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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)
GCP
Kassa Ayalew, MD, MPH
FDA, United States
Director, DCCE, OSI, Office of Compliance, CDER
Pediatrics
Corinne de Vries, PHD, MA, MSC
European Medicines Agency, Netherlands
EMA liaison official to the US FDA
Artificial Intelligence
Tala Fakhouri, PHD, MPH
FDA, United States
Associate Director for Data Science and Artificial Intelligence, CDER
Pediatrics
Dionna Green, MD
FDA, United States
Director, Office of Pediatric Therapeutics
Advanved Manufacturing
Evdokia Korakianiti, PHD, MSC
European Medicines Agency, Netherlands
Head of Quality and Safety of Medicines
Advanced Manufacturing
Manuel Osorio, PHD
FDA, United States
Senior Scientist for Emerging Technologies
Artificial Intelligence
Luis Pinheiro, PHARMD, MSC
European Medicines Agency, Netherlands
Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce
GCP
Peter Twomey, MA, MPHARM
European Medicines Agency, Netherlands
Head of Inspections
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