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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
Katherine Tyner, PhD
FDA Liaison to the EMA, Office of Global Policy and Strategy, OC
FDA, United States
In this interactive forum experts from EMA and FDA will address questions from the audience and share their experiences of collaboration in specific areas as well as on how both Agencies collaborate in addressing current regulatory, scientific, and communication challenges.
Learning Objective : Identify an overall understanding of the regulatory and scientific collaboration between EMA and FDA; Describe experience and explore specific areas of collaboration between the two Agencies; Examine how EMA and FDA are addressing regulatory and scientific challenges in new areas.
Speaker(s)
Panelist
Kerry Jo Lee, MD
FDA, United States
Assoc. Dir. for Rare Diseases; Program Manager, Advancing Rare Disease Cures Pro
Panelist
Adam C Fisher, PhD
FDA, United States
Director, Enterprise Project Staff, OQA, OPQ, CDER
Panelist
R. Angelo De Claro, MD
FDA, United States
Associate Director for Global Clinical Sciences, Oncology Center of Excellence
Panelist
Evdokia Korakianiti, PhD, MSc
European Medicines Agency, Netherlands
Head of Quality and Safety of Medicines
Panelist
Steffen Thirstrup, MD, PhD
European Medicines Agency, Netherlands
Chief Medical Officer
Panelist
Francesco Pignatti, MD
European Medicines Agency, Netherlands
Scientific Adviser for Oncology
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