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About CoE

The APEC Harmonization Steering Committee (RHSC) has established linkages with other harmonization/convergence initiatives, training institutions and key players in order to avoid duplication of effort, promote complementary action and make maximum use of resources. As a part of regulatory harmonization activities, the RHSC has initiated the establishment of Center of Excellence (CoE).

The CoE training is to benefit all parties that are engaged in the healthcare field by continuously providing quality training, and the following is the areas of pilot/formal training for APEC CoE:

  • Multi-Regional Clinical Trials (MRCT) - Good Clinical Practices (GCP) Inspection
  • Medical Product Quality and Supply Chain Integrity
  • Biotherapeutics
  • Pharmacovigilance (PV)
  • Medical Device
  • Advanced Therapies
  • Good Registration Management (GRM)

Furthermore, with endorsement of more CoEs on the horizon, the RHSC recognized the need for coordination of activities to pre-CoE workshops, Pilot CoE Programs and formal CoEs.

Therefore, the APEC Harmonization Center (AHC) was endorsed as CoE coordinator at the first Senior Officials Meeting (SOM) in February 2017.

According to the RHSC CoE Operating Model, the role of the AHC is as follows:

  • Maintain a public website to provide general information on APEC CoEs, mandatory items (Promotion Flyer, Registration Form, Agenda, etc.) form the CoEs
  • Maintains online system for receipt of CoE-related applications
  • Will manage written communications regarding CoE operations including approval letters, MoUs, assessment documents, etc. and will maintain a repository of CoE operating document (most updated versions of Operating Guidelines, templates, etc…)