The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the "PMDA-ATC Pharmaceuticals Review Seminar 2018" for pharmaceuticals reviewers from overseas regulatory authorities.
The Seminar will be offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) in Tokyo and Toyama prefecture, from June 18-22, 2018.
The Seminar will cover a wide range of topics including product review for not only new drugs but also generic drugs and biosimilars, CMC, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), etc. through the lecture and case study, aiming to provide the participants with opportunities to acquire knowledge and perspectives to enhance the regulatory system in the participants' own country or region.
The seminar is not open to the industry or non-regulatory authorities.
Participation from many regulatory authorities is welcomed.
The Seminar will focus on the following key regulatory activities.
- Consultations (Scientific Advice)
- Product review
- 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.
June 18 to 22, 2018. See attached program for draft schedule.
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 note that the venue of the first day is NOT PMDA office and details will be informed in due course.
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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