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.

Admission selection is based on the following 5 requirements: 1. Academic To be eligible for admission, you must possess the following: A Bachelor of Science degree, majoring in health science, pharmacy, some area in life sciences or a related field. 2. English Language Proficiency All applicants whose first language is not English must meet Humber’s English Language Proficiency Policy. 3. International Credit Evaluation Canadian citizens or permanent residents with international education are required to provide a WES or ICAS evaluation. 4. Resume Applicants must submit a detailed resume including education, work, and/or volunteer experience. Excellent resumes contain experiences that are relevant to the subject of interest. The resume itself should be well organized and easy to follow. Standard Canadian spelling and grammar should be used. 5. Video Introduction Applicants must submit a 3-5 minute video introduction outlining their interest in this field of study. The video should express why the applicant has an interest in Regulatory Affairs specifically in Humber College’s Regulatory Affairs graduate certificate program.