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.

Skills Needed

• To be successful in this class all students should have working knowledge of Google’s G Suite or Microsoft Office, proper email etiquette, and essential understanding of Canvas.

Learning Outcomes

At the conclusion of the course, you 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

Topics Include

• Working in a Regulated Environment
• Overview of the Food Drug & Cosmetics Act and the Code of Federal Regulations
• Understanding FDA and ICH Guidance Documents
• Overview of the Biopharmaceutical Process

Notes