The A to Z of Off Label Issues

Tuesday, March 30, 2010

Washington, DC | The Gaylord National


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.

Click here for the Full Agenda


Who Should Attend

Compliance officers, legal counsel, reimbursement specialists and sales & marketing managers

 


Registration
AdvaMed Member $1,195.00 Register Now
Non-Member $1,595.00
AdvaMed EGCC Member $895.00
Government $395.00

Agenda Overview
View Full Agenda
FDA’s Regulation of Off-Label Medical Devices
CMS Reimbursement for Unapproved Devices and Off-Label Use
Fraud and Abuse Issues in Off-Label Marketing
How to Create an Effective Off-Label Compliance Program
Good Reprint Practices
Product Liability and Off-Label Use
Product Liability and Off-Label Use

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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

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General Information

It is the responsibility of the registrant to verify their company’s active membership status prior to registering.  You may check if your company is an active member by clicking here.  There will be no adjustments or refunds made for registrations made as non-members, when registrant’s company is a member company.  Higher non-member rate will be charged for registrations received under member registration when companies are found to be non-members.


For Sponsorship Opportunities, Hotel Information and Seminar Logistics, please contact Veronica Allen.  For information regarding Registration issues, please contact Katia Kunze.

Please be advised that any registrations received after 5 pm on Wednesday December 27th will not appear on the participants roster.  It is MTLI policy not to release revised participants rosters after the seminar.

CANCELLATION & REFUND POLICY

All cancellations must be received in writing by Katia Kunze. All cancellations received 11 business days or more prior to the start of the program are subject to a 10 percent cancellation fee. There will be NO REFUNDS for cancellations received within the 10 business days prior to the start of the program including "no shows".

 
 
 
 
 
We welcome substitutions in lieu of cancellations at any time. Please contact Katia Kunze with the substitute's information. All cancellation refunds will be processed within 30 business days from date cancellation request is received.  Topics and speakers are subject ot change without notice.  Advamed reserves the right to cancel or reschedule any program, whereupon full registration feew will be refunded or applied to the rescheduled program in accordance with the registrant's preference.  In the event of cancelled programs, AdvaMed assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.

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Location Information

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.

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Frequently Asked Questions

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