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Pharmacoepidemiology standards published

The European Medicines Agency and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance have published guidance on methodological standards in studying the effects of drugs in large groups of people

The European Medicines Agency (EMA) and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) have published guidance on methodological standards in pharmacoepidemiology – the study of the effects of drugs in large groups of people.

The guidance gives reviews and access to the existing methodological guidance for research in pharmacoepidemiology and pharmacovigilance, with information on study designs and methods.

These are based on internationally agreed recommendations and key points from important guidelines, published articles and textbooks.

In a statement, agencies said: "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 ENCePP is an EMA project to strengthen the post-approval monitoring of medicinal products in Europe by facilitating studies focusing on the safety and benefit-to-risk ratio of marketed drugs.

A dedicated ENCePP working group consisting of experts in pharmacoepidemiological and pharmacovigilance research developed the guide, with the final publication developed following a public consultation.

The EMA has the guide available for download (PDF).

2nd June 2011

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