RGA 6675 — Therapeutic Product Development in Canada
3 semester hoursGraduateLecture
Focuses on Canadian legislation and regulations applicable to bringing therapeutic products to the Canadian market. Covers pharmaceuticals, biologics, generic drugs, and biosimilars. Examines each step of therapeutic drug development from preclinical testing to regulatory approval and postmarketing requirements. Studies relevant sections of the Canadian Food and Drugs Act and Regulations, Health Canada guidance documents, and various policies, as well as how regulatory affairs professionals can add value to organizations. Presents dedicated study of clinical trial applications and new drug submissions, as well as compliance activities.