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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)
Kassa Ayalew, MD, MPH
Director, DCCE, OSI, Office of Compliance, CDER, FDA, United States
FDA Update
Peter Twomey, MA, MPHARM
Head of Inspections, European Medicines Agency, Netherlands
EMA Update
Yoshiaki Nodera, MPHARM
Principal Inspector, Office of Non-clinical and Clinical Compliance I, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
PMDA Update
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