Álmath Spooner, PhD
Head of Europe Regulatory Policy , AbbVie, Ireland
Álmath is Head of Europe Regulatory Policy at AbbVie. Álmath dually qualified as a pharmacist and a barrister-at-law with a PhD from Trinity College Dublin and postgraduate qualifications in statistics and pharmaceutical medicine. Álmath has extensive experience in regulation and policy having held management and assessment roles at the Irish HPRA (2007-2019) and at EMA's PRAC (Vice Chair 2012-2018). Álmath was called to the Bar of Ireland in 2018 and practiced in Commercial Law prior to joining AbbVie in 2020. At EFPIA, Álmath chairs the Integrated Evidence Generation Working Group. She has prior experience in various global initiatives including at ICH. She is a member of the DIA Regional Advisory Council.
Daniel Millar, MBA
Senior Director, Strategic Business Transformation, Johnson & Johnson, United States
Daniel Millar leads Strategic Business Transformation in Quantitative Sciences at Janssen R&D. He is an advocate for utilizing quantitative innovation to advance patient-centric R&D while simultaneously delivering transformational efficiencies. Daniel is a founding leader and champion for multi-stakeholder engagement in the recently launched Innovative Medicines Initiative (IMI) public-private partnership for Integrated Research Platforms. Daniel obtained a MBA from the University of Chicago Booth School of Business and a BA in Mathematics from the University of Pennsylvania. He lives in Manhattan and enjoys traveling. His current “country number” is 115.
Elke Stahl, PhD
Senior Expert, Clinical Trials Department, Federal Institute For Drugs and Medical Devices (BfArM), Germany
Dr. Elke Stahl, Clinical Trial Unit BfArM, Germany. Clinical Trials Senior Expert. CoChair of the Clinical Trial Facilitation Group (CTFG) till 2022. Involved in EMA’s EU CTIS groups as BfArM’s representative, National Contact Point for the CTR in Germany, representative in European Commissions CT working groups. Prior BfArM 10 years experiences as a pharmacokineticist at Bayer HealthCare AG, Germany, in early research up to candidate selection. PostDoc at Hoffmann-La Roche Inc and University of North Carolina (UNC). Ph.D. in pharmacology and licenced pharmacist.
Jesper Kjær, MS
Global Director for Public, Private Partnerships, Strat Ops, Global Med Affairs, Novo Nordisk, 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.
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.
Clinical Disclosure Lead, Alcon Research, LLC, United States
Joyce Swart is the Clinical Disclosure Lead at Alcon Research, LLC, a major eye care device company operating in the global marketplace. For over 10 years she has been responsible for understanding disclosure requirements specific to medical device trials, developing disclosure practices and processes for companywide implementation, and overseeing the registration of medical device trials on ClinicalTrials.gov and other public registries. She is also skilled in registering drug studies and posting results on ClinicalTrials.gov and EudraCT. Joyce received her B.S. from Rutgers University, New Brunswick, New Jersey.
Nick Sykes, MS
Policy Advisor, EFPIA, Belgium
Currently working in Europe and International regulatory policy and strategy group in Pfizer. Been working for Pfizer since 1998. My main focus - lead a small team providing regulatory policy and strategy to Pfizer organisation particularly regulation of clinical trials. Previous employment includes SmithKline Beecham, Scrip and Cambridge Antibody Technology
Ruediger Pankow, DrSc
Regulatory Affairs Expert, CTIS SME and PO, Germany
Ruediger holds a university degree in Biology and is a clinical regulatory affairs professional with history of more than 16 years in the CRO industry at Parexel, where he last was Principal Consultant in the clinical trial regulatory services. He was involved in his company's EU Clinical Trials Regulation 536/2014 (EU CTR) readiness implementation, and has contributed for ACRO to EU CTR stakeholder activities with EU Regulators and EMA. Since 2019 he has been a sponsor product owner for ACRO in EMA's Clinical Trials Information System (CTIS) delivery project providing input on design and development of system functionalities and guidance material, and is DIA instructor of EMA's CTIS sponsor user training programme.
