The MRCT Center, in collaboration with Health Canada, conducted a 3-day training workshop in Ottawa, Canada, focused on Good Clinical Practice (GCP) and Multi-Regional Clinical Trials (MRCT), specifically the International Council of Harmonization (ICH) Guidelines ICH-E6(R2) and ICH-E17.
Seventy professionals from Canada participated in this successful in-depth and interactive training, including inspectors and reviewers from Health Canada as well as Canadian stakeholders from academia, hospitals, research institutes, CROs, and industry. Senior staff from Health Canada, Danish Medicines Agency, U.S. Food and Drug Administration (FDA), industry, and MRCT Center facilitated the interactive sessions. As one training participant said, “I’ve worked in this field for 13 years and this is the most helpful training I’ve been to.”
The objectives of the training were to:
- 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 expectations with regards 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
The MRCT Center is an APEC (Asia-Pacific Economic Cooperation) Training Center of Excellence for MRCT and GCP inspection and is endorsed as a training partner by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).