Menu
×
Don't Miss Out!
Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA!
DIA 2021 Global Annual Meeting
EMA-FDA Question Time
Session Chair(s)
Anabela Marcal, PharmD
- EMA Liaison Official to the US FDA
- European Medicines Agency, Netherlands
Sandra L. Kweder, MD
- Deputy Director, Europe Office, Office of Global Programs and Strategies, FDA
- FDA, 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
- Head of Division International Affairs
- European Medicines Agency, Netherlands
Development and Use of Medicines in Pregnancy and Lactation: FDA Update
Lynne Yao, MD
- Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER
- FDA, United States
Parallel Scientific Advice: EMA Update
Thorsten Vetter, DrMed
- Senior Scientific Officer, Scientific Advice
- European Medicines Agency, Netherlands
Parallel Scientific Advice: FDA Update
Shannon Thor, PharmD, MS
- International Policy Analyst, Office of Global Policy & Strategy, Europe Office
- FDA, United States
Quality/CMC Development in Early Access Approaches: EMA Update
Veronika Jekerle, PhD, RPh
- Head of Pharmaceutical Quality
- European Medicines Agency, Netherlands

Quality/CMC Development in Early Access Approaches: FDA Update
Laurie Graham
- Director, DIPAP, OPPQ, OPQ, CDER
- FDA, United States