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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Faculty of Health Sciences & Wellness News
FAQs in response to announcement Humber College To Pursue Independent Nursing Degree
Fri, March 13, 2020
Humber Health & Wellness Students Praised for Innovation and Professionalism at Career Fair
Mon, March 02, 2020
Premier Ford Tours Nursing Labs
Thu, February 27, 2020
Premier Doug Ford, Minister of Colleges and Universities Ross Romano, and other local MPPs, attended Humber recently.
The visit was to echo their early February Nursing announcement and to discuss the implications with senior administrators at Humber.
The Provincial Government announced its intention to amend the 1991 Nursing Act, thereby permitting interested Colleges to offer baccalaureate Nursing programs. Humber College will be seeking approval to offer stand alone Nursing education, with the BScN nomenclature, commencing in 2021. Visitors toured the facilities and spoke with our students.
No news at this time.
Every attempt is made to ensure that information contained on this website is current and accurate. Humber reserves the right to correct any error or omission, modify or cancel any course, program, fee, timetable or campus location at any time without prior notice or liability to users or any other Person.
On June 29, 2018, the Provincial Government of Ontario announced the renaming of the Ministry of Advanced Education and Skills Development (MAESD) to the Ministry of Training, Colleges and Universities (MTCU). Both names may appear on this website.