From February 1 to 4, 2021, PMDA held an online seminar entitled “PMDA-ATC Pharmacovigilance Webinar 2021“, as the 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 26 regulators from 15 economies (Azerbaijan, India, Indonesia, Korea, Malaysia, Myanmar, Nigeria, Philippines, Saudi Arabia, Singapore, Sri Lanka, Taiwan, Tanzania, Thailand and Uganda) participated in the webinar.
Recorded lecturers and case study materials were prepared by the staff members from PMDA, U.S.FDA, Japan Pharmaceutical Manufacturers Association (JPMA) and academic institutions, and provided in advance of the webinar, as the preliminary training materials.
The recorded lectures covered such topics as considerations on pharmacovigilance, overview of PV systems in the US, EU and Japan and international harmonization, evaluation of benefit/risk balance, pharmacoepidemiology, end-to-end labeling process, and communication of safety risk information. The lectures were then followed by the live question and answer sessions on the 1st and the 2nd day, where the participants actively engaged in the discussion.
On the 3rd and the 4th 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. The participants actively discussed the subject based on their own experiences in each economy and the facilitators assigned to each group from JPMA and PMDA provided assistance when necessary. After the group discussion, the representative from each group presented the results of the discussion to all the participants. The participants deepened their understanding throughout the group works (see agenda for details).
The webinar live session opened with the remarks by Mr. UZU Shinobu, Director of PMDA-ATC, video message from Dr. NAKASHIMA Nobumasa, Senior Executive Director and the incumbent Co-Chair of APEC-LSIF-RHSC and Mr. ONIYAMA Yukio, Director of Office of Pharmacovigilance I.
At the end of the Webinar, Dr. FUJIWARA Yasuhiro, Chief Executive of PMDA handed the course completion certificate virtually by recorded video, and Dr. SATO Junko, Director of Office of International Programs, gave the closing remarks.
<Opening & Closing>
<Lecturers and Facilitators>
Comments from participants:
<Recorded Lectures and Q&A sessions>
“It is an excellent lecture to understand what PMDA has done in PV activities and related studies.”
“Slides are useful and the presentations were well understood.”
“Thank you for the excellent explanations for all questions.”
< Case Studies >
"“The case studies were very well developed and mirrored real-life cases. I noted that a lot of work had been put into developing the case studies.”
“Very interactive and good hands-on practice and learning of the concepts of classifying different risks in the core data sheet.”
“Overall, the organization of the webinar was very good. The content of the webinar was also excellent and comprehensive. I benefited a lot from this webinar.”
“The webinar was well executed both in terms of content and time management.”
“The sessions were very fruitful to understand the knowledge on Pharmacovigilance.”
PMDA-ATC Seminars are held periodically, each with a different theme.
The Seminar announcements are posted on this website.
For any questions regarding PMDA Training Seminar, please contact us by clicking on the “Contact us” logo on top of the website, or please contact the Secretariat (e-mail: PMDA-ATC●pmda.go.jp).
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