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Regulatory Affairs II

PRA800

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PRA800 - Regulatory Affairs II

Prerequisites:

PRA700

This course focuses on the preparation of a drug submission. Students compile the necessary information and complete the necessary application forms for a Common Technical Document (CTD) New Drug Submission (NDS) Module 1 along with the overall plan for the compilation of a submission. There is a class presentation relating to policy application for submissions with possible practical application and possible suggestions for dealing with expected deficiency. Introduction to auditing and the Preapproval Inspection (PAI) for submission approval are discussed and an audit practical exercise performed.


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Contacts

Mary
Program As
cherry.langlois@senecacollege.ca
416491505022523