Featured Conference

The 3rd Annual Off-Label Usage Conference
How to Increase Revenues, Comply with Regulations, and Avoid Penalties
September 20-21, 2004 • Philadelphia, PA

Visit the conference website for more information and to register.

Off-label usage of drugs and medical devices accounts for a large percentage of profits yet also presents a minefield of potential legal, regulatory, ethical, and financial problems. To make matters worse, the regulatory and legal landscape has become more varied and confusing in recent years as organizations such as the DOJ, the OIG, and more have become involved. Here’s a chance for you to learn everything you need to know about this difficult topic in one easy stop.

This conference addresses the following issues (and more):

  • Understanding and complying with the FDA on off-label issues
  • Knowing who regulates off-label issues other than the FDA—and what you need to comply with
  • Using your First Amendment Rights to communicate valuable information
  • Proactive steps to take to minimize your off-label risks and avoid costly penalties
  • Transforming off-label data into valuable on-label information
  • Training your sales force on off-label issues: What to do, and what not to do
  • Maximizing your Medicare and Medicaid reimbursements while avoid penalties

Be sure to attend one of the two pre-conference workshops:

          Workshop 1: Effective Interactions between Pharmaceutical Manufacturers and Healthcare Professionals: Minimizing Your Company’s Regulatory and Liability Risks                Reviews of previous off-label workshops led by Alan Minsk for Pharmaceutical Education Associates:

“Very animated and dynamic speaker…very informative, knew subject matter extremely well.” Angela Sidoti, Imovex

“Topic and content was relevant and met the audience needs. He is a greater presenter.” Jerri Anne Johnson, Abbott Labs

“Alan is a very energetic speaker and the topic was timely. Audience was fully engaged for entire workshop.” Nancy Coddington, AstraZeneca

“Added humor to OIG/PhRMA content. Kept it real and comprehensive.” Jackie Ruka, DiMedix

          Workshop 2 (NEW WORKSHOP ADDED FOR UNIQUE ISSUES OF MEDICAL DEVICE COMMUNITY): Off-Label and Medical Devices: Unique Aspects, Issues, and Concerns for the Medical Device Community

Plus learn from these special features

  • In-depth three-part presentation on CME issues related to off-label usage
  • Comprehensive two-part discussion from plaintiff lawyers: hear a unique perspective and learn from the mistakes of other!

Hear from the collected experience of our well-regarded, diverse faculty:

Joel M. Androphy, Attorney, Berg & Androphy
Peggy J. Berry, Director, Promotional Regulatory Affairs, AstraZeneca
Barbara R. Binis, Partner, Product Liability, Reed Smith, LLP
Thomas Blok, Medical Director, Medical Affairs, Pfizer
Paul Kaufman, Civil Health Care Fraud Coordinator, U.S. Attorney’s Office, E.D.N.Y.
Daniel A. Kracov, Partner, Patton Boggs, LLP
Erika Kelton, Partner, Phillips & Cohen, LLP
Robert J. Klepinski, Managing Partner and President, Klepinski & Duval, PA
Leonard Lescosky, Director of Regulatory Affairs, Solvay Pharmaceuticals
Michael Loucks, Assistant US Attorney, Department of Justice (invited)
Mark McAndrew, Wiley, Rein, & Fielding, LLP
William A. McGrath, Partner, Wiley, Rein, & Fielding LLP
Alan G. Minsk, Partner and Leader, Food and Drug Practice Team, Arnall Golden Gregory, LLP
Viveca Parker, Assistant US Attorney, Eastern District of Pennsylvania, Department of Justice
Harold Pellerite, Center for Devices and Radiological Health, FDA (invited)
Judith Ribble, Director, Continuing Medical Education, Medscape
Mark H. Schaffer, Vice President, Continuing Medical Education, Thomson Professional Postgraduate Services
Elaine Tompary, Regional Manager Medical Science Liaison, McNeil Consumer and Specialty Pharmaceutical
Visit the conference website for more information and to register.

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