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[Session4]Think about the Data Quality of Clinical Trials by Learning the Regulation/Inspection
Session Chair(s)
Koji Miyata
Manager, Data Management Group, Data Science Development
Astellas Pharma Inc., Japan
Yoko Tokunaga, MPharm
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Speaker(s)
Updates on GCP inspection and Document-based inspection
Hiromichi Isaka, MPharm
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Office of Non-clinical and Clinical Compliance
China Specific DM Requirements
Han Yali
Pfizer (China) Research and Development Co., Ltd., China
Inspection of FDA, EMA and MHRA: Points and Trends related to Clinical Data Management
Priya Annamalai, MS
Abbvie, United States
Senior Manager, RDQA Inspection Management
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