Examine the laws, regulations, and regulatory agencies governing Pharmaceuticals, Devices, Biologics, and Combination Products marketed in the US. Examine the historical context in which the FDA evolved, its structure, and its relationship with other US regulatory agencies. Study the regulatory pathways for drugs, biologics, medical devices, and combination products as well as specific regulatory programs run by the US Food and Drug Administration.
Testimonials
"MBS has a great combination of classes like Regulatory Affairs where one can learn everything about how to file for a new drug application to the FDA process as well as learn about how to manage multiple projects through project management classes. I think this course has very well prepared me for the future challenges and gave me a hope to reach for the stars!" (Mansi Bengali, Biotechnology and Genomics, MBS'14)