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2016 APEC Good Registration Management (GRM) Regulatory Science Center of Excellence Pilot Workshop

2016 APEC Good Registration Management (GRM) Regulatory Science Center of Excellence Pilot Workshop 【Date:2017-08-31】 unit:藥品組

  In collaboration with APEC Life Science Innovation Forum (LSIF) Regulatory Harmonization Steering Committee (RHSC), Pharmaceuticals and Medical Devices Agency (PMDA), Asia Partnership Conference of Pharmaceutical Associations (APAC), APEC Harmonization Center (AHC), and Regulatory Affairs Professionals Society (RAPS), Taiwan Food and Drug Administration (TFDA) hosted 2016 APEC Good Registration Management (GRM) Regulatory Science Center of Excellence Pilot Workshop on November 15 to 17, 2017.

 

  The primary objectives of this pilot workshop were 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. This 3-day pilot workshop offered a total of 14 different sessions, including Common Sessions, Reviewer-Specific Sessions, and Applicant-Specific Sessions, to the participants. Experts were invited to share their experiences in topics related to good reviews and good submissions. A total of 56 trainees from 15 different APEC economies completed this training. The overall satisfaction was 4.48 on a scale of 5.

 

  With the success of this pilot workshop, TFDA and RAPS Taiwan Chapter were endorsed as a formal APEC Regulatory Science Training Center of Excellence in the area of Good Registration Management by the APEC LSIF-RHSC in February 2017. A memorandum of understanding (MOU) was signed among TFDA, RAPS Taiwan Chapter, and APEC LSIF in July 2017.

2016 APEC Good Registration Management (GRM) Regulatory Science Center of Excellence Pilot Workshop 01 

2016 APEC Good Registration Management (GRM) Regulatory Science Center of Excellence Pilot Workshop 02

2016 APEC Good Registration Management (GRM) Regulatory Science Center of Excellence Pilot Workshop 03

For more information, please refer to http://www.raps-in-taiwan.org.tw/apec/index.html.