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
- To learn review points of quality data, non-clinical data, clinical data and post-marketing safety plan of cell and gene therapy products.
- 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
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