraPanacea, France

  • Elena  Popa, MPharm

    Elena Popa, MPharm

    • Regulatory Policy & Innovation Lead
    • Bayer, Switzerland

    Elena is a pharmacist by training with a master in drug safety and pharmacovigilance. She joined Bayer as a Regulatory Policy & Intelligence Lead and provides direction and development of Regulatory Policy & Intelligence activities supporting Bayer’s pipeline and strategies, with a particular emphasis on the regulatory use and acceptance of RWD/RWE in drug development. Before joining Bayer, Elena was a Senior Manager, Scientific Programmes at Drug Information Association and engaged annually with over 500 stakeholders and volunteers from the entire healthcare ecosystem. In her free time, Elena is passionate about traveling, visiting art museums, painting and watching Formula 1 (#essereFerrari).

  • Smita  Robinson

    Smita Robinson

    • Director - Regulatory Labelling
    • Pfizer, United Kingdom

    Smita has over 20 years of experience in the pharma Industry at Pfizer. Her career started within pharmaceutical sciences where she had the role of clinical supplies manager. Here she worked on the delivery of clinical supplies demand, manufacturing, packaging and distribution for Human Health and Veterinary medicinal products. She then moved to Regulatory Operations. She was a labelling manager developing core labelling, USPI and EU CP labelling. From here she took on the role of leading and developing the translations model and organisation for regulatory operations. This then led to heading up the Investigator Brochure team. Today Smita works with the international labelling organisation leading the Digital Labelling Centre.

  • Stephan  Roenninger, DrSc

    Stephan Roenninger, DrSc

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

    Stephan Rönninger holds a PhD-engineering degree in organic chemistry from the TU Darmstadt, Germany, and was appointed as Adjunct Assistant Professor at GWU, Washington D.C. and is an Academic visiting expert of the National University of Singapore. He is in the Quality External Affairs organization in Amgen organizing the operational policy outreach and external ambassador program. He collaborates cross-functional internally and with external stakeholders including authorities, associations and competitors on topics regarding quality management, and good manufacturing and distribution practice (GMDP) as well as CMC topics by providing comments on regulatory guidelines, intelligence, and training.

  • Junko  Sato, PhD

    Junko Sato, PhD

    • Director, Office of International Programs
    • Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Office Director for the Office of International Programs. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 6 yrs. She also worked in U.S. FDA as a guest reviewer from 2002-2003, and in EMA as the Japan Liaison Officer from 2012-2014. She is actively involved in many academic societies, and contribute them as counselor, committee member, and a board member.

  • 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.

  • Adrian  van den Hoven

    Adrian van den Hoven

    • Director General
    • Medicines for Europe, Belgium

  • Sarah  Vaughan

    Sarah Vaughan

    • Head of Vigilance Development
    • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

    Sarah has worked in pharmacovigilance at the MHRA for the past 15 years, with 6 years as the Pharmacovigilance Information Unit Manager. She has been MHRA representative on the MedDRA Points to Consider Group, and worked on implementation of the 2012 EU Pharmacovigilance legislation. Her current role is the Head of Vigilance Development, focussing on the development and transformation of the Agency's vigilance systems for all medicinal product types. Sarah leads on key projects in the Agency's Patient Safety function, engaging with strategic stakeholders in the UK healthcare system for adverse incident data collection and signal management processes.

  • Kathy  Wang, MSc, RAC

    Kathy Wang, MSc, RAC

    • Director, Devices & Digital Therapeutics, CMC Regulatory Affairs
    • AstraZeneca, Sweden

    Kathy Wang is a regulatory affairs professional with strong record in the medical device and drug-device combination product field. In her current position as a Regulatory Affairs Director, Devices and Digital Therapeutics at Astrazeneca, she supports the company in developing and marketing drug and device combined products. She provides regulatory strategy support to projects from pre-clinical phase to marketing. Before joining Astrazeneca, she was responsible for the development and implementation of global regulatory strategies of implantable medical devices at Cochlear Ltd. Having lived and worked in China, Australia and Sweden, Kathy has extensive experience and strong interest in international regulatory affairs.

  • Susanne  Ausborn, PhD

    Susanne Ausborn, PhD

    • Global Head International Regulatory Policy
    • F. Hoffmann-La 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.

  • Priya  Bahri, PhD, RPh

    Priya Bahri, PhD, RPh

    • 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.

  • Patrick  Brady, PharmD

    Patrick Brady, PharmD

    • Head Regulatory Policy & Intelligence
    • Bayer AG / Research & Development, Pharmaceuticals, Germany

    Dr. Patrick Brady is Vice President, Regulatory Affairs at Bayer. In this role, he leads Bayer’s global regulatory policy and intelligence activities. He has more than 10 years of experience in Regulatory Affairs. Prior to joining Bayer, Patrick led international science and regulatory advocacy efforts across the pharmaceutical industry while working for the U.S. industry trade association, PhRMA. Dr. Brady completed his Doctor of Pharmacy degree at the University of Kansas in May 2003.

  • Karl  Broich, DrMed

    Karl Broich, DrMed

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

    Physician, MD (certifications in Neurology, Psychiatry, Behavioural Psychotherapy). BfArM in Bonn (Germany): 2000 to 2014 several executive functions, since 08/2014 head (President). Work in several EMA committees. Current research: clinical trials methodology CNS, biomarkers in drug development, Alzheimer’s disease and other neurodegenerative disorders.

  • Magda  Chlebus, MA

    Magda Chlebus, MA

    • Executive Director, Science Policy & Regulatory Affairs
    • EFPIA, 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.

  • Vicki  Edwards, RPh

    Vicki Edwards, RPh

    • Vice President, Pharmacovigilance Excellence and International QPPV
    • AbbVie, Inc., United Kingdom

    Qualified as a pharmacist in 1981 and started her career in hospital pharmacy. In 1983 she specialised in Drug Information Services and moved to Kuwait to set up and run the first National Drug Information Centre. On her return to the UK, Vicki spent the next four years in community pharmacy. In 1996 Vicki joined GlaxoWellcome and started her career in pharmacovigilance. In 2002 she moved to AstraZeneca UK Ltd as the Drug Safety Manager moving on to become Head of Drug Safety & Medical Information. Vicki joined Abbott in 2005 as European Qualified Person for Pharmacovigilance (EU QPPV). In 2013 moved to AbbVie as EU QPPV and Head of Affiliate Safety Excellence (ASE) and is now VP, Pharmacovigilance Excellence and I-QPPV.

