This course provides an in-depth understanding of the regulatory requirements and processes for pharmaceutical products involved in the submission, labeling, and approval of pharmaceutical products. The course will cover the regulatory review and market authorization (MA) process, with a focus on Canada and the United States.
Students will learn about the key players and decision-makers involved in the regulatory review and MA process in Canada, including Health Canada, the Canadian Agency for Drugs and Technologies in Health (CADTH). The course will also examine the US MA process and the healthcare setup for MA, including the role of the FDA and other stakeholders.
In addition, the course will address the Common Technical Document (CTD) and New Drug Submission (NDS) submission process, including the requirements and guidelines for submission. Students will gain an understanding of the importance of product labeling and the regulatory requirements for Product Monographs (PM) and other regulatory documents.
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 and have an applied understanding of the regulatory submission process.