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[V3-S1] [Educational Session] Comparison of Post-Marketing Safety Measures among Japan, the U.S. and the EU – From the Point of View of Risk Management -
Session Chair(s)
Yomei Matsuoka, MSC, RPH
Vice President, Pharmacoepidemiology and PMS Department, Daiichi Sankyo Co., Ltd., Japan
As multi-regional clinical trials increase, global application and approval and elimination of drug lag are about to be realized, while data of clinical trials in each country tend to decrease compared to before the implementation of multi-regional clinical trials. Therefore, the importance of safety measures in post-marketing phase are relatively increasing for clarifying details of drug safety and efficacy profiles in timely manner. In this context, we will share the difference in concept of risk management between Japan, the U.S., and the EU and the current status and challenges of post-marketing safety measures during this educational session.
Speaker(s)
Emiko Kondo, PHD
Office Director, Office of Safety II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Drug Safety Measures in Japan
Robert Reynolds, DRSC, MSC, FISPE
Vice President, Epidemiology, Worldwide Regulatory and Safety, Pfizer Inc, United States
Post-Marketing Safety Measures in the United States
Peter Bachmann
Retired from Head International Liaison Office and Conferences, Executive Depart, Federal Institute for Drugs and Medical Devices (BfArM), Germany
Post-Marketing Surveillance and Safety Measures in the EU