FDLI's Introduction to Drug Law & Regulation - Understanding How FDA Regulates the Drug Industry

November 20 - 21, 2008 • Washington, DC

This program can help you and your organization stay in compliance with FDA regulations and help minimize regulatory problems. Learn how the drug industry is being impacted by the enactment of the Food and Drug Administration Amendments Act of 2007 (FDAA Act). From the definition of “drug” to the different regulatory schemes for over-the-counter (OTC) and prescription (Rx) drugs, this meeting walks you through the major statutory provisions and regulations, and helps you develop a clearer understanding of how they work. You will receive a broad overview of FDA, the history of drug regulation, and details on specific areas of drug regulation. Additionally, you will examine FDA’s role in managing the drug approval process and how that process governs competition between branded and generic drugs. This program will help you think like an experienced drug professional. You will become more familiar with many of the acronyms used in the drug arena, such as, ANDA, IND, NDA, PDUFA and others. Further, you will gain a clearer understanding of how FDA enforces and implements the laws handed down by Congress. You will learn how all of these provisions and regulations affect what you do every day. This program will also cover the latest topics and important new developments affecting the drug industry, including prescription drug imports, risk management, OTC switches, Hatch-Waxman reform, and more.

Cathy Burgess is one of the speakers at this event. She is a co-presenter for multiple sessions, including sessions addressing "Regulation of Drug Manufacturing," "When FDA Knocks: How to Handle a CGMP Inspection," and "Import/Export Requirements and International Issues."