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European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
News article21 June 2012European Medicines Agency

First revision of the Guide on Methodological Standards in Pharmacoepidemiology

On 13 June 2012 the ENCePP Steering Group adopted the first revision of the Guide on Methodological Standards in Pharmacoepidemiology.

The revised guide continues 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 is specified as a reference to be consulted in the Good Pharmacovigilance Practice (GVP) modules on post-authorisation safety studies and risk management plans.

For more information see:

Standards & Guidances

Details

Publication date
21 June 2012
Author
European Medicines Agency