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

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

Are you considering applying for an ENCePP study seal?

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

Sixth revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology

The 6th revision of the ENCePP Methods Guide is now available on the ENCePP website. This latest version includes revisions, amendments and new references in all the chapters. Important changes were made to a number of chapters to take account of developments in some areas or the need for restructuring and clarification. Three new chapters have been added: Introduction, Patient registries, and Surveys.

Related information:

» ENCePP Guide on Methodological Standards in Pharmacoepidemiology

ENCePP Work Plan 2017-2019

The ENCePP Steering Group has adopted the network's new three year work plan. The main goal during 2017 to 2019 will be to optimise ENCePP's input to regulatory decision-making throughout the product life-cycle. Particular focus will be on the development of methods in impact research and to identify enablers and barriers to measuring the impact of pharmacovigilance.

Related information:

» ENCePP Work Plans

EU PAS Register

The European Union (EU) electronic Register of Post-Authorisation Studies (EU PAS Register) has reached a major milestone with 1000 registered studies in February 2017.

Related information:

» Over 1,000 studies now recorded in EU register of post-authorisation studies

» EU PAS Register