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KFC Hall

Mar 03, 2016 9:30 AM - Mar 04, 2016 5:00 PM

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

4th DIA Clinical Operations & Monitoring Workshop in Japan

Session 1 - Current and Future State of GCP Inspection from Regulatory Perspectives

Session Chair(s)

Satoshi  Saeki, MSc

Satoshi Saeki, MSc

Head of Japan Operational Excellence, Medical Affairs, Japan

Astellas Pharma Inc., Japan

Hazuki  Takaura, MSc

Hazuki Takaura, MSc

Inspector, Office of Non-clinical and Clinical Compliance

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Speaker(s)

Takeyuki  Sato

Current and Future State of GCP Inspection - From Regulatory Perspectives -

Takeyuki Sato

Foundation for Biomedical Research and Innovation at Kobe, Japan

Advisor

Hazuki  Takaura, MSc

Current and Future State of GCP Inspection - From Practical Insight of PMDA Inspector -

Hazuki Takaura, MSc

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Inspector, Office of Non-clinical and Clinical Compliance

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