Chair

Haruko Yamamoto

Chief Medical Officer, Associate Executive Director, Pharmaceutical and Medical Devices Agency

  
Dr. Haruko Yamamoto, a specialist of neurology, is the Chief Medical Officer/ Associate Executive Director at the Pharmaceutical and Medical Devices Agency. She has led the academic research organization at the National Cardiovascular Center for more than ten years, while worked as a specialist in cerebrovascular diseases. She also has led several investigator-initiated clinical studies evaluating new drugs and high-risk medical devices. She served as a member of the DIA Advisory Council of Japan for four years, and is a member of program committee of the Medical Device Symposium. Dr. Yamamoto holds a PhD in medicine from Osaka University, and teaches regulatory science in several graduate schools of medicine as an invited lecturer.
Members
  • Katsuhiko Ichimaru

    Review Director, Office of New Drug IV, Pharmaceuticals and Medical Devices Agency (PMDA)

  • Akiko Ikeda

    Associate Director, Regulatory Development Dept., Janssen Pharmaceutical K.K.

  • Yoichi Ishikawa

    Professor, Department of Pediatric Medication, Meiji Pharmaceutical University

  • Yasushi Jotatsu

    Managing Director, Department of Innovative Drug Discovery and Development, Japan Agency for Medical Research and Development (AMED)

  • Toshitaka Kawaratani

    Executive Vice President, CMIC Co., Ltd.

  • Daisuke Koga

    Division Director, Division of Planning and Management, Pharmaceuticals and Medical Devices Agency (PMDA)

  • Shigehiro Miki

    Representative Director, General Manager - Japan, PAREXEL International Inc.

  • Harumasa Nakamura

    Director of Clinical Research Support Office, Translational Medical Center, National Center of Neurology and Psychiatry

  • Junichi Nishino

    Head, Regulatory Affairs Department, Otsuka Pharmaceutical Co., Ltd.

  • Satoshi Saeki

    Executive Director, Head of Japan Operational Excellence, Medical Affairs, Japan, Astellas Pharma Inc.

  • Eri Sekine

    Region Head, Trial Monitoring, Japan Development, Global Development Ops., Novartis Pharma K.K.

  • Kozo Takase

    Professor Emeritus, Professor, Department of Research Development, Tokyo Medical and Dental University (TMDU)

  • Hideo Tomiya

    Executive Director, Educational Activities for Pharmaceutical Professionals, Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ)

  • Atsushi Tsukamoto

    Vice President, Development Regulaotry Affairs , Daiichi Sankyo Company, Limited

  • Kaori Watanabe

    CRC, Clinical Research Promotion Center, The University of Tokyo Hospital

  • Takayuki Yoshino

    Department of Gaestrointestinal Oncology, National Cancer Center Hospital East