US Regulatory Strategy for Biologics & Pharmaceutical Drugs

US Regulatory Strategy for Biologics & Pharmaceutical Drugs

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.

Learn how to navigate the US FDA regulations for getting your drug from bench to bedside.

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What you will 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

Rating: 4.85

Level: All Levels

Duration: 3 hours

Instructor: Brandon Too