PMDA-ATC Pharmacovigilance Webinar 2024
From February 26 to 29, PMDA held a webinar entitled “PMDA-ATC Pharmacovigilance Webinar 2024“. This webinar was intended for officials of overseas regulatory agencies. A total of 34 regulators from Azerbaijan, China, Chinese Taipei, Egypt, Ethiopia, India, Indonesia, Kazakhstan, Kenya, Malaysia, Pakistan, the Philippines, Uganda, and Zimbabwe participated.
The webinar opened with the remarks by Dr. UZU Shinobu, Senior Executive Director of PMDA and Director of PMDA-ATC. On the first day, lectures on Evaluation of Benefit/Risk Balance, Electronic Labeling and Adverse Drug Reaction (ADR) Case Evaluation were provided. On the second day, a case study on “ADR Case Evaluation” and “Identification of safety specification “was provided. On the third day, a case study on “Risk Management Plan” was provided. The participants were divided into groups and intensively discussed in each case study. On the final day, a case study on signal detection and lectures on Utilizing Real Word Data were provided. Throughout this webinar, in addition to PMDA staff members, lecturers and facilitators from Kitasato University, Keio University, and the industries also shared their expert knowledge and comments with participants, which contributed to this meaningful webinar. (see the program for details [152KB])
This event was closed with the remark by Dr. UZU Shinobu. Mr. HORIUTI Naoya, Senior coordinator of the webinar attended both the opening and the closing session. As a token of active participation in the workshop, the digital certification of Open Badge was given to the participants.
Photos and participant comments
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Comments from the participants:
“I got a deep understanding and knowledge about pharmacovigilance activity and risk minimization activity.”
“This has been one of my best webinars, quite educative and professional.”
“All the materials are very useful”