The Medical Device Regulatory and Compliance Congress Off-Label Promotion and Fraud and Abuse Track
  • Benchmarking Your Firm's Practices in Risk Management, Quality Systems, Fraud and Abuse, and Reimbursement
  • Classes Held in Harvard University's Annenberg Hall and Harvard Faculty Club
  • Congress Hotels: The Inn at Harvard and Harvard Square Hotel, Cambridge, MA
  • March 29 - 31, 2006
Phone: 800-684-4549

CAMBRIDGE, MA USA -- PHARMA UPDATE NEWS SERVICE(TM) -- JANUARY 26, 2006: The First Annual Medical Device Regulatory and Compliance Congress (Device Congress),, held on the campus of Harvard University March 29 - 31, 2006, will feature a special Off-Label Promotion and Fraud and Abuse Track. The Device Congress is sponsored by AdvaMed, Compliance-Alliance, Harvard Health Policy Review, Health Affairs, Medical Education Collaborative and a variety of leading publications.

Arthur Miller, Esq.
Bruce Bromley Professor of Law
Harvard Law School
Cambridge, MA

"It is my pleasure to welcome attendees of the Medical Device Congress to the campus of Harvard University. I hope that you will take advantage of this unique experience to study key Medical Device Regulatory and Compliance issues."

Medical Devices: Off-Label Promotion and Fraud and Abuse Track
March 30, 2006
Morning Session
Moderator: Robert Kelpinsk, of Counsel, Fredrikson & Byron, Former Sr Regulatory Counsel, Medtronic
8:30 a.m. Balancing the Public's Right to Know with the Government's Obligation to Protect Patients
What are the First Amendment concerns with the government effort to regulate advertising and promotion of medical devices? What is the proper role of the FDA and the Department of Justice?

  • Richard A. Samp, Esq., Chief Counsel, Washington Legal Foundation
9:15 a.m. Setting Promotional Strategy and Tactics after the Rebirth of the First Amendment
How do you assimilate the recent First Amendment court cases and FDA policy? What is FDA doing in reaction to the new world and how does it affect your submissions and ad campaigns?

  • Robert J. Klepinski, Esq., of Counsel, Fredrikson & Byron, Former Sr Regulatory Counsel, Medtronic
10:00 a.m. Break
10:30 a.m. How to Implement a System for Review of Product Promotion
What are key elements of a product review system? How do you get employees to adhere to the requirements?

  • Judith E. O'Grady, RN, MSN, Sr VP, Regulatory, Quality and Clinical Affairs, Integra Lifesciences
11:15 a.m. FDA's Recent Untitled Letters for Off-Label Promotion
What are some recent letters? How should companies respond to FDA when they get an untitled letter?

  • Stephen Terman, Esq. Partner, Olsson Frank and Weeda
Noon Lunch

Afternoon Session
Moderator: Peter Claude, Partner PricewaterhouseCoopers, LLP
1:30 p.m. Medical Device Prosecutions: Parallels between the 1990 Bard Prosecution and the 2005 Serono Prosecutions
What mistakes did the companies make? Steps firms can take to avoid those mistakes in the future.

  • Michael Loucks, Esq., First Assistant US Attorney, US Attorney's Office
2:15 p.m. The Top Ten Sales and Marketing Risk Areas
What are they now? What are they expected to be? What can you do to reduce your risk?

  • William T. Fitzgerald, Esq., Director, Global Compliance, Alcon Laboratories, Inc.
  • John Bentivoglio, Esq., Partner, King and Spalding, Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Dept of Justice
3:00 p.m. Break
3:30 p.m. Report on Industry Compliance Better Practices
PricewaterhouseCoopers will report on the results of its analysis of industry better practices around sales and marketing compliance requirements of the AdvaMed Code and selected safety reporting practices.

  • Peter Claude, Partner, PricewaterhouseCoopers LLP
  • Brian Riewerts, Senior Partner, Global Pharmaceutical Advisory Services Group, PricewaterhouseCoopers LLP
  • John Bentivoglio, Esq., Partner, King and Spalding, Former Special Counsel for Healthcare Fraud, and Chief Privacy Officer, US Dept of Justice
4:15 p.m. Model Programs: An Overview of Leading Medical Device Compliance Programs
What are the key elements? How do you get buy-in?

  • Catherine A. Sazdanoff, Divisional VP, Ethics & Compliance, Abbott Laboratories
5:00 p.m. Ask the Experts: Audience is invited to pose questions to leading medical device compliance professionals
5:30 p.m. Adjournment and Networking Reception

For sponsorship and exhibit information contact Joni Lipson, Exhibit Manager, 215-599-6626 phone, 215-545-8107 fax, or at


Register online at, call 800-684-4549, email:

Device Congress Office
7790 Barberry Ave.
Yucca Valley CA USA 92284