Speaker Program Structure and Evaluation

As compliance in healthcare practitioner speaker programs is a necessary prerequisite for pervasive culture of compliance, Porzio counsels clients on the implementation and continued monitoring of such programs.  In doing so, we consider the following:

  • Recent enforcement actions
  • Potential anti-kickback concerns
  • Compliance with
    • The OIG Guidance for Pharmaceutical Manufacturers
    • The PhRMA Code
    • The AdvaMed Code
    • Other industry guidances

We help life sciences companies:

  • Develop needs assessment criteria;
  • Set of fair market value compensation; and
  • Establish program logistics, including venue and meals, and preparation of relevant documentation;
  • Prepare agreement templates for healthcare practitioner speakers. 

We review speaker program materials for compliance with FDA regulations and other relevant laws and regulations.  We develop training presentations for speakers, highlighting legal obligations associated with speaking on behalf of life sciences companies.  We also assist with speaker program monitoring activities, including preparation of relevant forms and training for monitoring personnel.

Through our subsidiary’s, Porzio Life Sciences, LLC’s, Enforcements Actions Database, we can access government complaints, corporate integrity agreements, and deferred prosecution agreements, which allow us to efficiently and thoroughly provide benchmarking for life sciences companies’ speaker programs.