ENCePP is pleased to announce that Revision 3 of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology is now available.
In addition to the revision or update of most chapters, it includes a new chapter 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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(14 July 2014)
The new legislation will not come into force until the necessary IT platforms to support the exchange of information are in place (see Articles 80 and 81). This is anticipated as being no earlier than mid-2016.
For more information please see the EMA website
The European Medicines Agency (EMA) would like to inform you that the ENCePP Guide on Methodological Standards in Pharmacoepidemiology was adopted by the ENCePP Steering Group on 3 May 2011.
The document is now available on the following link:
http://www.encepp.eu/standards_and_guidances/documents/ENCePPGuideofMethStandardsinPE.pdf
The guide has been developed by a dedicated ENCePP Working Group consisting of experts in pharmacoepidemiological and pharmacovigilance research and has been subject to a public consultation. An overview of comments received and how each was addressed will also be available on the ENCePP website (www.encepp.eu)This guide is an important tool that reviews and gives direct electronic access to methodological guidance for research in pharmacoepidemiology and pharmacovigilance. It is planned that updates of the electronic document will be performed regularly with a view to maintaining the dynamic nature of the guide.
