メニュー 戻る8th DIA FDA IND/NDA Training Course in Japan

8th DIA FDA IND/NDA Training Course in Japan


概要

Click here to view the Program.

The globalization of the pharmaceutical industry means that it is no longer enough for regulatory and development staff and managers in Japanese pharmaceutical companies to understand only the Japanese regulations and process of drug development.
It is now essential for professionals in the field to understand the regulations, processes, and trends in other countries that participate in global drug development.
For several years DIA has offered a training course in the US focused on submission of IND/NDA to the FDA. The course is very popular with attendees from around the world, including Japanese participants. With this success, DIA has brought the course to Japan since 2012. The training features:
• Focus on regulations and processes (IND and NDA)
• How to work productively and efficiently with FDA
• Plus More
The trainers will be Dr. Alberto Grignolo and Dr. Carol H Danielson, who are two of the original FDA IND/NDA trainers in the US. The course will be conducted in English except that Workshops will be conducted in Japanese for a deeper understanding.

参加対象

This training will benefit regulatory and clinical development professionals in Japan who are intending/planning US submissions and clinical trials or similar projects.

プログラム委員会

  • Masayoshi  Higuchi
    Masayoshi Higuchi Department Manager, Business Strategy & Compliance 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 Japan Regulatory Portfolio Lead, Regulatory Affairs
    Pfizer R&D Japan, Japan
  • Yomei  Matsuoka, MSc, RPh
    Yomei Matsuoka, MSc, RPh Vice President, R&D / PV Quality Assurance Department
    Daiichi Sankyo Co., Ltd., Japan
  • Miwa  Tamada
    Miwa Tamada Manager, New Drug RA Department, Regulatory Affairs
    GlaxoSmithKline K.K., Japan
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お問い合わせ

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