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The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Guide on Methodological Standards in Pharmacoepidemiology (Revision 1, 2012, Revision 2, 2013, Revision 3, 2014)).

The ENCePP initiative aims to strengthen post-authorisation medicines research by facilitating the conduct of multi-centre, independent and scientifically robust studies focusing on safety and the balance of benefits and risks. This includes supporting high quality research and stimulating innovation that benefits patients and public health at large. The Guide on Methodological Standards in Pharmacoepidemiology has, therefore, been developed to offer a single overview document and web resource for methodological guidance for both experienced and new researchers in pharmacoepidemiology and pharmacovigilance. For each topic covered, direct electronic access is given to internationally agreed recommendations and key points from important guidelines, published articles and textbooks after an introductory review. The focus is on scientific rather than regulatory guidance although relevant legislation and good pharmacovigilance practice are cited, where appropriate. Where relevant, gaps in guidance in areas important to collaborative pharmacoepidemiology research have been addressed with what ENCePP considers good practice. The guide has been developed by a dedicated ENCePP Working Group consisting of experts in pharmacoepidemiological and pharmacovigilance research. The original guide was published online on 17 May 2011. Both the original and the current first revision of the guide have been subject to public consultation. The guide will be updated annually by structured review to maintain its dynamic nature. It may also be amended as necessary on an ad-hoc basis in response to comments received. Researchers are therefore kindly requested to refer any additional guidance document that they consider relevant, to encepp_comments@ema.europa.eu.

Methodological standards ; pharmacoepidemiology ; pharmacovigilance ; ENCePP ; research ; guidance

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