Learn more about the academic programs we are delivering in Summer 2025. If you have any questions about part-time studies, please contact us.
Corequisites:
PFT/APT810
This subject focuses on product development and registration in Canada. Students learn, and get a hands on approach to prepare a high quality clinical trial application (CTA), including generic and brand submissions. Emphasis is on the mechanics of preparing submissions in the Common Technical Document (CTD) format in Canada. Specifically, this subject clarifies the rules, regulations and guidelines on how submissions are prepared, and how deficiency letters are addressed to TPD. An overview of the e-CTD modules is provided in detail. (Lectures Only)