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Regulatory Affairs
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School of Health Sciences

2012/2013 Program Availability

North
Fall:
Open
Type:
Ontario Graduate Certificate
Postgraduate
Campus: North
Program Code:
07721
Length:

Three semesters, beginning in September
CONTACT INFORMATION:
Program assistant | 416.675.6622 ext. 4341 | clinical.regulatory@humber.ca
  • Our Program

    Regulatory Affairs certification from Humber is unique in offering in-depth, hands-on learning provided by faculty currently employed in the regulatory affairs environment. As well, the program’s Advisory Committee provides constant feedback regarding program development. Students will study the international health-care system, health-care legislation, and the procedures and practices for regulating the development, manufacture, quality assurance and marketing of health-care products. Because most companies develop products for an international market, the curriculum covers not only Canadian regulatory affairs but also international regulations and guidelines.
     

  • Your Career

    The Regulatory Affairs program relates to regulatory compliance of so called regulated industry. Humber’s program is focusing on the following industries: pharmaceutical, biotechnology, medical device, food and agriculture. Regulatory affairs professionals provide a vital link between companies and the government and, in their roles, they need to ensure that product development, manufacturing, and marketing practices meet or exceed government requirements and are safe for public use.

    Graduates of this program enjoy a high employment rate and they work for such employers as Amgen, AstraZeneca, CanReg, CropLife, GSK, Health Canada, Janssen-Ortho, Robarts, Sanofi, and others.
     

  • Workplacement

    A three-month industry internship lets students apply their skills and knowledge in a real-world work setting. Most internships are in the following sectors: pharmaceutical, biotechnology, medical devices industry, food industry and government.

     

  • Admission Requirement
    • A Bachelor of Science degree, majoring in Health Science, Pharmacy, some areas in Life Sciences or a related field. Candidates with a bioengineering background will be considered on an indi­vidual basis. Internationally-educated individuals must have the equivalent of a Canadian Bachelor of Science degree. Degrees com­pleted outside of Canada must be evaluated by one of the following: International Credential Assessment Service, University of Toronto Comparative Education Service or World Education Service
    • Testing in English writing skills and reading comprehension
    • Additionally, applicants must submit a detailed resumé describing their background (academic and experience), and cover letter outlining their understanding of the field of regulatory affairs and what they would bring to the field
    • Applicants are ranked based on the testing results and the best qualified are invited in for an interview/information session where the final selection is made for admission into the program 

    Note: For more information visit Selection Procedures.

    Meeting the minimum requirements does not guarantee admission to the program.

  • Fees

    The 2011/2012 fee for three semesters was

    – domestic $5,900.74
    – international $12,200.

    Amounts listed are the total of tuition, lab and material fees, student service and auxiliary fees for the first three semesters of the 2011/2012 academic year.

    Fees are subject to change.

    For more information visit Fees and Financial Assistance.

Curriculum

  • Semester 1

    Course CodeCourseCredits
    REGA 500Health-Care Legislation, Regulations and Guidelines

    Health-Care Legislation, Regulations and Guidelines

    Course Code: REGA 500
    Credits: 4
    This course focuses on legislation and regulations applicable to bringing a new medication to commercialization. The submission of prescription drugs, non-prescription drugs, biologics and natural health products will be examined, using as example the registration dossier for these, and the Canadian Food and Drug Act and Regulations. The submission of a prescription drug will be examined in detail, using as an example the entire package of study reports for a new drug. Students will gain knowledge in submission processes, guidelines and requirements and build skills in the researching and writing of various documents required for federal drug approval.
    		4
    REGA 502Health-Care Product Development

    Health-Care Product Development

    Course Code: REGA 502
    Credits: 3
    This course will examine the product development process for drugs, medical devices and biologics, including such aspects as discovery, the decision to develop a product, co-ordinating product planning and development, pre-clinical studies, clinical processes and manufacturing.
    		3
    REGA 503Provincial Formularies and Reimbursement Policy

    Provincial Formularies and Reimbursement Policy

    Course Code: REGA 503
    Credits: 2
    This course will focus on the processes and regulations associated with the administration of provincial drug benefit programs. Students will become familiar with the legislative framework that guides the selection and designation of drug products under provincial/territorial formularies and drug benefit programs. Also, the students will discuss and practice reimbursement procedures.
    		2
    REGA 505Biotechnology

    Biotechnology

    Course Code: REGA 505
    Credits: 3
    This course will provide an overview of production of biologics and other medical products. One of the major topics is GMP compliance during development and production process. The students also learn about different formulations of products, storage requirements and how environmental factors influence product stability. Additionally, the course will cover major laboratory techniques with discussions on data interpretation.
    		3
    REGA 508Negotiation Skills for Regulatory Affairs

    Negotiation Skills for Regulatory Affairs

    Course Code: REGA 508
    Credits: 2
    This course focuses on the regulatory context for interpersonal transactions. Students will enhance their interpersonal communication skills by developing active listening and interviewing skills. Understanding organizational dynamics and conflict strategies will assist students in developing skills in the use of collaborative and problem-solving approaches in negotiation. Problem-solving techniques will also be examined.
    		2
    REGA 510Medical Devices

    Medical Devices

    Course Code: REGA 510
    Credits: 3
    This course will introduce students to the field of medical devices. The course will define medical devices, explain existing regulations regarding the devices? approval and discuss clinical studies conductance. The main focus will be on the Canadian system, but the FDA regulations and the European regulations will also be covered.
    		3
    REGA 512Scientific and Technical Writing