  • Claudia   Ferreira

    Claudia Ferreira

    • Scientific Programs Team
    • DIA, Switzerland

  • 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.

  • Ian  Hudson

    Ian Hudson

    • Senior Advisor, Integrated Development
    • Bill and Melinda Gates Foundation, United States

    Dr. Ian Hudson has a leading role on the team in areas that include optimizing clinical studies and strengthening regulatory systems in Africa and other low-resource regions, particularly for malaria, polio, and COVID-19 drugs. Ian was a practicing pediatrician before joining SmithKline Beecham in 1989 to work in research and development. In 2001, he joined the UK government’s MHRA, where he served as director of licensing and then CEO. Ian was the UK delegate to the scientific committee of EMA’s Management Board, CHMP, later becoming its vice chair. He was also an honorary senior lecturer in clinical pharmacology at the University of London and served as chair of the International Coalition of Medicines Regulatory Authorities.

  • Christophe  Lahorte

    Christophe Lahorte

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

    Christophe Lahorte, PhD. performed academic research for 6 years at the University of Ghent. Since 2004 he has been actively involved within the R&D department of the Belgian agency for medicines and health products (FAMHP) in the quality assessment of CTA’s and PIP’s. He was member of the Paediatric Committee formulation working group (PDCO FWG) of EMA for 3.5 years. As a quality assessor he was also involved in the assessment of national & European scientific advice requests and assisted in several GMP inspections related to radiopharmaceuticals. Since 2009 has been the head of the FAMHP’s Sientific-Technical/Regulatory Advice & Knowledge Management Unit. He is also the head of the national Innovation Office at the FAMHP.

  • Nevena  Milisavljevic

    Nevena Milisavljevic

    • Regulatory Policy Lead
    • Roche, Switzerland

    Nevena Miletic is a pharmacist, with postgraduate studies in parmacoeconomics, Reg Affairs and QA, with more than 18 years of experience in pharma industry. Currently she works in Global Regulatory Policy at F. Hoffmann-La Roche and for the last five years, she is co-chairing IFPMA Africa Regulatory Network and CPP Network. She is also a member of IFPMA Regulatory Science and Africa Engagement Committees, DIA MEA Advisory Board, EFPIA ERAO PI WG, IATF etc., being involved in numerous projects with regulators and cross-industry collaborative platforms (e.g. Pre-ICDRA, ICDRA, IMI, SCoMRA etc.). Nevena is a strong advocate for regulatory convergence and harmonisation, with main interest in innovative approaches in drug development and review.

  • Emer  Cooke, MBA, MSc

    Emer Cooke, MBA, MSc

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

    Ms Cooke was nominated as Executive Director with a renewable five-year mandate by the Agency’s Management Board on 25 June 2020 and is the first woman at the helm of EMA. "I take up the role of Executive Director of EMA amid a public health crisis of unprecedented scale,” said Emer Cooke on her first day in office. “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.” Ms. Cooke obtained her degree in pharmacy from Trinity College in Dublin, Ireland. She has additional Masters degrees in Science and Business Admin., also from Trinity.

  • Scott  Askin, MSc

    Scott Askin, MSc

    • Global Program Regulatory Director
    • Novartis Pharma AG, Switzerland

    Currently working in the area of Regulatory Innovation for Novartis, Scott has over 20 years of industry experience from both the CRO world and within Pharma, in roles focusing on Data Management, Data Standards and Digital Innovation. Prior to his current role in Regulatory Affairs, Scott led several of Novartis’s digital innovation projects. Since his transition into Regulatory, Scott continues to advise digital program teams internally in areas such as eConsent, eSource, Decentralized Clinical Trials, Big Data & AI, and collaborates externally in several cross industry initiatives.

  • Christelle  Bouygues

    Christelle Bouygues

    • Acting Head of Regulatory Affairs, Office Scientific and Regulatory Management
    • European Medicines Agency, Netherlands

    Degree in Pharmacy and Regulatory Affairs. Joined the EMA in 2004 as Regulatory Affairs Adviser. She is responsible for provision of regulatory and procedural advice in relation to centralised procedures and referrals.

  • Kelly M. Dumais, PhD

    Kelly M. Dumais, PhD

    • Principal Scientific Advisor
    • Clario, United States

    Kelly is a Principal Scientific Advisor at Clario, a global data and technology company that helps to minimize risk in clinical trials. She has expertise in the implementation of electronic clinical outcome assessments (eCOA) and the development and validation of patient reported outcomes (PROs) to support labeling claims. She consults on best practices for questionnaire design and eCOA use to drive data integrity and patient engagement, and develops custom site rater training and participant training for improving accuracy in COA reporting and improving inter-and intra-rater reliability.

  • Leonardo  Dutra Rosa

    Leonardo Dutra Rosa

    • Head of the International Affairs Office
    • ANVISA, Brazil

    Head of Anvisa's International Affairs Office since March 2020, is a career diplomat who served at diplomatic missions in Lima (Peru) and Montevideo (Uruguay). At the headquarters of the Ministry of Foreign Affairs, he held, among others, the position of deputy head of the MERCOSUR Economic Division. He holds a degree in History from the Federal University of Rio Grande do Sul/Brazil and completed the training and advanced courses at the Rio Branco Institute, the Brazilian diplomatic academy.

