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EMA/ FDA Question Time
Session Chair(s)
Sabine Haubenreisser, PHD, MSC
Principal Scientific Administrator, Stakeholders and Communication Division, European Medicines Agency, Netherlands
Sandra Kweder, MD
Principal, Drug and Biological Products , Eliquent Life Sciences, United States
In this forum, EMA and FDA leadership will engage in a round table discussion on areas covered by the EMA/FDA confidentiality arrangements and discuss how both agencies contribute to global development and supervision of medicines. Experts from both Agencies who are at the forefront of EMA/FDA collaboration will explore topics such as use of real-world data, data transparency, mutual recognition agreement on GMP inspections and quality of medicines.
Learning Objective : Summarize key issues discussed by EMA and FDA; Identify regulatory hot topics; Discuss the areas covered under the bilateral cooperation between EMA and FDA aimed at bringing new medicines to patients throughout the world while assuring consistent standards of quality, efficacy and safety; Identify how to engage both agencies in the development of a medicine at the same time.
Speaker(s)
Alison Cave
Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Real World Data: EMA Perspective
Peter Marks, MD, PHD
Senior Vice President, Molecule Discovery and Head of Infectious Disease, Eli Lilly and Company, United States
Real World Data: FDA Perspective
Juan Garcia-Burgos, MD, PHD
Head of Public and Stakeholders Engagement Department, European Medicines Agency, Netherlands
Transparency: EMA Perspective
Jarilyn Dupont, JD
Director of Regulatory Policy, Office of Policy, OC, FDA, United States
Transparency: FDA Perspective
Anabela Marcal, PHARMD
EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands
Mutual Recognition Agreement on GMP Inspections: EMA Perspective
Dara Corrigan, JD
Acting Deputy Commissioner for Global Regulatory Operations and Policy, FDA, United States
Mutual Recognition Agreement on GMP Inspections: FDA Perspective
Agnès Saint-Raymond, DrMed
Head of Division International Affairs, European Medicines Agency, Netherlands
Quality of Medicines: EMA Perspective
Sarah Pope Miksinski, PHD
Executive Director, CMC Regulatory Affairs, Gilead Sciences, United States
Quality of Medicines: FDA Perspective
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