学历文凭
Graduate Certificate
专业院系
药物科学
开学时间
课程时长
课程学费
国际学生入学条件
A Bachelor of Science degree, majoring in health science, pharmacy, some area in life sciences or a related field.
Duolingo Language Test Scores - Between 125-130
IELTS - Overall 6.5 and No band below 6.0
TOEFL iBT - 88 (Minimum 22 in each component)
TOEFL PBT - 580
IDP—雅思考试联合主办方
雅思考试总分
6.5
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- 雅思总分:6.5
- 托福网考总分:88
- 托福笔试总分:580
- 其他语言考试:Pearson Language Test Evaluation (PTE): 61 - 64<br>Canadian Academic English Language Assessment Test (CAEL) - Overall band score of 70
课程简介
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 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. Following two online 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.
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