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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 AIFA Special Update: CSE and REORGANISATION

Update 1 March 2024 Below is the updated document with appointments and update timeline to 1 March 2024. Original text Pharma Value has ...
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negotiating orphan drugs

The Orphan Drug Comparator: a survey to identify challenges in price negotiations with AIFA

In collaboration with Rarelab, we launched a survey with the aim of assessing the actual impact of the use of comparators in the negotiation of orphan drugs, ...
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Drug Agency

Interministerial Decree for new AIFA regulation published

Yesterday, 15 January 2024, the Ministerial Decree for the reform of AIFA was published in the OJ. It will enter into force on 30 January 2024. ...
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FDA vs EMA - Comparison of marketing authorisations issued in 2023

Pharma Value has developed a paper comparing marketing authorisations issued by the FDA and EMA in 2023. The objective of the analysis is to ...
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Pharma Value Agenda 2024

Pharma Value Agenda 2024

Each year the introduction of the Pharma Value Agenda tells how the inspiration for the theme came about and the methodology behind the construction of the content. The Agenda has become a ...
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VII Ossfor Annual Report

On Tuesday 12 December 2023, the 7th Ossfor Annual Report was presented in the Zuccari Room of Palazzo Giustiniani in the Senate.
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Regional Access Timelines in Italy: Factors Affecting Speed and Equity

The analysis addresses differences in regional access times for drug reimbursement in Italy. Following the official publication for drug reimbursement in the ...
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Evolution of the Utilisation of the Alfa 5% Fund for Orphan Drugs and Rare Diseases

The poster addresses the evolution of the utilisation of the AIFA 5% Fund, established in 2003 for the acquisition of orphan drugs ...
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The Phrama Value team at ISPOR Europe

Pharma Value at ISPOR Europe 2023

Pharma Value will participate in ISPOR Europe 2023, which will be held from 12 to 15 November 2023 in Copenhagen. They will fly to Denmark Geneva ...
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