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[SESSION 1] Global Harmonization of Data Reliability and Management
Session Chair(s)
Yumiko Asami
Chapter Head of Clinical Data Science
Boehringer Ingelheim, Japan
Yukikazu Hayashi
Assistant Head of Clinical Development
A2 Healthcare Corporation, Japan
In anticipation of a paradigm shift in data reliability and management and data reliability due to the ICH GCP renovation, this session will discuss data reliability based on this new direction, and also discuss differences in the concepts of new drug application and data reliability between Japan, Europe, and the US.
Speaker(s)
NDA Review Processes in 3 ICH Regions, and Points to Consider on Data Integrity Standards in Japan
Masayoshi Higuchi
Chugai Pharmaceutical Co., Ltd., Japan
Head of Quality & Regulatory Compliance Unit,
Data Handling in Global Drug Development; Challenges and the Way to Go
Osamu Komiyama
Pfizer R&D Japan G.K., Japan
Senior Manager, Statistical Research & Data Science
Quality Management and Root Cause Analysis
Masataka Sano
Faculty of Social Systems Science, Chiba Institute of Technology, Japan
Associate Professor, Department of Management Information Science
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