RGA 6244 — Therapeutic Product Development in Canada
4 semester hoursGraduateLecture
Examines every step of the Canadian drug development and regulation process, from preclinical testing through postmarketing drug adverse reaction (DAR) reporting. Considers Canadian standards for nonclinical testing-quality assurance issues and good laboratory practice, good clinical practices, GMP, and use of ICH guidelines. Examines various Canadian drug submissions and their timelines, including New Drug Submission (NDS), Abbreviated New Drug Submission (ANDS), and Clinical Trial Applications (CTA).