Learn more about the academic programs we are delivering in Summer 2024. If you have any questions about part-time studies, please contact us.
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.
Students are invited to attend an information session.
For more details on related occupations, job market information and career opportunities, please visit the Government of Canada website.
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.
Part-time Studies courses are being offered in either of the following four formats: Online, Flexible, In-person, Hybrid. Click Availability below to see current offerings.
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)
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)
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.
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)
Upon successful completion of this ROA, students are able to:
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 sent to you electronically.
Maria Graziosi
Program Assistant
Maria.Graziosi@senecapolytechnic.ca
416-764-0964
Melanie Rubens
Program Coordinator
Melanie.Rubens@senecapolytechnic.ca
416-764-0973
For more information about this program, fill out the following form.
Students are invited to attend an information session.