The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology (Revision 2)

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology (Revision 1)

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

Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)

The European Medicines Agency (EMA) has the responsibility for the scientific evaluation, supervision, and safety monitoring of medicines in the European Union (EU) to ensure that their benefits outweigh their risks. While the roots of medicines' safety monitoring lie in the development of mechanisms for spontaneous reporting of suspected adverse reactions by health‐care professionals and patie...

ENCEPP CONSIDERATIONS ON THE DEFINITION OF NON-INTERVENTIONAL TRIALS UNDER THE CURRENT LEGISLATIVE FRAMEWORK (“CLINICAL TRIALS DIRECTIVE” 2001/20/EC) Agreed by the European Network of Centres for Pharmacoepidemiology

An analysis of characteristics of post-authorisation studies registered on the ENCePP EU PAS Register

Background: The objective of this study was to investigate the study design characteristics of Post-Authorisation Studies (PAS) requested by the European Medicines Agency which were recorded on the European Union (EU) PAS Register held by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Methods: We undertook a cross-sectional descriptive analysis of all s...