Regulatory Affairs

Course Code: REGA 5000

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.

Course Code: REGA 5002

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.

Course Code: REGA 5003

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.

Course Code: REGA 5005

This course will provide an overview of production of biologics and other medical products. One of the major topics is good manufacturing practices (GMPs) 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.

Course Code: REGA 5008

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.

Course Code: REGA 5010

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 Food and Drug Administration (FDA) regulations and the European regulations will also be covered.

Course Code: REGA 5012

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.

Course Code: REGA 5013

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.

Course Code: REGA 5501

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.

Course Code: REGA 5504

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.

Course Code: REGA 5506

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: investigational new drugs (INDs), new drug submissions/new drug applications/(NDSs/NDAs), CMC, drug identification number (DIN) application and Abbreviated New Drug Submissions (ANDS).

Course Code: REGA 5507

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.

Course Code: REGA 5509

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.

Course Code: REGA 5511

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.

Course Code: REGA 5514

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.

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