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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
13 July 2018

Seventh revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology

The 7th revision of the ENCePP Methods Guide is now available on the ENCePP website. This latest version includes some significant revisions, amendments and new references in all the chapters. A new chapter on methods for pharmacovigilance impact research has been added. This is complemented by the new Annex 2 which provides more detailed guidance on methods for pharmacovigilance impact research developed by an ENCePP Special Interest Group.

 

Related information:

» ENCePP Guide on Methodological Standards in Pharmacoepidemiology

 

16 March 2018
ENCePP Code of Conduct - Revision 4

Since 2010, the ENCePP Code of Conduct provides a set of principles and recommendations to promote scientific independence and transparency of observational research, especially where they may be threatened by the influence of study funders. On 15 March 2018 the ENCePP Steering Group adopted the 4th revision of the ENCePP Code of Conduct.

 

This major revision aims to clarify and support the practical implementation of the Code’s key principles of scientific independence and transparency. It acknowledges personal interests of researchers but distinguishes commercial, financial and institutional interests in a revised definition of conflicts of interests.

 

The Code also provides for research conducted with authorised medicines in the context of post-approval regulatory requirements for marketing authorisation holders. In addition, all processes for implementing the ENCePP Seal concept have been removed and summarised on the ENCePP Study Seal pages on the ENCePP website.

 

Related information:

» Summary of the main changes introduced with the fourth revision of the Code

» ENCePP Code of Conduct

» ENCePP Seal

 

 

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