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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)
Real World Data: EMA Perspective
Alison Cave, PHD
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Chief Safety Officer
Real World Data: FDA Perspective
Peter W. Marks, MD, PHD
DIA Fellow, United States
Transparency: EMA Perspective
Juan Garcia-Burgos, MD, PHD
European Medicines Agency, Netherlands
Head of Public and Stakeholders Engagement Department
Transparency: FDA Perspective
Jarilyn Dupont, JD
FDA, United States
Director of Regulatory Policy, Office of Policy, OC
Mutual Recognition Agreement on GMP Inspections: EMA Perspective
Anabela Marcal, PHARMD
European Medicines Agency, Netherlands
EMA Liaison Official to the US FDA
Mutual Recognition Agreement on GMP Inspections: FDA Perspective
Dara Corrigan, JD
FDA, United States
Acting Deputy Commissioner for Global Regulatory Operations and Policy
Quality of Medicines: EMA Perspective
Agnès Saint-Raymond, DrMed
European Medicines Agency, Netherlands
Head of Division International Affairs
Quality of Medicines: FDA Perspective
Sarah Pope Miksinski, PHD
Gilead Sciences, United States
Executive Director, CMC Regulatory Affairs