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APEC Pilot Center of Excellence

Focus Area: Training

APEC Pilot Center of Excellence

Background:

The MRCT Center received endorsement to become an Asia-Pacific Economic Cooperation (APEC) Pilot Center of Excellence (CoE).  Through this pilot, we aim to be certified as an APEC Training Center of Excellence for Multi-Regional Clinical Trials (MRCTs) and Good Clinical Practice (GCP) inspection in APEC economies. We launched this effort by establishing a multi-stakeholder planning committee, and conducted a pilot training for regulators from APEC economies April 10-13, 2018 at Harvard Faculty Club.

Current status: Active project

Impact: Improved regulatory capacity and oversight of clinical trials in emerging economies.

Objectives:

  • To build skilled capacity in clinical trial regulatory science to facilitate review and oversight of MRCTs and GCP inspection in APEC economies
  • To collaborate closely with others in the MRCT/GCP priority work area to determine the optimal curricula, method(s) and configuration to deliver training in a culturally-appropriate manner.

Key project milestones

  • February 2017: MRCT Center endorsed as Pilot Center of Excellence for Multi-Regional Clinical Trials (MRCTs) and Good Clinical Practice (GCP)
  • June 2017: First meeting of APEC Pilot CoE Program Committee
  • January 2018: Registration opened for APEC Pilot CoE training, April 10-13, 2018, at Harvard Faculty Club
  • April 2018: Conducted APEC Pilot CoE training on MRCT and GCP at Harvard Faculty Club

Program Manager: Carmen Aldinger