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DIA 2021 Global Annual Meeting


EMA-FDA Question Time

Session Chair(s)

Anabela  Marcal, PharmD

Anabela Marcal, PharmD

  • EMA Liaison Official to FDA
  • European Medicines Agency, Netherlands
Sandra L. Kweder, MD

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)

Agnès  Saint-Raymond, DrMed

Development and Use of Medicines in Pregnancy and Lactation: EMA Update

Agnès Saint-Raymond, DrMed

  • Head of Division International Affairs
  • European Medicines Agency, Netherlands
Lynne  Yao, MD

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
Thorsten  Vetter, DrMed

Parallel Scientific Advice: EMA Update

Thorsten Vetter, DrMed

  • Senior Scientific Officer, Scientific Advice
  • European Medicines Agency, Netherlands
Shannon  Thor, PharmD, MS

Parallel Scientific Advice: FDA Update

Shannon Thor, PharmD, MS

  • International Policy Analyst, Office of Global Policy & Strategy, Europe Office
  • FDA, United States
Veronika  Jekerle, PhD, RPh

Quality/CMC Development in Early Access Approaches: EMA Update

Veronika Jekerle, PhD, RPh

  • Head of Pharmaceutical Quality
  • European Medicines Agency, Netherlands
Laurie  Graham

Quality/CMC Development in Early Access Approaches: FDA Update

Laurie Graham

  • Director, DIPAP, OPPQ, OPQ, CDER
  • FDA, United States