PRA800 - Regulatory Affairs II

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Last revision date 2018-09-24 00:46:39.726
Last review date 2018-11-07 14:24:08.925

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.  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 practised.

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.
  4. Draft an acceptable analysis of needs.  
  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.

Cheating and Plagiarism
Each student should be aware of the College's policy regarding Cheating and Plagiarism. Seneca's Academic Policy will be strictly enforced.

To support academic honesty at Seneca College, all work submitted by students may be reviewed for authenticity and originality, utilizing software tools and third party services. Please visit the Academic Honesty site on for further information regarding cheating and plagiarism policies and procedures.

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Accommodation for Students with Disabilities
The College will provide reasonable accommodation to students with disabilities in order to promote academic success. If you require accommodation, contact the Counselling and Disabilities Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.