Apr 25, 2018
Successful APEC Center of Excellence Training Workshop on Multi-Regional Clinical Trials (MRCT) and Good Clinical Practice (GCP)
- 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.