The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the "PMDA-ATC Medical Devices Seminar 2016" for officials from overseas regulatory authorities who are engaged in the review of medical devices and in vitro diagnostics.
The Seminar will be offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) at PMDA Office in Tokyo, from November 7 to 11, 2016.
The Seminar will cover wide range of topics, such as regulations, consultations (scientific advices), product reviews, GCP/GLP/QMS, safety measures, standards, etc. Small group discussions among participants, and site visit to manufacturing facilities 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 participant's regulatory system.
The seminar is not open to the industry or non-regulatory authorities. The seminar is not intended for Japanese government employees, either.
Participation from many regulatory authorities is welcomed.
- Product classifications based on risk
- Scientific reviews
- Safety measures
international standards, IMDRF, etc)
system in the participant’s organization.
A basic knowledge of the regulations pertaining to the medical devices product review
in his/her organization is required.
The training will be provided in English (with simultaneous translation in some sessions).
All participants are expected to actively participate in all of the sessions.
November 7 to 11, 2016.
See attached for 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