Introduction to Regulatory Affairs and Compliance for Drugs, Biologics, and Medical Devices

A required course in the Regulatory Affairs & Compliance for Medical Devices and Regulatory Affairs & Compliance for Pharmaceuticals Certificate Programs.

This course presents an introduction to the field of regulatory affairs and to the laws and regulations governing healthcare products, including drugs, biologics, dietary supplements, and medical devices. Individuals from various disciplines who are new to the field of regulatory affairs will explore the regulatory pathways for each of these medical products and learn how to maintain regulatory compliance with U.S. regulations throughout the product lifecycle. Examine the structure of the FDA and the historical context of current FDA regulations governing healthcare products. Appreciate the complexities of global regulatory affairs through an introduction to the regulatory structure in the European Union. This course provides an introduction to the regulatory affairs profession and provides a framework for subsequent courses in the Regulatory Affairs and Compliance Certificate Program.

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