Speakers
Jarilyn Dupont, JD
Director of Regulatory Policy, Office of Policy, OC, FDA, United States
Director of Regulatory Policy/FDA Office of Policy. Prior to June 2002 worked in Office of Legislation; detailed to Office of Chief Counsel and Acting Director of Office of Crisis Management. Counsel for US House Judiciary Subcommittee and legislative counsel for Member. Attorney since 1977. has also served as Acting Deputy Director of the FDA Europe Office on a detail
Daniel Sigelman
Senior Policy Advisor and Transparency Initiative Coordinator, FDA, United States
Noël Wathion, RPh
Deputy Executive Director, European Medicines Agency, Netherlands
Noël Wathion is the Deputy Executive Director of the EMA since February 2016. He is also the Chief of Policy. He joined the Agency in 1996, and has since held several senior managerial positions, including Head of the Post-Authorisation Evaluation of Medicines for Human Use Unit, Head of the Patient Health Protection Unit, and EMA’s Chief Policy Adviser.
Fergus Sweeney, PhD
Head of Clinical Studies and Manufacturing Task Force, European Medicines Agency, Netherlands
Fergus Sweeney is Head, Clinical Studies and Manufacturing Taskforce at the European Medicines Agency since March 2020, covering Clinical Studies (Clinical Trial Information System), Biological Health Threats and Vaccine Strategy and supports strategy development in manufacturing and personal data protection in health research on medicines. He joined the EMA Inspections Service in 1999, and became Head of Compliance and Inspections (2009) and Head of Division Inspections and Human Medicines Pharmacovigilance in 2013 (including Scientific Committee Services from 2016). He has a BA (Physiology 1979) a Dr de 3eme Cycle (cancer biology 1982), and PhD (Pharmacology 1986). Fergus worked in clinical research mainly in QA from 1982 to 1999.
David K. Lee
Chief Regulatory Officer for Health Product and Food Branch, Health Canada, Canada
David K. Lee is the Chief Regulatory Officer for the Health Products and Food Branch, Health Canada.He was previously the Director of the Office of Legislative and Regulatory Modernization. In this capacity, he led modernization initiatives for the Food and Drugs Act and Regulations. Prior to that he was the Director of the Office of Patented Medicines and Liaison. David received his law degree at Queen’s University and articled at the Federal Court of Canada. He has lectured extensively on intellectual property law and food and drug law both nationally and internationally.
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