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[SESSION 2] Scaling up RBM Implementation towards Clinical Risk Management
Session Chair(s)
Misato Kuwagaki, MS
Associate Director, Data Sciences
Eli Lilly Japan K.K., Japan
Yumi Sugiura, MRCP
Global Clinical Operations, Global Data Management and Centralized Monitoring
Bristol-Myers Squibb K.K., Japan
ICH-E6 (R2) requires sponsors to implement a Quality Management system to manage quality throughout all stages of the clinical trial process. Through this Quality Management system, the sponsor should focus on trial activities essential for ensuring human subject protection and reliability of trial results, using a risk-based monitoring (RBM) approach. However, internal organizational issues and processes have impacted adopting ICH E6 (R2) requirements at many companies. In this session, we are aiming to digest, through actual data manager experience at a pharmaceutical company, how the data manager could increase understanding of the capability to scale the risk-based approach to clinical risk management.
Speaker(s)
Implemantaion of “Optimal RBM” in the Organization How Do We Achive It?
Aya Kitao
Ono Pharmaceutical Co., Ltd., Japan
Senior Manager, Quality Management, Data Science
Identifying the Professional Patient in Clinical Trials
Richard Zink, PhD
JMP Statistical Discovery, United States
Principal Research Statistician
For Implementation of RBM - Fill the Gap of Specialist -
Kenji Fujisawa
Kowa Company, Ltd., Japan
Five Years of Global Risk-Based Monitoring Implementation: Centralized Monitoring on RBM Studies
Yumi Sugiura, MRCP
Bristol-Myers Squibb K.K., Japan
Global Clinical Operations, Global Data Management and Centralized Monitoring
Atsushi Kawashima, MPharm
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Inspector, Office of Non-Clinical and Clinical Compliance
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