Dictionary of Pharmacovigilance

Pharmacovigilance is, in essence, the process of monitoring the everyday use of medicines to identify previously unrecognized adverse drug reactions thereby assessing their risk/benefit balance in order to determine what action, if any, is necessary to improve their safe use by providing information to users to optimize safe and effective use while monitoring the impact of any action taken. The discipline along with its operational and legal facets, for both regulatory authorities and pharmaceutical industry, envelop colossal terminology that has precise legal and scientific significance. Such terminology may vary from country to country, or more confusingly, different countries may use identical or similar abbreviations, terms or phrases to mean different entities. This dictionary contains a list of abbreviations, terms and phrases (in English) giving definitions of commonly (and rarely) encountered pharmacovigilance terms.