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東京ビッグサイト | 有明

2018年11月11日 (日) 午前 9:30 - 2018年11月13日 (火) 午後 5:40

〒135-0063, 東京都江東区有明3-11-1



[V1-S3] Current Situation and Future Perspectives of Risk Based Monitoring

Session Chair(s)

Norio  Shimazaki

Norio Shimazaki

Director, Regional Clinical Operations Japan, Korea and Taiwan

Bristol-Myers Squibb K.K., Japan

Several years have passed since many sponsors began implementing Risk Based Monitoring (RBM), however confusion continues at the site where clinical trials are still ongoing. Especially from the perspective of medical institutions, the following comments have been made: “The introduction of RBM has increased the requirements from sponsors and the number of procedures has increased”; “Some companies want to unify the method of performing RBM”. It is likely that the confusion has been caused by paying attention to only to procedures and not to what matters most: the core meaning of RBM. In this session, we will discuss the current situation and future perspectives based on Roles & Responsibilities of CRAs and CRCs and others in addition to the knowledge gained from GCP inspection in RBM implementation trials. We hope this session will help you deepen your understanding of the essence of securing Data Integrity.


Nagako  Umino

Response to RBM - Efforts to Visualize the Clinical Trial Process

Nagako Umino

I’rom Group Co., Ltd., Japan

Project Management Department, Technical Solution Section

Hideaki  Ueda

Risk Based Monitoring Transformed the Clinical Research Experience

Hideaki Ueda

PAREXEL International, Japan

Associate Client Relationship Director

Misato  Kuwagaki, MS

Continuous Improvement of RBM Including PMDA Inspection Lesson Learnt

Misato Kuwagaki, MS

Eli Lilly Japan K.K., Japan

Associate Director, Data Sciences

Yumi  Sugiura, MRCP

We Can’t Look Back, Only Ahead to RBM.

Yumi Sugiura, MRCP

Bristol-Myers Squibb K.K., Japan

Global Clinical Operations, Global Data Management and Centralized Monitoring