US Regulatory Strategy for Biologics & Pharmaceutical Drugs
What you’ll learn
Navigate through the US FDA regulations for drug research and development
Conduct primary and secondary research to develop a regulatory strategy
Understand the role of a Regulatory Affairs professional in drug development
This course includes:
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.
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.
Who this course is for:
- Scientists, physicians, and life science entrepreneurs who want to bring a biologic or drug to the US market
- Regulatory Affairs professionals who want to improve their US regulatory knowledge for biopharmaceuticals
- Biopharmaceutical industry analysts and consultants who want to better understand drug development for investment and business purposes
- Students interested in a regulatory affairs career in the biopharmaceutical industry