PMDA-ATC Pharmaceuticals Review Webinar 2023
The PMDA held the “PMDA-ATC Pharmaceuticals Review Webinar 2023” from September 26 to 28, 2023. This lively online webinar was intended for officials of overseas regulatory agencies involved in the review of pharmaceuticals, attended by twenty-nine regulators from Botswana, China, Chinese Taipei, Egypt, India, Indonesia, Kazakhstan, Malaysia, the Philippines, Saudi Arabia, Singapore, South Africa, and Thailand.
The webinar was opened with the remarks by Dr. UZU Shinobu, Senior Executive Director of PMDA and Director of PMDA-ATC, followed by Dr. YAGINUMA Hiroshi, Senior Coordinator for International Training.
On the first day of the webinar, lectures on new drug approval reviews, global clinical trials, and digital transformation for approval reviews were provided. On the second day, participants engaged in discussions in the case study group work on new drug reviews and attended a lecture on the review of biosimilars. On the third day, there was a lecture on the review of chemistry, manufacturing, and control (CMC) and a case study lecture on the review of generic drugs. Each lecture was followed by a Q&A session. All lecturers and facilitators of the webinar were PMDA staff members. (see the program for details)
This event was closed with the remark by Dr. UZU Shinobu. As a token of active participation in the seminar, the digital certification of Open Badge was given to the participants.
Photos and participant comments
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Comments from the participants:
“Thank you for the excellent organization of the training and the extremely rich, informative and practical work program.”
“This seminar is really good for the reviewer who has just started in this responsibility.”
“Thank you for all the speakers for the comprehensive and insightful material.”
“Better understanding of the various functions of the regulatory process.”
“Nice and Interactive.”