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KFC Hall

Mar 08, 2018 9:30 AM - Mar 09, 2018 5:10 PM

1-6-1 Yokoami, Sumida-ku, Tokyo, 130-0015 Japan

6th DIA Clinical Operations and Monitoring Workshop in Japan

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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

Toshiyuki Hata, PhD

Deputy Review Directior, Office of New Drug III

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Satoshi Saeki, MSc

Satoshi Saeki, MSc

Head of Japan Operational Excellence, Medical Affairs, Japan

Astellas Pharma Inc., Japan

Speaker(s)

Makoto Hirose, MSc

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

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