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Report of the PMDA-ATC Pharmacovigilance Webinar 2022

PMDA-ATC Pharmacovigilance Webinar 2022

On January 31 and from February 2 to 4, 2022, PMDA held a 4-day online seminar entitled “PMDA-ATC Pharmacovigilance Webinar 2022,“as a Center of Excellence (CoE) Workshop in the Asia-Pacific Economic Cooperation, Life Sciences Innovation Forum, Regulatory Harmonization Steering Committee (APEC-LSIF-RHSC). This webinar was designed for regulatory officials in charge of pharmacovigilance (PV) from overseas regulatory authorities. Total of 24 regulators from 10 economies (Azerbaijan, India, Indonesia, Malaysia, Myanmar, Pakistan, Philippines, Sri Lanka, Thailand and Vietnam) joined the webinar.

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

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 U.S. FDA, Japan Pharmaceutical Manufacturers Association (JPMA) and academic institutions.

The webinar comprised lectures and Q&A on Evaluation of benefit/risk balance throughout product lifecycle, End-to-end labeling process (including E-labeling), Recent pharmacovigilance activities in the US and Pharmacoepidemiology. On the 2nd and 3rd day, the participants were divided into five groups and engaged in the case studies using the mock data for discussion on safety specifications and risk minimization activities under the risk management plan with facilitators from JPMA. After the group discussion, the representative from each group presented the results of the group discussion to all participants. On the 4th day, participants engaged in the group discussion on pharmacovigilance methods in the case study using adverse event case report and case lists. The participants deepened their understanding PV throughout these lectures and group discussions. (see agenda for details).

The Webinar closed with remarks by Dr. FUJIWARA Yasuhiro, Chief Executive of PMDA, and Dr. SATO Junko, Director of Office of International Programs. The course completion certificate was handed to the participants virtually by Dr. FUJIWARA.

Photos and participant comments

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Comments from the participants:
 “I learned a lot about risk-benefit balancing.”
 “Presentation is clear and very informative. Moreover, it can give direct message about the analysis used in PV.”
“Group work was challenging, but summary at the end was good.”
“Both Group Task 1 and Group Task 2 achieved the objectives of the webinar. The material provided from PMDA was very systematic and useful for group work. I think we got the take home massage of the webinar.”
“Thank you so much for this very informative, interactive and excellent training.”
“Excellent program that helps a lot to understand the pharmacovigilance activity.”
“The activity was well organized, the presenters were very informative.”

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