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.
The National Commission for Updating the Essential Levels of Care (LEA) was renewed by Ministerial Decree of 18/03/2024. The President of the Commission ...
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, ...
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 ...
On Tuesday 12 December 2023, the 7th Ossfor Annual Report was presented in the Zuccari Room of Palazzo Giustiniani in the Senate.
Manage Cookie Consent
We use cookies to optimise our website and services.
Functional
Always active
Technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
Preferences
Technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.
Statistics
Technical archiving or access that is used exclusively for statistical purposes.Technical storage or access is used solely for anonymous statistical purposes. Without a subpoena, voluntary compliance by your Internet Service Provider, or additional records from third parties, information stored or retrieved for this purpose alone cannot usually be used for identification purposes.
Marketing
Technical storage or access is necessary to create user profiles to send advertisements, or to track the user on one website or several websites for similar marketing purposes.
