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GCP Renovation: How Will GCP Inspection Change in Europe, Japan, and the US?
Session Chair(s)
Junko Sato, PhD
Associate Executive Director
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
In this session, we will invite speakers from EMA, FDA, and PMDA, and share the latest regulations, perspective to revised ICH guidelines, and challenges to implement the guideline in own region.
Learning Objective : Recognize direction of revising ICH-GCP guideline; Discuss how to utilize it in real inspection.
Speaker(s)
FDA Update
Kassa Ayalew, MD, MPH
FDA, United States
Director, DCCE, OSI, Office of Compliance, CDER
EMA Update
Peter Twomey
European Medicines Agency, Netherlands
Head of Inspections
PMDA Update
Yoshiaki Nodera, MPharm
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Principal Inspector, Office of Non-clinical and Clinical Compliance I
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