PRA700 - Introduction to Pharmaceutical Regulatory Affairs

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Last revision date Feb 12, 2019 2:37:21 PM
Last review date Mar 18, 2019 9:40:47 AM

Subject Title
Introduction to Pharmaceutical Regulatory Affairs

Subject Description
This subject 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 various CTD (Common Technical Document)  formats, Clinical stage and NDS (New Drug Submission) applications to issuance of the NOC (Notice of Compliance) and Post -NOC Amendments are examined. 

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. Describe the role of the Regulatory Affairs department in a pharmaceutical firm, its relationship to other departments in the firm and to external regulatory bodies.
  2. Describe the development stages of a drug product or medical device and the corresponding legislated submission requirements.
  3. Implement those sections of the drug legislation in which the Regulatory Affairs department is routinely involved, for example: recall, complaint handling and ADRs, SOPs, regulatory inspections, and deficiency correction.
  4. Describe current legislation for patents, trademarks and copyrights and how it affects the submission approval process.
  5. Characterize Post-NOC Changes and SU/PAC Changes based on the requirements of the Therapeutics Products Directorate (TPD) and the Food and Drug Administration (FDA).
  6. Prepare an acceptable submission for a DINA Application in Non-eCTD Electronic format and Establishment Licence (EL). 
  7. Apply  the various sections of a drug submission and the regulatory requirements related to them in preparing requisite forms and communications.
  8. Compare the submission requirements for a Natural Health Product with classical pharmaceutical applications.
  9. Explain the Canadian and U.S. submission filing requirements for a Medical Device.  

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