ENCePP publishes the 'guide on methodological standards in pharmacoepidemiology'
The European Medicines Agency and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) have published the ENCePP guide on methodological standards in pharmacoepidemiology, an important tool that reviews and gives direct electronic access to the main existing methodological guidance for research in pharmacoepidemiology and pharmacovigilance.
The aim of the ENCePP initiative is to strengthen the post-authorisation monitoring of medicines by facilitating the conduct of multi-centre, independent and scientifically robust studies focusing on safety and the balance of benefits and risks.
In line with this objective, the new guide provides a structured architecture for thinking and learning about study design and methods through the presentation of internationally agreed recommendations and key points from important guidelines, published articles and textbooks.
The intention of the guide is not to duplicate the text from existing guidance but rather to offer the researcher a single overview document and web resource including an overview of the relevant recommendations.
The guide has been developed by a dedicated ENCePP Working Group consisting of experts in pharmacoepidemiological and pharmacovigilance research and has been subject to a public consultation.
Updates of the electronic document will be performed regularly with a view to maintaining the dynamic nature of the guide.