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December 2016 |
End of year closureThe 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.
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11 November 2016 |
ENCePP plenary meeting 2016The 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.
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8 November 2016 |
Report of survey on academia frameworkThe 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 RegisterA 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.
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12 July 2016 |
Third revision of the ENCePP Checklist for Study ProtocolsThe 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.
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12 July 2016 |
Fifth revision of the ENCePP Guide on Methodological Standards in PharmacoepidemiologyThe 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: |
8 April 2016 |
Key regulatory science results of the PROTECT project publishedSince 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
Related information: EMA press release |
8 March 2016 |
ENCePP activity report 2015The 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.
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9 February 2016 |
ENCePP Methods Guide End-User SurveyThe 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.
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For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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.
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