US Regulatory Strategy for Biologics & Pharmaceutical Drugs
- 4.6
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Brief Introduction
Learn how to navigate the US FDA regulations for getting your drug from bench to bedside.Description
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.
Requirements
- Requirements
- A background in medical science and/or the biopharmaceutical industry is helpful but not required.
- A curiosity in understanding how the drug development process works.
Brandon Too
4.6 Raiting
US Regulatory Strategy for Biologics & Pharmaceutical Drugs
- 4.6
-
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Learn how to navigate the US FDA regulations for getting your drug from bench to bedside....
