安大略省法规事务研究生证书

亨伯的法规事务研究生证书课程重点在于开发在制药，医疗器械或生物技术行业进行法规事务所需的概念，技能和技术。您将了解与健康相关产品的开发，制造，质量保证和营销有关的法规体系，立法，程序和惯例。描述加拿大卫生保健系统和省级处方中的政府程序。解释行业监管专业人员的角色和职责。解释药物经济学中与保健和保健产品的社会经济相关的概念。说明加拿大和国际医疗保健法规，包括（例如）良好生产规范，良好实验室规范，良好临床规范，良好文档规范，国际标准组织（ISO），食品药品法法规，环境保护法，法规合规性/检查，药品企业许可以及
Humber’s Regulatory Affairs graduate certificate program equips graduates with the transferable skills needed to build successful careers in a variety of sectors requiring regulatory affairs expertise and training. This online 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.<br><br>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. Program Delivery: Courses are scheduled over two 14-week semesters and offer a blend of self-directed online modules and synchronous remote classes. A work placement occurs in Semester 3 and is in-person.