Pmda - Pharmaceuticals and Medical Devices Agency
Menu
Close

Events and Symposia

PMDA-ATC Review of Cell therapy and Gene therapy products Seminar 2025 for South-East Asian countries

banner of the seminar

Click here to see the Promotion Flyer [273KB]

Introduction

The Pharmaceuticals and Medical Devices Agency (PMDA) are pleased to announce the “PMDA-ATC Review of Cell therapy and Gene therapy products Seminar 2025 for South-East Asian countries” for reviewers of South-East Asian countries. This seminar will be held IN PERSON from July 15 to 17, 2025.
This seminar will provide review points of quality, non-clinical and clinical data of CGTP. Lecture on post-marketing safety plan is included as well. As a practical training, there will be case studies with PMDA approved products.

Key Objectives of This Seminar

  1. To learn review points of quality data, non-clinical data, clinical data and post-marketing safety plan of cell and gene therapy products.
  2. To understand practical review points of cell and gene therapy products by the case studies.

Who should apply

Regulators of South-East Asian countries ONLY (Intermediate or higher level)

  • Working experience of Cell therapy and Gene therapy products review for over 2 years.
  • English will be used in the lectures and discussions during the seminar. Participants need an ability to readily communicate in English.
  • All participants are recommended to take the PMDA-ATC E-learning Course of “Advanced Therapy Medicinal Products” prior to attending the live sessions.

Date / Time

  • July 15 (Tuesday), 2025: 10:00 to 16:20 JST (UTC+9)
  • July 16 (Wednesday), 2025: 10:00 to 16:10 JST (UTC+9)
  • July 17 (Thursday), 2025: 10:00 to 15:40 JST (UTC+9)

Program

See the attached program [164KB]

Fee

There is no registration fee for this seminar.

  • Information on travel and hotel reservation assistance will be announced to the approved participants.
  • International travel insurance is not covered by PMDA, but PMDA strongly recommends participants to consider obtaining it on your own.

Seminar Location

Vision Center Tokyo TORANOMON
T-LITE Bldg. 5th floor, 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

 (Note: For the purpose of security, @ in the e-mail addresses are replaced with [at]. Please replace [at] with @ when you send an e-mail.)