FDA Regulatory and Compliance Symposium Features Special Sessions on Drug Safety and Risk Management
  • Managing Risks - From Pipeline to Patient
  • August 22 - 25, 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) -- APRIL 21, 2006: The Second FDA Regulatory and Compliance Symposium,, August 22 - 25, 2006, in Cambridge, MA announced today that it will feature special sessions on Drug Safety and Risk Management.


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

  • 8:00 am Overview of Drug Safety and Risk Management by Linda Horton, Esq., Partner, Hogan & Hartson, Former Director of International Policy, FDA, Brussels, Belgium and Geoffrey Levitt, Esq., Vice President and Chief Counsel, Regulatory and Research, Wyeth Pharmaceuticals, Collegeville, PA
  • 8:15 am Premarket Assessment of Drug Safety at the FDA by Paul Seligman, MD, Director of the Office of Pharmacoepidemiology and Statistical Science, CDER, FDA, Washington, DC
  • 9:00 am Where is EU Drug Safety Law Headed: Are Controls Tightening? By Linda Horton, Esq., Partner, Hogan & Hartson, Former Director of International Policy, FDA, Brussels, Belgium
  • 9:45 am Innovator Drug Development in a Pharmacovigilant Environment by Gregory Page, Ph.D., FDA Life Sciences Practice Leader, Life Science and Healthcare Regulatory Practice, Deloitte & Touche, Jericho, NY and George Serafin, Senior Manager, Life Science and Healthcare Regulatory Practice, Deloitte & Touche, Parsippany, NJ
  • 10:30 am FDA Oversight of Drug Safety: What Works, What Doesn't by Geoffrey Levitt, Esq., -Vice President and Chief Counsel, Regulatory and Research, Wyeth Pharmaceuticals, Collegeville, PA
  • 11:45 am Risk Management Strategy Through the Life Cycle of Pharma and Biotech Products by William Charles Lucas, Esq., Vice President and General Counsel, Therapeutic Areas Legal Lead, Pfizer and Former Vice President and General Counsel, Biotechnology Industry Organization (BIO), New York, NY; Stephen Paul Mahinka, Esq., Partner, Chair, Life Sciences Interdisciplinary Practice, Morgan, Lewis & Bockius LLP, Washington, DC; and James Pagliaro, Esq., Leader, Global Litigation and Product Liability Practices, Morgan, Lewis & Bockius LLP, Philadelphia, PA
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.


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