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EMA-FDA GCP Initiative: Current Status and Future Perspectives

Track:
Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice

Day & Time:
June 17, 1:30PM - 3:00PM (Pacific Standard Time)

Session Number:
272

Room Number:
11B

Level:
Intermediate

Type:
Session

Title:
EMA-FDA GCP Initiative: Current Status and Future Perspectives

Chair(s):
Anabela Marcal, PharmD
Head of Compliance and Inspections Department
European Medicines Agency, European Union, United Kingdom

Description:
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(s):
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.

Presentation(s) & Speaker(s):
EMA Perspective
Anabela Marcal, PharmD
Head of Compliance and Inspections Department
European Medicines Agency, European Union, United Kingdom

FDA Perspective
Kassa Ayalew, MD, MPH
Medical Officer, OSI, Office of Compliance, CDER
FDA, United States