Introduction to Drug, Biologics, and Biosimilars Law and Regulation

The course will cover the administrative agencies impacting the drug, biologics, and biosimilars industries, clarify which Food and Drug Administration (FDA) center oversees regulation of particular products, and identify the areas of overlap between industries and product regulations. As one of the opening presentations, Deborah’s overview of FDA’s origins and regulatory processes will supply context for the forthcoming discussion of manufacturing issues, advertising and promotion, regulatory statutes, and enforcement.

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