ENCePP interface with Health Technology Assessment (HTA)

The ENCePP working group on HTA presented a well-received poster and workshop at the ISOP conference which took place in early November 2013 in Dublin.

Related information:

» Poster: Introducing the ENCePP Working Group on Health Technology Assessment

» Presentations:

• PASS-PAES-HTA studies
• Additional Data Collection for Drugs in Europe HTA perspective

• Post-authorisation studies in Europe: bridging the gap between regulatory and HTA stakeholders needs by better design of studies (1)

• Post-authorisation studies in Europe: bridging the gap between regulatory and HTA stakeholders needs by better design of studies (2)

ENCePP plenary meeting - 12 November 2013

The 12th ENCePP plenary meeting will be taking place at the premises of the European Medicines Agency in London on Tuesday, 12 November 2013.

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

Related information:

» Draft Agenda, ENCePP Plenary Meeting 12/11/2013

» ENCePP Plenary Rules of Procedure and Mandate

European Medicines Agency begins to publish recommendations based on safety signals

The European Medicines Agency has published the first overview listing the recommendations stemming from the assessment of safety signals by the Pharmacovigilance Risk Assessment Committee (PRAC).

Related information:

» EMA News

ENCePP survey of EU Member States national legal requirements on data protection

ENCePP has published the results of a survey conducted among EU Member States on national requirements on data privacy for the conduct of pharmacoepidemiology research.

Related information:

» ENCePP outputs

ENCePP meeting with pharmaceutical industry

A report of the meeting between ENCePP and industry associations which took place on 22 May 2013 is now available.

Related information:

»  Meeting Report - ENCePP Steering Group & Industry Associations

Second revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology

The Guide continues to be the single most downloaded document on the ENCePP website with over 30,000 hits in 2012. The Guide is updated annually to maintain its dynamic nature and ENCePP has just published a second revision. New sections on ‘Effect modification’ and ‘Handling of missing data’ are included. A set of ‘Specific topics’ with two chapters on ‘comparative effectiveness research’ and ‘vaccine safety and effectiveness’ has also been inaugurated.

The revised guide continues to offer a single overview document and web resource for methodological guidance for both experienced and new researchers in pharmacoepidemiology and pharmacovigilance. For each topic covered, direct electronic access is given to internationally agreed recommendations and key points from important guidelines, published articles and textbooks after an introductory review. Where relevant, gaps in guidance have been addressed with what ENCePP considers good practice.  For ease of access to individual topics of interest, a web version has been published with links to each chapter and section. A consolidated version is also available for download.

Related information:

» ENCePP Guide on Methodological Standards in Pharmacoepidemiology

ENCePP plenary meeting - 18 June 2013

The 11th ENCePP plenary meeting will be taking place at the premises of the European Medicines Agency in London on Tuesday, 18 June 2013.

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

Related information:

» Draft Agenda, ENCePP Plenary Meeting 18/06/2013

» ENCePP Plenary Rules of Procedure and Mandate

ENCePP Leaflet

The ENCePP leaflet has been updated and is now available for download.

Related information:

» ENCePP Leaflet 2013

» About Us

ENCePP to meet with pharmaceutical industry

The ENCePP Steering Group will be meeting with representatives from the pharmaceutical industry on 22 May 2013 at the European Medicines Agency in London. The meeting aims to facilitate dialogue and establish the means to further enhance the use of the network for the conduct of post-authorisation studies. To facilitate discussions on the day a survey has been launched aiming at gathering feedback relating to the industry perception of ENCePP, its resources and guiding principles.

Related information:

» ENCePP Steering Group

Response from ENCePP Working Group on Health Technology Assessment (HTA) to public consultation on the Commission's delegated act on post-authorisation efficacy studies (PAES)

The ENCePP Working Group on Health Technology Assessment (HTA) has submitted a statement to the European Commission in response to the public consultation on the Commission's delegated act on post-authorisation efficacy studies (PAES).

Related information:

» Commission Consultation Paper

» Response document

ENCePP Checklist for Study Protocols (Revision 2)

The ENCePP Steering Group has adopted revision 2 of the ENCePP Checklist for Study Protocols. Revision 2 aligns the Checklist with the good pharmacovigilance practices (GVP) module VIII on post-authorisation studies.

Related information:

»ENCePP Checklist for Study Protocols (Revision 2)

» Standards & Guidances

» Good pharmacovigilance practices

ENCePP Work Plan 2013-2014

The ENCePP Steering Group has adopted the network's new two-year work plan. The agreed focus during 2013-2014 will be on optimisation of the network including continued capacity building and resource efficiency, and generating best evidence to support regulatory decision-making.

Related information:

ENCePP Work Plan 2013-2014

ENCePP Activities 2012

The ENCePP Secretariat has published a document summarising ENCePP activities in 2012. In addition to the key milestones achieved during 2012, the executive summary also includes some key metrics relating to research capacity building, as identified in the network's strategy for the impact evaluation of ENCePP, as well as some ENCePP website statistics.

Related information:

ENCePP Activities 2012 - Executive Summary