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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 September 2020

Virtual workshop on the draft guideline on registry-based studies

 

A workshop on the draft guideline on registry-based studies scheduled for Monday, 19 October 2020 from 12:30-17:00 (CET) has been announced on the EMA website.

 

This half-day virtual workshop will give an overview of the Guideline that will be published for consultation at the end of September 2020, and will provide the opportunity for stakeholders to ask questions for clarification.

The meeting will be broadcast live on EMA’s website. In addition, there will be a limited capacity to participate in the virtual room for people who wish to make verbal contributions to the meeting. Interest in joining the virtual room can be expressed by completing the online form by 9 October 2020. After this deadline, the EMA will review the requests received and will select the participants to ensure a fair representation of the different stakeholders.

 

Related information:

» Workshop agenda

» Expression of interest form

 

Contact point: EMAregistries@ema.europa.eu

 

10 July 2020

Eighth revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology published

 

The 8th revision of the ENCePP Methods Guide has been published on the ENCePP website. This latest version includes revisions, amendments and new references in most of the chapters. Revisions were performed by the authors in collaboration with the editorial group. External comments received were also considered.

For this 8th revision, a foreword highlights the importance of the Guide for pharmacoepidemiological studies carried-out in the context of the COVID-19 pandemic in order to provide valid results useful for clinicians and regulators. The foreword guides the reader to the chapters that may be particularly relevant for such studies.

» ENCePP Guide on Methodological Standards in Pharmacoepidemiology

 

27 May 2020

EMA calls for high-quality observational research in context of COVID-19

 

The EMA published a press release on 26 May 2020, calling for for high-quality observational research in the context of COVID-19. The text emphasises that when planning observational studies, researchers should adhere to existing guidelines on the appropriate design and conduct of pharmacoepidemiological studies in order to generate reliable and reproduceable evidence, including the ENCePP Guide on methodological standards in pharmacoepidemiology. EMA also reminds researchers to post all protocols and reports of observational COVID-19 studies in the EU PAS register to ensure transparency and scrutiny of study design and results. This text refers to the ENCePP COVID-19 Response Group promoting use and dissemination of valid and reliable methodologies appropriate to COVID-19.

 

 

 

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