Good Clinical Practice (GCP) and Multi Regional Clinical Trials (MRCT) Training: ICH E6(R2) and ICH E17

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

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, respectively
• 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 to fulfilling the requirements of ICH E6(R2) and ICH E17

For Regulators:

• 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

Further information on registration will follow.

For any questions please contact HPFB_ICH_DGPSA@hc-sc.gc.ca .