PFT810 - Regulatory Affairs Pharmaceutical

Outline info
Last revision date 2018-07-20 11:49:17.077
Last review date 2018-07-20 11:49:24.96

Subject Title
Regulatory Affairs Pharmaceutical

Subject Description
This subject describes the role of the Regulatory Affairs department in a pharmaceutical firm and focuses on the "submission process" -- the regulatory requirements at the various stages in a drug product's development from inception through IND (Investigational New Drug) and NDS (New Drug Submission) to issuance of the NOC (Notice of Compliance). The functions of relevant divisions of Health Canada are discussed. Also covered are: DINs (Drug Identification Numbers), Provincial Formulary Submissions, drug labelling and drug advertising, SOPs (Standard Operating Procedures), complaint handling (including Adverse Drug Reactions), recalls, Drug Master Files (DMF), and regulatory inspections. (Lecture only)

Credit Status
One credit toward the Industrial Pharmaceutical Technology Certificate Program

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 and its relationship to other departments in the firm and to external regulatory bodies.

2. Apply selected pieces of legislation which regulate the sale of pharmaceuticals in Canada.

3. Trace the development stages of a drug product and identify the various submission requirements with reference to the applicable sections of the relevant legislation.

4. Implement those sections of the GMPs in which the Regulatory Affairs department may be involved, for example: recall, complaint handling including ADRs, SOPs, regulatory inspections.

5. Develop labelling for a drug product.

6. Prepare a Clinical Trial Application, DIN application.

7. Describe and understand the CTD organizational structure (Modules 1 - 5).

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.

PFT930 - Industrial Drug Legislation

Topic Outline

  • Introduction of Subject; What is Regulatory Affairs? Background to Food and Drugs Act and the legislative process
  • Structure of Food and Drugs Act and Regulations; Organizational Structure of Health Canada and Role
  • Drug Development Cycle and Regulatory Submissions, Requirements, Patents
  • Divisions 5 & 8 of Food and Drug Regulations; Overview of CTD structure (Module 1 - 5)
  • CTA Preparation; Class Exercises
  • Validation; Good Laboratory Practices (GLPs); TPD Expectations
  • DIN Applications
  • Overview of Labelling Legislation and Guidelines; Advertising
  • Bulk Pharmaceutical Chemicals and Drug Master Files; Plant Master Files; SOPs and Change Control; Post-Marketing Changes and Annual Drug Notification
  • Complaints and Adverse Drug Reactions (ADRs)
  • ICH Stability Requirements
  • Formulary Submission Guidelines
  • Preparation of Formulary Submissions; Review; Subject Evaluation

Mode of Instruction

  • Participative lectures involving small group discussions and class exercises
  • Case Studies
It is recommended that students expect to spend at least one to two hours per week on reading and written assignments.  

Prescribed Texts
Food and Drugs Act

Reference Material
Drugs Directorate / ICH Guidelines

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.

Grading is based on the following marking scheme:
Mid-Term 1 * 25%
Mid-Term 2 *  25%
Final Exam *  50%

* Unmarked copies of legislation and guidelines relative to this subject may be used during the exams.

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.


Approved by: Denis Gravelle