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Report of the PMDA-ATC Pharmacovigilance Webinar 2023

PMDA-ATC Pharmacovigilance Webinar 2023

From February 6 to 9, 2023, the PMDA held a webinar entitled “PMDA-ATC Pharmacovigilance Webinar 2023,” as the Center of Excellence (CoE) Workshop in the field of pharmacovigilance recognized by the Asia-Pacific Economic Cooperation, Life Sciences Innovation Forum, Regulatory Harmonization Steering Committee (APEC-LSIF-RHSC). This webinar was designed for officials in charge of pharmacovigilance (PV) from overseas regulatory authorities. A total of 31 regulators from 16 economies (Azerbaijan, Bhutan, China, Chinese Taipei, Ethiopia, India, Indonesia, Malaysia, Myanmar, the Philippines, Saudi Arabia, South Korea, Singapore, Thailand, Tunisia and Uganda) took part.

Before attending the live webinar, the participants took the PMDA-ATC E-learning course, “Pharmacovigilance,” covering the following subjects; PV system, PV international cooperation, PV activities and drug safety assessment, etc.

The live webinar opened with remarks by Mr. UZU Shinobu, Senior Executive Director of PMDA and Director of PMDA-ATC, Dr. NAKASHIMA Nobumasa, Associate Executive Director and the Co-Chair of APEC-LSIF-RHSC and Mr. HORIUCHI Naoya, Senior Coordinator for International Training of PMDA. Subsequent lectures were provided by the Japan Pharmaceutical Manufacturers Association (JPMA), Kitasato University, Keio University, U.S. FDA and PMDA.

The live webinar comprised lectures and Q&A sessions on evaluation of benefit/risk balance, labeling process including e-labeling, PV of COVID-19 vaccines, recent PV activities in the United States, pharmacoepidemiology, and utilization of real-world data. The participants engaged in the case study group discussion on safety specifications, causality assessment and risk minimization activities under the theme of risk management plan on the 2nd and 3rd days, and on the PV methods on the final day. The participants deepened their understanding PV throughout these lectures and group discussions (see agenda for details).

At the end of the webinar, Dr. FUJIWARA Yasuhiro, Chief Executive of PMDA handed the course completion certificate to each participant virtually.

Photos and participant comments

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Comments from the participants:
“The webinar is great, nice to know the pharmacovigilance system worldwide”.
“It helps me to understand more about planning risk minimization activity”.
“It is very interesting, since we have not implemented e-labeling”.
“It was very useful and well organized”.
“Medication errors-related issues in Pharmacovigilance to be considered. Overall, very great efforts”.
“Very good organization and implementation”.
“Great deliberation by the team”.