Fia Westerholm, DVM, MSc
Programme Assurance Manager, European Medicines Agency, Netherlands
Programme Assurance Manager in the Clinical Trials Information System (CTIS) programme managed by the European Medicines Agency to enable implementation of the Clinical Trials Regulation (CTR). Educational background and degrees in veterinary medicine, toxicology and social sciences. More than 20 years of experience alternating between private and public sector in the area of medicines, including in research and development, assessment and regulation of medicines as well as management at EU & national level. At EMA since 2005.
Treatment Information and Access Director, Health Policy Advisor, European Organisation for Rare Diseases (EURORDIS), France
François is a patient and works at the European Organisation for Rare Diseases as Director of Treatment Information and Access since 2003. He's been involved in EUnetHTA since the first Joint Action back in 2010, and supervises Eurordis policy and advocacy on HTA. François also represents Eurordis at the European Medicines Agency.
Peter Richard Arlett, MD, FFPM, FRCP
Head Data Analytics and Methods Task Force, European Medicines Agency, Netherlands
Peter Arlett is Head of the Data Analytics and Methods Taskforce at the European Medicines Agency. In this role he leads on operations and transformation on clinical evidence at the EMA including clinical trials, real world evidence, safety reporting and data science including AI. He is Chair of the EMA Data Board, Co-Chair of the HMA-EMA Big Data Steering Group, Co-chair of the EMA AI Coordination Group, Co-chair of the Vaccine Monitoring Platform Steering Group and Member of the ACT EU Steering Group In addition to his role at EMA, Peter is Honorary Professor at the London School of Hygiene and Tropical Medicine. He is also a Fellow of the Royal College of Physicians of Edinburgh and of the Faculty of Pharmaceutical Medicines of London
Senior Manager, Clinical Records Management, Strategic Clinical Operations, AbbVie, United States
Scott has over a decade of experience with clinical trial disclosure, initially working for smaller sponsors as a one-person clinical trial disclosure department, to later operating in larger organizations, serving as an expert in summary results reporting and clinical document redaction/anonymization for public disclosure. As part of implementation planning for the EU Clinical Trials Regulation, Scott is AbbVie’s representative in the EMA CTIS sponsor master trainer programme.
Jerome De Barros, MS
Policy Officer - Digital Health, European Commission, Belgium
Dominique Hamerlijnck, MBA
Patient Expert, Atini, Netherlands
Dominique Hamerlijnck has a Masters in Philosophy, specialised in ethics and a Masters in Business Administration. Dominique is one of the European Patients’ Academy on Therapeutic Innovation (EUPATI) fellows. Next to her professional life for the past 25 years Dominique is also working as a patient expert especially in the field of severe asthma. She has been involved in many Dutch and EU projects in a patient advisory capacity. She is the patient co-chair for a European Respiratory Society Clinical Research Cooperation on severe asthma. She is a member different patient advisory groups and has been successful in getting the patient voice heard in health technology development.
Xavier Kurz, MD, PhD, MSc
Head of Data Analytics Workstream, European Medicines Agency, Netherlands
Xavier Kurz graduated in 1982 as a Medical Doctor at the University of Liege, Belgium. He specialised in Tropical Medicine and worked for several years in public health projects in Africa and Asia. He obtained a MSc (1991) and a PhD (1997) in Epidemiology and Biostatistics at McGill University, Montreal, Canada. He then joined the Department of Pharmacology of the University of Liege and the Belgian Centre for Pharmacovigilance (Ministry of Health) as scientific expert. He joined the European Medicines Agency (EMA) on 1st September 2005. He is currently leading the Data Analytics team within the Data Analysis and Methods Task Force.
Karen A Noonan, MA
Senior Vice President, Global Regulatory Policy, Association of Clinical Research Organizations (ACRO), United States
Karen joined the Association of Clinical Research Organizations (ACRO) in 2014. Founded in 2002, ACRO represents the world’s leading clinical research and technology organizations. In her role as Senior Vice President of Global Regulatory Policy, she leads ACRO’s global regulatory advocacy. Karen has an MA in political science, and a BA in French.
