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6th DIA Regulatory Communication Training Course in Japan


Overview

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It is important for regulatory and development staffs to make a decision about drug development based on scientific evidence, while understanding the current drug development environment and having a wide view regularly. Furthermore, clinical trials should be conducted under regulations and medical condition, and require reliable results. However, sometimes common procedure does not work well for actual development and review when scientific progress intervene. The final decision about drug approval has been reached based not only on clinical trial results, but also on various factors at the time of approval. Sometimes several stakeholders share opposing views due to their difference of position and philosophy in a review process. Is it possible to persuade various stakeholders based on scientific data?

Regulatory and development staff might face these complex situations and be forced into an important decision-making bind. It is quite difficult to convince the other party to change their opinion. Appropriate evaluation based on regulatory science is required for drugs to be accepted by sponsors and regulatory authorities, as well as patients and health care professionals. If staff fail to achieve a balanced decision, the drug will not be regarded as having a favorable benefit/risk balance in its actual use.

In this training course, participants will play the role as reviewer and make a decision about mock product. All participants will be divided into several groups and share their decision* with the group. Each group will be required to discuss and put together a conclusion, and make a presentation about the group decision, explaining their rationale for the conclusion and respond to facilitators’ comments on their conclusion. In this training course, participants will learn accountability for various stakeholders such as patients, parents, academic societies, doctors, nurses, company CEOs, and regulatory authorities. This training course will be a unique workshop and benefit regulatory and development professionals.

Program Committee

  • Teruyo  Arato, PhD
    Teruyo Arato, PhD Professor, Clinical Research and Medical Innovation Center
    Hokkaido University Hospital, Japan
  • Masaharu  Doi
    Masaharu Doi Associate Director, PRA HEALTHSCIENCES
    Takeda PRA Development Center KK, Japan
  • Yoshikata  Furuya, MSc
    Yoshikata Furuya, MSc Director, Vaccine Policy, Health Policy
    MSD K.K., Japan
  • Katsuhiko  Ichimaru
    Katsuhiko Ichimaru Deputy Director for MID-NET project
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Akiko  Ikeda, RPh
    Akiko Ikeda, RPh Senior Manager, Policy Intelligence Dept., Integrated Market Access Division
    Janssen Pharmaceutical K.K., Japan
  • Toshiko  Ishibashi, PhD, RN
    Toshiko Ishibashi, PhD, RN Clinical Operation I, JAPAN, Clinical Operation
    Ono Pharmaceutical Co., Ltd., Japan
  • Takaaki  Ishine
    Takaaki Ishine Senior Clinical Research Specialist
    MSD K.K., Japan
  • Tetsunari  Kihira, PhD
    Tetsunari Kihira, PhD Director, Office of Vaccines and Blood Products
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Yomei  Matsuoka, MSc, RPh
    Yomei Matsuoka, MSc, RPh Senior Director, Safety Planning Group 1, Pharmacovigilance Department
    Daiichi Sankyo Co., Ltd., Japan
  • Naomi  Misaki
    Naomi Misaki CRC, Research Management
    St. Luke's International Hospital, Japan
  • Norikazu  Takahata
    Norikazu Takahata President
    Plus Action for Children, Japan
  • Nao  Tsuchida, MD, PhD
    Nao Tsuchida, MD, PhD Chief
    National Hospital Organization Headquarters, Japan
  • Jun  Yamakami, PhD
    Jun Yamakami, PhD Regulatory Development
    Sanofi K.K., Japan
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Contact us

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

Tel: +81-3-6214-0574
Fax: +81-3-3278-1313
Japan@DIAglobal.org
www.diajapan.org