The A to Z of Off Label Issues

March 30, 2010 — The Gaylord National, Washington, DC

Overview |  Agenda |  Speakers |  Logistics |  Fees

Overview

Navigating the gray area of off-label issues is a challenge for the most conscientious medical product manufacturers. How and when can one appropriately provide information to health care professionals exercising the practice of medicine without overstepping the bounds of approved indications? This seminar, featuring prominent attorneys and speakers from industry and government, deals with regulatory, reimbursement, product liability, and legal compliance issues, and offers a forum for discussion of the interdisciplinary challenges that confront many different parts of a company.

Agenda

Click here to Download.

Speakers

Thomas Crane, Partner, Mintz Levin & Program Chair
Deb Wolf, Associate Director for Regulatory Guidance Government Affairs, CDRH, FDA
Virginia Gibson, First Assistant U.S. Attorney, Eastern District of Pennsylvania
Thomas Sullivan, Partner, Morgan Lewis
Coleen Klasmeier, Partner, Sidley Austin

Elizabeth Jungman, Associate,Covington & Burling
Edward Wilson, Partner, Hogan & Hartson
Hank Walther, Assistant Chief, Fraud Section, Criminal Section, U.S. Department of Justice
Sue Seferian, Health Care Compliance Officer, Johnson & Johnson Pharmaceutical, Research & Development, LLC
Retta Riordan, President, Riordan Consulting, LLC

Hotel & Meeting Logistics

The Gaylord National Resort & Convention Center
201 Waterfront Street
National Harbor, MD 20745
301-965-2000 (reservations)

A limited number of rooms have been reserved at this hotel for seminar participants, at the reduced rate of $209. Please make your reservations by contacting the hotel at 301-965-2000 and identifying yourself as a member of the Advanced Medical Technology Association "Off Label" group  X-ADVA0. This rate will be available until March 12, 2010. Room and rates are subject to availability after this date. Please make your reservations early as the block will fill up quickly.

Registration Fees



Please contact skinchen@advamed.org for Group Discounts (Discount does not apply to AdvaMed Accel, Government, or Non-Profit Organizations)