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The 23rd DIA Japan Annual Workshop for Clinical Data Management


Session-02: Big Picture of ICH Guidelines Revision that Data Manager should Know

Session Chair(s)

Koji  Miyata

Koji Miyata

  • Manager, Data Management Group, Data Science Development
  • Astellas Pharma Inc., Japan
Keisuke  Utsumi

Keisuke Utsumi

  • Head, Clinical Platforms & Sciences, Japan Development
  • GlaxoSmithKline K.K., Japan

Speaker(s)

Osamu  Komiyama

Two Big Changes GCP Renovation will Bring Us

Osamu Komiyama

  • Senior Manager, Regulatory Policy, Regulatory Affairs
  • Pfizer R&D Japan, Japan
Mutsuhiro  Ikuma

Goal of the Revision of ICH E8(R1) "General Considerations for Clinical Studies"

Mutsuhiro Ikuma

  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Hideki  Suganami, PhD

Summary of ICH E9(R1)

Hideki Suganami, PhD

  • Director, Clinical Data Science Dept.
  • Kowa Company, Ltd., Japan