This introductory program provides a comprehensive overview of the laws and Food and Drug Administration regulations affecting the drug industry, and will help you and your organization get products approved and navigate regulatory problems. Experts will review the essential elements of FDA drug regulation in a systematic and comprehensive way. From the definition of “drug” to the different regulatory schemes for over-the-counter (OTC) and prescription (Rx) drugs, speakers walk you through key regulations and policies and will help you determine how those regulations and policies are applied. You will receive a broad overview of the FDA regulatory structure, the history of drug regulation, detail on specific areas such as the approval process, and gain an understanding of how FDA enforces and implements the laws passed by Congress. This program will also cover the latest topics and important new developments affecting the drug industry, such as the Food and Drug Administration Safety and Innovation Act, risk management, Rx to OTC switches, regulation of marketing and current Good Manufacturing Practice requirements, enforcement and much more. At the end of this two day program, you will begin to think like an experienced drug law professional.