logo BDSP

Base documentaire

  1. International guidelines on post-authorisation research and surveillance.

    Article - En anglais

    Recently, post authorisation research and surveillance has become more and more important.

    This article investigates which common standards already exist and which methods and tools are used in this context.

    This paper focusses on a draft version of the « Notice to applicants for marketing authorisations for medical products for human use in the European Community » which will be mandatory for all EC member countries after its finalization.

    Mots-clés Pascal : Surveillance biologique, Chimiothérapie, Traitement, Autorisation mise sur marché, Manuel, Union européenne, Homme

    Mots-clés Pascal anglais : Biological monitoring, Chemotherapy, Treatment, Marketing authorization, Manuals, European Union, Human

    Logo du centre Notice produite par :
    Inist-CNRS - Institut de l'Information Scientifique et Technique

    Cote : 97-0120385

    Code Inist : 002B02A07. Création : 21/05/1997.