Introduction to US FDA and European Laws and Regulations

Catalog description

This course will provide students with broad general competencies in regulatory affairs for all US FDA regulated product classes (drugs, biologics, and devices) throughout the product lifecycle (pre-clinical development, clinical development, and post marketing). Emphasis will be placed on regulatory interactions, submissions, other communications and inspections, for each product class and for each phase of the product lifecycle. European regulations will also be reviewed. This course is designed to provide a broad overview of the United States regulatory system, with some European Union structure and regulation highlights. Students will gain a basic understanding of how the FDA regulates the approval of various products and how this has changed over time, as well as the necessary inputs companies must be aware of when applying for regulatory approvals in the USA.