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[V5-S5] Risk-based Approach to Monitoring — Part 1: Current Status and Outlook
Session Chair(s)
Naoyuki Yasuda, MSc
Associate Executive Director , Office of International Programs
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Yuji Fukuda
Manager, PMS Management
Eli Lilly Japan K.K., Japan
Speaker(s)
Current Status of RBM Implementation in Japan
Reiko Oku
Teijin Pharma Limited, Japan
Data Manager, Pharmaceutical Development Administration
Points to Consider for RBM Implementation: A View from Investigational Site
Yukiko Enomoto
Nihon University Itabashi Hospital, Japan
Clinical Research Center
The Expectations for Institutions and the Proposal from Sponsors on RBM
Yuri Kitayama
Otsuka Pharmaceutical Co., Ltd., Japan
Clinical Management
Items to be Covered by the Sponsor at the Study Preparation Phase
Ryoichi Muraoka, DVM
INTAGE Healthcare Inc., Japan
Manager, Clinical Development Department
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