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The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the “PMDA-ATC with National Cancer Center MRCT Webinar 2021" for officials engaging in new drug application reviewers from overseas regulatory authorities. The webinar is offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC), with the collaboration of the Clinical Research Support Office of the National Cancer Center Japan (NCC), and will be held on Cisco Webex in order to support for the establishment and maintenance of clinical trial sites in Asian region.
The webinar is held as the workshop of Asia-Pacific Economic Cooperation, Life Sciences Innovation Forum, Regulatory Harmonization Steering Committee (APEC-LSIF-RHSC) Center of Excellence, however, the webinar is open to non-APEC economies as well.
With the increase in global product development, the ICH E17 guideline (General principle for planning and design of Multi-Regional Clinical Trials) has been finalized and its training material has been developed. Product reviews based on multi-regional clinical trials 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. The seminar will be led not only by PMDA reviewers and NCC experts but also by representatives from academia and industry, allowing participants to think and discuss from multiple perspectives.
The webinar is not open to the industry. Participation from many regulatory authorities is welcomed. In addition, a few clinical investigators recommended by NCC will also join.
January 11-15, 2021
January 18, 2021 1:00 P.M. -5:00 P.M. JST (UTC+9)
January 19, 2021 2:00 P.M. -4:00 P.M. JST (UTC+9)
January 20, 2021 2:00 P.M. -4:00 P.M. JST (UTC+9)
January 21, 2021 2:00 P.M. -4:00 P.M. JST (UTC+9)
See attached for the program
Number of participants: approx. 30
Close of registration: November 3, 2020
There is no registration fee for this webinar.
Each participating agency is responsible for obtaining computer access to Cisco Webex program and LOGOSWARE Platon.
For more information, please contact:
Secretariat, PMDA Asia Training Center
Office of International Programs
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan
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