PRA101 Introduction to Regulatory Affairs

This course is designed to provide students with an overview of the regulatory requirements and processes involved in the development, approval, and post-marketing surveillance of pharmaceutical products. The course will cover the legal and ethical framework of drug regulation, including the role of regulatory authorities, such as Health Canada, the Food and Drug Administration (FDA) in the United States, and the European Medicines Agency (EMA) in Europe.

Students will learn about the key elements of the regulatory approval process and address the post-marketing surveillance of pharmaceutical products. Students will gain an understanding of the importance of regulatory compliance, quality assurance, and the impact of regulatory affairs on the pharmaceutical industry.

Learning Points:

• The Canadian and global pharmaceutical industry
• The legal and ethical framework of drug regulations in Canada, the US, and global
• Regulatory Bodies, Agencies, Structures, and Systems – Canada (Health Canada), US (FDA), and Global
• Regulatory Affairs as a Profession: Roles & Responsibilities
• The key elements of drug development and the regulatory approval process
• The regulatory compliance and quality assurance requirements for pharmaceutical products
• Types of drugs and classification
• International Conference on Harmonization (ICH) (M4): CTD/eCTD
• Market authorizations process for pharma drugs and medical devices
• Pharmacovigilance and Oversight of Marketed Products

This course is ideal for students interested in pursuing a career in pharmaceutical regulatory affairs, drug development, or related fields. The course is also relevant for professionals working in the pharmaceutical industry who want to expand their knowledge of regulatory affairs and compliance.