Humber’s Regulatory Affairs graduate certificate program prepares graduates with the transferable skills needed to build successful careers in a variety of sectors requiring regulatory affairs expertise and training. This program focuses on developing the concepts, skills and techniques required to work in regulatory affairs in the pharmaceutical, health products, medical devices, biotechnology industries, food industries and other sectors that require a regulatory component. You will gain knowledge of the regulatory system, legislation, procedures and practices which relate to the development, manufacture, quality assurance and marketing of health-related and consumable products.
The importance of internationally harmonized regulations and future trends in the industry is examined by analyzing relevant international and Canadian legislation and regulations. You will study a wide range of regulations and standards including good manufacturing practices (GMP), good laboratory practices (GLP), good clinical practices (GCP), good documentation practices (GDP), the International Organization for Standardization (ISO), the Canadian Food and Drugs Act (CFDA), the Environmental Protection Act, principles of regulatory compliance and inspections, drug establishment licensing, and related standards and guidelines.
Teamwork and communication skills are reinforced throughout the program and you will acquire information technology skills that assist communication and data management specific to regulatory affairs.
You will become familiar with the steps necessary for product submission; assembling documents and statistical evidence; the complexity of product registration, negotiation and follow-up; and linking the federal government and provincial formularies.
You will also benefit from:
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 academic course-based semesters, students complete a three-month (450 hours) internship work placement that provides opportunities to apply and integrate theoretical knowledge and skills into real-world work settings. Internship 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 on placement sites, and assessments are carried out by assigned supervisors at the site of placement. Humber assists students in finding their placements by working with our 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 regulatory affairs, and field specific background 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 regulatory) 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. The comprehensive training we provide, combined with previous degrees and work experience, make our 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 that exist in pharmaceutical, medical devices, biotechnology, consulting, inspection, quality assurance, research institutes, government agencies, and any related industry or sector that requires regulatory expertise.
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