  • Giovanna  Ferrari, PhD

    Giovanna Ferrari, PhD

    • Regional Labelling Lead, Senior Director
    • Pfizer Ltd, United Kingdom

    Giovanna Ferrari is a Senior Director at Pfizer with over 15 years’ experience working in the regulatory sector of the pharmaceutical industry, specialising in labelling & product information since 2009. She currently works within the Pfizer International Labeling Group with regional responsibility for Europe and is also the global business owner for the Pfizer process for management of country labeling documents. Externally, Giovanna has represented Pfizer in a wide range of industry forums over the last few years, in particular focussing on e-labelling, and is the industry lead for a highly innovative and patient-focussed digital health information project that is being progressed via an IMI public-private partnership – Gravitate Health

  • Barbara  Freischem, DVM

    Barbara Freischem, DVM

    • Executive Director
    • European Biopharmaceutical Enterprises (EBE), Belgium

    Barbara Freischem joined European Biopharmaceutical Enterprises (EBE) as Executive Director in July 2015. EBE represents the voice of biopharmaceutical companies of all sizes in Europe and is a specialised group within EFPIA. Prior to joining EBE, Barbara served at the World Organisation for Animal Health (OIE) with responsibilities in authorisation of veterinary medicines, research coordination, whole genome sequencing in animal health and antimicrobial resistance. Her previous positions include leading the global trade association for the animal health industry, working in a global pharmaceutical company, as well as working as a Regulator at the European Medicines Agency and the German Regulatory Authority for Veterinary Medicines.

  • Yasuhiro  Fujiwara, MD, PhD

    Yasuhiro Fujiwara, MD, PhD

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

    Dr. Yasuhiro Fujiwara was previously Director-General, Strategic Planning Bureau of the National Cancer Center, and the Deputy Director of the Hospital (Research), National Cancer Center Hospital. He is a medical oncologist, specializing in breast cancer. Before joining NCCH, he was a deputy director of the Evaluation Division II of PMDEC, later merged with other organization to form PMDA of the Ministry of Health and Welfare and Labor between 1997 – 2002, making his current position as Chief Executive his second appointment. Between Jan 2011 to Feb 2013, he was a Deputy Secretary General of Office of Medical Innovation, Cabinet Secretariat of Japan, and led health policy issues regarding life science.

  • Lorenzo  Guizzaro

    Lorenzo Guizzaro

    • Scientific Officer
    • European Medicines Agency, Netherlands

    Lorenzo Guizzaro is a medical doctor and statistician working in the CNS area at the European Medicines Agency. He holds a master’s degree in drug development science from King’s College London.

  • Hilmar  Hamann, PhD

    Hilmar Hamann, PhD

    • Head of Information Management Division
    • European Medicines Agency, Netherlands

    Dr. Hilmar Hamann is the Head of Information Management at the European Medicines Agency where he focuses on transforming technology capabilities for the Network of Regulatory Agencies in the EU and its stakeholders to become an all-digital, efficient and data-driven Network of the future. Prior to joining EMA, from 2011 to 2020, he served as the Director for Business Informatics at the U.S. Food and Drug Administration leading the transformation of medicines regulatory data, advancing data analytics, and modernizing the scientific computational and collaboration platforms that underpin operations.

  • Marie-Laure  Hecquet

    Marie-Laure Hecquet

    • Policy Advisor
    • EDQM/Council of Europe, France

  • Nasir  Hussain

    Nasir Hussain

    • Associate Director of Regulatory Intelligence
    • Gilead Sciences, United Kingdom

  • 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. She has been a Product Team Leader for numerous Biological medicinal products applications including Recombinant proteins, Vaccines, ATMPs and Biosimilar applications. In 2014 she became a Quality Specialist within the Specialised Scientific Disciplines Department where she provides specialised scientific input to various procedures including ITF, scientific advice, PRIME, marketing authorisation and post-marketing procedures. She has also coordinated the development of a number nt guidelines in the area of Advanced Therapies, Recombinant proteins and Biosimilars.

  • Nadege  Le Roux, DrPH, PhD

    Nadege Le Roux, DrPH, PhD

    • Regulatory Policy Senior Director
    • Bristol-Myers Squibb Company, Switzerland

    As Senior Director of Regulatory Policy and Intelligence at BMS, Nadège is leading taskforces to evaluate the European regulatory framework in the perspective of global environment. She works with stakeholders to advocate for policies supporting development of innovative medicines and regulatory systems. She has worked in the pharmaceutical industry for over 20+ years and is currently focused on regulatory policies relating to the European pharmaceutical legislative ecosystem to advance innovation, orphan drug development, patient engagement as well as the modernization of the regulatory procedures via digitalisation.

  • Ritu  Nalubola, PhD

    Ritu Nalubola, PhD

    • Director, FDA Europe Office
    • FDA, Belgium

    Dr. Ritu Nalubola is the Director of FDA Europe Office, located within the U.S. Mission to the EU in Brussels, Belgium. Prior to taking on this role in 2018, she served as a Senior Policy Advisor in FDA’s Office of Policy in the Office of the Commissioner, where advised senior leadership at FDA, HHS, and other U.S. government agencies on complex and cross-cutting policy issues, including related to biotechnology, nanotechnology, food safety, nutrition, international standards, and trade-related matters. Most recently, Dr. Nalubola was the primary lead for FDA’s efforts to modernize the regulatory system and facilitate innovation in biotechnology products. She started her FDA career at CFSAN in 2001.

  • Handan  Öztunca

    Handan Öztunca

    • Head of Marketing Authorization Department
    • Turkish Medicines and Medical Devices Agency (TITCK), Turkey

    She graduated from Hacettepe University, Faculty of Pharmacy and hold M.Sc degree in Pharmacognosy from the same University. She had worked in Department of Biological Products, as unit supervisor in Marketing Authorization Department, Biological and Biotechnological Products Unit and at the same time as a member in Biotechnological Quality Assesment Commision in Turkish Medicines and Medical Devices Agency (TITCK). Between 2018-2021, she worked as the Head of Herbal and Supplementary Products Department. As of August 2021, she was appointed as the head of Department of Marketing Authorization and continuing in this position since than.

