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Session Chair(s)
Kyoko Minamoto
Medical Technologist
National Cancer Center, Japan
Yumi Sugiura, MRCP
Global Clinical Operations, Global Data Management and Centralized Monitoring
Bristol-Myers Squibb K.K., Japan
Speaker(s)
Risk-Based Approaches to Assess Data Integrity in Medical Product Development
Richard Zink
JMP Statistical Discovery, United States
Principal Research Fellow
Views from PMDA -The Impact of ICH E6 Revision-
Hazuki Takaura, MSC
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Inspector, Office of Non-clinical and Clinical Compliance
ICH E6 Revision and QMS
Hironobu Saito, PHD
Tottori University, Chromosome Egineering Research Center, Japan
Specially Appointed Professor
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