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ACCSQ PPWG - PMDA-ATC Pharmaceutical Review Seminar 2025

ACCSQ PPW - Pharmaceutical Review Seminar

Click here to see the flyer [180KB]

Introduction

The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce that we will be organizing the “ACCSQ PPWG - PMDA-ATC Pharmaceutical Review Seminar 2025” for reviewers of PPWG member states. The seminar will be held IN PERSON from October 7 to 10, 2025.
This seminar offers practical training on new drug review. Topics will include Japanese regulatory requirements, key considerations in the new drug evaluation process, the structure and content of PMDA review reports, Risk Management Plans (RMPs), and case studies based on PMDA approved products.

Key Objectives of this Seminar

  1. Enhance data evaluation skills across quality, non-clinical and clinical data of new drugs.
  2. Support capacity building to strengthen assessment process of ASEAN Joint Assessment (JA) and bilateral reliance schemes.
  3. Support capacity building to strengthen full assessment of new drugs at each authority.

Who should apply

Regulators of ASEAN member states ONLY (Intermediate or higher level)

  • Staff of regulatory authorities with solid working experience of 1) pharmaceuticals review for over 4 years or 2) ASEAN JA for over 2 years.
  • Participants must have sufficient English proficiency to actively engage in, and benefit from lectures and discussions conducted in English.
  • All participants are recommended to view designated material before participating in the seminar.

Dates / Time

  • October 7 (Tuesday), 2025 10:00 to 16:30 JST (UTC+9)
  • October 8 (Wednesday), 2025 9:30 to 17:00 JST (UTC+9)
  • October 9 (Thursday), 2025 9:30 to 17:10 JST (UTC+9)
  • October 10 (Friday), 2025 9:30 to 15:30 JST (UTC+9)

Program

See the attached program [126KB]

Fee

There is no registration fee for this seminar.

Seminar Venue

Vision Center Tokyo TORANOMON
Address: T-LITE Bldg 5F 2-4-7 Toranomon, Minato-ku, Tokyo

Contact Us

For more information, please contact:
Secretariat, PMDA Asia Training Center
E-mail: PMDA-ATC[at]pmda.go.jp

Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs

Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan

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