Regulatory and Medical Compliance




  • Verification of the compliance of promotional and institutional activities in accordance with the requirements of laws, ethics codes, corporate internal procedures
  • Regulatory and medical evaluation of promotional and non-promotional materials (disease awareness and institutional including press releases and documentation for market research), specialized press, websites, conferences, etc
  • Regulatory and medical evaluation of materials to be used by corporate figures such as Medical Science Liaisons, Regional Account Managers
  • Writing, revision and updating of local standard operating procedures
  • Support in the main areas of risk related in particular to the collaboration with HCP, HCO, scientific societies, patient associations, etc
  • Submission of promotional materials to AIFA and follow up in case of requests
  • Congresses: 360-degree management of authorization procedures, including of relationships with ECM providers and secretariats, submission of the requests for authorization through the AIFA Front End system, follow up until approval and submission of final balance costs of the event
  • Support for the registration of sales force to regions, notification to AIFA and to Regions of sales force activities