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ENCePP News Archive

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)

25 July 2018

ENCePP website and EU PAS Register unavailable from 27 to 30 July 2018

All European Medicines Agency (EMA) information technology (IT) systems will be temporarily unavailable from 18:00 on Friday 27 July to 6:00 on Monday 30 July 2018 (UK time), due to an essential exercise to test the Agency’s IT systems.


During this period, it will not be possible to access the EMA public website or any other EMA-hosted website or online application. Normal service will resume on 30 July.

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

7 March 2018
EU PAS Register

The EU PAS Register will be affected by essential maintenance activities from Saturday 10 March (from 7:00 UK time) and continuing on Sunday 11 March. During this period EU PAS Register users will not be able to populate or modify certain study fields: country, substance, ATC Code and medical condition related information. Users may continue to consult studies and/or amend other fields.


Related information:

» EU PAS Register

12 January 2018
ENCePP: 10 year anniversary article published online

An article reviewing ENCePP’s main achievements over the past ten years, discussing its impact on the benefit-risk evaluation of medicinal products in Europe and outlining future perspectives has been published online in Pharmacoepidemiology and Drug Safety (open access).


Related information:

» Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)

9 January 2018
ENCePP activity report 2017

The ENCePP Secretariat has published a summary of the network's activities in 2017. 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:

» ENCePP activity report 2017

3 January 2018
2018 ICPE abstract submission

Abstracts for the 34th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (2018 ICPE) are now being accepted online. Deadline for submission is 14 February 2018.


Related information:

» 2018 ICPE - Submission of abstracts




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