The International Council for Harmonisation (ICH) E6 guideline is the global standard for Good Clinical Practice (GCP) in human clinical trials. The recently updated ICH E6(R3) introduces key changes aimed at enhancing trial quality, participant safety, and data integrity. This short course provides an overview of how Health Canada will align its inspection processes and compliance expectation with the revised guideline.
Health Canada Inspectors play a critical role in verifying compliance. With the adoption of ICH E6(R3), their approach to inspections and oversight will evolve to reflect the updated standards.
Course Topics:
- Overview of Key Changes in ICH E6(R3)
- Research Ethic Board (REB)/Institutional Review Board (IRB) and Qualified Investigator (QI) Obligations
- Sponsor Responsibilities
- Data Governance for Clinical Trials
- Ask the Regulators
This course is essential for clinical trial Study teams and professionals seeking to understand the practical implications of ICH E6(R3) and how Health Canada’s expectations will be interpreted and enforced.
Register Here!