PRA700 - Introduction to Pharmaceutical Regulatory Affairs

Outline information
Semester
Schools offering this subject
Last revision date 2017-05-29 00:25:23.155
Last review date 2017-07-17 00:16:28.709

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 CTD (Common Technical Document) Clinical stage and NDS (New Drug Submission) application 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 CTD 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.  

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 http://library.senecacollege.ca for further information regarding cheating and plagiarism policies and procedures.

Discrimination/Harassment
All students and employees have the right to study and work in an environment that is free from discrimination and/or harassment. Language or activities that defeat this objective violate the College Policy on Discrimination/Harassment and shall not be tolerated. Information and assistance are available from the Student Conduct Office at student.conduct@senecacollege.ca.

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.