FDA Regulatory and Compliance Symposium Features Drug and Device Development and Clinical Trials
  • Managing Risks - From Pipeline to Patient
  • August 22 - 25, 2006
  • Classes Held in Harvard University's Annenberg Hall and Sanders Theatre, Cambridge, MA
  • Symposium Hotel: The Charles Hotel, Cambridge, MA
Phone: 800-684-4549

CAMBRIDGE, MA USA -- HEALTHCARE UPDATE NEWS SERVICE(TM) -- JUNE 2, 2006: The Second FDA Regulatory and Compliance Symposium,, August 23 - 25, 2006, in Cambridge, MA announced today that it will feature special sessions on Drug and Device Development and Clinical Trials.


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

  • 2:00 pm Overview of Drug and Device Development and Clinical Trials by David Ceryak, Esq., Associate General Counsel, Eli Lilly and Company, Indianapolis, IN (Co-chair)
  • 2:15 pm A Cross-functional Perspective of Key Issues Facing New Product Introductions by Claudio Pincus, President, The Quantic Group, Livingston, NJ and R. Owen Richards, President, Quantic Regulatory Services, Livingston, NJ
  • 3:00 pm Climbing the Ivory Tower: Special Challenges for Sponsors of Clinical Trials at Academic Sites by Greg Koski, Ph.D., MD, CPI Associate Professor of Anesthesia, Senior Scientist, Institute for Health Policy, Massachusetts General Hospital, Partners Health Care System, Harvard Medical School and Former Director, Office for Human Research Protections, Office of Public Health and Science, Office of the Secretary, HHS, Boston, MA
  • 4:15 pm Risk Management Through Electronic Enforcement by Joseph Vinhais, RAC, Vice President of Regulatory Compliance, Brooks Software, Chelmsford, MA
  • 5:00 pm Deciphering Section 505(b)(2) and Its Implications for Product Life Cycles and Regulatory Strategies by David Ceryak, Esq., Associate General Counsel, Eli, Lilly and Company, Indianapolis, IN; Jeffrey Chasnow, Esq., Senior Corporate Counsel, Pfizer, New York, NY; and James Czaban, Esq., Shareholder, Heller Ehrman, LLP, Washington, DC
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
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

Lester M. Crawford, DVM, Ph.D.
Senior Counsel, Policy Directions Inc.; Former Commissioner, FDA, 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