The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), coordinated by the European Medicines Agency, has completed the second revision of the ENCePP guide on methodological standards in pharmacoepidemiology. This guide is a key tool in supporting high quality post-authorisation studies. It offers a comprehensive overview of methodological guidance for researchers in pharmacoepidemiology andpharmacovigilance and is internationally recognised as a reference for researchers in this area.
The aim of the ENCePP initiative is to strengthen the post-authorisation monitoring of medicines by facilitating the conduct of multicentre, independent and scientifically robust studies focusing on safety and the balance of benefits and risks. The revision of the guide includes two new chapters on comparative effectiveness research and on the safety and effectiveness of vaccines. New sections on specific methodologies related to effect modification (differences in the effects of medicines depending on subgroups of patients) and handling of missing data have also been added.
Each section of the guide contains web links to internationally agreed recommendations and key points from important guidelines, published articles and textbooks. Advice on good practice is provided for those areas where gaps in guidance have been identified. Users can view the guide as HMTL webpages with links to each chapter and section and also as a consolidated PDF version for download.
The guide is updated annually to ensure that all developments in the field are incorporated.
ENCePP is a network of over 170 research centres, existing networks and providers of healthcare data, which is coordinated by the European Medicines Agency. Its goal is to strengthen post-authorisation monitoring of medicines by facilitating the conduct of multicentre, independent studies focusing on safety and on the balance of benefits and risks, using available European research expertise. As such, ENCePP is seen as a key element in generating robust ‘best’ evidence to support regulatory decision-making for the benefit of public health.