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14th DIA Japan Annual Meeting 2017

[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

      Yomei Matsuoka, MSc, RPh

      • Senior Director, Safety Planning Group 1, Pharmacovigilance 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.
      Emiko  Kondo, PhD

      Drug Safety Measures in Japan

      Emiko Kondo, PhD

      • Office Director, Office of Safety II
      • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
      Robert  Reynolds, DrSc, MSc, FISPE

      Post-Marketing Safety Measures in the United States

      Robert Reynolds, DrSc, MSc, FISPE

      • Vice President, Epidemiology, Worldwide Safety
      • Pfizer Inc., United States
      Peter  Bachmann

      Post-Marketing Surveillance and Safety Measures in the EU

      Peter Bachmann

      • Deputy-Head, European Union and International Affairs
      • Federal Institute for Drugs and Medical Devices (BfArM), Germany

Contact us

Please contact the DIA Japan office in Tokyo for further information.

Tel: +81-3-6214-0574
Fax: +81-3-3278-1313