PFT816 - International Regulatory Affairs

Outline info
Last revision date 2018-07-20 11:49:18.987
Last review date 2018-07-20 11:49:27.963

Subject Title
International Regulatory Affairs

Subject Description
This subject provides students with a review of the functions and purposes of international harmonization and International Regulatory Affairs. Pharmaceutical regulations in USA, European countries, Japan and MENA region are examined as well as the regulations in a selected number of other geographic locations. Drug submission requirements based regulations in these countries are compared.

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. Demonstrate an understanding of the basic principles for drug submissions in the US, Europe, Japan, MENA region, Latin American region and other selected countries.

2. Differentiate the regulatory pathways to file new drug and generic drug applications in these countries .

3. Describe the requirements for a Marketing Authorization Application in these countries.

4. Gain an understanding of International Conference on Harmonization (ICH) and its impact on global drug regulation.

5. Know where to find relevant regulatory information regarding drug submission in these regions.

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.

PFT815 - Advanced Regulatory Affairs

Topic Outline

  • Overview of international drug registration processes
  • International conference on Harmonization and its impact on global drug regulation. WHO, drug registration and the developing world
  • Drug registration in the European Union - EU CTD
  • Overview of FDA drug registration procedures and the FDA's CTD
  • The CTD around the world
  • Relationship of patents to international drug registration
  • Drug regulations in  Japan, China, and India
  • Drug registration in selected African states and the Persian Gulf region
  • Regulatory environment in Latin American countries
  • Amendments to the dossier - an international approach
  • An outline to Medical Devices - regulations in the EU and USA
  • Impact on the environment on disposal of pharmaceutical hazardous waste
  • Regulations and controls
  • Radiopharmaceutical registration international implications
  • Review

Mode of Instruction

  1. Participative lectures involving small group discussions and class exercises
  2. 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

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:
Assignments 25%
This will be an essay-form, literature/Internet researched type essay and written in class (details and explanations to be announced)
Take home CTD exercises 15%
This will required sessions on your computer, working in your student groups of two or three
Group presentations (groups of 3) 25%
A list of appropriate topics relating to regulatory affairs will be provided, but student groups may suggest a new topic to present which must be agreed to by the instructor. An overall grade will be given to the group plus and adjustment for individual performance
Please note: Attendance is expected at all lectures. Missing 2 or more lectures without valid reasons will result in a percentage points being deducted from the student's grade
Final Examination 35%

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