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KEYNOTE ADDRESS - ICH E6 Revision Impacts to Clinical Operations
Session Chair(s)
Satoshi Saeki, MSc
Head of Japan Operational Excellence, Medical Affairs, Japan
Astellas Pharma Inc., Japan
Speaker(s)
Overview of E6 (R2)
Ryosuke Sakai
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Office of Non-clinical and Clinical Compliance
PMDA’s Expectations for E6 (R2) and Local Implementation Plan
Makoto Hirose, MSc
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Office Director, Office of Non-clinical and Clinical Compliance
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