  • Jan  Paehler

    Jan Paehler

    • Head Of The Health Sector, Director General International Partnerships
    • European Commission, Belgium

  • Joseph M Rymsza

    Joseph M Rymsza

    • Vice President, Global Safety, Regulatory and Quality Technology Solutions
    • IQVIA, United States

  • Elizabeth  Scanlan, PhD, MSc

    Elizabeth Scanlan, PhD, MSc

    • Scientific Communication Officer
    • European Medicines Agency, Netherlands

    Elizabeth Scanlan joined the European Medicines Agency in 2016 where she is a Scientific Communication Specialist with a focus on communication of information on safe and effective use of medicines to patients and healthcare professionals. 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.

  • Khushboo  Sharma, MBA

    Khushboo Sharma, MBA

    • Chief Regulatory Innovation Officer
    • Accumulus Synergy, United States

    Khushboo Sharma was the Chief of Staff/Senior Vice President at Biotechnology Innovation Organization. Khushboo joined BIO after spending 11 years in various roles at the US FDA. Previously, Khushboo was the Deputy Director of Operations in the Office of New Drugs at the FDA. As Deputy Director of Operations, she oversaw business, regulatory and programmatic operations and supported regulatory review for the new drugs regulatory program. In 2021, Khushboo was named one of In Vivo’s 30 Rising leaders across the biopharma, and health technology sectors. Prior to joining the FDA, Khushboo worked as a scientist at Janssen Pharmaceuticals, where she managed oncology and various therapeutic monoclonal antibody clinical drug development studies

  • Marlene  Thomas

    Marlene Thomas

    • Senior International Scientific Director
    • F. Hoffmann-La Roche, Switzerland

  • Andrew  Thomson, PhD, MA, MS

    Andrew Thomson, PhD, MA, MS

    • Statistician, Methodology Taskforce
    • European Medicines Agency, Netherlands

    Andrew Thomson is a statistician in the Taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and across all therapeutic areas. He also is the lead of the Statistics subgroup of ICH E11A on pediatric extrapolation, as well as the Regulatory Chair. Before joining EMA, he headed the Epidemiology Unit in the Vigilance and Risk Management of Medicines Division of the MHRA, the UK regulator and was also previously a Statistical Assessor within the Licensing Division of the MHRA.

  • Stephanie  Von Klot, PhD, MPH, RPh

    Stephanie Von Klot, PhD, MPH, RPh

    • Lead Safety Data Scientist
    • Boehringer Ingelheim International Gmbh, Germany

  • Anne  Willemsen, MSc

    Anne Willemsen, MSc

    • Senior Project Manager, Joint Production Co-Lead Partner - Pharmaceuticals
    • ZIN - National Health Care Institute, Netherlands

    Anne holds double Masters Degrees in Health Sciences, specialising in both Health Technology Assessment and Health Policy. This led her through research and project management roles within the Dutch National Healthcare Institute over the past five years. Anne now spearheads the team responsible for the coordination of EUnetHTA Pharmaceutical Joint Assessments, working to correlate stakeholder interest and maximise benefit outcomes of European collaboration on HTA. She is also involved in developing methods for patient and healthcare professional engagement within the context of these EUnetHTA Assessments.

  • Sacha  Wissink, PhD

    Sacha Wissink, PhD

    • Executive Director, Regulatory Affairs Europe
    • MSD Netherlands, Netherlands

    Dr. Wissink joined Regulatory Affairs Europe MSD in January 2014 to lead the company’s oncology efforts, including the registration of the PD-1 inhibitor, Keytruda® as well as its developmental activities. Prior to joining Regulatory Affairs Europe, Dr. Wissink was Director, Global Regulatory Affairs at MSD responsible for Alzheimer’s Disease development. Dr Wissink started her career in Industry in Regulatory Affairs in Organon in 1999, and held different positions of increasing responsibility within Organon, Schering-Plough and MSD. Dr. Wissink received her PhD in Molecular Biology from the University of Utrecht. Prior to joining industry, she held the position of Postdoctoral Fellow at the Hubrecht institute, Utrecht, the Netherlands.

  • Hiroyuki  Arai, PhD

    Hiroyuki Arai, PhD

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

    Dr. Hiroyuki Arai has served as an Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA) since April 2020. Before joining PMDA, he was a professor of Department of Health Chemistry, Graduate School of Pharmaceutical Sciences at the University of Tokyo (2000-2019). He also served as a dean (2016-2018) there. He graduated in 1979 and received his PhD (Biochemistry) in 1984 from the University of Tokyo. His overseas experience includes the University of Illinois (1984-1986) and Tufts University School of Medicine (1986-1988).

  • Stephanie  Croft

    Stephanie Croft

    • Technical Officer
    • World Health Organization, Switzerland

  • Sophie  Dagens, LLM

    Sophie Dagens, LLM

    • Junior Regulatory Officer
    • Medicines For Europe, Belgium

  • Jean-Christophe  Delumeau, MD, PhD

    Jean-Christophe Delumeau, MD, PhD

    • Senior Expert
    • Institute of Pharmacovigilance, Czech Republic

    Jean-Christophe Delumeau graduated in medicine (MD), molecular pharmacology (PhD), toxicology and psychiatry in France. Then he joined a research program on intracellular signaling at Inserm. In 1991, he re-oriented to clinical research in neurology in France, Switzerland and Japan. In 2002 he was appointed by Bayer to lead pharmacovigilance organisations in Japan (until 2009) then in Asia-Pacific. He is a founding member and coordinator of ISoP’s Special Interest Group on Risk Minimisation Methods for Asian Countries. His focus is to create and facilitate the deployment of novel risk minimization methods applicable to a wide array of countries and health care systems, especially in developing countries.

  • Claudia  Dollins, PhD, RAC

    Claudia Dollins, PhD, RAC

    • Executive Director, Precision Medicine & Companion Diagnostics
    • Bristol-Myers Squibb, 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 her time in the pharmaceutical industry, she has built global Digital Health, Companion Diagnostics, Medical Devices, and Combination Product Regulatory organizations within Merck Healthcare KGaA and Bristol-Myers Squibb, overseeing both global development and life-cycle management activities. She currently serves as the Head, Global Regulatory Science, Precision Medicine and Digital Health at Bristol-Myers Squibb.

