Regulatory Affairs

• Hours: 1
• Credits: 0
• Pre-Requisites:
• CoRequisites:
• Estimated required text and/or learning resource costs: No cost.

Regulation plays a key role in protecting public safety. In this course, students develop an understanding of regulation theory and design in a variety of industries, including pharmaceutical, medical devices, food, natural health products and health care. Students examine the importance of regulations in Canada, US, and Europe by reviewing regulatory agencies overseeing these industries, and learn about different stages of product development in the pharmaceutical industry (non-clinical, clinical, product marketing application and post-marketing activities) and health care service regulation. Students learn to apply regulatory principles to products across their life cycle and production, and health service regulatory practice.

• Hours: 42
• Credits: 3
• Pre-Requisites:
• CoRequisites:
• Estimated required text and/or learning resource costs: No cost.

In this course students acquire project management skills essential to project success in a regulatory environment. By applying principles, approaches and tools of effective project management and collaboration, students learn how to effectively plan and execute projects.

• Hours: 42
• Credits: 3
• Pre-Requisites:
• CoRequisites:
• Estimated required text and/or learning resource costs: $104.25

This course provides a comprehensive introduction to Quality Assurance (QA) as it applies to regulatory affairs in industries such as pharmaceuticals, medical devices, food, natural products manufacturing, and healthcare. Students will learn to implement and maintain Quality Management Systems (QMS) and develop Standard Operating Procedures (SOPs) to ensure regulatory compliance. Key QA tools such as Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPAs), and the change control process will be covered, along with developing essential skills for conducting inspections and audits. By mastering these concepts, students will be equipped to ensure the production of safe, effective, and compliant products and services.

• Hours: 56
• Credits: 4
• Pre-Requisites:
• CoRequisites:
• Estimated required text and/or learning resource costs: No cost.

In this course students will learn how to deliver high quality scientific and technical information concisely and accurately to create high quality regulatory submissions using appropriate formats and graphical support. Students will learn how to leverage their knowledge of regulatory stakeholders to gain buy-in and delivering effective industry-specific materials to a variety of regulatory agencies.

• Hours: 42
• Credits: 3
• Pre-Requisites:
• CoRequisites:
• Estimated required text and/or learning resource costs: No cost.

Regulation plays a key role in protecting public safety. In this course, students develop an understanding of the regulatory framework for conducting clinical research with an emphasis on the ICH, GCP, and CFR guidelines. Students learn the role that different regulatory agencies play in the approval of new drugs, devices and procedures, such as Health Canada, FDA, EMA, etc. Using the knowledge of appropriate clinical trial regulations, the students build skills to appropriately support the clinical research application process and successful completion without endangering human participants.

• Hours: 42
• Credits: 3
• Pre-Requisites:
• CoRequisites:
• Estimated required text and/or learning resource costs: $80.75

Informed decision making requires a set of skills in interpreting and evaluating data. In this course students build critical thinking skills necessary for examining clinical and nonclinical data and its implications for decision making in regulatory settings. Students learn different types of statistical analyses and apply appropriate statistical concepts to data analysis.

• Hours: 56
• Credits: 4
• Pre-Requisites:
• CoRequisites:
• Estimated required text and/or learning resource costs: No cost.