Early Access

• Evaluation of feasibility of early access programs for the specific disease area, indication, product
• Expert support to companies for regulatory and logistic aspects of setting up early access programs
• Support to clinicians/scientific societies/patient associations for the preparation and follow-up of requests:
  • for inclusion in the list of reimbursed product according to Law 648/96
  • for named patient reimbursement according to Law 326/2003 (Fondo AIFA 5%)
  • for compassionate use/expanded access according to DM 7^th September 2017