メニュー 戻る5th DIA European Medicines Regulations Training Course

5th DIA European Medicines Regulations Training Course

This course will give you an overview of the European regulatory system to provide you with the tools you need to develop a successful regulatory strategy.


概要

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This course will give you an overview of the European regulatory system to provide you with the tools you need to develop a successful regulatory strategy. You will be given information about the different routes for obtaining a license for the European market, including centralized or decentralized procedures; mutual recognition procedures; national procedures; and the specific procedures for orphan drugs, pediatrics, advanced therapies, and combination products. The course will cover the different steps and time lines for each procedure, the clockstops, the compiling of questions, and other key topics.

You’ll also receive a brief introduction to the unique set up of the European regulatory environment, including the different responsibilities of the European Commission, the member states, the European Medicines Agency (EMA), the National Competent Authorities (NCAs), and the Heads of Medicines Agencies (HMA).

Please note: the language of this training course will be English only, but Japanese speaking will be welcomed during group discussions.

プログラム委員会

  • Masayoshi  Higuchi
    Masayoshi Higuchi Head of Regulatory Affairs Department
    Chugai Pharmaceutical Co., Ltd., Japan
  • Akiko  Ikeda, RPh
    Akiko Ikeda, RPh Senior Manager, Policy Intelligence Dept., Integrated Market Access Division
    Janssen Pharmaceutical K.K., Japan
  • Yumi  Inukai
    Yumi Inukai New Drug Regulatory Affairs Dept.
    Daiichi Sankyo Co., Ltd., Japan
  • Miyuki  Kaneko
    Miyuki Kaneko Manager, Japan Regulatory Lead
    Pfizer Japan Inc., Japan
  • Yomei  Matsuoka, MSc, RPh
    Yomei Matsuoka, MSc, RPh Senior Director, Safety Planning Group 1, Pharmacovigilance Department
    Daiichi Sankyo Co., Ltd., Japan
  • Miwa  Tamada
    Miwa Tamada New Drug RA Department, Regulatory Affairs
    GlaxoSmithKline K.K., Japan
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お問い合わせ


Please contact DIA Japan for further information.

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+81.3.6214.0574