ENCePP Activities 2011

The ENCePP Secretariat has published a document summarising ENCePP activities in 2011. In addition to the key milestones achieved during 2011, 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.

For more information see:

- Report on ENCePP Activities in 2011

ENCePP Guide on Methodological Standards in Pharmacoepidemiology - Revision 1

ENCePP has started the first annual revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology. In order to collect comments from interested parties, a line- numbered version and a template for comments (Excel worksheet) have been made available on the ENCePP website. Comments should be sent before 31 March 2012 to encepp_comments@ema.europa.eu, preferably using the template.

Related information:

- ENCePP Standards & Guidances

ENCePP Code of Conduct - Revision 2
On 21 November 2011 the ENCePP Steering Group adopted the 2nd revision of the Code of Conduct 1 year after its initial launch.

The review also resulted in a revision of the Implementation Guidance for the Sharing of ENCePP Study Data (Annex 4 to the Code) providing further clarification on the Code’s requirement to provide access to data and the introduction of a form to declare interests (Annex 5).

For more information see:

- Summary of the main amendments introduced with the 2nd revision

- ENCePP Code of Conduct

ENCePP interpretation of the definition of non-interventional trials

On 22 November 2011 the ENCePP Steering Group adopted the ENCePP position paper on the interpretation of the definition of non-interventional trials under the current legislative framework (“Clinical Trials Directive” 2001/20/EC). The aim of this position paper is to promote a common interpretation and understanding of the definition of ‘non-interventional trial’ in the context of the current legislative framework and based on widely accepted methodological definitions and clinical practice. This, in turn, is to further facilitate post-authorisation medicines research, thereby protecting and promoting public health.

For more information see:

- ENCePP interpretation of the defintion of non-interventional trials

ENCePP Linking Policy & Third Party Announcements in ENCePP Partners Forum

The ENCePP Steering Group recently adopted the 'ENCePP Linking Policy' providing guidance relating to links to third party websites and the announcement of third party activities on the ENCePP website.

In parallel, a process has been put in place to deal with requests from third parties to post announcements in the ENCePP Partners Forum.

For more information see:

- ENCePP Linking Policy

- Notice Board

- Contact Us

ENCePP Plenary Meeting - 23 November 2011

The next ENCePP Plenary meeting will take place on Wednesday, 23 November 2011, 9.30-16.30 at the European Medicines Agency in London. ENCePP partners wishing to nominate a representative who will attend this event are invited to do so via the electronic pre-registration form.

For further information see:

- Mandate and Rules of Procedure of the ENCePP Plenary

- Draft Agenda

ENCePP Information Day

The 2nd joint DIA/EMA ENCePP Information Day will be taking place on Monday, 7 November 2011 at the European Medicines Agency in London. This information day is aimed at pharmaceutical industry staff, in particular those responsible for risk management plans and post-authorisation studies (e.g. pharmacovigilance, pharmacoepidemiology and regulatory affairs) and academics, regulators, editors of medical journals, funding bodies and other professionals specialising in the field of observational research.

For more information see:

- ENCePP Information Day Programme

To register for this event, please visit the DIA Website

ENCePP Checklist for Study Protocols

On 19 August 2011 the ENCePP Steering Group adopted the first revision of the Checklist of Methodological Standards for ENCePP Study Protocols. The major outcome of the revision has been to make the Checklist a 'stand-alone' document in line with the ENCePP Guide on Methodological Standards. This also reflects more general use of the Checklist outside the context of an application for ENCePP study status. The name of the Checklist has, therefore, been amended to "ENCePP Checklist for Study Protocols" (Revision 1). The revision does not, however, interfere with the Checklist being a requirement for ENCePP studies and for obtaining an ENCePP seal.

For more information see:

- Standards & Guidances

ENCePP Workshop with Medical Journal Editors

On 29 June 2011 a workshop with medical journal editors took place with the aim of introducing ENCePP and its key principles to journal editors and to obtain their feedback on the initiative. A record of the meeting is available here.

