Events
Duane Morris Partner Frederick R. Ball to Speak at the Food and Drug Law Institute's Introduction to Drug Law and Regulation Conference
November 8, 2010 | Washington, D.C.
| Park Hyatt Washington
Duane Morris partner Frederick R. Ball will be speaking at the Food and Drug Law Institute (FDLI) Introduction to Drug Law and Regulation Conference, to be held on November 8-9, 2010, in Washington, D.C. The conference theme is "Understanding How the Government Regulates the Drug Industry."
About the Program
This is the premier course to help you and your organization stay in compliance with FDA regulations and help minimize regulatory problems. By attending this two-day program, you will learn the essential elements of the laws and regulations that affect you in the drug industry. 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. Furthermore, you will learn how the FDA enforces and implements the laws handed down by Congress. You will learn how all of these provisions and regulations affect what you do each 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.
Who Should Attend
You should attend this program if you're in regulatory affairs, from the legal community or from a federal or state agency, and need an overview on drug law and regulation. It also is a good refresher program for seasoned regulatory affairs and legal professionals. This meeting will promote an informal, classroom atmosphere where dialogue and questions will be encouraged. FDLI suggests that attendees dress comfortably, i.e., "casual business attire."
For more information or to register to attend the conference, please visit the FDLI website.
