Introduction to Pharmaceutical Regulatory Affairs


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PRA700 - Introduction to Pharmaceutical Regulatory Affairs


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.

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