Scientific Administrator, CTIS expert, European Medicines Agency, Netherlands
Pharmacist with a Master degree in Pharmacovigilance, working experience at EMA in the Compliance and Inspection department, since 2016 working on the development CTIS and leading on CTIS transparency aspects, EMA liaison at the Clinical Trials Coordination Group (CTCG) and from October 2023 Programme Manager for the ACT EU initiative.
Cecile Spiertz, MSc
Cecile Spiertz is a senior director at J&J, Head External Innovation, Clinical Trial Platforms and current project lead for the IMI Project EU-PEARL. She has a strong operational track record in successful delivery of global clinical development programs for Janssen Immunology R&D in her most recent positions as Global Operations Head and Strategy&Operations Lead for the Immunology clinical development organisation. She brings > 25 years of experience in phase 1, 2, 3 of drug development in various scientific and operational leadership roles, in different companies and is highly skilled in leading global cross-functional teams and innovation projects.
Solange Corriol-Rohou, DrMed, MD, PhD
Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France
Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French Medicines Agency/EMA and academia to the pharmaceutical industry, she has gained strategic experience in drug development. She is quite active within EFPIA, ICH and IMI, and passionate about paediatric drug development.
Bert Hartog, PhD, MSc
Senior Director, Clinical Innovation, R&D Development, Janssen Pharmaceutica, Netherlands
Bert is an experienced Senior Director and Innovation Leader. He leads transformational innovation projects that have the goal to shape the future of clinical trial execution, improve the clinical trial experience and position Janssen as a role model in patient-centered clinical research. Bert is an international industry expert in Clinical Research and Digital Health. He graduated in Biomedicine and obtained a PhD in Medicine from Utrecht University. His main focus is developing capabilities for digital health solutions in clinical trials, including harmonization of digital outcome measures and technologies for patient engagement and remote monitoring.
Pall Jonsson, PhD, MS
Programme Director - Data and RWE, National Institute for Health and Care Excellence (NICE), United Kingdom
Dr Jonsson is Programme Director at the National Institute for Health and Care Excellence (NICE) where he heads up Data and Analytics. His team has a strategic role in ensuring NICE is at the forefront of harnessing new and emerging opportunities for using real world data to inform NICE’s guidance to the health and care sectors. Before joining the Data and Analytics team, he was Associate Director for Science Policy and Research, responsible for NICE’s portfolio of international research projects in areas such as big data and real-world evidence. Dr Jonsson has a PhD in bioinformatics from the University College London. Before joining NICE, he worked in academia, biotech and the pharmaceutical industry.
Jonathan Mackinnon, PhD
Associate Director, Medical Writing Services, Parexel, Spain
Dr. Jonathan Mackinnon is an Associate Director of Medical Writing Services at Parexel and a subject matter expert for protocol development. As part of this role, he regularly consults with clients and medical writers on protocol development and plays an active role in addressing ongoing protocol-related challenges within the industry, including decentralized clinical trials, complex innovative designs, and EU-CTR. He also teaches postgraduate courses in Protocol Development and Trial Design at the London School of Hygiene and Tropical Medicine.
Bhausaheb S. Patil, MPharm
Head Business Operations - Decentralized Clinical Trials, IQVIA, United Kingdom
Bhausaheb Patil has over 25 years of experience in the clinical research industry, having held various local and global roles to promote patient safety, data integrity and regulatory compliance to bring new medicines to patients faster and more safely. Bhausaheb has worked in a variety of functions such as clinical monitoring, clinical operations, project and resource management, and risk-based monitoring approaches. He is a seasoned manager at mid-to-senior levels within the clinical research industry.
Gerhard Schlueter, DrSc, MSc
Head of Strategic and Technical Operations, Regulatory Affairs, Bayer AG, Germany
Currently Head of Strategic & Technical Operations within Regulatory Affairs at Bayer Pharma leading a global team focusing on submission, labeling, outsourcing, quality management, and RIM activities. Before that Gerd directed the global Regulatory Strategy teams for oncology, hematology, and ophthalmology at Bayer. He was member of the DIA Euro organizing committees for the meetings 2018 in Glasgow and 2020 in Brussels.
