The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the "PMDA-ATC Pharmacovigilance Seminar 2018" for 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 5-8, 2018.
The Seminar is held as a workshop of Asia-Pacific Economic Cooperation, Life Sciences Innovation Forum, Regulatory Harmonization Steering Committee (APEC-LSIF-RHSC) Centers 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, risk management, global safety data collection and labeling. Small group discussions among participants focusing on risk management plan 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 US 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.
February 5-8, 2018
See attached the draft program
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:
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
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