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PRA700 - Introduction to Pharmaceutical Regulatory Affairs
This subject describes the role of the Regulatory Affairs department in a pharmaceutical firm and focuses on the "submission process". The regulatory requirements at the various stages in a drug product's development from inception through CTA'S (Clinical Trial Applications) and NDS (New Drug Submission) applications to issuance of the NOC (Notice of Compliance) will be examined. Students will become familiar with the Food and Drugs Act and GMPs upon completion of this course.

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