  • Helen  Edelberg

    Helen Edelberg

    • Deputy Office Director for Safety, Office of New Drugs
    • FDA, United States

    Dr Helen Edelberg is Head of Med Safety Assmt for Innovative Med & Gbl Safety Risk Mgmt, which provides authoritative expertise on development & execution of rigorous & innovative risk mgmt strategies at BMS. A strategic & innovative biopharmaceutical exec & physician with ~20 years Reg/PV & academic med/clin practice experience, she has presented on devt & implementation of best practices to accelerate product devt, approval & ongoing benefit-risk evaluation in a variety of settings.

  • Inci   Ergönül

    Inci Ergönül

    • Head of Clinical Trials Department
    • Turkish Medicines and Medical Devices Agency (TITCK), Turkey

  • Tanja  Fahlbusch, DrMed, MD, MHA

    Tanja Fahlbusch, DrMed, MD, MHA

    • Senior IPV Process Liaison
    • F.Hoffmann-La Roche Ltd, Switzerland

  • Marco  Farinelli

    Marco Farinelli

    • Supply Chain Manager
    • AstraZeneca; Chair of the Supply Chain WG at EFPIA, Italy

  • Flora  Giorgio, MPharm

    Flora Giorgio, MPharm

    • Deputy Head of Unit Medical Devices, DG SANTE – Medical Products and Innovation
    • European Commission, Belgium

    Flora is a pharmacist by training. She is heading the team of Health Technology Assessment at the European Commission in DG Health (SANTE), Unit "Medical devices and health technology assessment". The team is responsible for the Legislative Proposal on HTA, for the Secretariat to the HTA Network, and oversees the activities of the Joint Action EUnetHTA. Flora joined the EC in 2006 in DG CNECT, she worked in the ICT for the Health Unit. Before joining the EC she was the Secretary General of the PGEU, the European Association of Community pharmacists and also worked in a community pharmacy.

  • 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

  • Ali  Hansford, PhD, MSc

    Ali Hansford, PhD, MSc

    • Head of Regulatory Strategy Policy
    • ABPI, United Kingdom

  • Rhydian  Howells

    Rhydian Howells

    • Senior Manager, Regulatory Affairs
    • KPMG LLP, United Kingdom

    An experienced regulatory professional with a proven track record over 20 years of supporting companies with the clinical development, regulatory approval and commercialisation of novel ATMP and biological products.

  • Brad  Jordan, PhD

    Brad Jordan, PhD

    • Senior Director, Head of Regulatory Affairs Policy
    • Flatiron Health, United States

    Dr. Brad Jordan is a Head of Regulatory Affairs Policy at Flatiron Health, where his team works to advance the use of Real-World Evidence for regulatory decision-making. Brad was at Amgen for 15 years prior to joining Flatiron, where he led Global Regulatory and R&D Policy for Oncology and for Biosimilars and Biologics.

  • Dominique  Lagrave, PharmD

    Dominique Lagrave, PharmD

    • VP 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.

  • Lada E Leyens, PhD, MSc

    Lada E Leyens, PhD, MSc

    • Regulatory Program Director
    • F. Hoffmann-La Roche Ltd, EFPIA's Clinical Research, 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.

  • Obaidullah  Malik

    Obaidullah Malik

    • Director
    • Drug Regulatory Authority of Pakistan , Pakistan

  • Grazia  Mohren

    Grazia Mohren

    • Senior Marketing Director
    • Science 37, United States

  • Karen  Quigley

    Karen Quigley

    • Clinical Data Publication Manager
    • European Medicines Agency, Netherlands

    Dr Karen Quigley has a degree in pharmacy from Trinity College Dublin and a postgraduate Masters in Science degree from the same university specialising in the field of controlled drug delivery and rheology. She subsequently obtained her PhD from the Faculty of Medicine, University of London. Karen joined the EMA 15 years ago working in the areas of mutual recognition, scientific advice, veterinary medicines authorisation and availability of medicines. In 2016 she joined the Clinical Data Publication team working on Policy 0070. Prior to joining the Agency, she worked at the Council of Europe in Strasbourg and with the Health Products Regulatory Agency in Dublin.

  • 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.

  • 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.

  • Jenna  Willis

    Jenna Willis

    • Associate Safety Director
    • F. Hoffmann-La Roche, United Kingdom

  • Tiago  Villanueva

    Tiago Villanueva

    • Vice-President
    • UEMO, Portugal

    Tiago Villanueva is a family physician working in the Portuguese National Health Service and Vice-President, European Union of General Practitioners / Family Physicians (UEMO). He represents UEMO in the Healthcare Professionals Working Party of the European Medicines Agency.

  • Michael  Zaiac

    Michael Zaiac

    • Head of Medical Affairs Oncology Region Europe
    • Novartis, Switzerland

  • Rinol  Alaj, MBA

    Rinol Alaj, MBA

    • Director, Clinical Outcomes - Assessments and Innovation
    • Regeneron Pharmaceuticals, United States

    Rinol’s professional focus is centered around integrated Innovation, design thinking, and clinical operation with 15 years of experience in startup and pharma industry. Savvy, results-oriented leader with proven success in transforming and building eCOA organizations from the ground up. In his current role he leads Clinical Outcome Assessment and Patient Innovation team within Regeneron pharmaceutical.

  • Michael  Berntgen, PhD

    Michael Berntgen, PhD

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

    The Scientific Evidence Generation Department aims to support the development of medicines to ensure generation of robust and relevant scientific evidence, also in collaboration with other stakeholders. Activities include the provision of scientific advice & methodology qualification, support to medicines for the paediatric population & for orphan diseases, provision of expertise & support in translational sciences. The department monitors the portfolio related to human medicines, manages the PRIME scheme and facilitates collaboration with downstream decision-makers, to foster timely access to medicines. Michael is a pharmacist with a PhD and a Master of Regulatory Affairs. From 1999 to 2006, he worked in the industry in Germany and the UK.

