The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the "PMDA-ATC Multi-Regional Clinical Trial (MRCT) Seminar 2019" for new drug application reviewers from overseas regulatory authorities. 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 January 21-24, 2019.
This seminar is held as a workshop of the 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.
With the increase in global product development and the finalization of the ICH E17 guideline (General principle for planning and design of Multi-Regional Clinical Trials), product reviews based on MRCTs driven data are also increasing. Under this situation, it is essential that regulators adequately evaluate the benefit-risk balance while keeping in mind the ethnic factors.
The seminar aims to promote drug development and convergence of regulations by sharing accumulated experiences of Japan, such as protocol designing and planning of MRCT, clinical data evaluation, clinical operation, regulatory review based on results of GCP inspections, post-market safety evaluation of approved drugs based on MRCT. The seminar will be led not only by PMDA reviewers but also by representatives from academia and industry, allowing participants to think and discuss from multiple perspectives.
The seminar is not open to the industry or non-regulatory authorities.
Participation from many regulatory authorities is welcomed.
January 21 to 24, 2019
See attached for the draft program
Number of participants: approx. 30
Close of registration: November 2, 2018
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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