返回 Agenda
Session Chair(s)
Shoji Takamatsu, PHD
Office Director, Office of Safety II
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Speaker(s)
Changes between pre- and post implementation of RMP in Japan and future concerns – especially both from NDA review process and inquiries regarding safety
Tomoko Misaki
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Difference between EU-BRMP and Japan-RMP – Those features perspectives
Junko Sato, PHD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director
Impact of PDUFA V from risk management perspective - Where it is and where to go (TBC)
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
Company perspective: Changes after implementation of Japanese RMP
Yoshiaki Ohashi, PHD
Chugai Pharmaceutical Co.,Ltd., Japan
Audit and Supervisory Board Member