Humber’s Regulatory Affairs graduate certificate program focuses on developing the concepts, skills and techniques required to work in regulatory affairs in the pharmaceutical, medical device or biotechnology industries. 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 products.
The importance of internationally harmonized regulations and future trends in the industry will be examined by analyzing relevant international and Canadian legislation and regulations. You will study a wide range of regulations and standards including good manufacturing practices, good laboratory practices, good clinical practices, good documentation practices, the International Organization for Standardization (ISO), the Canadian Food and Drugs Act, the Environmental Protection Act, principles of regulatory compliance and inspections, drug establishment licensing, and related standards and guidelines. Teamwork and communication skills are emphasized 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; how to assemble documents and statistical evidence; the complexity of product registration, negotiation and follow-up, and how these are linked to the federal government and provincial formularies.
Course detail
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.
Modules
Semester 1
• 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
Semester 2
• 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
Semester 3
• REGA 5040: Internship
• REGA 5041: Integative Seminar
Work Placement
Following two academic course-based semesters, students complete a three-month placement that provides opportunities to apply and integrate theoretical knowledge and skills into real-world work settings. Most placements are in the following sectors: pharmaceutical, biotechnology, medical device organizations, government agencies or food industries.
Your Career
Our graduates work in a spectrum of fields such as pharmaceutics, biotechnology, medical devices, natural health product industries or in government.
How to apply
Click here to apply:
http://humber.ca/admissions/how-apply.html Funding
For information on funding, please use the following link:
http://humber.ca/admissions/financial-aid.html
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