FDA Deputy Commissioner Scott Gottlieb, MD, Former FDA Commissioner Jane Henney, MD, Former FDA Chief Counsel Dan Troy and Associate US Attorney Jim Sheehan to Keynote the 2006 FDA Regulatory and Compliance Symposium
  • Managing Risks - From Pipeline to Patient
  • August 24 - 26, 2006
  • Classes Held in Harvard University's Annenberg Hall and Sanders Theatre, Cambridge, MA
  • Symposium Hotels: The Charles Hotel, Cambridge, MA
Phone: 800-684-4549

CAMBRIDGE, MA USA -- PHARMA UPDATE NEWS SERVICE(TM) -- MARCH 9, 2006: The Second FDA Regulatory and Compliance Symposium,, August 23 - 25, 2006, in Cambridge, MA announced today its keynote faculty to date.

Thomas W. Abrams, RPh, MBA
Director, Division of Drug Marketing, Advertising, and Communications, Food and Drug Administration, Washington, DC
Sheldon T. Bradshaw, Esq.
Chief Counsel, Food and Drug Administration, Washington, DC
Scott Gottlieb, MD
Deputy Commissioner for Medical and Scientific Affairs, Office of the Commissioner, Food and Drug Administration, Washington, DC
David J. Horowitz, Esq.
Director , Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, Washington, DC
Paul Seligman, MD
Director of the Office of Pharmacoepidemiology and Statistical Sciences, Center for Drug Research and Evaluation, Food and Drug Administration, Washington, DC
James Sheehan, Esq.
Associate United States Attorney, U.S. Attorney's Office for the Eastern District of Pennsylvania, Philadelphia, PA

Lester M. Crawford, DVM, Ph.D.
Senior Counsel, Policy Directions Inc., Former Commissioner, Food and Drug Administration, Washington, DC
Jane E. Henney, MD
Senior Vice President and Provost for Health Affairs, University of Cincinnati Medical Center, and Former Commissioner of Food and Drugs, Food and Drug Administration, Cincinnati, OH
Philip J. Hilts
Lecturer, Deparment 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 New York Times Notable Book of the Year , Boston, MA
John F. Kamp, J.D., Ph.D.
Of Counsel, Wiley Rein & Fielding, Executive Director, Coalition for Healthcare Communication, Washington, DC
Wayne L. Pines
President, Regulatory Services and Healthcare, APCO Worldwide, Former Deputy Commissioner for Communications, Food and Drug Administration, Washington, DC
Peter J. Pitts
Senior Vice President, Director of Health Affairs, Manning, Selvage and Lee, President, Center for Medicines in the Public Interest and Former Associate Commissioner for External Relations, Food and Drug Administration, New York, NY
Eric J. Topol, MD
Professor of Genetics, Case Western Reserve University School of Medicine, Cleveland, OH
Daniel E. Troy, Esq.
Partner, Sidley Austin Brown & Wood, Former Chief Counsel, Office of the General Counsel, Food and Drug Administration, 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.


J.T. Hroncich
300 N. Washington St., Suite 200
Falls Church, VA 22046
Phone: (703) 538-7643
Fax: (703) 538-7007
Joni Lipson
100 North 20th Street, 4th Floor
Philadelphia, PA 19103
Phone: (800) 546-3750
Fax: (215) 545-8107


For further registration information, go to, call 800-684-4549, email or write:

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