7th ENCePP Plenary Meeting

The seventh plenary meeting of ENCePP which took place on 30 June 2011 has heard that the network has grown considerably over the past few months, with over 100 resources from 17 different European countries now registered. With a record attendance from ENCePP partners, the meeting featured sessions on the possible interaction between ENCePP and health-technology-assessment bodies and the definition of non-interventional trials. Representatives from the United States Food and Drug Administration and Health Canada also attended, providing updates on their national initiatives on the safety monitoring of medicines after authorisation.

Meeting report:

- 7th ENCePP Plenary Meeting Report

ENCePP Plenary Meeting – 30 June 2011

The next ENCePP Plenary meeting will take place on Thursday, 30 June 2011, 9.30-16.30 at the European Medicines Agency in London. ENCePP partners wishing to nominate a representative who will attend this event are invited to do so via the electronic pre-registration form.

For further information see:

- Mandate and Rules of Procedure of the ENCePP Plenary

- Draft Agenda (Update 22 June 2011)

ENCePP Reponse to the Revision of the CT Directive

ENCePP has submitted a response to the European Commission’s public consultation on the concept paper on the revision of the ‘Clinical Trials Directive’ 2001/20/EC. The key message from ENCePP is in relation to an amended definition of a non-interventional trial and a link to the ENCePP contribution is provided below.
Meanwhile, looking to the current definition, the interpretation of current clinical practice and the role of ethics committees for non-interventional studies will be elaborated in a position paper that is being developed by ENCePP on the interpretation of the definition of a non-interventional trial within Directive 2001/20/EC. The final position paper relating to the current legal framework will be available in Q3 2011.

For more information see:

- Commission Concept Paper

- ENCePP Response

ENCePP Q & A

A new Q&A section has been added to this website which provides answers to the most frequently asked questions about ENCePP and its key principles.

Please see: ENCePP Q & A

Guide on Methodological Standards in Pharmacoepidemiology

On 3 May 2011 the ENCePP Steering Group adopted the Guide on Methodological Standards in Pharmacoepidemiology, an important tool that reviews and gives direct electronic access to methodological guidance for research in pharmacoepidemiology and pharmacovigilance.

The guide provides a framework for thinking and learning on study design and methods through the presentation of internationally agreed recommendations and key points from important English-language guidelines, published articles and textbooks. The intention is to go further than compile an inventory of existing guidelines and to offer the researcher a single overview document and web resource with a brief introduction or overview of the relevant recommendations. Gaps in guidance in areas important to collaborative pharmacoepidemiology research have been addressed with what ENCePP considers as good practice. The guide focuses on scientific rather than regulatory guidance.

For more information see:

- Standards & Guidances

ENCePP Activities 2010

The ENCePP Secretariat has published an executive summary of ENCePP Activities 2010 which is available here.

Public Access to a Number of EudraCT Data Fields

Since 2004 it is mandatory for sponsors of clinical trials to register their application with EudraCT, the EU clinical trials database. As of 22 March 2011, the European Medicines Agency released to the public an extract from EudraCT that allows the search for information on clinical trials in European Union (EU) member states and the European Economic Area (EEA) and clinical trials which are conducted outside the EU/EEA if they form part of a paediatric investigation plan (PIP). Users can find information on the design of each clinical trial, the sponsor, the investigational medicinal products, the therapeutic areas involved and the status (authorised, ongoing, complete) of the clinical trial, but the website does not provide information on the results of clinical trials.

Historical data (information entered into the EudraCT database between 1 May 2004 and the release of version 8.0 of the EudraCT database on 10th March 2011) will be gradually published online from 22 March 2011.

For more information see:

- European Medicines Agency Press Release

- EU Clinical Trials Register

ENCePP Response to Public Consultation on the Commission's comprehensive approach on personal data protection in the European Union

ENCePP has submitted a statement to the European Commission in response to the public consultation on the Commission's communication on a comprehensive approach on personal data protection in the European Union.

