Save the Date – Good Clinical Practice (GCP) and Multi Regional Clinical Trials (MRCT) Training: ICH E6 (R2) and ICH E17
Health Canada is hosting a 3-day training series for regulators and other research stakeholders to gain a better understanding and knowledge of Health Canada expectations with regards to compliance with the Canadian clinical trial regulations and GCP inspection processes.
When: February 26-28, 2019
Where: John G. Diefenbaker Building (Old City Hall) – 111 Sussex Drive, Ottawa, Ontario
What: Didactic and Case-based learning, presentations, and open discussion
Who: Regulators from Health Canada (reviewers and inspectors), and individuals from industry, academia, and non-profit organizations
Registration: No cost. *Note:Training is being offered to approved applicants. Please complete the application and submit as soon as possible to firstname.lastname@example.org with the subject line “ICH Training Application”.
For information or questions, please contact HPFB_ICH_DGPSA@hc-sc.gc.ca .
• 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, respectively
• Use case studies to apply the changes to ICH E6(R2) addendum and ICH E17 to increase the acceptability of MRCT data by multiple regulatory authorities
• Demonstrate practical approaches to fulfilling the requirements of ICH E6(R2) and ICH E17
• Describe and demonstrate best practices to assess clinical trial regulatory submissions, including study design, data packages, essential documents, reports, and filings for alignment with ICH GCP and MRCT
• Describe inspection methodologies 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 and GCP inspection processes