US Regulatory Strategy for Biologics & Pharmaceutical Drugs

Course details

Understanding, navigating, and complying with the United States Food & Drug Administration (FDA)'s regulations is vital to translating medical discoveries from "bench to bedside". In this course, we will explore why regulations are important for public health, how to navigate through the FDA regulations to market a biologic or pharmaceutical, and practice developing a regulatory strategy.

At the end of this course, we will understand the drug development process and learn the key regulatory steps toward FDA approval. With this knowledge, we will also develop our ability to conduct regulatory intelligence and develop a regulatory strategic plan.

Scientists, physicians, entrepreneurs, public health professionals, industry analysts, consultants, and biomedical students interested in the biotechnology and pharmaceutical industry may find this course valuable.