|REGA 5020: Health Care Legislation, Regulation and Guidelines|
|REGA 5021: Product Development-Premarket|
|REGA 5022: Product Development-CMC|
|REGA 5023: Medical Products Safety|
|REGA 5024: Communication|
|REGA 5025: Pathophysiology and Pharmacology|
|REGA 5030: Management of Regulatory Submissions|
|REGA 5031: Management of Global Regulatory Submission|
|REGA 5033: Regulation of Food Products and Agrichemicals|
|REGA 5034: Medical Devices|
|REGA 5035: Provincial Formularies and Reimbursement Policy|
|REGA 5036: Emerging Biotechnology|
|REGA 5041: iSucceed: Regulatory Affairs|
|REGA 5040: Internship|
Upon successful completion of the program, a graduate will:
Describe the government processes 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 including (as examples) Good Manufacturing Practices, Good Laboratory Practices, Good Clinical Practices, Good Documentation Practices, International Standards Organization (ISO), Food and Drug Act Regulations, the Environmental Protection Act, Regulatory compliance/inspection, Drug Establishment Licensing and related standards and guidelines.
Describe international harmonization of regulations and the impact on manufacturing and the submission process.
Explain the Product Development Process.
Outline the Quality Control Process.
Demonstrate information technology skills in the use of software applicable to regulatory affairs submissions, in document and database management systems, in data correction techniques and in the use of the Internet for research.
Define drug (prescription and non-prescription)/medical device/biologic submission process requirements.
Prepare a drug/medical device/biologic submission to the Therapeutic Products Program (TPP) including supplemental documentation.
Demonstrate the problem solving process as it relates to pharmacovigilance and post-marketing surveillance.
Demonstrate effective interviewing and negotiating skills in managing a clinical study.
Following two online academic course-based semesters, students complete a three-month (450 hours) work placement that provides opportunities to apply and integrate theoretical knowledge and skills into real-world work settings. Work placements are conducted in a wide range of organizations such as pharmaceutical, natural health products (NHP), medical device and biotechnology companies, as well as contract research organizations, hospitals, government agencies/departments and scientific institutions.
To progress into Semester 3, students must have successfully completed the first two semesters. During Semesters 3, students complete their learning at placement sites, and assessments are carried out by assigned supervisors at the site of placement. While Humber does assist students in finding their placements by working with industry partners to identify openings, students are responsible for finding their own work placement that is aligned with learning outcomes of our program.
Every year our program receives excellent feedback from the industry regarding the professional preparation of the graduates and the content of the program; our graduates are an important resource for the industry. This is an outcome of our ongoing efforts to ensure that students have a solid understanding of regulatory affairs and field-specific knowledge.
Regulatory Affairs Specialists help the government and businesses to ensure that product development, manufacturing, and marketing practices meet government standards and ensure products are safe for public use. Regulatory affairs is a mandatory and necessary undertaking (ethically and regulatorily) in development, inspection, quality assurance, and safety assessment of new and existing consumable, therapeutic, and diagnostic products.
The medical, pharmaceutical, food, and natural products industry is facing constant development. As a society focused on health and wellness as well as safety and efficacy much attention is being given to the safe development of new interventions, supplements, and drugs as well as the improvement of society’s overall health and wellbeing. Comprehensive training combined with work experience and previous degrees make Humber students highly marketable.
The Regulatory Affairs Graduate Certificate program at Humber is strategically designed, developed and delivered with high efficiency, during the first two semesters of the program. Subsequently, theoretical learning is extensively applied through hands-on experiences during the 3rd semester, including a 450 hours internship placement.
The fundamental skills are taught, developed, and reinforced throughout the one-year comprehensive program. Work ready graduates are developed in this program to confidently transition into the workforce.
If you are policy and guidelines-oriented, self-regulated, have collaborative interpersonal skills and enjoy critical thinking, the Regulatory Affairs program and a career in this field may be for you.
It is our vision and mission to offer our learners the means to excel in the field of Regulatory Affairs by providing industry relevant professional, technical, theoretical, and hands-on experience. We strive to develop work ready learners upon graduation through a collaborative partnership between students and the program. The internship component of this program, which follows two academic semesters, provides students a practical environment and offers ample opportunities to integrate theoretical learning into real industry hands-on experience. Additionally, the internship placement will provide students an opportunity to expand their professional network through interaction with peers, faculty and colleagues. It is our hope that upon graduation students will effectively and confidently transition to work force, related to their field of study.
Our graduates typically pursue careers in the regulatory affairs departments in pharmaceutical, medical devices, biotechnology, consulting, inspection and quality assurance agencies, research institutes, government agencies, and any related industry or sector that requires regulatory expertise.
Credential: Ontario Graduate Certificate
Length: 3 semesters
Health Sector Regulatory Compliance
Credential: Ontario Graduate Certificate
Length: 3 semesters
|September 2022||Online||Not Available|
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No news at this time.
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On October 21, 2019, the Provincial Government of Ontario announced the renaming of the Ministry of Training, Colleges and Universities (MTCU) to the Ministry of Colleges and Universities (MCU). Both names may appear on this website.