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About ENCePP

Find out more about the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance.

 

Are you a company seeking to commission or collaborate in the conduct of a post-authorisation study (PAS)?

Find out more

Do you wish to register a study in the EU PAS Register?

Find out more

Are you considering applying for an ENCePP study seal?

Read a personal account of the ENCePP study approval process

Are you interested in the recommendations from the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) on safety signals?

Review the list of signals discussed

 

 

 

Latest News
8 April 2016
Key regulatory science results of the PROTECT project published

Since 2009, the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) has generated a significant amount of scientific research in pharmacovigilance, pharmacoepidemiology and benefit-risk evaluation, including 72 original articles in peer-reviewed scientific journals, as well as 14 doctoral theses and 3 master theses carried out in universities across the EU. In a special issue of the journal Pharmacoepidemiology and Drug Safety published this week, a series of 16 articles provide guidance for observational studies on medicines in several databases and several countries with common protocols. This guidance aims to increase consistency in findings from safety studies and revealing causes of differential drug effects, and will lead to updates to the methods guide of ENCePP. Other key recommendations published recently include a comprehensive review of good detection practices that identified significant improvements to signal detection methods, recommendations for benefit-risk assessment methodologies and visual representations based on real-world case examples to facilitate clear and transparent decision-making, and new methods to collect data directly from patients, including via the internet, applied to the collection of information from pregnant women via the web to better understand the safety of medicines during pregnancy.

 

Related information: EMA press release | Main results of the four key publications| PROTECT website | PROTECT benefit-risk website

9 February 2016
ENCePP Methods Guide End-User Survey

The ENCePP Working Group on Research Standards and Guidances has developed a short questionnaire with a view to enhancing the ENCePP Guide on Methodological Standards in Pharmacoepidemiology. Users of the Guide are encouraged to submit their feedback.

 

Related information:

» ENCePP Methods Guide End-User Survey

» Methodological Guide

 

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