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24th DIA Japan Annual Workshop for Clinical Data Management

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[Session4]Think about the Data Quality of Clinical Trials by Learning the Regulation/Inspection

Session Chair(s)

Koji  Miyata

Koji Miyata

  • Manager, Data Management Group, Data Science Development
  • Astellas Pharma Inc., Japan
Yoko  Tokunaga, MPharm

Yoko Tokunaga, MPharm

  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Speaker(s)

Hiromichi  Isaka, MPharm

Updates on GCP inspection and Document-based inspection

Hiromichi Isaka, MPharm

  • Office of Non-clinical and Clinical Compliance
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Han  Yali

China Specific DM Requirements

Han Yali

  • Pfizer (China) Research and Development Co., Ltd., China
Priya  Annamalai, MS

Inspection of FDA, EMA and MHRA: Points and Trends related to Clinical Data Management

Priya Annamalai, MS

  • Senior Manager, RDQA Inspection Management
  • Abbvie, United States

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