Certificate - Regulatory Affairs
- 1 year
- Duration
- 28,183 CAD
- Price
- Rolling admission
- Start
- Rolling admission
- Deadline
- Certificate
- Degree
- Online
- Format
- Canada
- Location
Program description
Graduating from Humber's Regulatory Affairs graduate certificate program gives students the tools they need to succeed in a wide range of fields that value regulatory affairs knowledge and training. Graduates of this online program will be prepared to work in regulatory affairs for a variety of companies, including those dealing with pharmaceuticals, health products, medical devices, biotechnology, food, and others. In this course, you will learn about the laws, regulations, processes, and practices that govern the research, design, production, testing, and sale of consumer and health-related goods.
By reviewing applicable Canadian and international laws and regulations, we can look at the significance of globally harmonized regulations and the direction the industry is headed in. In this course, you will learn about many different types of rules and regulations, such as GMP, GLP, GCP, GDP, the International Organization for Standardization, the Canadian Food and Drugs Act, the Environmental Protection Act, principles of regulatory compliance and inspections, drug establishment licensing, and linked standards and guidelines.
You will learn how to operate in a team, improve your communication and interpersonal skills, and become proficient in the use of information technology to aid in regulatory affairs-specific data management and communication.
Assembling paperwork and statistical proof, navigating the intricacies of product registration, negotiating, and follow-up, and establishing a connection between federal and provincial formularies are all things you'll learn about in this course.
Program structure
Semester 1
- Regulatory Communications & Ethical Practice
- Health Legislation, Regulations and Guidelines
- Product Development - CMC
- Post Market Surveillance
- Drug Product Lifecycle
Semester 2
- Regulatory Projects on Emerging Trends
- Product Development-Premarket
- Medical Devices
- Provincial Formularies and Reimbursement Policy
- Management of Regulatory Submissions
- Professional Preparation - Regulatory Affairs
Semester 3
- Field Experience - Regulatory Affairs
Price
Fees per semester:
- Tuition 8,753 CAD
- Compulsory Ancillary Fee 444 CAD
- Compulsory Student Union Fee 66 CAD
- IGNITE Health and Dental Insurance Fee 111 CAD
- Enhanced Student Experience Fee (Optional) 20 CAD
- Program Ancillary Fee 0.00 CAD
- Co-op/Placement 0.00 CAD
Total 9,394 CAD
Requirements for applicants
International Academic Equivalencies:
- A Bachelor of Science degree or equivalent, majoring in health science, pharmacy, some area in life sciences or a related field
English Proficiency requirements are:
- A minimum TOEFL Academic Level score of 550 (paper based) or 80 (internet based) or
- an IELTS with an overall minimum score of 6.0 (with no single band score below 5.5) or
- CAEL with an overall band score of 60 or
- Cambridge English Test with B2 First / C1 Advanced / C2 Proficiency 169 (with no single subscore below 162) or
- Duolingo Language Test with score 105 and above+
- International applicants may be asked to submit an ICAS or WES evaluation.
About the university
Humber College Institute of Technology & Advanced Learning (known as Humber College) was fonded in 1967. The college is located in Toronto, Canada.
The Humber North and the Lakeshore are the two primary campuses at Humber.
Humber College offers over 200 programs in 40 fields of study.
Students at Humber receive a polytechnic education. We educate theory, incorporate practical, hands-on training, and collaborate with employers to provide students with real-world learning opportunities. This innovative and entrepreneurial approach, which is taught in state-of-the-art and creative learning facilities, prepares students for today's and tomorrow's careers.
We are committed to your long-term success. A Humber education will help you map a sure path to your career and keep you up to date on shifting trends in the professional world as technology advances. Our programs combine theory and practice, allowing you to get practical experience both in the classroom and on the work. Professors with industry experience will teach you what skills are in demand.
