Training

Overview of Good Registration Management (GRM) Training

Good Registration Management (GRM) is a concept to promote efficient registration process for medical products by promoting Good Review Practice (GRevP) and Good Submission Practice (GSubP) cooperatively.

In Feb. 2016, APAC GSubP Guideline was endorsed by APEC Regulatory Harmonization Steering Committee (RHSC), and has merged with GRevP to become one of the pilot programs for APEC Training Centers of Excellence for Regulatory Sciences (CoEs) (APEC Training CoEs). APAC Regulations and Approvals Expert Working Group (RA-EWG) fully support the CoEs by design training materials and send trainers for GSubP.

2016 APEC Good Registration Management Regulatory Science CoE Pilot was held on November 15-17 in Taipei. The training is designed under the “Train the trainer” concept, which means applicants and reviewers who attended the CoE pilot as trainees will cascade the training down to each economy.

Training videos and materials

2016: Training videos and materials can be found in 2016 APEC.

2017 APEC Good Registration management (GRM) Regulatory Science Center of Excellence Workshop

Date and Venue

Date: October 31 to November 2, 2017
Venue: national Taiwan University Hospital (NTUH) International convention Center, Taipei