[ Event ]
Duane Morris Partner Frederick R. Ball to Speak at Food and Drug Law Institute Conference
June 26, 2008 | Washington, D.C.
| L'Enfant Plaza Hotel
Duane Morris Partner Frederick R. Ball will speak at the Food and Drug Law Institute's "Introduction to Drug Law and Regulation" conference, to be held on June 26-27, 2008, at the L'Enfant Plaza Hotel in Washington, D.C.
About the Program
Program Description
With the recent enactment of the Food and Drug Administration Amendments Act of 2007 (FDAA Act), learn how the drug industry is being impacted by this legislation. This program can 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. Further, you will gain a better 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.
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.
For more information or to register online, please visit the FDLI website.