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Session 1 / Venue 2: Risk-based Approach to Monitoring
Session Chair(s)
Satoshi Saeki, MSc
Head of Japan Operational Excellence, Medical Affairs, Japan
Astellas Pharma Inc., Japan
The process to assure accuracy of CRF data with source data thorough periodical onsite monitoring is resource intensive approach. However it is doubtful whether those are paid off by the data quality. In August 2011, FDA and EMA published draft guidance and reflection paper mentioning risk based approach to monitoring. Those clearly mentioned that they don’t require industries to conduct 100% SDV, and recommend: 1.) Greater reliance on centralized monitoring; 2.) On-site monitoring based on the identified risk, to perform preventive and corrective action; 3.) Different approach to critical data and noncritical data Through this session, you will be introduced overview and points to consider of the risk based approach to monitoring, as a new feature to assure study data quality.
Speaker(s)
Overview of the Risk-based Approach to Monitoring
Takahiro Negishi
Nippon Boehringer Ingelheim Co., Ltd., Japan
Risk Management Plan: What should be done at the study planning and preparation phase?
Kazuki Furuno
Mochida Pharmaceutical Co., Ltd., Japan
Data Science Expert Committee, Drug Evaluation Committee, JPMA
How should central and on-site monitoring work better?
Yoko Kurose, MPharm
Pfizer R&D Japan, Japan
Senior Manager, Monitoring Group
Risk-based Approach to Source Data Verification
Ryoichi Muraoka, DVM
INTAGE Healthcare Inc., Japan
Manager, Clinical Development Department
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