  • Nihan Burul  Bozkurt, PhD

    Nihan Burul Bozkurt, PhD

    • Health Policies Director
    • AIFD, Turkey

    Nihan Burul Bozkurt received her B.Sc. degree in Pharmacy from Hacettepe University. She holds M.Sc. and Ph.D. degrees in Pharmacology from the same University. After getting her Ph.D. she worked in her own project as a guest researcher in Karolinska Institutet, Alzheimers Disease Research Center, Stockholm, Sweden. After having worked in Pharmacology Department at Hacettepe University she joined Novagenix Bio Anaytical R&D Centre. She has conducted several clinical trials as Clinical Director. Since May 2016 she has been working for Ministry of Health, Turkish Medicines and Medical Devices Agency as the Head of Clinical Trials Department.

  • Jasper-Hugo  Brouwers

    Jasper-Hugo Brouwers

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

  • Catherine  Chronaki

    Catherine Chronaki

    • Secretary General
    • HL7 Europe Foundation, Belgium

  • Owen  Corbin, JD

    Owen Corbin, JD

    • Sr Dir DCT Regulatory and Privacy
    • IQVIA, United States

  • Brendan  Cuddy

    Brendan Cuddy

    • Scientific Senior Specialist, Quality and Safety of Medicines Department
    • European Medicines Agency, Netherlands

    Brendan Cuddy joined the European Medicines Agency in October 2002. He was Head of the Manufacturing and Quality Compliance Service at the Agency from 2014 – 2020. Brendan is currently the Chairman of the Good Manufacturing and Distribution Practice Inspectors Working Group (GMDP IWG). Brendan obtained his degree in Chemistry from University of Dublin, Trinity College in Ireland. He holds a Master’s degree from the National University of Ireland in Quality and Operations Management and a postgraduate diploma in Pharmaceutical Manufacturing Technology from University of Dublin, Trinity College which satisfies the educational requirements for Qualified Person.

  • 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; practices, strategies and incentives driving improvements in the pharmaceutical R&D process; and the economics of new drug development. Maria has been a researcher and strategist in the healthcare sector for more than a decade. She has held positions at Cleveland Clinic and New York-Presbyterian Hospital of Columbia and Cornell Universities. Maria holds a bachelor’s degree in economics and master’s degree from The Fletcher School of Law and Diplomacy at Tufts University.

  • Thierry  Gastineau, PharmD

    Thierry Gastineau, PharmD

    • Global Head Quality Innovation, Culture & Engagement
    • Sanofi , France

    Thierry Gastineau is Global Quality Head of Innovation, Culture and Engagement at SANOFI vaccines. He has 35 years of experience in the Pharmaceutical Industry, mainly in World Wide Regulatory Affairs and Quality activities. He is a member of multiple associations and working groups, in particular the following ones: • Vaccines Europe: Co-leader of CMC/Quality Core Team and LCM working group • IFPMA: Leader of the Vaccines Head of Quality group and of the working group on Post Approval Changes • Leader of the CMC/GMDP Covid-19 joint Vaccines Europe / IFPMA Task Force By education, he is Pharmacist and he holds a post graduate in molecular biology

  • Louise  Gill, PhD

    Louise Gill, PhD

    • Vice President, Regulatory Policy, Global Regulatory Affairs
    • GSK, United Kingdom

    Louise Gill is VP, Regulatory Policy at GlaxoSmithKline. She leads the regulatory policy and intelligence organisation accountable for defining and driving the global regulatory policy topics. Louise also co-leads the Accumulus Synergy Europe team. Louise has worked in the pharmaceutical industry for over 25 years and held roles of increasing responsibility including: Regulatory leadership to support Brexit; Regulatory Head Europe and Canada accountable for the affiliates in the region and leading Regulatory Therapeutic teams. Louise obtained her doctorate in Biochemistry from Oxford University and has a passion for developing early talent.

  • Jesper  Kjær, MS

    Jesper Kjær, MS

    • Co-Chair, EMA/HMA Big Data Steering Group; Director of Data Analytics Centre
    • Danish Medicines Agency (DKMA), Denmark

    Director of Data Analytics Centre at the Danish Medicines Agency and co-chair of HMA / EMA Big Data Steering Group. 20 years for life science experience in academia and industry. Been leading EU framework programme workpackages, IMI and TransCelerate Biopharma workstreams in the past. Currently active in development of FHIR for clinical research and use of AI/ML in life science.

  • Daisuke  Koga

    Daisuke Koga

    • Division Director, Division of Planning and Management
    • Pharmaceuticals and Medical Devices Agency (PMDA), Japan

  • Claudia  Louati

    Claudia Louati

    • Policy Advisor, FDA-Europe Office
    • U.S. Food and Drug Administration, Belgium

  • Remco  Munnik

    Remco Munnik

    • Associate Director
    • Iperion, Netherlands

    Remco Munnik is Associate Director of Iperion Life Sciences Consultancy, with over 20 years of experience in Regulatory Affairs, with a special focus on Global submission procedures, electronic submission (eCTD) and regulatory data management (xEVMPD, ISO IDMP and RIMS). He has worked at both pharmaceutical industry and consultancy. In addition, Remco has been directly involved in the development and roll-out of the EU Telematics environment and has in-depth knowledge of the systems. Remco is member of the EMA ISO IDMP Taskforce Product & Organisation group.

  • Lars Bo  Nielsen

    Lars Bo Nielsen

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

  • Jan  Petracek, MD, MSc

    Jan Petracek, MD, MSc

    • CEO
    • Ivigee, Czech Republic

    Jan Petracek, MD, MSc, DIC, MIoD, FISoP, has gained international recognition with over 20 years of expertise in pharmacovigilance and drug safety. Dr. Petracek has been instrumental in providing guidance to many of the world’s leading biotech organizations and has a wealth of knowledge and experience to share. His pharmacovigilance clients appreciate pragmatic approach and sensible solutions to every problem they may encounter while battling with global pharmacovigilance demands. He serves clients as EU QPPV, auditor, trainer and advisor.

