Speaker Program Structure and Evaluation
Porzio regularly counsels clients on the implementation and continued monitoring of healthcare practitioner speaker programs. In doing so, we consider recent enforcement actions, potential anti-kickback concerns, and compliance with the OIG Guidance for Pharmaceutical Manufacturers, the PhRMA Code, the AdvaMed Code and other industry guidances. We assist with needs assessment criteria, consideration of fair market value compensation, program logistics, including venue and meals, and preparation of relevant documentation. We prepare agreement templates for healthcare practitioner speakers, including an acknowledgement to abide by legal obligations associated with product promotion. 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.
