FDA Regulatory and Compliance Symposium Features Compliance and FDA Enforcement
  • Managing Risks - From Pipeline to Patient
  • August 24 - 26, 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 -- PHARMA UPDATE NEWS SERVICE(TM) -- JUNE 12, 2006: The Second FDA Regulatory and Compliance Symposium,, August 23 - 25, 2006, in Cambridge, MA announced today that it will feature special sessions on Compliance and FDA Enforcement.


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

  • 2:00 pm Overview of Compliance and FDA Enforcement by Marc Wilenzick, Esq., Senior Corporate Counsel, Pfizer, New York, NY (Co-chair)
  • 2:15 pm Beginning the Next 100 Years of FDA Regulation - There Have Been a Few Changes Since 1906 by Martin Browning, President and Co-Founder, EduQuest and Former Special Assistant to the Associate Commissioner for Regulatory Affairs, FDA, Hyattstown, MD
  • 3:00 pm The Policy and Regulatory Challenges of Authorized Generics by David Balto, Esq., Partner, Robins, Kaplan, Miller & Ciresi and Former Policy Director of the Bureau of Competition of the Federal Trade Commission, Washington, DC
  • 4:00 pm Regulation, Compliance, Culture or All of the Above by Gary Giampetruzzi, Esq., Senior Corporate Counsel, Government Investigation Section, Pfizer, Legal Division, New York, NY; Ann Bacon, Esq., Compliance Counsel, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT; Heather Powell, Esq., Compliance Counsel, Cephalon, Inc., West Chester, PA; and Adam Turteltaub, Corporate Relations Executive, LRN, Los Angeles, CA
  • 4:45 pm Compliance Panel Discussion: PDUFA and FDA Reform by Daniel Carpenter, Professor and Director of Graduate Studies, Department of Government, Harvard University, Cambridge, MA; Daniel Kracov, Esq., Partner, Co-Head, Pharmaceutical and Medical Device Practice, Arnold & Porter, Washington, DC; and Marc Wilenzick, Esq., Senior Corporate Counsel, Pfizer, New York, NY (Moderator)
  • 5:45 pm Role of Technology in Commercial Risk Management and Compliance by John McGrory, President and CEO, Edge Dynamics, Redwood City, CA
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