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European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
News article1 July 2021European Medicines Agency1 min read

9th Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology published

The 9th annual Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology has been published. 

The Guide is maintained by the ENCePP Research Standards and Guidance working group under EMA’s coordination. The 9th Revision has been extensively amended and re-organised with an improved structure.The foreword from the co-chairs of the ENCePP Steering Group highlights the importance of the Guide in the context of the COVID-19 pandemic and vaccination campaigns. Nearly all chapters contain relevant guidance on methodological standards to be used in COVID-19 studies, with references to selected publications illustrating relevant methodological aspects.

This version will continue supporting sound pharmacoepidemiological research, including into COVID-19, and will provide a useful resource for clinicians, marketing authorisation holders and applicants, and regulators.


Publication date
1 July 2021
European Medicines Agency