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KEYNOTE ADDRESS 2 - The Latest Update on Local Implementation Plan in Japan to Align with the Updated ICH-GCP Requirements
Session Chair(s)
Toshiyuki Hata, PhD
Deputy Review Directior, Office of New Drug III
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Satoshi Saeki, MSc
Head of Japan Operational Excellence, Medical Affairs, Japan
Astellas Pharma Inc., Japan
Speaker(s)
Update of JGCP Implementation with ICH E6 (R2)
Makoto Hirose, MSc
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Office Director, Office of Non-clinical and Clinical Compliance