For more information see:

- Commission communication on data protection COM(2010)609 of 4/11/2010

- ENCePP Response

ENCePP Work Plan 2011-2012

The ENCePP Steering Group has adopted the ENCePP Work Plan 2011-2012. Building on the initial phase of establishment, during 2011 and 2012 the priority will be to consolidate ENCePP as an important and internationally renowned resource in the field of pharmacovigilance and pharmacoepidemiology that delivers for health protection and promotion.

More details here >>

Public Consultation - Summary of comments received

The comments received in response to the public consultations on the ENCePP Code of Conduct and the Checklist of Methodological Standards for ENCePP Study Protocols and their outcomes have been published on the ENCePP website.

For more information see:

- Overview of comments received: Code of Conduct

- Overview of comments received: Checklist of Methodological Standards

Report of the 6th ENCePP Plenary

The report of the 6th ENCePP Plenary which took place at the European Medicines Agency on 18 November 2010 has been published.

More details here >>

Launch of E-Register of Studies

On 18 November 2010, the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) launched the electronic ENCePP Register of Studies (E-Register of Studies) that aims to provide a publicly accessible resource for the registration of pharmacoepidemiological and pharmacovigilance studies.

Registration of studies in the E-Register of Studies is one of the "CoRe requirements" of being an "ENCEPP Study" and is, therefore, mandatory for “ENCePP Studies” only. All other studies, including those that do not qualify as an "ENCePP Study" (e.g. studies that have already started) can still register in the E-Register of Studies and their submission is encouraged.

For more information see:

 - Press Release

 - E-Register of Studies

 - ENCePP Studies

Public Consultation: ENCePP Guide on Methodological Standards in Pharmacoepidemiology

On 5 November 2010, a public consultation was launched on a draft Guide on Methodological Standards in Pharmacoepidemiology. The Guide seeks to assure high quality pharmacoepidemiological "ENCePP Studies", to fuel learned regulatory decision making and to stimulate innovation that benefits patients and public health at large.

More details here >>

ENCePP Plenary Meeting -18 November 2010

The next ENCePP Plenary meeting will take place on Thursday, 18 November 2010, 9.30-16.30 at the European Medicines Agency in London. ENCePP partners wishing to nominate a representative who will attend this event are invited to do so via the electronic pre-registration form.

For further information see:

Mandate and Rules of Procedure of the ENCePP Plenary

Draft Agenda

European Medicines Agency awards first 'ENCePP study' seal for post-marketing study

The European Medicines Agency and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) have awarded the first 'ENCePP study' seal to an observational study investigating the "long-term outcomes and adverse events of therapy with inhaled corticosteroids, long-acting beta-2-agonists and anticholinergic drugs in hospitalised patients with Chronic Obstructive Pulmonary Disease (COPD)". The study is coordinated by the Department of Epidemiology, Lazio Regional Health Service.

For further information see: Press release published on 1st October 2010

ENCePP Code of Conduct - Revision 1

On 12 September 2010 the ENCePP Steering Group adopted a revision of the Code of Conduct and implementation guidance to clarify the conditions of providing access to study data.

For further information see: ENCePP Code of Conduct

DIA ENCePP Information Day

The DIA ENCePP Information Day will take place on 26 November 2010
at De Vere Venues Canary Wharf, London.

For further information and detailed programme see:
- ENCePP Information Day Programme

To register for this event, please visit the DIA website.

Funding Opportunities for Adverse Drug Reaction Research through the European Commission's 7th Framework Programme

In an effort to stimulate collaboration and thus facilitate the establishment of consortia, the ENCePP Secretariat has created a new section in the ENCePP partners' forum entitled "FP7 5th Call", with subsections for each topic. We hope this will give ENCePP partners the opportunity to express their interest in participating (or even leading a project consortium!)  in each individual topic.

For further information see: Announcement of EMA priorities - 5th Call FP7