• Farmacovigilanza (Pharmacovigilance - Drug Safety)
• Accesso allargato (Expanded access)
• AIFA (Agenzia Italiana del Farmaco)
• D.M. 8/5/2003
• Azienda Farmaceutica
• Comitato Etico
• NSCLC (Cancro al polmone non a piccole cellule)
• Negoziazione sul prezzo
• Affari regolatori (Regulatory Affairs)
• Nivolumab
• Uso terapeutico
• Sofosbuvir
• Uso compassionevole (Compassionate use)
• HCV (Virus dell'Epatite C)
• Sperimentazione clinica dei farmaci

The purpose of this Thesis is the discussion about regulatory aspects of "compassionate use" of drugs and in particular the relative Italian regulations and necessary procedures to apply them correctly (for example, important documents to be submitted to the Ethics Committee).
At last two drugs were considered and they are:
1) "Sofosbuvir", today on the market, and for which, when it wasn't on the market yet, the Italian Medicines Agency (AIFA) had started up the programme for compassionate use that has allowed to provide drugs free of charge to all patients who needed this therapy.
But when Sofosbuvir went on the market, problems began, because of its high cost.
2) "Nivolumab" is still in phase III of clinical trial in Europe, but it is already on the market in USA.
For this drug the AIFA has started up the programme for compassionate use, but expanding the access to all patients who have the same disease (in particular, the NSCLC - non small cell lung cancer), because of interesting results of Nivolumab.