- Canadian Association of Professional Regulatory Affairs (CAPRA)
- Drug Information Association (DIA)
- Pharmaceutical Sciences Group (PSG)
- Regulatory Affairs Professional Society (RAPS)
Pharmaceutical Regulatory Affairs & Quality Operations (RAQC)
About the Program
Focus your career by specializing in this one-year graduate certificate program. You will gain a fundamental understanding of regulatory affairs and quality operations. Studies of regulatory compliance in Canada and internationally will prepare you for a career involving drug or medical regulations and quality assurance functions and roles. During the first semester, you will learn the fundamentals of regulatory affairs and quality operations. Your second semester will focus on more detailed exposure to the areas of regulation and quality operations. This program offers an optional work term(s), similar to the length to an academic semester, if you meet all the academic requirements.
Part-time option is available >
Credential Awarded
Ontario College Graduate Certificate
Duration
2 Semesters (1 Year)
Starts
January, May, September
Program and Course Delivery
This program is offered online and is also available in Seneca's flexible delivery format. With flexible delivery, using innovative learning spaces and technology, professors teach students in a classroom or lab and broadcast in real time to students attending remotely. In flexible courses, students have the choice of coming on campus or learning online.
Skills
Throughout this program you will develop the following skills:
- Understand Canadian and international drug and other health care legislation, regulations and guidelines
- Understand process, regulations and the impact of manufacturing
- Prepare submissions, including supplemental documentation, to the Therapeutic Product Program
- Understand good manufacturing processes
- Negotiating in managing the review process
Work Experience
Optional Work Term
Students meeting all academic requirements may have the opportunity to complete an optional work term(s) in a formal work environment. The work term(s) is similar in length to an academic semester and typically involves full-time work hours that may be paid or unpaid. In programs with limited work term opportunities, additional academic requirements and a passing grade on a communication assessment may be required for eligibility. Eligibility for participation does not guarantee a work position will be secured. Additional fees are required for those participating in the optional work term stream regardless of success in securing a work position.
Your Career
When you graduate from this program, these are the types of career options you can explore:
- Regulatory affairs associate
- Regulatory affairs assistant
- Quality assurance associate
- Quality assurance investigator
- Documentation administrator
- Medical information associate
Affiliations/Associations
Program of Study
| Course Code | Course Name | Weekly Hours |
|---|---|---|
| Semester 1 | ||
| PBB814 | Biotechnology and Biopharmaceuticals | 4 |
| PFM714 | Product Formulation and Manufacturing | 3 |
| PQA711 | Introduction to Quality Assurance | 3 |
| PRA700 | Introduction to Pharmaceutical Regulatory Affairs | 6 |
| TWC713 | Technical Writing and Communication I | 3 |
| WTP100 | Work Term Preparation * | 1 |
| Work-Integrated Learning Term | ||
| RAQ441 | Pharmaceutical Regulatory Affairs, Work Term * | 30 |
| Semester 2 | ||
| IRA815 | International Regulatory Affairs and Harmonization | 3 |
| PCR901 | Introduction to Clinical Research | 3 |
| PEC715 | Pharmacoeconomics | 3 |
| PQA811 | Quality Assurance II | 4 |
| PRA800 | Regulatory Affairs II | 6 |
- *
Work-Integrated Learning option only
Program Learning Outcomes
This Seneca program has been validated by the Credential Validation Service as an Ontario College Credential as required by the Ministry of Colleges and Universities.
As a graduate, you will be prepared to reliably demonstrate the ability to:
- Describe the government process within the Canadian health care system and provincial formularies.
- Explain the roles and responsibilities of a regulatory professional in industry.
- Explain the concepts in pharmacoeconomics as they relate to the socioeconomic aspects of health care and health care products.
- Explain Canadian and international health care legislation and regulations.
- Describe international harmonization of regulations and the impact on manufacturing and the submission process.
- Demonstrate information technology skills in the use of software applicable to regulatory affairs submissions, in document and database management systems, and in the use of the Internet for research.
- Explain the Product Development Process.
- Outline the Quality Control Process.
- Define drug, medical device, and biologic submission process requirements.
- Prepare a drug, medical device, and biological submission to the Therapeutic Products Program (TPP) including supplemental documentation.
- Demonstrate the problem solving process as it relates to post-marketing surveillance and pharmacovigilance.
- Demonstrate effective interviewing and negotiating skills in managing the review process.
Admission Requirements
- Ontario university or college degree or equivalent in science with a focus on chemistry, biology or pharmaceutical
- English proficiency for graduate certificates
Canadian citizens or permanent residents educated outside of Canada must provide a World Education Services (WES) or ICAS Canada credential evaluation.
Pathways
As a leader in academic pathways, we offer a range of options that will allow you to take your credential further in another Seneca program or a program at a partner institution.
To learn more about your eligibility, visit the Academic Pathways web page.