Health-Care Legislation, Regulations and Guidelines

Course Description

This course focuses on legislation and regulations applicable to bringing a new medication to commercialization. The submission of prescription drugs, non-prescription drugs, biologics and natural health products will be examined, using as example the registration dossier for these, and the Canadian Food and Drug Act and Regulations. The submission of a prescription drug will be examined in detail, using as an example the entire package of study reports for a new drug. Students will gain knowledge in submission processes, guidelines and requirements and build skills in the researching and writing of various documents required for federal drug approval.