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The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the “PMDA-ATC Pharmacovigilance Webinar 2021” for overseas regulatory authority officials who are engaged in pharmacovigilance activities. The webinar will be offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) on Cisco Webex.
The webinar is held as a workshop of Asia-Pacific Economic Cooperation, Life Sciences Innovation Forum, Regulatory Harmonization Steering Committee (APEC-LSIF-RHSC) Center of Excellence; however, the webinar is open to non-APEC economies as well.
The webinar will cover wide range of topics on pharmacovigilance, including internationally recognized regulations, global safety data collection and evaluation of accumulated safety data, risk management based on the risk management plan including pharmacovigilance plan and risk minimization action plan including risk communication like labeling per safety specification. Group discussions among participants using case studies are planned as well.
The aims of the webinar are to provide chances for the participants to refer back to their work and to find any additional opportunity for enhancement of the regulatory system in participants’ economies for pharmacovigilance in the post-marketing phase.
The webinar will be led not only by PMDA staff members from pharmacovigilance area but also by representatives from U.S.FDA, academia and the pharmaceutical industry, allowing participants to think and discuss from multiple perspectives on pharmacovigilance.
The webinar is not open to the industry or non-regulatory authorities.
Participation from many regulatory authorities is welcomed.
By participating in this workshop based on the core curriculum endorsed by APEC-LSIF-RHSC, the participants will learn the following knowledge that they could utilize in order to enhance the pharmacovigilance system in the participant's own organization:
January 21-29, 2021
February 1, 2021 2:00 P.M. -4:40 P.M. JST (UTC+9)
February 2, 2021 2:00 P.M. -4:30 P.M. JST (UTC+9)
February 3, 2021 2:00 P.M. -4:30 P.M. JST (UTC+9)
February 4, 2021 2:00 P.M. -4:50 P.M. JST (UTC+9)
See attached for the program
Number of participants: approx. 30
Close of registration: December 2, 2020
There is no registration fee for this webinar.
Each participating agency is responsible for obtaining computer access to Cisco Webex program and LOGOSWARE Platon.
For more information, please contact:
Secretariat, PMDA Asia Training Center
Office of International Programs
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan
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