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Understanding Legal and Regulatory Developments in Off-label Promotion
Understanding Legal and Regulatory Developments in Off-label Promotion


 
Our Price: $395.00

Product Code: WB-7046
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About the Product
Includes 1 hour and 30 minute Windows Media Video File and PowerPoint presentations for immediate download.


Off-label promotion continues to be the focus of many government investigations, actions, and settlements in the pharmaceutical and medical device industries. Understanding the current legal, compliance and regulatory framework in this area, including evolving evaluations by FDA of various aspects of off-label promotion, is fundamental to successful compliance efforts in this hot area. This timely session, by a leading expert in the field, will provide a comprehensive review of the current state of affairs in the off-label world and will specifically consider:
  • The current legal, regulatory and compliance issues relating to off-label promotion
  • Drawing the distinction between “dissemination of accurate scientific and medical information” and “off-label promotion”
  • FDA’s Draft Guidance on responding to unsolicited requests for “off-label” use- have the rules changed?
  • Citizen Petition seeking clarification on the “off-label” rules
  • Dissemination of third party clinical practice guidelines
  • Forecasting potential effects of United States v. Caronia
  • The role of the OIG and the states in prosecutions for off-label promotion
  • How various Corporate Integrity Agreements address potential off-label promotion- what can we learn?
  • Off-label and product liability
  • The Allergan and Par litigation against FDA and interaction with OIG prosecutions

Speaker:

Howard L. Dorfman
Vice President and General Counsel
Ferring Pharmaceuticals Inc.


Target Audience

  • Compliance
  • Regulatory Affairs
  • Corporate Counsel
  • Promotion Compliance
  • Legal Affairs

Target Industry

  • Pharmaceutical
  • Medical Device
  • Biotechnology
  • Diagnostic


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