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9th DIA FDA IND/NDA Training Course in Japan

All prices are exclusive of 10% Japanese consumption tax

Overview

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The process of new drug development has become increasingly global in the past two decades. Many companies are conducting multinational clinical studies and aiming for simultaneous submission of New Drug Applications (NDAs) in Japan, the US, the EU, China and other countries. 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 has proved to be hugely popular with attendees from around the world, including from Japan. Following the success of the US course, the program has been delivered in Japan since 2012 with the contents tailored to meet the needs of the local audience. The training features:
•A focused look at the regulations and processes in IND/NDA
• Guidance on how to work productively and efficiently with FDA
•12 hours’ of training materials delivered on-demand and available to view for approximately 1 month
•Live Q&A sessions with the trainers
The trainers for this year’s course will be Dr. Alberto Grignolo and Dr. Carol H Danielson. Dr Grignolo and Dr Danielson developed the original US version of the program and have extensive experience of the delivering the course.

Who should attend?

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

Program Committee

  • Masayoshi  Higuchi
    Masayoshi Higuchi Head of Quality & Regulatory Compliance Unit,
    Chugai Pharmaceutical Co., Ltd., Japan
  • Akiko  Ikeda, RPh
    Akiko Ikeda, RPh Associate Director, Regulatory Development Dept., Regulatory Affairs 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, Pharmacoepidemiology and PMS 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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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