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Off-Label Promotion For Medical Devices: Understanding, Assessing and Reducing the Risk
Off-Label Promotion For Medical Devices: Understanding, Assessing and Reducing the Risk

Our Price: $395.00

Product Code: WB-7111

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About the Product
Includes 1 Hour and 20 minute Windows Media Video File and PowerPoint presentations for immediate download.

Life science legal professionals are well-versed in the regulatory repercussions of off-label promotion with state and federal regulators, but a far more menacing threat looms. Tort claimants frustrated with the lack of a civil remedy are fashioning a new approach and they are finding support in some courts and the federal government itself. This program will discuss the emergence of the “tort” of off-label promotion from criminal enforcement and prosecutions and what further issues industry will face in warding off this threat. To prevent and limit these claims, it is critical for device manufacturers to understand the elements of these claims that create the risk of off-label promotion civil liability. This program will focus on:

  • Identifying conduct that attracts regulators, prosecutors and tort claimants
  • Methods for managing risks associated with off- label promotion
  • Revising compliance policies to include off-label prevention tactics
  • Defense case analysis and enforcement trends
  • Elements of duty to warn and appropriate training

Samuel J. Louis

Michael A. Walsh

Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:

  • Legal Affairs
  • General/Corporate Counsel
  • Legal Compliance
  • Chief Compliance Officers
  • Litigation
  • Senior Executives

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