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Foundations in U.S. FDA Regulations of Drugs & Biologics and Regulatory Submissions | REGL.X409
New to the industry? Or maybe you need a basic understanding of the U.S. FD&C Act and U.S.
FDA regulations related to biopharmaceutical product development and approval?
Are you seeking a career in regulatory affairs? Maybe you just want some practical regulatory
advice for working in the industry? This course will give you basic information on the
regulatory environment in the biopharmaceutics industry and answer your questions: how
to work in a regulated environment, what are the roles available to you, and what are the key
foundational aspects of regulatory affairs. This course will also help you gain an understanding of the basics of the biopharmaceutical development process. Live discussions,
class group exercises, etc. will be used to help you in navigating through the basics US FDA
regulations related to biopharmaceutics development and approval. You will learn about the
differences between the various types of human therapeutics, including the various
regulatory development options utilized in the industry.
Learning Outcomes:
At the end of the course, students should be able to
- Discuss FDA’s jurisdiction and the reason for food, drug, and cosmetic laws
- Define the various regulatory pathways available for biopharmaceutical products
- Understand individual roles/responsibilities and how the biopharmaceutical industry works in general
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