On Thursday, Aug. 24, 2006, the FDA Symposium will feature the following sessions:

• 8:00 am Overview of Managing Risks in Pharmacovigilance by John Kamp, JD, Ph.D., Executive Director, Coalition for Healthcare Communication and Of Counsel, Wiley Rein & Fielding LLP (Co-chair) and Wayne Pines, President, Regulatory Services and Healthcare, APCO Worldwide and Former Associate Commissioner for Public Affairs, FDA, Washington, DC (Co-chair)
• 8:15 am Moving from DTC to DTC Squared: Direct-to-Patient Communications in the 21st Century by Peter Pitts, President, Center for Medicines in the Public Interest, Senior Vice President for Global Health Affairs, Manning, Selvage & Lee and Former Associate Commissioner for External Relations, FDA, New York, NY
• 9:00 am Meeting the Latest FDA and OIG/DOJ Marketing Rules by Wayne Pines, President, Regulatory Services and Healthcare, APCO Worldwide and Former Associate Commissioner for Public Affairs, FDA, Washington, DC
• 9:45 am Pharma Funding, Fraud and the First Amendment: A Critical View of Recent Federal Enforcement Actions by John Kamp, JD, Ph.D., Executive Director, Coalition for Healthcare Communication and Of Counsel, Wiley Rein & Fielding LLP, Washington, DC
• 11:00 am Innovative Models of Compliance Education: The 'Intellinex' Case Study by Jeffrey Lenow, MD, JD, FAAFP, Associate Professor, Department of Family and Community Medicine, Jefferson Medical College of Thomas Jefferson University and EVP, Chief Medical Officer, CardinalHealth, Medford, NJ
• 11:45 am The Most Important Element to Assure That Your Sales and Marketing Compliance Program Is Working Effectively by Kelly Freeman, Ph.D., Director, Compliance and Ethics, Eli Lilly and Company, Indianapolis, IN

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
Scott Gottlieb, MD Deputy Commissioner for Medical and Scientific Affairs, Office of the Commissioner, FDA, Washington, DC
Paul Seligman, MD Director of the Office of Pharmacoepidemiology and Statistical Science, CDER, FDA, Washington, DC
James Sheehan, Esq. Associate United States Attorney, U.S. Attorney's Office for the Eastern District of Pennsylvania, Philadelphia, PA
David J. Horowitz, Esq. Deputy Associate Commissioner for Compliance Policy, Office of Regulatory Affairs, FDA, Washington, DC

Lester M. Crawford, DVM, Ph.D. Senior Counsel, Policy Directions Inc.; Former Commissioner, FDA, Washington, DC
James C. Greenwood President and Chief Executive Officer, Biotechnology Industry Organization (BIO); Former Representative (R-Pa), U.S. House of Representatives, Washington, DC
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

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 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.

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