In recent years, the regulations governing pharmacovigilance in Europe and, consequently, in Italy, have evolved significantly. The purpose of these regulations is to promote and protect public health by creating a Pharmacovigilance System capable of maintaining efficient and constant surveillance of drug use. The heart of the system is built on the establishment of a network, with the individual Pharmacovigilance Systems active within each pharmaceutical company, each of which holds a Marketing Authorization for medicinal products.
With the introduction of these regulations, companies are obligated to organize their own Pharmacovigilance System to meet the prescribed requirements. This means that the Marketing Authorization Holder (MAH) needs to set up a complex Pharmacovigilance System operating within a quality system in line with the guidelines published by the European Medicines Agency (EMA) on this topic. In other words, pharmaceutical companies are required to make significant investments in terms of resources, time, and personnel dedicated to creating and maintaining a company-wide Pharmacovigilance System.
Asgenia aims to be the best reference for entrusting these sensitive activities.
