Featured Conference

4th Annual Conference on Off-Label Usage
Legal Scrutiny, Reimbursement and Legitimate Practices
September 26 – 27, 2005 * Park Hyatt Hotel, Philadelphia, PA

Visit the conference website for more information and to register.

Why Attend This Conference:

  • Distinguish lawful off-label communication from illegal off-label promotion
  • Hear updates from key enforcers on the latest off-label cases, including whistleblower, unfair competition, and false advertising.
  • Identify helpful ways to reduce your companyÂ’s legal exposure
  • Hear the latest on reimbursement issues for off-label uses including Medicare Part D
  • Discover how- and when- to turn off-label data into on-label information
  • Investigate clinical trials disclosure and off-label dissemination

Conference Highlights:

  • Featured presentations by the Director of FDA CDRH Office of Compliance, the US AttorneyÂ’s Office, the Chief of Healthcare and Fraud Unit, and more!
  • Parallel tracks on Medical Devices and Pharmaceutical Industry explore all relevant concerns
  • Exclusive Post Conference Workshop:
    CME and the OIG –
    Continuing Medical Education and Off-Label Issues: Complying with the Office of the Inspector GeneralÂ’s New Guidelines

Hear from Our Distinguished Faculty:

Peggy Berry, ASTRAZENECA
Timothy Ulatowski, FDA CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
Monica Schultz, REGULATORY AND CLINICAL RESEARCH INSTITUTE
Dr. Steven Brotman, WYETH PHARMACEUTICALS
Kevin “Kip” Piper, HEALTH RESULTS GROUP LLC
Michael Loucks, FIRST ASSISTANT U.S. ATTORNEY, DISTRICT OF MASSACHUSETTS
Susan Winkler, CHIEF OF HEALTH CARE FRAUD UNIT US ATTORNEYÂ’S OFFICE, BOSTON, MASSACHUSETTS
Viveca Parker, US ATTORNEYÂ’S OFFICE, EASTERN DISTRICT OF PENNSYLVANIA
Daniel Kracov, PATTON BOGGS LLP
Laurence Freedman, PATTON BOGGS LLP
Erika Kelton, PHILLIPS & COHEN LLP
Thomas Muldoon TAKEDA PHARMACEUTICAL
Mark McAndrew, WILEY, REIN&FIELDING LLP
Mark Schaffer, THOMSON HEALTHCARE
Maureen Doyle-Scharff, ABBOTT LABS, ROSS PRODUCTS DIVISION

What attendees have said about past Off-Label Usage Conferences:

“A variety of perspectives offered in a complete, informative, detailed program.”

“The speakers kept the audience enthralled with details of specific legal cases as seen from opposing perspectives.”

“Good discussions and a lot of well presented, new information.”

For more information and to register, please visit the website.

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