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Session 3: Discussion on Risk-based Monitoring Approach from a Clinical Operations Perspective
Session Chair(s)
Mitsuo Hayashi, MSc, RPh
Director & Head, Clinical Enablement
MSD K.K., Japan
Satoshi Saeki, MSc
Head of Japan Operational Excellence, Medical Affairs, Japan
Astellas Pharma Inc., Japan
The last few years have seen a dramatic change in the environment surrounding clinical development, with IT advances such as EDC, IWRS and ePRO enabling sponsors to monitor the status and progress of clinical trials both remotely and in a timely manner. These changes have led Europe and the US to build on the Risk-based Quality Management approach and propose Risk-based Monitoring, a new concept designed to protect subjects and maintain clinical trial data integrity more efficiently. This concept is prompting a fundamental revision of the traditionally held views on monitoring. In Japan, where discussions for introducing Risk-based Monitoring have just begun, the specifics of how to adapt Risk-based Monitoring to current practices are still to be defined. In this session, the key success factors for the implementation of Risk-based Monitoring will be presented from the viewpoint of a non- Japanese CRO, and the specific activities undertaken by both domestic and foreign pharmaceutical companies in Japan to successfully implement Risk-based Monitoring will be described. In addition, representatives from PMDA and a study site will also join the panel discussion and directions of Risk-based Monitoring, which we should seek for in Japan, will be discussed from respective positions.
Speaker(s)
FDA Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring
Ann Meeker-O'Connell, MS
FDA, United States
Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC
Key Factors for the Success of Risk-based Monitoring
Kyle Given
Medidata Solutions Worldwide, United States
Principal, Strategic Consulting Services
Initiatives taken by Japanese company to adapt Risk-based Monitoring
Yuta Yamaga
Mitsubishi Tanabe Pharma Corporation, Japan
Initiatives taken by Foreign Affiliated Company to adapt Risk-based Monitoring
Keiji Funayama, PhD
Novartis Pharma K.K., Japan
Field Operation Group, Oncology Global Development, Oncology Development Dept
Efforts to Adapt Risk-based Monitoring in a Clinical Trial Site
Yuji Kumagai, MD, PhD
Kitasato University Hospital, Japan
Professor, Kitasato Clinical Research Center
Mari Shirotani, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Office Director, Office of Advanced Evaluation with Electronic Data
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