The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the “PMDA-ATC Pharmacovigilance Seminar 2020” for overseas regulatory authority officials who are engaged in pharmacovigilance activities. The seminar will be offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) at the PMDA Office in Tokyo, on February 3 - 6, 2020.
The Seminar 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 Seminar is open to non-APEC economies as well.
The Seminar 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 Seminar 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 Seminar 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 seminar 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 their countries/regions:
Employees of regulatory authority with working experience in pharmaceutical field over 3 years including at least 1 year in pharmacovigilance.
February 3 - 6, 2020
See attached the draft program
Number of participants: approx. 30
Close of registration: November 15, 2019
Sending address: atc_seminar●nta.co.jp
(Note: For the purpose of security, @ in the e-mail addresses are replaced with ●. Please replace ● with @ when you send an e-mail.)
There is no registration fee for this seminar.
Information on travel and hotel reservation assistance will be announced to the approved participants.
Pharmaceuticals and Medical Devices Agency (PMDA):
Shin-kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku,Tokyo 100-0013, Japan
Please use public transportation. Nearest Tokyo Metro Subway Stations:
For more information, please contact:
Registration and Travel:
Subcontractor, Nippon Travel Agency
Secretariat, PMDA Asia Training Center
Office of International Cooperation
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan