PRA800 - Regulatory Affairs II

Outline info
Semester
School
Last revision date Jan 26, 2026 1:35:17 AM
Last review date Mar 16, 2026 12:15:22 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 (CMC) 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 Pre-approval 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 requirement which addresses the required parameters included in an electronic NDS.
  2. List the similarities and differences between a Clinical Trial Application (CTA) and Special Access Program (SAP) 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 to support a marketing driven submission change.
  5. Prepare an electronic CTD Module 1 New Drug Submission in its entirety including applicable Health Canada forms for a specified product.
  6. Analyze 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
    9. CTD.
  9. Explain the impact of marketing on regulatory affairs pre and post approval
  10. Perform a facility inspection, applying the principles of auditing practices.
  11. Determine the warranted corrective action for a given facility inspection.
  12. Explain pediatric regulatory requirements in Canada.

Academic Integrity
Seneca upholds a learning community that values academic integrity, honesty, fairness, trust, respect, responsibility and courage. These values enhance Seneca's commitment to deliver high-quality education and teaching excellence, while supporting a positive learning environment. Ensure that you are aware of Seneca's Academic Integrity Policy which can be found at: http://www.senecapolytechnic.ca/about/policies/academic-integrity-policy.html Review section 2 of the policy for details regarding approaches to supporting integrity. Section 2.3 and Appendix B of the policy describe various sanctions that can be applied, if there is suspected academic misconduct (e.g., contract cheating, cheating, falsification, impersonation or plagiarism).

Please visit the Academic Integrity website http://open2.senecac.on.ca/sites/academic-integrity/for-students to understand and learn more about how to prepare and submit work so that it supports academic integrity, and to avoid academic misconduct.

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@senecapolytechnic.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 Accessibility Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.

Camera Use and Recordings - Synchronous (Live) Classes
Synchronous (live) classes may be delivered in person, in a Flexible Learning space, or online through a Seneca web conferencing platform such as MS Teams or Zoom. Flexible Learning spaces are equipped with cameras, microphones, monitors and speakers that capture and stream instructor and student interactions, providing an in-person experience for students choosing to study online.

Students joining a live class online may be required to have a working camera in order to participate, or for certain activities (e.g. group work, assessments), and high-speed broadband access (e.g. Cable, DSL) is highly recommended. In the event students encounter circumstances that impact their ability to join the platform with their camera on, they should reach out to the professor to discuss. Live classes may be recorded and made available to students to support access to course content and promote student learning and success.

By attending live classes, students are consenting to the collection and use of their personal information for the purposes of administering the class and associated coursework. To learn more about Seneca's privacy practices, visit Privacy Notice.

Prerequisite(s)
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
None

To find out the cost of books and learning material go here.

Any courses not listed on the bookstore webpage do not require any resources for purchase. All resources will be provided by your instructor.

Reference Material
None

Required Supplies
None

Student Progression and Promotion Policy

http://www.senecapolytechnic.ca/about/policies/student-progression-and-promotion-policy.html

Grading Policyhttp://www.senecapolytechnic.ca/about/policies/grading-policy.html

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)
OR
EXC Excellent
SAT Satisfactory
UNSAT Unsatisfactory

For further information, see a copy of the Academic Policy, available online (http://www.senecapolytechnic.ca/about/policies/academics-and-student-services.html) or at Seneca's Registrar's Offices. (https://www.senecapolytechnic.ca/registrar.html).


Modes of Evaluation

Assignments
  • 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:  http://library.senecapolytechnic.ca

LAB COURSES
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

Punctuality
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:
Health Canada Guidance Document/Topic Presentations 20%
***Mock New Drug Submission  
1. Project Plans 10%
2. Pre-NDS Meeting Request, Agenda, and Minutes 10%
3. NDS (Modules 1 and 2.3 eCTD) 30%
Audit and Resolution Assignment 15%
Quiz 10%
Class Participation 5%
 


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.

PLEASE RETAIN THIS SUBJECT OUTLINE FOR POSSIBLE FUTURE USE IN SUPPORT OF CREDIT APPLICATIONS AT OTHER EDUCATIONAL INSTITUTIONS

Approved by: Martin Tame