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Pharma

Value

To be able to find the right path for the introduction of a medicine in Italy, it is necessary to explore and translate the map of the regulatory environment, identifying and analysing the expectations and reports of decision-makers.

We assist those who turn to us in understanding and obtaining a fair price and reimbursement for a medicine. Finding a common ground, by appropriately mediating between Company profit, patient needs and the limited resources of the National Health Service, is a victory for all interest groups involved.
Through the years, we have learnt that the reality of things is more complex than whatever had been planned.
Even when everything is well-prepared and strategies corresponding to the value of the medicine, in accordance with the regulatory objectives of the agencies, and accommodating to drug governance guidelines, are proposed, the pathway to the authorisation of a medicine may well progress differently than expected. Not to mention any external variables that could slow down, if not hinder, the access of a medicine to the market.
Integrated skills are needed to help with navigation
Though quite detailed, the map we have provided cannot define the complexity of the terrain. Our experience comes to the aid when it is not clear.
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  • All
  • Scenario analysis
  • Notes
  • Drug Policy
  • Rare Diseases
  • Mapping
  • Team Pharma Value
Team Pharma Value

Easter 2021 - our best wishes

Il #TeamPharmaValue vi fa tantissimi auguri qualsiasi cosa festeggiate! Con questa animazione abbiamo voluto raccontare la nostra visione per la Pasqua 2021. ...
1st OsMed Report on Parallel Import (IP) and Export of Medicines for Human Use by AIFA Notes

1st OsMed Report on Parallel Import (IP) and Export of Medicines for Human Use by AIFA

I° Rapporto OsMed sull’importazione parallela (IP) ed esportazione dei medicinali per uso umano di AIFA Puoi rivederlo qui https://lnkd.in/dRgRGUV Nella presentazione di ...
Notes

New application form for listing of medicines under Law 648/96

AIFA ha pubblicato un nuovo modulo per la richiesta di inserimento di medicinali nell’elenco ai sensi della legge 648/96; si evincono alcune ...
Notes

Scientific Committee on Post-Market Surveillance of COVID-19 Vaccines (CSV-Covid19)

L’AIFA, il 14 dicembre 2020, ha costituito un comitato scientifico per la sorveglianza post-marketing dei vaccini COVID-19 (CSV-Covid19). Il CSV-Covid19 rimarrà in ...
Notes

Coronavirus: new set-up for the Scientific Technical Committee. Reduction in the number of members and new professionalism

Con il Decreto del Capo Dipartimento della Protezione civile n. 371 del 5 febbraio 2020, è stato istituito il Comitato Tecnico Scientifico ...
Notes

Working Group for the Coordination of the National Antimicrobial Resistance Strategy

Tornano gli appunti di Pharma Value con l’aggiornamento della composizione del Gruppo di lavoro per il coordinamento della strategia nazionale di contrasto ...
COVID19 Technical Scientific Committee Mapping

Redefinition of the Scientific Technical Committee (STC) COVID-19

Con ordinanza del Capo Dipartimento della Protezione civile n. 663 del 18 aprile 2020 e delle successive ordinanze: n. 673 del 15 ...
Notes

New Criteria and Procedures for the negotiation of prices of medicines reimbursed by the Italian Health Service

On 30 December 2020 AIFA approved the document containing the provisions required by art. 2 of Ministerial Decree of 2 August 2019, ...
Notes

AIFA National Report 2019 'The use of antibiotics in Italy'

Il 29 Dicembre è stato presentato il Rapporto Nazionale 2019 “L’uso degli antibiotici in Italia” il quale fornisce dati e analisi sull’andamento ...
Notes

Highlights on the AIFA Pricing Guidelines

Sono state finalmente pubblicate le Linee Guida AIFA per la compilazione del dossier a supporto della domanda di rimborsabilità e prezzo di ...
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