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We constantly analyse the legislation and regulatory information related to a specific medicine in order to appraise the context in which the company operates

We put all our knowledge into play to anticipate risks and seize every opportunity, but above all to understand the rules of the game and display our creativity with them. We spread material and information proceeding from our investigation into medicines governance and regulatory science. In fact, we deem it necessary to be aware of the complexity of the results of research, regulation and drug policy in order to be able to work in a cultural ecosystem aiming both at promoting research outcomes that are useful to patients and at encouraging politicians to protect people’s health. The wider the knowledge of each interest group, the greater their ability to interact and achieve transparency of procedures and health protection.

  • All
  • Scenario analysis
  • Notes
  • Drug Policy
  • Rare Diseases
  • Mapping
  • Team Pharma Value
All
  • All
  • Scenario analysis
  • Notes
  • Drug Policy
  • Rare Diseases
  • Mapping
  • Team Pharma Value

New authorisations in EU 2019-21. An analysis from AIFA's horizon scanning

L’attività di horizon scanning per AIFA è strategica in quanto permette di identificare le tecnologie sanitarie nuove, emergenti per confrontarle con quelle ...
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Analysis of applications for inclusion of drugs on the 648/96 list. Focus on CTS evaluations.

Ginevra Mastroianni, Sara De Franceschi, Valeria Viola (Pharma Value) La Legge 648/1996 consente di erogare un farmaco non ancora autorizzato o non ...
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Pharma Value's experience at the 1st GIRF Congress - ISPOR Group Rome for Future

On 19 and 20 May, the 1st GIRF Congress - ISPOR Rome for Future Group - was held in Naples, recognising the importance ...
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Recovery of unused resources from the AIFA National Fund 5%

The Fund 5% for rare diseases, which allows access to medicines which do not have a MA in Italy, and which represent ...
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Recovery of unused resources of the AIFA National Fund 5%

The 5% Fund for rare diseases, which allows access to medicines that are not yet marketed in Italy and which represent a hope ...
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The use of antibiotics in Italy: National Report - Year 2020

On 10 March 2022, the 'National Report on the Use of Antibiotics in Italy -2020' was presented on AIFA's YouTube channel ...
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Appeal by Bayer VS Ministry of Health, MEF and AIFA on the new P&R criteria - Council of State ruling

On 7 January 2022, the Council of State issued its judgment (15 March 2021, no. 3095) on the appeal filed by ...
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Why this agenda

The year 2021 was the year of starting again, of picking everything up where we left off, while finding that someone or something ...
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New criteria for access to the 5% fund of Law 326/2003

On 30 November 2021, AIFA defined the new access criteria for Law 326/2003. This law was supplemented by Law ...
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