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Session 2: Step in Standardization in Japan!
Session Chair(s)
Manami Hashimoto
Manager, Oncology Data Mgt Gr, Integrated Science & Operations Dept,Oncology Div
Novartis Pharma K.K., Japan
Mariko Mizumoto
Associate Director, Electronic Data System Mgt Gr, Clinical Data & Biostats Dept
Daiichi Sankyo Co., Ltd., Japan
Electronic data submission to PMDA was concreted. It will lead to higher requirement for standardization. We would like to share our challenges and current status for standardization, not only data format but also process, focused on seeing submission in Japan. Then let’s discuss the next step!
Speaker(s)
Masato Kobayashi presentation
Masato Kobayashi
Astellas Pharma Inc., Japan
Asc Dir, Clinical Quality Assurance, Clinical & Research Quality Assurance
Using Standard Library of Clinical Data Management: Pros and Cons of Standardization
Yasuharu Shibata, MSc
MSD K.K., Japan
Head of Clinical Data Management, Cliinical Data Management
Data Harmonization across Standards, Platforms and CROs to Meet Regulatory Requirements across the Globe
Belinda Gardner
Pfizer Japan Inc., Japan
Senior Director, Development Operations
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