The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the "PMDA-ATC Medical Devices Seminar 2019" 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 25 to 29, 2019.
This year’s seminar is held as APEC-LSIF-RHSC's APEC Center of Excellence Pilot Workshop; however, the Seminar is open to non-APEC economies as well*.
The seminar is not open to the industry or non-regulatory authorities. Participation from many regulatory authorities is welcomed.
* APEC-LSIF-RHSC: Asia-Pacific Economic Cooperation (APEC), Life Sciences Innovation Forum (LSIF), Regulatory Harmonization Steering Committee (RHSC)
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 facility 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.
- 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 consecutive translation in some sessions).
- All participants are expected to actively participate in all of the sessions.
November 25 to 29, 2019
See the draft program (attached)
Number of participants: approx. 30
Close of registration: September 6, 2019.
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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