  • Melissa  Ream

    Melissa Ream

    • AHSN
    • in collaboration with UK’s National Health Service, United Kingdom

  • Andreas F. Stange

    Andreas F. Stange

    • Vice President MHS Global IVD
    • TÜV SÜD , Germany

  • Wendy  Yan, MD, MBA

    Wendy Yan, MD, MBA

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

    Wendy Yan is Senior Vice President, Global Head of Regulatory Affairs, for BeiGene, a commercial-stage biotechnology company focused innovative molecularly-targeted and immuno-oncology drugs for treatment of cancer. She has more than two decades of regulatory affairs experience, having previously served as Director, Head of Regulatory Affairs China, Global Regulatory Strategist, at Bayer Healthcare Global R&D Center; as Director, Head of Regulatory Affairs, GlaxoSmithKline Pharmaceuticals China; and as Senior Regulatory Affairs Manager at AstraZeneca. A licensed pharmacist, Wendy earned her undergraduate degree in Medicine at Beijing Traditional Chinese Medicine University, and her MBA at Staffordshire University (UK).

  • Rosa  Castro

    Rosa Castro

    • Senior Policy Manager for Healthcare Delivery and Networks’ Coordinator
    • European Public Health Alliance, Belgium

    Dr Rosa Castro is Senior Policy Manager for Healthcare Delivery and Networks’ Coordinator at the European Public Health Alliance (EPHA). Among other activities, she coordinates the European Alliance for Responsible R&D and Affordable Medicines, the EU4Health Civil Society Alliance, and represents EPHA at the Patients’ and Consumers Working Party (PCWP) of EMA.She has a PhD in European Law and Economics, and an MA in Bioethics and Science Policy.Dr Castro was a postdoctoral Fellow at the European Uni Inst and a lecturer on intellectual property and international health law. Before joining EPHA, she worked at the Fed. of European Academies of Medicine and at a public policy consultancy, where she managed EU-funded projects on public health.

  • Kevin  Cunningham

    Kevin Cunningham

    • Scientific Officer
    • European Medicines Agency, Netherlands

    Dr. Kevin Cunningham is the PRIME Scientific Coordinator at the European Medicines Agency. He is responsible for coordination of the PRIME scheme, including management of eligibility procedures, as well as support to PRIME-eligible medicinal products. Previously worked as a non-clinical assessor at the Health Products Regulatory Authority (HPRA), Ireland, before joining EMA in 2015 to work on the implementation of the EU Clinical Trials Regulation through the development of the Clinical Trials Information System (CTIS), and most recently as a scientific officer in the EMA Scientific Advice Office.

  • Mariam  Al Jalahma

    Mariam Al Jalahma

    • CEO
    • National Health Regulatory Authority (NHRA), Bahrain

  • Elena  Bonfiglioli

    Elena Bonfiglioli

    • Managing Director, Health and Life Sciences
    • Microsoft, Belgium

  • Anne  Bourrelly, MBA, MSc

    Anne Bourrelly, MBA, MSc

    • GTL Regulatory Information Management
    • F Hofmann-La Roche Ltd, Switzerland

    Anne Bourrelly, MSc, MBA joined F. Hoffmann-La Roche Ltd´s IDMP program in 2018 focussing on master data process alignment. In March 2021 she became PMS FG Data Industry lead, co-shaping the EU IDMP IG and took on the EFPIA’s ERAO IDMP Subgroup chair in January 2022. Anne has over 28 years experience in drug development, the past 16 years with F. Hoffmann-La Roche Ltd, covering Labeling, Regulatory Program Management and Regulatory Information Management.

  • Lynne  Corner

    Lynne Corner

    • COO and Director
    • VOICE at the UKs National Innovation Centre for Ageing (NICA), United Kingdom

  • Roberto  Frontini

    Roberto Frontini

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

  • Dag R. Jordbru

    Dag R. Jordbru

    • NOMA, Norway

  • Lyne  Le Palaire, MSc

    Lyne Le Palaire, MSc

    • Quality Advocacy Leader
    • Sanofi, France

  • SHAIK RIZWAN WAHEED  NA

    SHAIK RIZWAN WAHEED NA

    • Regulatory Affairs Specialist
    • Novo Nordisk, Denmark

  • Álmath Máire Spooner, PhD, RPh

    Álmath Máire Spooner, PhD, RPh

    • Director of Regulatory Policy and Intelligence
    • AbbVie, Ireland

    Álmath is a qualified pharmacist and barrister with a PhD from Trinity College Dublin and postgraduate qualifications in statistics, law and pharmaceutical medicine. Álmath has extensive experience in healthcare product regulation and policy with 12 years experience at the Irish Health Products Regulatory authority. Álmath was the first Vice Chair of EMA's PRAC and served from 2012-2018. Álmath was called to the Bar of Ireland in 2018 and practiced in Commercial Law prior to joining AbbVie's Global Regulatory Policy and Intelligence team as Director in 2020. At AbbVie, Álmath is the global policy lead for Patient Focused Drug Development and Pharmacovigilance and European lead for RWE, Digital Health and clinical pharmacology.

  • Shannon  Thor, PharmD, MS

    Shannon Thor, PharmD, MS

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

    Lieutenant Commander Shannon Thor is a pharmacist and officer in the United States Public Health Service. She serves as an International Policy Analyst in FDA’s Europe Office where she is responsible for providing leadership and technical expertise on international public health initiatives and US-European Union relations. Her previous experience at FDA includes policy advisor roles in the Office of Health and Constituent Affairs and the Office of New Drugs. Prior to FDA, LCDR Thor served as an officer in the US Navy, where she supervised pharmacy operations and directed medication safety programs at military medical centers around the world.

  • Britt  Vermeij

    Britt Vermeij

    • Senior Director Regulatory Policy & Intelligence Europe
    • Teva Pharmaceuticals; IATF Chair, Netherlands

  • Bettina  Ziegele

    Bettina Ziegele

    • Chair DG SNSA of the EU-Innovation Network at EMA & Liaison Officer,
    • Division Major Policy Issues, Paul-Ehrlich-Institut, Germany

    Bettina Ziegele is Liaison Officer at the Paul-Ehrlich-Institut and former Head of the Innovation Office at the Paul-Ehrlich-Institut - the national competent authority for vaccines and biomedicines in Germany. Focused on supporting pharmaceutical developments especially in the area of personalized medicine and ATMP, she was working as an expert at the Federal Ministry of Health for the past two years. In a subsequent delegation to the German Joint Committee, G-BA, she broadened her knowledge dealing with HTA aspects of pharmaceutical development at national and European level. Bettina Ziegele is a member of the EU Innovation Office Network at EMA and Head of the Drafting Group of the “Simultaneous National Scientifc Advice”.