Patrice Verpillat, DrMed, MD, PhD, MPH
Head of Real World Evidence, European Medicines Agency, Netherlands
He is a medical doctor, specialist in epidemiology. He has worked during 20 years in the pharmaceutical industry where he had positions in several international companies, always dealing with real world data (RWD) and non-interventional studies (NIS) in order to bring RWE into research, access and life-cycle product management. Dr. Verpillat has published over 70 articles in Medline referenced journals. He has been involved in many organisations such as ENCePP, ICH M14 working group, European pharma association (efpia) and ISPE.
President, Duchenne Parent Project, Netherlands
Founder and President of the Duchenne Parent Project Netherlands since 1995, Chair and co-founder of the World Duchenne Organization and board member of Eurordis. She is the mother of an adult son with Duchenne MD & orthodontist by training; chair of the Ethics Board & member of the Executive Committee of TREAT-NMD; volunteer for Eurordis; a patient expert for the European Medicines Agency. Involved in several publications regarding Standards of Care and drug development for Duchenne Muscular Dystrophy, concerning development of outcome measures & role of Biomarkers. She is co-author of a handbook on psychosocial aspects of DMD. She participates in several EU funded projects, such as Asterix, Adapt Smart, RD-Connect Vision-DMD & Share4Rare.
Director, International Patient Collaboration, EUPATI Spain, Spain
Rob has been Communications Coordinator at the European Patients’ Academy (EUPATI), a project on patient education and engagement in the research system, for more than 3 years. He has been part of Eurordis as consultant in patient group growth since 2008 and is working on surveys on patient satisfaction with clinical care. Rob was involved in the US AIDS Treatment Activists Coalition, and in its Drug Development Committee. Previously, at Treatment Action Group (TAG), he was the Antiretroviral Project Director for four years. Rob helped in implementing international patient advocacy and education in Europe. He worked with the European AIDS Treatment Group from 1995 – 2002.
Amos De Jong, MSc
PhD candidate, Utrecht University, Netherlands
Amos de Jong is a PhD student at the Utrecht University, the Netherlands. His thesis work focuses on the regulatory aspects of clinical trial innovation, in particular regarding decentralized clinical trials. The work is embedded within the Innovative Medicines Initiative Trials@Home consortium. Amos completed a BSc and MSc in Biomedical Sciences from the VU University Amsterdam.
Maria Elgaard Sørensen
Special advisor, Danish Medicines Agency, Denmark
Maria Elgaard is a special adviser and project manager at the Danish Medicines Agency and currently in an interim position as team manager in the CT unit. Educational background is M.SC.Pharm and she has been working as an assessor of clinical trials application for several years. As of 2016 she has been increasingly engaged in the CTIS project currently as MSPO and master trainer. Nationally she has been appointed business specialist in both the European and the Danish IT solutions for handling clinical trials and other national systems with interaction to the clinical trials area.
Christine Fletcher, MSc
VP/Head, Speciality and Primary Care Statistics, GlaxoSmithKline, United Kingdom
Chrissie is the VP Speciality & Primary Care Statistics at GSK. Chrissie has worked in the Pharmaceutical Industry for over 30 years and has experience of developing and commercialising new medicines in a variety of therapeutic areas across all phases of clinical development. Chrissie is actively engaged in Statistical societies, Pharmaceutical trade associations and initiatives relating to the Pharmaceutical Industry. She is currently the Chair of the Statisticians in the Pharmaceutical Industry (PSI), the EFPIA lead for the Innovation in Clinical Trials Pillar, a working group in the Clinical Research Expert Group, she is one of the PSI representatives on the EFSPI Council and she is the lead for the EFSPI Statistics Leaders Forum.
