PMDA-ATC Review of Cell therapy and Gene therapy products Webinar 2024 for PPWG member state
The PMDA held the “PMDA-ATC Review of Cell therapy and Gene therapy products Webinar 2024 for PPWG member states“ from June 27 to 28. In April 2024, the PMDA held the PMDA-ASEAN Reliance Meeting, inviting the regulatory authorities of ASEAN member states and the World Health Organization (WHO) to the PMDA. In the meeting discussions, it was demonstrated that the technical skills of the ASEAN regulators who were engaged in pharmaceutical review should be enhanced to promote the utilization of the Reliance. Considering this point, the seminar provided ASEAN regulatory reviewers with a practical case-study-based training program to improve their skills in reviewing cell therapy and gene therapy products. A total of 26 people from Brunei Darussalam, Indonesia, Malaysia, the Philippines, Singapore, Thailand, and Vietnam participated in the program.
The webinar opened with the remarks by Dr. SUZUKI Hiroshi, Executive Director of PMDA.
On the first day of the program, lectures were provided on an overview of the review of cell therapy and gene therapy products and quality and non-clinical data. On the second day, lectures focused on the review of clinical data, environmental risk assessment, and case studies on cell therapy products, such as CAR-T and ocular disease. Seven lecturers and facilitators were appointed from the PMDA.
(see the program for details[134KB])
This event was closed with the remark by Dr. SUZUKI Hiroshi. As a token of active participation in the webinar, the digital certification of Open Badge was given to the participants.
Photos and participant comments
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Comments from the participants:
“In general, this webinar covers all topics related to cell and gene therapy regulation. I personally have a better understanding after this webinar.”
“This seminar has helped me get a good overview on the key points that PMDA uses for the quality, safety and efficacy evaluation of cell and gene therapy products. The concepts were well presented by all speakers.”
“The webinar is very comprehensive and informative.”
“The webinar is very interesting, the material is dense, substantial and beneficial for my work.”