PFT815 - Advanced Regulatory Affairs


PFT810 Regulatory Affairs Pharmaceutical

This course 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 made on the mechanics of preparing submissions in the Common Technical Document (CTD) format in Canada. Specifically, this course 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. (Lecture only)

Loading availability...