Pharmacovigilance represents the set of activities that are undertaken to ensure a safe and appropriate use of medicines.

It consists of a fundamental tool for the safe control of medicine use, aimed at safeguarding public health. For this reason, it establishes specific obligations for the health authorities and the companies selling medicinal products. It also requires close collaboration between all professionals involved, supranational health authorities, national and local health authorities and pharmaceutical companies. A conscious involvement of end users, i.e. the patients, is also highly desirable.

Pharmacovigilance is a multidisciplinary activity, making use of the contribution of pharmacologists, epidemiologists, clinicians and statisticians.

• Relatively new, created in the wake of sensational events that have painfully affected the population (a case in question is that of thalidomide), it is also a complex science, far from having yet found its final form.
  In accordance with current regulations and European and national guidelines, we are able to offer our customers complete outsourcing of the service of Pharmacovigilance, including for example:
   
  Local contact and Qualified Person for pharmacovigilance
• Control of the national network of pharmacovigilance for possible adverse reactions related to the products
  Requests for follow-up information
• Weekly research and evaluation of literature cases, and of safety and efficacy studies
• English translation of reports which occur in the Italian territory and generation of CIOMS (in the case the client already has an European QPPV, e.g. multinational or foreign companies)
• Insertion of potential adverse reactions that occur outside EU countries in Eudravigilance
• Transmission of Italian literature cases in the RNF and of cases outside the EU in Eudravigilance
• Preparation and submission of PSURs to the Competent Authorities
• Contact point with local Competent Authorities
• Cooperation in SOP preparation
• Refresher training company course that may be carried out on-line or at our offices in Rome, Milan or at the premises of the company itsel