PRA800 - Regulatory Affairs II

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Last revision date Feb 12, 2019 2:37:53 PM
Last review date Mar 18, 2019 9:40:46 AM

Subject Title
Regulatory Affairs II

Subject Description

This subject focuses on the preparation of a drug submission. Students compile the necessary information and complete the necessary application forms for a CTD New Drug Submission (NDS) Module 1 in electronic format.  Submissions and suggestions for dealing with expected deficiencies are both covered. The parameters of a Drug Master file and the Chemistry and Manufacturing Control section of a New Drug submission are discussed as well as the actions required when a revision is necessary.  The concepts of auditing and the Preapproval Inspection (PAI) for submission approval are discussed and audit procedures practiced. The basic principles of Pharmaceutical Marketing as it affects drug development and submission compliance are discussed.

Credit Status
This is a credit toward the Ontario Graduate Certificate Program in Pharmaceutical Regulatory Affairs and Quality Operations offered through the School of Biological Sciences and Applied Chemistry and the Faculty of Continuing Education and Training.

Learning Outcomes
Upon successful completion of this subject the student will be able to:

  1. Explain the CMC for a submission requirements which addresses the required parameters included in an electronic NDS.
  2. List the similarities and differences between a CTA and SAP drug submission.  
  3. Research a drug product or Drug Master File for the purposes of a submission strategy.
  4. Draft an acceptable analysis of submission needs o abbriviate a marketing driven submission change. 
  5. Prepare a electronic CTD Module 1 New Drug Submission in its entirety including applicable TPD forms for a specified product. 
  6. Present an analysis of a current health Canada policy including its implementation and application parameters. 
  7. Apply pre-submission strategies based on market need as they apply to advanced approval, conditional approval and decision dispute resolution.
  8. Explain the regulatory requirements for a Drug Master File and the Chemistry and Manufacturing section of a CTD.
  9. Perform a facility inspection, applying the principles of auditing practices.
  10. Determine the warranted corrective action for a given facility inspection.

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