N2 is working in partnership with Health Canada (HC) on their consultation to seek input from Canadians and key stakeholders on their draft of GUI-0043: “Risk classification guide of observations related to clinical trial inspections of human drugs.”
Feedback will be collected until December 14, 2021. As an N2 member, we encourage you to provide your feedback through the N2 mechanism to support Health Canada’s structured approach and to facilitate collation of the feedback.
Please follow these links to the GUI-0043 draft guidance document in English and French, and the following link to provide your comments/feedback:
If you have questions, related to N2’s involvement with Health Canada’s consultation on GUI-0043 please contact:
Karen Arts, N2 Operations Support
Jennifer Li, N2 Quality Committee
In the event that your organization wishes to provide feedback directly to Health Canada, please visit the links below.