The Guide on Methodological Standards in Pharmacoepidemiology offers a single web resource for methodological ENCePPEnglish language guidance in pharmacoepidemiology. For each topic covered, direct electronic access is given to internationally agreed recommendations, and key points from important guidelines, published articles and textbooks are highlighted. Where relevant, gaps in existing guidance are addressed with what ENCePP considers good practice.
The guide is updated annually by structured review to maintain its dynamic nature. It may also be amended as necessary in response to comments received. For this purpose, any comment and additional relevant guidance document may be forwarded to encepp_comments@ema.europa.eu.
The current version of the Guide is Revision 3, dated July 2014. In addition to the revision or update of most chapters, it includes a new chapter 9.3. on Design and analysis of pharmacogenetic studies, written in collaboration with the Special Interest Group in Molecular Epidemiology, Biomarkers and Pharmacogenetics of the International Society of Pharmacoepidemiology (ISPE).
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