Regulatory Science of Medical Products
Online ISSN : 2189-0447
Print ISSN : 2185-7113
ISSN-L : 2185-7113
New Initiatives of Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC)
Akiko OGATAAya MYOENZONO
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2024 Volume 14 Issue 1 Pages 159-171

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Abstract

PMDA established Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) in 2016 which provides trainings for regulators in Asia and around the world. In 2020, against the background of the COVID-19 global pandemic, PMDA-ATC began offering virtual style seminars so called “webinars”. The webinar was the first attempt for PMDA-ATC, but it offers programs that emphasize mutual communication, such as group discussions using case studies in the same manner as previous in-person seminars. In addition, PMDA-ATC started offering video-based E-learning training materials that provide training opportunities to those who are unable to participate the seminars and webinars and are also used as pre- and post- learning of the webinars. There are two types of the E-learning training materials in PMDA-ATC: one is distributed using the YouTube “Pmda Cannel”, which can be viewed by anyone from around the world, and the other is the “PMDA-ATC E-Learning Course”, which is available only to foreign regulators. The contents are not just video of lectures but are designed to be an efficient and effective learning tool. One content is a short video of about 10 minutes, and narration by native English-speakers and PowerPoint animation are inserted. In order to disseminate these PMDA-ATC activities more widely, Facebook and Twitter began disseminating information in June 2022. PMDA-ATC also introduced issuing Digital Certificates for Seminar/Webinar Completion in the form of Open Badges. We would summarize the new initiatives in responses to DX (Digital Transformation) in PMDA-ATC.

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© 2024 Society for Regulatory Science of Medical Products
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