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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 , Eliquent Life Sciences, 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)
Agnès Saint-Raymond, DrMed
Head of Division International Affairs, European Medicines Agency, Netherlands
Development and Use of Medicines in Pregnancy and Lactation: EMA Update
Lynne Yao, MD
Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Development and Use of Medicines in Pregnancy and Lactation: FDA Update
Thorsten Vetter, DrMed
Senior Scientific Officer, Scientific Advice, European Medicines Agency, Netherlands
Parallel Scientific Advice: EMA Update
Shannon Thor, PHARMD, MS
FDA Liaison to the European Medicines Agency, FDA, United States
Parallel Scientific Advice: FDA Update
Veronika Jekerle, PHD, RPH
Head of Pharmaceutical Quality, European Medicines Agency, Netherlands
Quality/CMC Development in Early Access Approaches: EMA Update
Laurie Graham
Director, DIPAP, OPPQ, OPQ, CDER, FDA, United States
Quality/CMC Development in Early Access Approaches: FDA Update
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