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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
12 November 2018
Use of patient disease registries for regulatory purposes

The EMA cross-committee task force on registries has published a discussion paper on methodological and operational considerations in the use of patient disease registries for regulatory purposes. As explained in the document, interested parties are invited to send their comments and suggestions by 30/06/2019. Responses will be considered in the finalisation of the document in consultation with the relevant EMA committees by the end of 2019.

 

Related information:

» Patient registries (EMA website)

» Discussion paper: Use of patient disease registries for regulatory purposes – methodological and operational considerations

 

18 October 2018

ENCePP Checklist for Study Protocols - Revision 4

The ENCePP WG1 has finalised Revision 4 of the ENCePP Checklist for Study Protocols and it is now published on ENCePP website.

 

As a reminder, the EMA Guidance for the format and content of the protocol of non-interventional post-authorisation safety studies requires that a copy of the ENCePP Checklist for Study protocols, completed and signed by the main author of the study protocol, should be included in Annex 2 of the PASS study protocols.

 

Related information:

» ENCePP Checklist for Study Protocols (Revision 4)

 

 

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