PMDA-ATC Pharmaceuticals Review Webinar 2024
The PMDA held the “PMDA-ATC Pharmaceuticals Review Webinar 2024” from December 10 to 12, 2024. This webinar was intended for officials of overseas regulatory agencies involved in the review of pharmaceuticals and attended by 35 regulators from Bangladesh, Bhutan, Brunei Darussalam, China, Chinese Taipei, Egypt, Hong Kong China, Kazakhstan, Mozambique, Myanmar, Pakistan, Philippines, Rwanda, Saudi Arabia, Tanzania, Uzbekistan, and Vietnam.
The webinar was opened with the remarks by Dr. KONDO Emiko, Senior Executive Director of PMDA, Director of the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs., followed by Dr. KOIKE Hisashi, Senior Coordinator for International Training.
On the first day of the webinar, lectures on the outline of drug reviews and review reports; the chemistry, manufacturing, and control (CMC) review of generic drugs; and the review of drugs using drug delivery systems (DDS) were provided. On the second day, lectures on the bioequivalence (BE) guideline in Japan, the design and evaluation of BE studies, and the regulatory framework and review practice of over-the-counter drugs/quasi-drugs were provided. On the third day, there was a lecture on the review of biosimilars and a case study lecture on the review of generic drugs. Thirteen of the PMDA staff members served as both lecturers and facilitators. (see the program for details[67KB])
This event was closed with the speech from Dr. KONDO Emiko. Dr. KOIKE Hisashi also attended the closing ceremony. 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:
"I find it informative, beneficial and useful to my work."
"Was a good initiative, I learn a lot about generics products."
"I will discuss on the topics of the webinar with my colleagues and share how PMDA regulates medical products."
"I enriched my knowledge and try to input those things in evaluation."
"The topics are applicable to our daily work."