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Overview

Regulatory compliance is a driving force within the pharmaceutical industry and it is ever evolving to ensure safety and effectiveness. FDA, Health Canada and EMEA are just a few of the key players in the global regulatory environment.

Career Opportunities

For more details on related occupations, job market information and career opportunities, please visit the Government of Canada website.

National Occupational Classification (NOC) - Government of Canada

The National Occupational Classification (NOC) provides a standardized language for describing the work performed by Canadians in the labor market. It gives statisticians, labor market analysts, career counselors, employers and individual job seekers a consistent way to collect data and describe and understand the nature of work.

Entry Requirements

Ontario Secondary School Diploma or University/College Preparation: Grade 12 English, Chemistry, Mathematics and Grade 11 Biology are required. Mature students with work experience are considered on that basis, but may be advised to take College preparatory Chemistry, English, Biology, and Math.

Students who hold a diploma or degree from another country and have the above credits may directly enrol into the IPT program. You do not have to show your documents or write an admission test.


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Curriculum

PFT810
Regulatory Affairs Pharmaceutical
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Corequisite(s):

PFT930 - Industrial Drug Legislation

This course 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 (Notice Of Compliance). The functions of relevant divisions of the Health Protection Branch are discussed. Also covered are: DINs (Drug Identification Numbers), Provincial Formulatory Submissions, drug labelling and drug advertising, SOPs (Standard Operating Procedures), compliant handling (including Adverse Drug Reactions), recalls, Plant Master Files (PMF), Drug Master Files (DMF) and regulatory inspections. (Lecture only)




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PFT815
Advanced Regulatory Affairs
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Prerequisite(s):

PFT810 Regulatory Affairs Pharmaceutical

This course focuses on product development and registration in Canada. Students learn, and get a hands on approach to prepare a high quality clinical trial application (CTA), including generic and brand submissions. Emphasis is made on the mechanics of preparing submissions in the Common Technical Document (CTD) format in Canada. Specifically, this course clarifies the rules, regulations and guidelines on how submissions are prepared, and how deficiency letters are addressed to TPD. An overview of the e-CTD modules is provided in detail. (Lecture only)




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PFT816
International Regulatory Affairs
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Prerequisite(s):

PFT815 - Advanced Regulatory Affairs

This course 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.




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PFT930
Industrial Drug Legislation
Availability
 

Prerequisite(s):

It is strongly recommended that students have basic computer skills as this course requires computer access.

This course examines the organizational role, responsibilities and requirements of the Health Canada related to the production, labelling, selling, and advertising of drugs, radiopharmaceuticals, biologics, natural health products and medical devices in Canada. A review of USA and EU laws and regulations is also covered. (Lecture only)




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Program Outcomes

Upon successful completion of this ROA, students are able to:

  1. Describe the submission requirements related to a new drug, the approval process, drug registration and ongoing regulatory requirements (complaint handling, inspections recalls).
  2. Comply with relevant Good Manufacturing Practices (GMP), local as well as international regulatory requirements and drug legislation.
  3. Apply knowledge of regulations and its interpretations to meet various submission and compliance requirements.

Completion

Recognition of Achievement

Upon successful completion of the program requirements, please submit a Request for Recognition of Achievement Form to the Faculty of Continuing Education and Training. There is no cost for this and your Recognition of Achievement will be mailed to you.

Program Contacts

Georgina Ioannou
Program Assistant
Georgina.Ioannou@senecacollege.ca
416.491.5050 x22946


Joanne Bonnet
Academic Program Manager
Joanne.Bonnet@senecacollege.ca
416.491.5050 x22528