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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

Urgent provisions on the testing of medicines for epidemiological emergencies by COVID - Article 40

Attention! ART.40 of DECREE-LAW no. 23 of 8 April 2020 'Urgent measures on access to credit' repeals ART.17 of the Cura Italia ...
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Easter 2020, our best wishes

Best wishes for a Happy Easter from the whole Pharma Value team. For us, Easter - today - is perfectly ...
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Single National Ethics Committee of the Lazzaro Spallanzan National Institute for Infectious Diseases

Single National Ethics Committee of the Lazzaro Spallanzani National Institute for Infectious Diseases

Article 17 of the Cura Italia decree-law states that the national opinion on protocols for the testing of medicines for the epidemiological emergency by COVID ...
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List 648/96 - AIFA How to apply for inclusion of a drug/therapeutic indication not yet authorised by the SSN

In these times of the COVID-19 emergency we often hear about the '648/96' list and reimbursed drugs for off-label use... but ...
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Drugs in clinical trials: compassionate use activation procedure

In this time of COVID-19 emergency we often hear about 'Compassionate Use' The DM 7/9/2017 regulates the free supply by ...
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The course of a drug pricing and reimbursement procedure in Italy

In these quarantine days, Pharma Value wants to share with you some useful content for those working in the regulatory and market ...
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The Words in the New Decree on Negotiating Criteria

Many in the industry have analysed the interministerial decree on the new negotiation criteria published in the Official Journal on 24 July 2020, making ...
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