To take advantage of the early bird discount for the Second FDA Regulatory and Compliance Symposium at Harvard University, go to www.fdasymposium.com/registration.html, call 800-684-4549, email registration@hcconferences.com.

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."

Rarely has the life science industry been met with 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 drug makers 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 drug makers prepare for the full impact of the many changes flowing from the FDA and Congress, while clarifying many of the uncertainties. The Symposium will also provide practical solutions to the challenges and risks faced throughout the product life cycle - from the drug pipeline to manufacturing to patient delivery.

Choose from multiple tracks! On Day 2 of the Symposium, select the tracks that best meet your needs. Each one features a powerful line up of industry experts, thought leaders and policymakers. Choose from three morning tracks: Drug Safety and Risk Management; Advertising, Promotion and Compliance; or Where the FDA and CMS Meet. Choose from two afternoon tracks: Drug and Device Development and Clinical Trials, or Compliance and FDA Enforcement.

GOVERNMENT KEYNOTE SPEAKERS: 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 T. 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 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

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 Daniel E. Troy, Esq. Partner, Sidley Austin Brown & Wood; Former Chief Counsel, Office of the General Counsel, FDA, Washington, DC