The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the "PMDA-ATC Multi-Regional Clinical Trial (MRCT) Seminar 2018" 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 15-18, 2018.
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 ICH E17 guideline (General principle on planning/designing MRCTs) close to being harmonized, 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, GCP inspections, post-marketing issues and safety measures for approved products 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. As changes from the previous program, PMDA adds new sessions which are clinical site tour and introduction of review systems and regulations by participants in the program for this fiscal year.
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.
January 15 to 18, 2018.
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
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