    Scientific and Technical Writing

    Course Code: REGA 512
    Credits: 1
    This course is designed to enhance the writing, editing, and comprehension strategies of students for whom writing is an important function in their employment. The goal of this course is to provide some of the tools that students need to continue improving their own writing. Students will focus on writing skills, including grammar elements and spelling, and will practice editing, organizing, and summarizing scientific documents, as well as becoming familiar with different types of internal and external business communications.
    		1
    REGA 513Regulations of Agrichemicals

    Regulations of Agrichemicals

    Course Code: REGA 513
    Credits: 1
    This course provides an overview of the agrichemicals industry and regulations. The regulations and guidelines governing pest control products in Canada will be reviewed, so that the student will gain an understanding of how to make a submission for federal registration. All components of the agrichemical development process will be covered from research, field trial testing and interpretation to label design and international food trade issues.
    		1

    Semester 2

    Course CodeCourseCredits
    REGA 501Information Technology

    Information Technology

    Course Code: REGA 501
    Credits: 1
    The Information Technology (IT) segment of the program presents basic information on technology used in the pharmaceutical industry, with emphasis on new initiatives in the electronic submitting of regulatory information, and on the type of software and systems used in regulatory affairs departments.
    		1
    REGA 504Recent Trends in Therapeutics

    Recent Trends in Therapeutics

    Course Code: REGA 504
    Credits: 4
    This course is designed to introduce students to the fundamentals of pharmacology. It will focus on the relationship between a drugs mechanism of action at the molecular level and its effect on the patient. Course material will balance both basic and clinical aspects of drug action, with the goal of providing students with a fundamental understanding of the field of pharmacology. The general principles of pharmacokinetics, pharmacodynamics and pharmacogenomics will be introduced and students will examine the effect of drugs on body systems. A prior knowledge of basic physiology, anatomy and biochemistry is recommended to fully appreciate the topics discussed in this course.
    		4
    REGA 506Regulatory Submissions

    Regulatory Submissions

    Course Code: REGA 506
    Credits: 4
    In this course, students will gain knowledge in submission processes, guidelines and requirements. In addition, students will build skills in the researching and writing of various documents, dossiers and segments of those documents for federal, provincial and international medical device or biologic product approval. The course will be split in following modules: INDs, NDS/NDAs, CMC, DIN application and ANDS
    		4
    REGA 507Post-Marketing Compliance

    Post-Marketing Compliance

    Course Code: REGA 507
    Credits: 2
    This course will outline the medical and regulatory aspects of adverse reactions and adverse events. Post-marketing support functions of a regulatory affairs department (including, literature reviews, post marketing surveillance, summary of product characteristics, label changes, advertising and patient information) will also be examined. The principles of marketing (advertising, sales promotion and distribution) to the medical community will be examined.
    		2
    REGA 509International Regulations and Initiatives

    International Regulations and Initiatives

    Course Code: REGA 509
    Credits: 4
    This course will focus on international legislation regulating product development in US, Europe, Japan, and other countries. Students will learn about similarities and differences between Canadian and non-Canadian legislations, and their impact on regulatory submissions.
    		4
    REGA 511Overview of Regulatory Affairs Industry

    Overview of Regulatory Affairs Industry

    Course Code: REGA 511
    Credits: 2
    This course is designed to give students opportunities to meet representatives from industry. Each week, the students will have seminars provides by experts from biotech, pharma or medical devices industry. Additionally, this course will introduce students to specialists from fields, which co-operate very closely with regulatory affairs or have impact on the activities of regulatory affairs. Examples of such fields are: marketing and advertising, research and development, legal, contract manufacturing, etc.
    		2
    REGA 514Regulations of Agricultural Biotechnology and Food Products

    Regulations of Agricultural Biotechnology and Food Products

    Course Code: REGA 514
    Credits: 1
    Products produced through biotechnology are revolutionizing the agriculture and food industries. This course will explore the regulations governing new products in this field. Plant novel traits/novel foods and feeds will be covered as will the role of the Canadian Food Inspection Agency in monitoring food safety. Newly emerging technologies and their regulation such as plant-made pharmaceuticals (molecular farming) will also be discussed, as well as topics such as international trade in GM foods, labeling and the international biosafety protocol.
    		1

    Semester 3

    Course CodeCourseCredits
    REGA 515Work Experience

    Work Experience

    Course Code: REGA 515
    Credits: 4
    Products produced through biotechnology are revolutionizing the agriculture and food industries. This course will explore the regulations governing new products in this field. Plant novel traits/novel foods and feeds will be covered as will the role of the Canadian Food Inspection Agency in monitoring food safety. Newly emerging technologies and their regulation such as plant-made pharmaceuticals (molecular farming) will also be discussed, as well as topics such as international trade in GM foods, labeling and the international biosafety protocol.
    		4
    REGA 516Integrative Seminar

    Integrative Seminar

    Course Code: REGA 516
    Credits: 1
    Products produced through biotechnology are revolutionizing the agriculture and food industries. This course will explore the regulations governing new products in this field. Plant novel traits/novel foods and feeds will be covered as will the role of the Canadian Food Inspection Agency in monitoring food safety. Newly emerging technologies and their regulation such as plant-made pharmaceuticals (molecular farming) will also be discussed, as well as topics such as international trade in GM foods, labeling and the international biosafety protocol.
    		1