Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) are pleased to announce the “PMDA-ATC Review of Cell therapy and Gene therapy products Webinar 2024 for PPWG member states” for reviewers of ASEAN PPWG member states. This webinar will be held virtually from June 27 to 28, 2024.
This webinar will cover review points of quality, non-clinical, clinical and post-marketing plan. It will also provides case studies using PMDA approved products.
Key Objectives of This Webinar
- To learn review points of quality, non-clinical, clinical and post-marketing plan.
- To understand practical review points by the case studies.
Who should apply
Regulators of ASEAN PPWG member states 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 webinar. 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 session.
Date / Time
- June 27 (Thursday), 2024 : 14:00 to 16:35 JST (UTC+9)
- June 28 (Friday), 2024 : 14:00 to 17:10 JST (UTC+9)
Program (subject to change)
See the attached program [134KB]
Application
Close of registration application: May 9, 2024.
To apply for the webinar, please make sure to complete all the necessary items on the application form, including the signature by the applicant's supervisor, before the closing date. Click the link to apply: https://www12.webcas.net/form/pub/pmda-atc/aseanctgt2024
- Confirmation of registration and additional information will be sent to the approved participants after the closing date.
Fee
There is no registration fee for this webinar. Any expenses incurred with participation in the webinar will not be covered by PMDA.
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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