  • Jacques  Demotes, MD, PhD

    Jacques Demotes, MD, PhD

    • Director General
    • European Clinical Research Infrastructure Network (ECRIN), France

  • Jessica  Liu

    Jessica Liu

    • VP, M&A Management Department
    • Tigermed Consulting, China

  • Greet  Musch, PhD

    Greet Musch, PhD

    • General Director
    • FAMHP, Belgium

    Mrs Greet Musch obtained a PhD in Pharmaceutical & Biomedical Sciences @ Free University Brussels. She joined the Pharma Industry for 8 years as responsible for all the chemical and pharmaceutical analytical activities related to the development of new innovative drugs . She moved to the Federal Public Health services as senior quality assessor. Since Aug 2004 she was in charge of the R&D department. On Feb 2009 she has been designed as Director-general for the DG Pre-authorisation in the FAMHP.

  • Katja  Pecjak

    Katja Pecjak

    • Director of Regulatory Affairs & EU QPPV
    • Billev farmacija vzhod d.o.o, Slovenia

  • Andrei  Spinei, MPharm, MSc

    Andrei Spinei, MPharm, MSc

    • Scientific Administrator
    • European Medicines Agency, Netherlands

    Andrei Spinei is a Scientific Administrator in the Quality and Safety of Medicines Department at EMA working on GMP, quality defects and product recalls, sampling and testing and international collaborations on GMP and inspections. He holds an MSc. in Pharmacy and before joining the European Medicines Agency he has worked for several years in regulatory affairs in the pharmaceutical industry.

  • Christelle  Anquez-Traxler, PharmD

    Christelle Anquez-Traxler, PharmD

    • Regulatory and Scientific Affairs Manager
    • AESGP, Belgium

    Dr. Anquez-Traxler graduated as a pharmacist and has a Master’s Degree in European Regulatory Affairs as well as in Economics of Health Products. She manages regulatory and scientific affairs for the Association of the European Self-Medication Industry since 2004. She was previously working for the US FDA at the Office of International Programs.

  • Mark  Duman

    Mark Duman

    • Patient Advocate
    • Diabetes UK, United Kingdom

  • Francisco A. Nogueira, MA

    Francisco A. Nogueira, MA

    • Chief Executive Officer
    • Accumulus Synergy, United States

    Frank joined from Genentech, a Roche company, where he as a Vice President focused on applying his 20 years of enterprise, regulatory strategy, asset development and commercialization experience to deliver enterprise value and bring medicines to patients. As a senior leader he served in multiple global head positions, including Business Strategy, Project and Portfolio Management, Regulatory Operations, Medical Writing, Labeling & Established Products, Data Transparency, and Quality & Compliance. Most recently we oversaw the development and delivery of Roche’s Oncology medicines portfolio to China and Lifecycle leader of an Alzheimer’s molecule.

  • Declan  Noone

    Declan Noone

    • PRAC Patient Representative
    • President of the European Haemophilia Consortium (EHC), Ireland

  • Representative Invited

    Representative Invited

    • Head of Unit 'Digital Health' unit - DG SANTE
    • European Commission

  • Paul  van Geffen

    Paul van Geffen

    • Senior Manager, Quality & Regulatory Compliance
    • Deloitte Risk Advisory, Netherlands

  • Patrick  Middag, MBA, MSc

    Patrick Middag, MBA, MSc

    • Director
    • Deloitte Risk Advisory, Belgium

    Patrick Middag, M.Sc., MBA, leads the European alignment of global Regulatory IT initiatives at Bristol-Myers Squibb and is the company’s IDMP program IT lead. He started at BMS in global labeling systems implementation, at that time focusing on PIM and Translation Management. Patrick maintains external focus as a vice chair of EFPIA’s ERAO and as an active member of the SPOR Task Force including the PMS-subgroup. Patrick started his career as an IT professional in 1995. Working for mid-size pharmaceutical companies since 2001, he has experience with Enterprise Architecture, business-IT strategy alignment, and process improvement. Patrick obtained an Executive MBA degree from the Vlerick Business School in 2007.

  • Ricki  Chase, MS

    Ricki Chase, MS

    • Vice President
    • Lachman Consultant Services, Inc., United States

  • Raun  Kupiec, MS

    Raun Kupiec, MS

    • Head of Global Regulatory Affairs
    • Vifor Pharma Management , Switzerland

    Mr. Kupiec is a recognised authority on regulatory operations, and has served on multiple industry committees and editorial boards – including TOPRA, RAPS, EuropaBio and joint industry/regulator projects at the EMA. He is currently a member of the EFPIA Telematics WG, and representative to ICH M2.

  • Yann  Le Cam, MBA

    Yann Le Cam, MBA

    • Chief Executive Officer
    • Eurordis-Rare Diseases Europe, France

    Yann Le Cam was one of the founders of EURORDIS-Rare Diseases Europe in 1997. He is the organisation’s Chief Executive Officer since 2000. Yann initiated Rare Diseases International (RDI) in 2009. He is an elected member of the RDI Council and Chair of the RDI Advocacy Committee. He is a founding member of the NGO Committee for Rare Diseases (United Nations, New York) in 2014 and its Vice-Chair. Yann is a Co-Chair of the Global Commission to End the Diagnostic Odyssey of Children with Rare Diseases since its launch in 2018. Yann is a member of the World Economic Forum’s Health Stewards Board from 2020 and of its Global Precision Medicine Council since 2019. More on recent past positions https://www.eurordis.org/staff

  • Deepika  Lakhani

    Deepika Lakhani

    • Vice President, Regulatory and Quality
    • PAVmed Inc., United States