Pharma Value

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.

Team Pharma Value

Thoughts, the Newsletter

16 July 2021

Pensierini sarà la Newsletter di Valeria Viola, una mail che non racconterà specificamente le attività di Pharma Value, così come non sarà ...

Special - The rules for CTS and CPR renewal AIFA

Notes

The renewal of the AIFA Commissions is imminent. What are the rules?

28 June 2021

A settembre scadranno le Commissioni AIFA (CTS e CPR). NOMOS centro studi parlamentari e Pharma Value fanno il punto sulle regole per ...

Notes

Who are the members of the technical table for rare diseases of the Ministry of Health

25 June 2021

Il 21 giugno 2021 è stato istituito il Tavolo tecnico in tema di malattie rare. Il Tavolo riunisce esperti clinici e accademici, ...

Team Pharma Value

Privilege is invisible to the eyes.

7 June 2021

Abbiamo chiesto alla Fondazione Giacomo Brodolini di aiutarci a ragionare sul privilegio, in questo mese del Pride dove i social si colorano ...

Notes

ERN and rare diseases: the report of the Incisive Health Morning Club co-organised by Nomos, in collaboration with Pharma Value

3 June 2021

Il 20 maggio si è tenuto l’Incisive Health Morning Club co-organizzato da Nomos Centro Studi Parlamentari e Pharma Value in collaborazione con ...

Scenario analysis

Modification of national requirements in the blue box for medicines

9 April 2021

AIFA ha pubblicato una comunicazione sull’aggiornamento circa i requisiti nazionali da inserire in Blue Box. C’è un impatto importante sulle attività regolatorie ...

Team Pharma Value

Easter 2021 - our best wishes

2 April 2021

Il #TeamPharmaValue vi fa tantissimi auguri qualsiasi cosa festeggiate! Con questa animazione abbiamo voluto raccontare la nostra visione per la Pasqua 2021. ...

Notes

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

31 March 2021

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

30 March 2021

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)

19 March 2021

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 ...