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Apr 25, 2018

Successful APEC Center of Excellence Training Workshop on Multi-Regional Clinical Trials (MRCT) and Good Clinical Practice (GCP)

In April 2018, the MRCT Center held a 3 1/2-day training workshop at the Harvard Faculty Club focused on Multi-Regional Clinical Trials (MRCT) and Good Clinical Practice (GCP) as an APEC (Asia-Pacific Economic Cooperation) Pilot Center of Excellence (CoE), and specifically on ICH-E17 and ICH-E6(R2).

Twenty-two professionals from twelve economies participated, and all but one were governmental regulators.  Senior staff from the U.S. Food and Drug Administration (FDA), Health Canada, Health Products Regulatory Authority (HPRA) Ireland, Pharmaceuticals and Medical Devices Agency (PMDA) Japan, industry partners, PhRMA, and MRCT Center facilitated the interactive sessions.  The training was co-hosted by the APEC Harmonization Center (AHC).

 

 

 The objectives of the workshop were to:


  • Enhance regulatory cooperation in the APEC region on the evaluation and regulation of MRCTs
  • Demonstrate practical approaches to fulfilling the requirements of GCP as presented in ICH E6(R2)
  • Describe the concepts of MRCTs and key considerations in MRCT design as presented in ICH E 17 guidance
  • Increase the acceptability of MRCT data by multiple regulatory authorities

With near unanimity, the participants rated the program as “excellent,” including the organization of the training, the faculty lectures, case studies/breakout groups, question and answer and “ask the expert” sessions, and the course materials. The vast majority of participants agreed that the training increased their knowledge and understanding of MRCTs and GCP and that the knowledge or techniques gained from this training will be practically useful in their field.  Participants found the faculty knowledgeable of their respective training topics and networking with other participants was helpful. Based on this training, participants envisioned what they will do differently when they go back to their place of work.