April 22-23 Meeting Covers Gamut of Food and Drug Legal, Regulatory & Policy Issues

WASHINGTON, March 12 /PRNewswire-USNewswire/ -- Margaret Hamburg, Commissioner, Food and Drugs, will address the 2010 Food and Drug Law Institute's Annual Conference April 22 at the Hilton Washington Hotel in Washington, DC.

The FDLI meeting is the largest and longest-running conference for stakeholders interested in law, regulation and policy in the food and medical products area, including government officials; practicing attorneys; food, pharmaceutical, device, biologics, dietary supplement, veterinary medicine, tobacco and cosmetic manufacturers; academics; and consultants.

"By bringing together experts from regulated industry, FDA and Congress, FDLI's Annual Conference provides a valuable educational opportunity and a central venue to discuss and debate emerging issues, as well as to continue the dialogue about issues, some of which have been debated and not resolved for the past 100 years," said FDLI President and CEO Susan C. Winckler.

In addition to Hamburg's address, attendees will hear major presentations April 22 from many other senior FDA leaders, including Ralph Tyler, FDA's Chief Counsel; Michael Chappell, FDA's Associate Commissioner for Regulatory Affairs (Acting), and the following officials:

> Karen Midthun, Director (Acting), Center for Biologics Evaluation and Research (CBER);

> Janet Woodcock, Director, Center for Drug Evaluation and Research (CDER);

> Jeffrey Shuren, Director, Center for Devices and Radiological Health (CDRH);

> Stephen Sundlof, Director, Center for Food Safety and Applied Nutrition (CFSAN); and

> Tracey Forfa, Executive Director, Center for Veterinary Medicine (CVM).

In addition, the Annual Conference features breakout sessions on significant cutting-edge issues in food and drug law, regulations and policy, including:

> Personalized Medicine: FDA has struggled for years with how to approach co-development of therapeutics and diagnostics, which tailor treatment to an individual's genetic profile. With several leading biopharmaceutical firms pursuing such co-development, discussions regarding the expected regulatory pathway are even more important.

> Bisophenol A (BPA) and Food Additives: Speakers will discuss the emerging science on BPA and how U.S. and European governmental agencies regulate, and plan to regulate, in this area.

> Monoclonal Antibodies (MAbs): Presentations during this session will provide both FDA and industry perspectives on the unique aspects of developing MAbs for clinical use.

To view the complete program, visit www.fdli.org/conf/annual/10.

To register for the conference, including Early Bird discounts (until March 22), visit www.fdli.org/conf/annual/10 or call (202) 371-1420.

Media: For more information, contact Michael Levin-Epstein, Editor-in-Chief, FDLI, (202) 222-0897; e-mail: mdl@fdli.org

Since 1949, FDLI has provided high-quality education and conferences, valuable publications and a neutral forum for discussion of important issues in the food and drug law arena.

SOURCE Food and Drug Law Institute

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