Event

ACI Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry

April 28, 2014
04:45 PM - 05:30 PM

In response to the unique challenges facing biopharmaceutical and medical device companies in this daunting enforcement climate, the 8th National Conference on FCPA & Anti-Corruption for the Life Sciences Industry provides a forum for the key players — top federal prosecutors, preeminent corporate counsel, and leading FCPA practitioners — to come together for critical networking and benchmarking on how to combat the next wave of FCPA allegations

Please join Morgan Lewis partner Kelly A. Moore for the panel “The Top 10 Clinical Trial Mistakes That Can Lead to an FCPA Enforcement Action: Practical Lessons for Conducting International Trials in High Risk Markets." Topics include:

  • Case studies: Which activities during recent clinical trials have raised red flags to enforcement authorities?
  • Managing risk when making payments to principal investigators, other healthcare professionals (HCPs), or consultants in connection with a clinical trial
    • Transparency of payments in clinical trial contracting: best practices in budget drafting
    • Determining fair market value of the payments made to HCPs
    • Compliance with local anti-corruption laws and sector-specific guidance
  • Providing equipment for use during a trial
    • Legal and ethical concerns regarding “donated equipment”
    • Protocols for leasing equipment
    • Options for handling equipment following trial completion
  • Risk management with respect to CROs involved in investigator retention and payment
    • Ensuring that all payments are disclosed to and approved by sponsor
    • Ensuring proper training of CRO / consultant staff regarding FCPA and anti-corruption law
    • Best practices in CRO contract drafting