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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
- Manager, Data Management Group, Data Science Development
- Astellas Pharma Inc., Japan
- Head, Clinical Platforms & Sciences, Japan Development
- GlaxoSmithKline K.K., Japan
Two Big Changes GCP Renovation will Bring Us
- Senior Manager, Regulatory Policy, Regulatory Affairs
- Pfizer R&D Japan, Japan
Goal of the Revision of ICH E8(R1) "General Considerations for Clinical Studies"
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Summary of ICH E9(R1)
Hideki Suganami, PhD
- Director, Clinical Data Science Dept.
- Kowa Company, Ltd., Japan