A proper management of the development, of the regulatory activities, of the pharmacovigilance and of the distribution is essential for achieving and maintaining the goals of innovation, competence, integrity and quality of work that the whole Group aims to.

Our activities

 

RESEARCH AND DEVELOPMENT

 

I.B.N. Savio constantly innovates and/or develops the Group portfolio, autonomously, in cooperation with research institutes and other companies or by outsourcing.

REGULATORY AFFAIRS

 

Thanks to its multidisciplinary experience acquired in many years of activity, I.B.N. Savio  effectively supports the companies of the Group and its own Customers to obtain and maintain all the needed authorisations for the pharmaceutical products, medical devices and food supplements commercialisation, guaranteeing compliance to all applicable local, national and international regulations over time.

The attention to the scientific progress and the constant updating to the highest and strictest international standards, ensures a strong competitive advantage in the management of both strategic activities and operative steps throughout the whole lifecycle of products.

PHARMACOVIGILANCE

 

The Pharmacovigilance has been defined by the World Health Organisation as “The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem”.

To the benefit of all the companies of the Group, the Pharmacovigilance service of I.B.N. Savio, performed by people with a significant experience of medicinal products, medical devices and food supplements, operates with the final purpose of constantly monitoring the tolerability profile of its medicinal products over the whole lifecycle, collecting all the adverse reactions reports, even if relative to well-known effects, potentially associated to a medicine use.

What is meant by adverse reaction? 

An adverse reaction is a noxious and unintended response to a drug product:
▪ used according to the directions contained in the marketing authorisation, or

 

▪ not used according to the directions contained in the marketing authorisation (including overdosage, misuse, abuse, therapeutical mistakes), or
▪ associated to the exposition due to professional reasons.

Please find below the way reporting of suspected adverse reactions can be made:

Healthcare operators and/or citizens can notify suspected adverse reactions to the competent Authority (Agenzia Italiana del Farmaco- AIFA):
- directly online on the website www.vigifarmaco.it, following the guided procedure
- by filling the file (in electronic or paper form) to be sent to the Responsible of Pharmacovigilance and sending it to the Responsible of Pharmacovigilance of the local structure or to the MA holder of the medicinal product suspected for the adverse reaction. The MA holder shall take care of sending the file to the Responsible of Pharmacovigilance of the local structure.

The files for Healthcare Operators or Citizens are available below:
- the “paper file” for reporting a suspected adverse reaction (introduced by the Ministerial Decree 12/12/2003) can be downloaded and printed by clicking on:

• Healthcare Operators:

• Citizens

the “electronic file” for reporting a suspected adverse reaction can be filled online by clicking on:
• Healthcare Operators

• Citizens

The references and e-mail contacts of all the Responsible of Pharmacovigilance of the local structures all over the national territory are available by clicking on
http://www.agenziafarmaco.gov.it/it/responsabili.

Such Responsibles of Pharmacovigilance shall insert the reports of suspected adverse reactions into the National Pharmacovigilance Network. This way a constant and continuous monitoring of the adverse reactions and safety of use of the medicinal products shall be performed.
Please refer to.: Agenzia Italiana del Farmaco

The spontaneous reporting made by physicians, pharmacists, other healthcare operators and patients themselves is essential to allow the Health Authorities operating on Pharmacovigilance and the pharmaceutical companies as well to define the tolerability and safety profile of medicinal product (benefit/risk ratio) and keep it updated.

To contact the Pharmacovigilance Office of I.B.N. SAVIO :
Tel: +39 3898536958
farmacovigilanza@ibnsavio.it

DISTRIBUTION

 

I.B.N. Savio takes care of the distribution of all the products belonging to the companies of the Group to the whole Wholesalers/Pharmacies/Hospitals supply chain on the national territory. To do this, I.B.N. Savio uses highly qualified logistic partners, able to assure the respect of the good storage and distribution practices in order to guarantee the absolute quality of its products for their whole shelf life.