返回 Agenda
Session Chair(s)
Satoshi Saeki, MSC
Head of Japan Operational Excellence, Medical Affairs, Japan
Astellas Pharma Inc., Japan
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,Clinical Operations, Development Japan
Risk-based Approach to Source Data Verification
Ryoichi Muraoka, DVM
Ark Medical Solutions Inc., Japan
Manager, Clinical Research Department