第5回DIAクリニカルオペレーション・モニタリング ワークショップ

Satoshi Saeki, MSc

Head of Japan Operational Excellence, Medical Affairs, Japan

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