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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
17 January 2019
ENCePP activity report 2018

The ENCePP Secretariat has published a summary of the network's activities in 2018. The report provides a list of key achievements, a number of metrics relating to the network's expertise and experience, plus some website statistics.

 

Related information:

» Work plans and activity reports

11 December 2018
ENCePP activities during EMA’s third phase of Business Continuity Planning (BCP)

 

The European Medicines Agency’s (EMA) Brexit preparedness business continuity plan (BCP) entered into its third phase on 1 October 2018. The BCP allows safeguarding core activities related to the evaluation and supervision of medicines while the Agency prepares for the consequences of the United Kingdom’s exit from the European Union, both in terms of the impact on the Agency’s operations as well as its physical move to Amsterdam in March 2019. Measures of the third BCP phase include a temporary suspension of the activities of non-product related working parties and the development and revision of guidelines until 30 June 2019. In April 2019, once the Agency has completed its move to its temporary building in Amsterdam, these measures will be further reviewed. This decision has a temporary impact on ENCePP related activities requiring EMA organisational and meeting support, such as the ENCePP plenary meeting scheduled for November 2018, which has been cancelled. This also affects meetings and teleconferences of the ENCePP Steering Group, Working Groups and Special Interest Groups. ENCePP activities undertaken by partners and not requiring EMA organisational and meeting support continue as before.

 

In view of these developments the ENCePP Steering Group has agreed an action plan for all ongoing and outstanding activities of the current ENCePP work plan which will allow a smooth continuation once EMA resumes its organisational support to ENCePP activities after BCP.

 

The ENCePP Secretariat will continue to update ENCePP partners about any BCP related changes over the coming months.

 

Related information:

» United Kingdom's withdrawal from the European Union ('Brexit')

» ENCePP Work plan 2017-2019 - BCP action plan

 

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

 

 

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