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ENCePP News Archive

December 2016

End of year closure

The ENCePP Secretariat will remain closed from 23 December 2016 to 2 January 2017 inclusive.

1 December 2016

ENCePP Steering Group 2017-2019

The new ENCePP Steering Group has taken up its mandate following the ENCePP plenary meeting on 22/11/2016. The Steering Group consists of 16 members, six of which are elected representatives from the ENCePP plenary. The term of service is three years.


Related information:

» ENCePP Steering Group

11 November 2016
ENCePP plenary meeting 2016

The 15th ENCePP plenary meeting will be taking place at the premises of the European Medicines Agency in London on Tuesday, 22 November 2016.

Participation is open to representatives from research centres and networks that have joined ENCePP.


Related information:

»  Draft Agenda - 15th ENCePP Plenary meeting

» ENCePP Plenary meeting reports

8 November 2016
Report of survey on academia framework

The European Medicines Agency has published on its website a concise report of a survey targeted to academic stakeholders in the context of the definition of a framework of collaboration with academia. It concludes that, in view of the growing complexity with which new medicines are being developed, evaluated and monitored it has become indispensable that academia and regulators develop a partnership that will foster a proactive process to support innovation and channel it into the continuous evolution of regulatory science.


Related information:

» Survey report - EMA consultation on the proposal of a collaboration framework with academia

14 July 2016
Upgrade of EU PAS Register

A new version of the EU PAS Register was released on 14 July 2016. This latest upgrade includes a number of performance enhancements and important improvements in terms of searching and data management. From now on it will be possible to search the database by the unique study identifier which will also be displayed with the study record on screen and included on printouts. A new mandatory data field titled 'RMP study category' has also been introduced.


Related information:

» EU PAS Register upgrade July 2016 - What's new?

» EU PAS Register

12 July 2016
Third revision of the ENCePP Checklist for Study Protocols

The Checklist has been revised and now includes reference to sections, rather than page numbers of protocols. It has also undergone editorial review and reference to HTA endpoints has been added in section 6.4.


Related information:

» ENCePP Checklist for Study Protocols

12 July 2016
Fifth revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology

The Guide is updated annually and revision 5 – with updates, amendments or clarifications of most chapters - is now available on the ENCePP website. This latest version also includes a new chapter on using data from social media and electronic devices as a data source.

With a view to further enhancing the Guide, users are encouraged to submit their feedback by completing a short questionnaire.

Related information:
» ENCePP Guide on Methodological Standards in Pharmacoepidemiology
» ENCePP Methods Guide End-User Survey

8 April 2016
Key regulatory science results of the PROTECT project published

Since 2009, the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) has generated a significant amount of scientific research in pharmacovigilance, pharmacoepidemiology and benefit-risk evaluation, including 72 original articles in peer-reviewed scientific journals, as well as 14 doctoral theses and 3 master theses carried out in universities across the EU. In a special issue of the journal Pharmacoepidemiology and Drug Safety published this week, a series of 16 articles provide guidance for observational studies on medicines in several databases and several countries with common protocols. This guidance aims to increase consistency in findings from safety studies and revealing causes of differential drug effects, and will lead to updates to the methods guide of ENCePP. Other key recommendations published recently include a comprehensive review of good detection practices that identified significant improvements to signal detection methods, recommendations for benefit-risk assessment methodologies and visual representations based on real-world case examples to facilitate clear and transparent decision-making, and new methods to collect data directly from patients, including via the internet, applied to the collection of information from pregnant women via the web to better understand the safety of medicines during pregnancy.


Related information: EMA press release| Main results of the four key publications| PROTECT website| PROTECT benefit-risk website

8 March 2016
ENCePP activity report 2015

The ENCePP Secretariat has published a summary of ENCePP activities in 2015. The report includes a list of key achievements and also provides some metrics relating to the network's growth and strengthening, as well as some ENCePP website statistics.


Related information:

» ENCePP activity report 2015

9 February 2016
ENCePP Methods Guide End-User Survey

The ENCePP Working Group on Research Standards and Guidances has developed a short questionnaire with a view to enhancing the ENCePP Guide on Methodological Standards in Pharmacoepidemiology. Users of the Guide are encouraged to submit their feedback.


Related information:

» ENCePP Methods Guide End-User Survey

» Methodological Guide



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