Post-Market Authorisation – Operational Activities

AXPHARMA deals with cases of post-market authorisation pharmacovigilance in a very broad range of brand-name and generic products in all therapeutic classes (pulmonology, oncology, orphan diseases, etc.).


Whether these activities have been outsourced to AXPHARMA to deal with European or national regulatory requirements or for another specific client need, our staff carry out all the typical tasks required of case management.

    • These include:

      • dealing with all cases, wherever they originate from, including the French CRPV, the Italian AIFA website, healthcare professionals, cases reported in the literature or recorded directly from patients, etc.;

      • systematic investigations carried out by pharmacovigilance professionals and their assistants in order to have all the information necessary for a medical evaluation of the case;

      • medical evaluations including WHO/French accountability that must be carried out by a pharmacovigilance professional;

      • submissions to the relevant authorities, including EudraVigilance, in accordance with the appropriate processes (Gateway, EV Post or EVWEB);

      • regular reporting to the client on each mandate;

      • systematic quality control, by physicians and pharmacists, of all the data captured.


      But also:

      • monitoring Post-Authorisation Safety Studies (PASS) after drafting of the protocol;

      • monitoring Authorisations for Temporary Use (ATU) and Recommendations for Temporary Use (RTU).


      AXPHARMA has two databases that help it to carry out its pharmacovigilance activities, both of which are E2B compliant and validated in accordance with current requirements. AXPHARMA also captures data using ARGUS or any other database that a client might be using.

      Screening literature and bibliographies:

      In accordance with current legislation, periodic screenings of literature must be carried out for every drug that pharmaceutical companies produce. This is in order to identify any cases of adverse effects that may have been reported.

      In liaison with the team of pharmacovigilance professionals, literature screening should be carried out as follows:

        • on defined products or drugs
        • in databases of scientific articles, such as Medline or EM Base when requested, Toxline, INIST or ARPI
        • internationally, when dealing with parent companies
        • nationally, when dealing with European countries where the products are commercialised

      Documentalists also carry out specific screenings of bibliographies or of medical information linked to the drafting of pharmacovigilance reports or any other report linked to product efficacy. This type of screening can also be carried out for other fields of vigilance.

      ction des territoires européens où sont commercialisés les produits

Les documentalistes réalisent également les recherches ponctuelles bibliographiques ou d’Information Médicale en lien avec la rédaction de rapports de PV ou de tout autre rapport lié à l’efficacité du produit. Ces recherche s’appliquent bien évidement aux autres domaines de vigilance.