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Session 4 - Risk Based Approach to Monitoring (RBM) Expectations to Data Managers/Central Monitors from Monitors & Sites
Session Chair(s)
Kazuya Doi, MBA, MPharm
Eli Lilly Japan K.K., Japan
Norio Shimazaki
Director, Regional Clinical Operations Japan, Korea and Taiwan
Bristol-Myers Squibb K.K., Japan
Do you know How Monitoring system and operations change with RBM? Do you know how did a relation with investigational sites change with RBM? It is good for Data Managers to hear voices from monitors who face with investigational sites. This collaboration session is held with DIA Clinical Operation and Monitoring Workshop (COM). Let’s hear our customer voices and discuss what can do together! We will have another session in DIA COM in March 2016 and will give Data Managers / Central Monitors feedbacks to monitors conversely.
Speaker(s)
The Experience Obtained from RBM Pilot Study
Manabu Takata
Bristol-Myers Squibb K.K., Japan
Regional Clinical Operation Japan
Changing Mindset and Approach to Implementation of Process Management Monitoring which is Foundation of Risk Based Monitoring
Izumi Omura
Takeda Pharmaceutical Company Limited, Japan
RBM: The Shionogi Experience
Yoshiyasu Yoshioka
Shionogi & Co., Ltd., Japan
Misato Kuwagaki, MS
Eli Lilly Japan K.K., Japan
Associate Director, Data Sciences
Yumi Sugiura, MRCP
Bristol-Myers Squibb K.K., Japan
Global Clinical Operations, Global Data Management and Centralized Monitoring
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