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EMA-FDA Question Time
Session Chair(s)
Anabela Marcal, PharmD
EMA Liaison Official to the US FDA
European Medicines Agency, Netherlands
Sandra Kweder, MD
Principal, Drug and Biological Products
Greenleaf Health, United States
The EMA and FDA have a long history of scientific and regulatory collaboration. In this interactive session experts from both Agencies will address questions from the audience and share their experiences of collaboration in specific areas.
Learning Objective : Describe the regulatory and scientific collaboration between EMA and FDA; Review the experience and explore specific areas of collaboration between the two Agencies; Discuss how the collaboration between the two Agencies contributes to global development and supervision of medicines.
Speaker(s)
Development and Use of Medicines in Pregnancy and Lactation: EMA Update
Agnès Saint-Raymond, DrMed
European Medicines Agency, Netherlands
Head of Division International Affairs
Development and Use of Medicines in Pregnancy and Lactation: FDA Update
Lynne Yao, MD
FDA, United States
Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER
Parallel Scientific Advice: EMA Update
Thorsten Vetter, DrMed
European Medicines Agency, Netherlands
Senior Scientific Officer, Scientific Advice
Parallel Scientific Advice: FDA Update
Shannon Thor, PharmD, MS
FDA, United States
Deputy Director, Office of Global Policy & Strategy, Europe Office
Quality/CMC Development in Early Access Approaches: EMA Update
Veronika Jekerle, PhD, RPh
European Medicines Agency, Netherlands
Head of Pharmaceutical Quality
Quality/CMC Development in Early Access Approaches: FDA Update
Laurie Graham
FDA, United States
Director, DIPAP, OPPQ, OPQ, CDER
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