SCF is a point of reference for companies that want to learn more about specific pharmaceutical themes through tailored-made or in-house training courses. We also manage complete events aimed at the involvement of medical professionals.

 

SCF offers years of experience in the field, our knowledge, organizational capacity and Italian and international professionals, to reach the specific requests of the clients.

The most requested themes have been:

• Market access,
• Pharmaceutical legislation,
• Pharmacoeconomics,
• Regulatory affairs,
• Clinical studies and GCP,
• Pharmacovigilance,
• Medical devices, dietary supplements and cosmetics.

Moreover, since 2016 SCF has organized the School of Negotiations, where every year professionals in the area of market access and regulation from the most important multinational pharmaceutical companies participate; this has become an annual appointment for training excellence on the themes of negotiation and Italian reimbursement process.

The introduction of a new product on the market needs a whole understanding of legislative aspects, mechanisms of reimbursement and access to the market both at the national and regional levels.

We believe that for the market access of medicines and medical devices to be effective, a multi-step approach is required, where the various phases are tightly interconnected:

 

MARKET ACCESS STRATEGY

The identification of the strategy for market access begins before obtaining authorization, because we think that the timing in parallel with pricing, are the fundamental components of a successful strategic analysis, which is supported by the involvement of the most suitable stakeholders, represented by the most important professional at both national and regional levels.

 

PRICING AND REIMBURSEMENT

Once the strategy has been identified, we use our skill in the area of pricing and reimbursement, which consists in a preliminary analysis of competitors, and a differentiated approach in cases of medicines and medical devices.

 

MEDICINES

Thanks to our experience over the years, we have the know-how for the preparation of the pricing and reimbursement dossier (P&R), according to Deliberation CIPE 2001.

Moreover, thanks to a collaboration with a network of professionals, we can carry out:

• Epidemiological studies,
• Ad-hoc pharmacoeconomic analysis, from cost-effect studies to Budget Impact Analyses (BIA),

We support pharmaceutical companies also in the preparation of audits at the AIFA.

 

Our activity does not end with reimbursement at the national level, but we are a partner for market access at the regional level, thanks to our knowledge of reimbursement processes that are in force in the various regions.

 

REGIONAL ACCESS MANAGER (RAM)

With the aim of meeting the needs of start-ups and new pharmaceutical companies, we propose a professional RAM in outsourcing who represents the conjunction between the company and the region, indispensable to create a solid network of knowledge that can monitor regional needs.

 

MEDICAL DEVICES

We can manage the reimbursement of medical devices through continuous monitoring of regional tenders, preparing the necessary documentation to present for access to the tender, following the whole process to the end.

The implementation of a quality system is an added value for companies and a guarantee of quality for their clients.

 

The international standard ISO 13485 is the reference standard for the management quality system, specific for companies that operate in the medical sector. The standard specifies the requisites for the system of management of the quality of the organizations that operate both in design and production of medical devices, as well as of the design and supply of correlated services.

Our specialized team have the recognized specific knowledge of ISO 9001 and ISO 13485, and are able to support companies in the implementation of:

• Quality systems, also in the request for certification,

• Manual of quality system and relative SOP,
  • Risk management plan (RMP),
  • Management of the relationship with the Certified Bodies,
  • Assistance during audits.

Moreover, we also provide the quality responsible person in outsourcing.

Pharmacovigilance is all the activities finalized for identifying, evaluating, understanding and preventing adverse effects correlated with the use of medicines, with the aim of assuring a favourable benefit/risk relationship for the users.

SCF offers to its clients a complete management in outsourcing of the service of pharmacovigilance, through the certified Qualified Person for European Pharmacovigilance (EU-QPPV), to carry out all the activity that a pharmaceutical company has to guarantee, to be compliant with the pharmacovigilance legislation in force, through the implementation of:

• a management system for the quality of Pharmacovigilance and relative Standard Operating Procedure (SOP),
• Periodic Safety Update Reports (PSUR),
• Risk Management Plan (RMP),
• Activity of monitoring of the National Pharmacovigilance Network (RNF) as referring company,
• Monitoring of national and international scientific literature for medical products and active substances,
• Preparation, maintenance and updating of the Pharmacovigilance System Master File (PSMF),
• Management of the Safety Reports in Eudravigilance,
• Updating of medical products in the European database Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
• Taking on the role of Local contact point,
• Planning, conduction and reporting of Pharmacovigilance audit and relative management and planning of corrective and preventative actions from an audit.

Moreover, pharmacovigilance activities could be performed also during the conduction of clinical studies through:

• Preparation of the specific SOP,
• Full-time receiving and reporting of Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR) through Eudravigilance,
• Preparation and transmission to the competent authorities of the Developed Safety Update Reports (DSUR).

REGULATORY AFFAIRS CONSULTANCY IN COMPLIANCE WITH LEGISLATION

Continue reading

Thanks to our excellent knowledge of the relevant legislation, which ranges from clinical studies to market access, we support companies from the planning phase and optimization of medical products, medical devices, cosmetics, dietary supplements, biocidal products and medical-surgical aids.

SCF’s aim is to identify the regulatory strategy that can realize products that answer market needs that are in continual evolution, making companies leaders in their sector.

Our activity includes the preliminary analysis of the specific sector, regulatory affairs consultancy and design of new formulations, or of optimization of products already on the market, having a network of competent professionals necessary to make an idea a finished product.

Moreover, we will be right beside you in the process of obtaining a patent.