This Asia-Pacific Economic Cooperation (APEC) Pilot Center of Excellence (CoE) training program on Multi-Regional Clinical Trials (MRCTs) and Good Clinical Practice (GCP) is a 3 1/2-day workshop — April 10-13, 2018 — hosted by the MRCT Center. It is specifically designed for regulators with responsibility for multi-regional clinical trials, drug review and approval, with priority to those from emerging economies.
The workshop goals are to advance the understanding of the ICH E17 (Multi-Regional Clinical Trials) and ICH E6(R2) (Good Clinical Practice) guidelines to facilitate their adoption and implementation. Case-based learning, presentations, and open discussion of scientific, statistical, and practical approaches will be used. The Faculty will include regulators from the USFDA, EMA, Health Canada and others with the assistance of academic and industry leaders.
Barbara Bierer, MD, MRCT Faculty Director will participate in a panel discussion on APEC regulatory convergence at the BIO 2018 conference in Boston, MA.
Dr. Barbara Bierer, MRCT Center Faculty Director, and Mr. Mark Barnes, MRCT Center Faculty Co-Director, will co-host a conference with the Organisation of Pharmaceutical Producers of India (OPPI) at their offices on clinical trials regulatory issues.
Click here to view the Annual Meeting Slides (for sponsors only).
The principal topics discussed at the MRCT Center 2018 Annual Meeting were:
European Union General Data Protection Regulation (GDPR)
Representation of Diverse Populations
Advancing the Study of Clinical Trials
Capacity Building
Health Literacy in Clinical Research.
The meeting was followed by the Executive and Steering Committee meeting in the afternoon (1:00 PM -5:00 PM), which was open to MRCT Center sponsors only.
The MRCT Center will be facilitating didactic and case-based learning, presentations, and open discussion for regulators from Health Canada (reviewers and inspectors), and individuals from industry, academia, and non-profit organizations
Learning Objectives:
Describe the standards of Good Clinical Practice (GCP) and key considerations in Multi-Regional Clinical Trials (MRCTs) design as set out in ICH E6(R2) and ICH E17 guidance, with particular focus on how the guidelines are applied by Health Canada.
Use case studies, to apply the changes of ICH E6(R2) addendum and ICH E17 to increase the acceptability of MRCT data by multiple regulatory authorities
Demonstrate practical approaches that Health Canada may take to fulfill the requirements of ICH E6(R2) and ICH E17 consistent with ICH standards
For Regulators:
Describe and demonstrate best practices to assess clinical trial regulatory submissions by Health Canada, including study design, data packages, essential documents, reports, and filings for alignment with ICH GCP and MRCT
Describe inspection methodologies that may be taken by Health Canada to assess clinical trial conduct for alignment with ICH GCP and MRCT standards, including review of corrective actions.
For other Stakeholders:
Gain better understanding and knowledge of Health Canada expectation with regard to compliance with the Canadian clinical trial regulations.
Gain better understanding and knowledge of Health Canada GCP inspection processes to better prepare for an inspection
