BREG 5000
Introduction to US FDA and European Laws and Regulations

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.

Biocon Academy students only