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EMA-FDA GCP Initiative: Current Status and Future Perspectives
Session Chair(s)
Anabela Marcal, PharmD
EMA Liaison Official to the US FDA
European Medicines Agency, Netherlands
The session will cover the current status of the EMA-FDA collaboration on inspections involving clinical research and discuss the achievements, such as a mutual understanding of inspection procedures, and challenges of such an initiative. The most recent and future areas of collaboration will be addressed.
Learning Objective : Discuss the current state of play of the initiative; Recognize the achievements of the initiative in terms of exchanges of information, collaborative inspections, inspection coverage, and mutual understanding of inspection procedures; Describe the most recent and future areas of further collaboration.
Speaker(s)
EMA Perspective
Anabela Marcal, PharmD
European Medicines Agency, Netherlands
EMA Liaison Official to the US FDA
FDA Perspective
Kassa Ayalew, MD, MPH
FDA, United States
Director, DCCE, OSI, Office of Compliance, CDER
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