Fiona Maini, MS
Principal Global Compliance and Strategy Principal, Medidata a Dassault Systèmes Company, United Kingdom
As a Medidata Global Compliance and Strategy Principal, Fiona’s focus includes evaluation of GxP relevant regulatory changes coupled with the regulatory aspects of technological advancements and geo-political dynamics impacting the Life Sciences and Healthcare industries, specifically within in the clinical research domain. In this role Fiona regularly interacts with authorities on emerging patient centric technologies. Fiona is currently the Chair of the ACRO Decentralised Clinical Trials Working Party in the EU, focused on the end to end process, technology, data and regulatory frameworks for virtual clinical trials. Fiona is also a member of the EU Alliance on Artificial Intelligence. Prior to Medidata Fiona was a Director at Deloitte,
Ana Zanoletty Perez
Head of Clinical Trials Transformation workstream, European Medicines Agency, Netherlands
Ana qualified as a pharmacist and following various roles managing clinical trials for the biopharmaceutical industry joined EMA in 2006. At EMA she spent her initial years coordinating initial marketing authorisation procedures, and later transitioned into the management of post-authorisation procedures. Ana has been Programme Manager for the Accelerating Clinical Trials in the EU (ACT EU), a European clinical trials transformation initiative which is co-lead by EC, HMA and EMA, and is currently the Head of the Clinical Trials Transformation workstream at EMA.
Guido Grass, MD
Ethic Commission, University of Cologne, Germany
Education 1989-1995 Medicine, University of Cologne, Germany Occupational Carreer Until 2000 Doctoral Thesis on animal models for sepsis research 1998-2002 Research associate (MD) Department for Visceral Surgery, University of Cologne, Germany 2000-2002 Research associate (MD) Department for Surgery II, Biochemical and Experimental Division, University of Cologne 2002-2005 Research associate (MD) Coordinating Center for Clinical Trials Cologne Current Postion Since 2005 Head of the Office of the Ethics Committee of the Medical Faculty of the University of Cologne, Germany Miscellanous Since 2014 Member of the board of the Working Party of Medical Ethics Committees in Germany EC Representive in several EMA working groups
Olga Kholmanskikh Van Criekingen, MD, PhD
Clinical assessor, Federal Agency for Medicines and Health Products, Belgium
Olga Kholmanskikh is a clinical assessor at the Federal Agency for Medicines and Health Products (FAMHP), a Belgian National Competent Authority, since 2012. She is an MD by training and holds PhD in Biomedical and Pharmaceutical Sciences. She leads the Complex Clinical Trials (CCTs) working subgroup at Clinical Trials Coordination Group (CTCG) of the Heads of Medicines Agencies (HMA).
Maria Mavris, PhD
Patient Relations, European Medicines Agency, Netherlands
Maria Mavris first joined EMA as a seconded expert from a patient organisation in 2014 and then as a staff member from 2017. As part of the Public and Stakeholder Engagement department of EMA, her work focuses on involving patients all along the regulatory lifecycle of medicines with a particular focus on committee membership and scientific advice. Maria is also involved in the development of training to support patients’ representatives in EMA’s work, health technology assessment.
Vada Perkins, DrSc, MSc
Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer-Ingelheim, United States
Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal products worldwide. He received his degrees from Johns Hopkins University, University of Southern California, and the University of Maryland.
Mira Zuidgeest, PharmD, PhD, MSc
Associate Professor, University Medical Center Utrecht, Netherlands
Mira Zuidgeest is an Associate Professor at the University Medical Center Utrecht. Trained both as pharmacist and epidemiologist and with a PhD in pharmacoepidemiology in the field of paediatric asthma, her current work focuses on clinical trial innovation, both methodological and operational. She is board member of the GetReal Institute (www.getreal-institute.org) and led the development of a decision-support tool for randomised clinical trials integrated into routine clinical practice (www.getrealtrialtool.eu). As academic lead for the IMI Trials@Home project (www.trialsathome.com), she researches possibilities of centering trials around patients rather than clinical sites by use of innovative technologies (Decentralised Clinical Trials)
Monique Al, PhD
Special advisor CCMO, Central Committee on Research Involving Human Subjects (CCMO), Netherlands
Monique Al is currently special advisor at the Central Committee on Research Involving Human Subjects (CCMO) in The Netherlands. Since May 2023 she is the vice-chair of the Clinical Trial Coordination Group. She is the lead of the CTCG ethics advisory group. Her background is Clinical Nutrition with a PhD in Human Biology. She has worked for several nutritional and pharmaceutical companies in the field of clinical research before she started in 2001 as a scientific staff member at the CCMO.
Greet Musch, PhD
strategic adviser , 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.
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