PRA800 - Regulatory Affairs II

Outline info
Last revision date 2018-04-10 14:20:56.198
Last review date 2018-04-10 14:21:03.574

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.

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

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.

PRA700 Introduction to Pharmaceutical Regulatory Affairs

It is the student's responsibility to ensure that the prerequisites are met.  If you do not have the required prerequisite subject (or have an advanced standing for the prerequisite subject) you will be asked to withdraw with the risk of academic/financial penalty. 

Topic Outline

  • Drug Development and NDS Project Expectations and Required Actions Outlined
  • CTD Structure and Content       
  • CTA and Special Access
  • Orphan Drugs
  • Access to Information and FOI
  • Priority Review
  • DMF
  • Applications to sell on-patent drugs under General Council Decision
  • Management of Submissions and Drug Review
  • Drug policy presentations
  • CMC Section of an NDS/NDA (Module 3)
  • Auditing Practices and Pre-Approval Inspections
  • Audit Practical and Discussion

Mode of Instruction
Lectures, presentations and practical assignments.

Prescribed Texts
Prepared subject notes

Canada's Food and Drugs Act

Reference Material

Required Supplies

Promotion Policy

Grading Policy
A+ 90%  to  100%
A 80%  to  89%
B+ 75%  to  79%
B 70%  to  74%
C+ 65%  to  69%
C 60%  to  64%
D+ 55%  to  59%
D 50%  to  54%
F 0%    to  49% (Not a Pass)
EXC Excellent
SAT Satisfactory
UNSAT Unsatisfactory

For further information, see a copy of the Academic Policy, available online ( or at Seneca's Registrar's Offices.

Modes of Evaluation

  • Assignments are due at the beginning of the class on which they are due.
  • A late penalty of 10% per day is assessed for late assignments, including those not handed in at the beginning of class when due.
  • Material will not be accepted after one week following the due date and/or when the marked material is returned to students, whichever comes first.
  • Assignments are to be prepared by computer.

Absenteeism and Exams
  • Students should be aware that absenteeism almost guarantees an inability to achieve satisfactory grades.
  • Students who are absent for an examination due to an emergency (e.g., motor vehicle accident, hospitalization or death in the family) may provide official documentation within five days of the missed exam and be provided a deferred exam at a later date.  Official documentation includes a death notice or an original doctor’s certificate identifying the date, length of time expected absence and the specific reason for the absence.  Examinations missed without official documentation and approval result in a grade of zero.
  • There are no deferred options for missed tests.  The value of missed tests, at the discretion of the Faculty, will be added to other evaluation components

English Proficiency
  • All written work should demonstrate the following characteristics for clarity and conciseness:
-writing is consistent with the rules of English grammar
-spelling and punctuation are correct
-sentences are structured correctly
-main ideas are supported with specific, relevant examples and reasons
-work flows logically through supporting statements/paragraphs
-work is arranged in correct format (e.g., as a report, essay)
-up to 10% of the final grade may be deducted on all work if the above English competencies are not met.

Format for Assignments
  • Students must use the standard, APA style for quoting sources.   Help is available at:

Laboratory Attendance

The laboratory component is essential and therefore it is strongly recommended  that you attend all labs.  Any missed labs must be supported with a legal document with three days of the lab.  Any student who fails to attend 2 scheduled laboratory classes for a 7 week subject and more than 3 laboratory classes for a 14 week subject will not pass the subject.    

Laboratory Safety
Students are required to review and understand the safety procedures and guidelines outlined on the first class and sign the sheet to this effect before beginning work in the laboratory.  Students must also wear a lab coat and safety glasses when conducting experiments.
A student who arrives without the proper safety equipment will not be permitted to participant in the lab but will be asked to leave the class.  The student will receive no grade for the lab missed.

General Policies and Guidelines

Show consideration for your colleagues and respect for faculty by arriving on time to class. If you know in advance of a class that you are going to be late, please let your faculty know.

Cell Phone Usage
As a courtesy to your fellow students and faculty, cell phones should remain turned off while in class. If, in the case of an emergency, the cell phone must remain on, please notify the teacher before class begins.

Information Technology Acceptable Use Policy
All students are responsible for abiding by the College's Information Technology Acceptable Use Policy and for obeying Provincial and Federal laws/regulations regarding the use of computer equipment, facilities and/or networks.

Grading is based on the following marking scheme:
CTD Module Project 40%
NDS Project Plan 15%
Policy Presentation  15%
Audit and Resolution Assignment 15%
DMF Revision Assignment 15%

Other Evaluation Considerations
The student is expected to comply with the Safety Rules for working in the laboratory, sign the safety contract, and WILL NOT UNDER ANY CIRCUMSTANCES WEAR CONTACT LENSES in the laboratory.  The student will know where all safety equipment is located in the laboratory and will be familiar with WHMIS concepts and signage.


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