Registration for Fall 2026 programs and courses is now open. Learn more about the academic programs we are delivering in Fall 2026. If you have any questions about part-time studies, please contact us.
Prerequisites:
Admission to the program
This course describes the role of the Regulatory Affairs department in a pharmaceutical organization and focuses on the "submission process" and the legal requirements that control the process for pharmaceuticals, Natural Health Products and Medical Devices. The regulatory requirements at the various stages in a drug product development from inception through CTD (Common Technical Document) Clinical stage and NDS (New Drug Submission) application to issuance of the NOC (Notice of Compliance) are examined. The control and submission parameters for Medical Devices are discussed.
Ancillary fees will be added at checkout and will vary based on the number of courses selected. For details on how the fees are calculated, please refer to ancillary fees for part-time studies.