This workshop is a part of the activity of APEC 2020 Roadmap to Promote Good Registration Management, co-championed by Chinese Taipei and Japan, under APEC Life Science Innovation Forum - Regulatory Harmonization Steering Committee (LSIF-RHSC). The objectives of this roadmap are to promote the concept of GRM and enhance mutual trust for regulatory convergence among the APEC member economies by 2020. To establish a sustainable platform for promoting regulatory convergence, capacity and cooperation in areas of medical products, RHSC has been promoting the model of Center of Excellence (CoE) for each priority work area since 2015. RAPS Taiwan Chapter was endorsed to host a CoE pilot workshop for GRM in 2016.
The primary objectives of this pilot workshop are to advance the APEC Roadmap to promote GRM through focused training and to optimize curriculum and train-the-trainer model that will serve as the foundation for an APEC GRM Regulatory Science Center of Excellence. The workshop will bring together APEC economies and key stakeholders, including regulatory agencies, academia and industry, to discuss the best practices and regulatory science for GRM. To support the vision of regional regulatory convergence for medical products by 2020, the feedback from the CoE pilot workshop will serve as a reference for update and revision of the training program.
2016 APEC Good Registration Management (GRM) Regulatory Science Center of Excellence Pilot Workshop
VenueˇFCHANG YUNG-FA FOUNDATION International Convention Center
Date:15-17 November, 2016
Address: No. 11, Zhongshan S. Rd., Taipei City 100, Taiwan (R.O.C.)
|The APEC LSIF Regulatory Harmonization Steering Committee|
|Food and Drug Administration, Ministry of Health and Welfare, Taiwan|
|Pharmaceuticals and Medical Devices Agency, Japan|
|Asia Partnership Conference of Pharmaceutical Associations|
|The APEC Harmonization Center|
|Regulatory Affairs Professionals Society|