Thomas W. Abrams, RPh, MBA Director, Division of Drug Marketing, Advertising, and Communications, CDER, FDA, Washington, DC
Peter B. Bach, MD, MAPP Senior Advisor, Office of the Administrator, Centers for Medicare & Medicaid Services, Washington, DC
Sheldon Bradshaw, Esq. Chief Counsel, FDA, Washington, DC
Igor Cerny, Pharm.D. Director, Advisors and Consultants Staff, Office of Executive Programs, Center for Drug Evaluation and Research, FDA, Washington, DC
Jon E. Clark Associate Director for Policy Development and GMP, Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Washington, DC
Richard Cooper, JD Partner, Williams & Connolly, LLP, Former Chief Counsel, Office of the General Counsel, FDA, Washington, DC
Scott Gottlieb, MD Deputy Commissioner for Medical and Scientific Affairs, Office of the Commissioner, FDA, Washington, DC
David J. Horowitz, Esq. Deputy Associate Commissioner for Compliance Policy, Office of Regulatory Affairs, FDA, Washington, DC
CAPT Paul J. Seligman, MD, MPH Associate Director for Safety Policy and Communication, Center for Drug Evaluation and Research, FDA, Silver Spring, MD
James Sheehan, Esq. Associate United States Attorney, U.S. Attorney's Office for the Eastern District of Pennsylvania, Philadelphia, PA
Daniel Troy, Esq. Partner, Sidley Austin Brown & Wood, Former Chief Counsel, Office of the General Counsel, FDA, Washington, DC

Rarely have there been so many major changes and uncertainties with such far-reaching consequences to drug development, manufacturing, monitoring and marketing. And rarely has there been a greater need to bring together representatives and advisors from government and the world's leading drugmakers to share strategies for regaining consumer confidence in today's medicines.

The FDA Regulatory and Compliance Symposium-a unique three-day, high-level forum in one of the world's most famous academic settings-will help drugmakers prepare for the full impact of all the changes flowing from the FDA and Congress, while clarifying many of the uncertainties. The Symposium will also provide practical, state-of-the-art solutions to the challenges of eliminating or reducing risks throughout the product life-cycle-from the drug pipeline to manufacturing to patient delivery.

The Symposium takes place on the campus of Harvard University. Classes are held in Annenberg Hall of the Sanders Theatre Complex. Inspired by the great halls of Oxford and Cambridge Universities, this room is arguably the most impressive space at Harvard. Harvard University, the oldest institution of higher learning in the United States, was established in 1636. Today, Harvard has grown to become a great undergraduate and graduate research university.

KEYNOTE SPEAKERS:

Jane E. Henney, MD Senior Vice President and Provost for Health Affairs, University of Cincinnati Academic Health Center; Former Commissioner, FDA, Cincinnati, OH
Philip J. Hilts Former Science Reporter, The New York Times and The Washington Post; Lecturer, Department of Journalism, Boston University; Author, Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation and RX for Survival: Why We Must Rise to the Global Health Challenge; Winner, 2004 Los Angeles Times Book Prize for Science and Technology and The New York Times Notable Book of the Year distinction, Brookline, MA
John F. Kamp, J.D., Ph.D. Executive Director, Coalition for Healthcare Communication; Of Counsel, Wiley Rein & Fielding LLP, Washington, DC
Wayne L. Pines President, Regulatory Services and Healthcare, APCO Worldwide; Former Associate Commissioner for Public Affairs, FDA, Washington, DC
Peter J. Pitts President, Center for Medicines in the Public Interest; Senior Vice President for Global Health Affairs, Manning, Selvage & Lee; Former Associate Commissioner for External Relations, FDA, New York, NY
Eric J. Topol, MD Professor, Department of Genetics, Case Western Reserve University, Cleveland, OH

Arthur Miller, Esq. Bruce Bromley Professor of Law Harvard Law School Cambridge, MA "It is my pleasure to welcome attendees of the FDA Symposium to the campus of Harvard University. I hope that you will take advantage of this unique experience to study key Food and Drug Administration regulatory and compliance issues in this extraordinary academic environment."

SPONSORED BY:
EXHIBIT & SPONSORSHIP INFORMATION:

J.T. Hroncich 300 N. Washington St., Suite 200 Falls Church, VA 22046 Phone: (703) 538-7643 Fax: (703) 538-7007 E-mail: jhroncich@fdanews.com

Joni Lipson 100 North 20th Street, 4th Floor Philadelphia, PA 19103 Phone: (800) 546-3750 Fax: (215) 545-8107 E-mail: joni.lipson@rmpinc.com

REGISTRATION INFORMATION:

For further registration information, go to www.fdasymposium.com/registration.html, call 800-684-4549, email registration@hcconferences.com or write:

FDA Symposium Office
7790 Barberry Ave.
Yucca Valley CA USA 92284