Interest of pharmacoepidemiology in pharmacovigilance: Post-authorization safety studies in regulatory pharmacovigilance activity

How can the quality of medical data in pharmacovigilance, pharmacoepidemiology and clinical studies be guaranteed?

The development of medicinal products is subject to quality standards aimed at guaranteeing that database contents accurately reflect the source documents. Paradoxically, these standards hardly address the quality of the source data itself. The objective of this work was to propose recommendations to improve data quality in three fields (pharmacovigilance, pharmacoepidemiology and clinical stud...

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology

Draft Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiology Assessment

Draft Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiology Assessment

Pharmacovigilance and post-black market surveillance.

Pharmacovigilance can be defined as a set of practices aiming at the detection, understanding and assessment of risks related to the use of drugs in a population, and the prevention of consequential adverse effects. In a narrower sense, the term refers exclusively to postmarket surveillance. This paper briefly outlines how pharmacovigilance has come to play a central role in the regulation of n...