ACI's 14th National Pharmaceutical Compliance & Enforcement Forum

讨论议题包括：

• Lessons to be learned from recent CIA agreements: Separating out individual considerations and identifying across-the-board negotiation points
  
  
  
  • How much of your global and domestic business will be covered by the CIA?
  
  
  • What kind of monitoring controls and systems need to be implemented?
  
  
  • What kind of restraints on HCP relationships can you enter into?


• What trends about OIG priorities can be extrapolated from recent CIAs?


• Determining the ramifications of multi-violators


• Distinguishing between boiler-plate and investigation specific provisions
  
  
  
  • What provisions are subject to modification based on company specific factors?
  
  
  • Insights into what provisions have been successfully tailored by other companies


• Creating a cooperative relationship with your appointed monitors and communicating effectively with the OIG during the pendency of the CIA


• Proactively fortifying your compliance system based on the requirements of other pharmaceutical and medical device CIAs before negotiating with the government


• Living under a CIA
  
  
  
  • Understanding the effects
  
  
  • Getting the Board of Directors involved
  
  
  • Discussing the likelihood of “probation” becoming a new standard


• Preparing for potential tax consequences to settlements – distinguishing between repayments and penalties
  
  
  
  • Evaluating what constitutes a “reportable event”
  
  
  • Setting up internal review organizations and data collection as to implementation of programs


• Preparing for allegations of a breach
  
  
  
  • Identifying who can enforce CIA conditions
  
  
  • Comparing jurisdictional views on whether a breach of a CIA can give rise to an action under the False Claims Act
  
  
  • Updating investigators on what systems have been implemented and providing data on efficacy
  
  
  • Retaining independent review organizations

For more information, visit the event website.