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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
Senior Director, Regulatory Policy Leader EMEA & CMC, Johnson & Johnson, Netherlands
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
Assoc. Dir. for Rare Diseases; Program Manager, Accelerating Rare Disease Cures , FDA, United States
Panelist
Director, Enterprise Project Staff, OQA, OPQ, CDER, FDA, United States
Panelist
Deputy Director (Acting), Oncology Center of Excellence, FDA, United States
Panelist
Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Panelist
Chief Medical Officer, European Medicines Agency, Netherlands
Panelist
Scientific Adviser for Oncology, European Medicines Agency, Netherlands
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