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Session 2 / Venue 2: What is going on after J-RMP Implementation?
Session Chair(s)
Shoji Takamatsu, PhD
Office Director, Office of Safety II
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
In Japan, draft RMP should be submitted as an attachment of CTD1.11. It is disclosed on PMDA website once a product is launched. To deal with this situation, each company is developing RMPs referring e.g., EU RMP. Meanwhile, more excellent and effective risk management are oriented in EU/US according to implementation of EU GVP/PDUFA V. In this session, the most recent situation is updated by EU/ US and Japan from regulatory perspective, and both industries and competent authorities discuss current issues and solutions for them.
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
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