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RSSOn 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 next ENCePP Plenary meeting will take place on Wednesday, 23 November 2011, 9.30-16.30 at the European Medicines Agency in London.
The 2nd joint DIA/EMA ENCePP Information Day will be taking place on Monday, 7 November 2011 at the European Medicines Agency in London.
On 19 August 2011 the ENCePP Steering Group adopted the first revision of the Checklist of Methodological Standards for ENCePP Study Protocols.
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.
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.
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 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.
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.
Since 2004 it is mandatory for sponsors of clinical trials to register their application with EudraCT, the EU clinical trials database.
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.
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.
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) .
On 5 November 2010, a public consultation was launched on a draft Guide on Methodological Standards in Pharmacoepidemiology.
The next ENCePP Plenary meeting will take place on Thursday, 18 November 2010, 9.30-16.30 at the European Medicines Agency in London.
The European Medicines Agency and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) have awarded the first 'ENCePP study' seal.
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.
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.
Launch of Database of Data Sources
This Work Plan defines the objectives and milestones for the year 2010 in the context of the implementation of the ENCePP network, as well as the means of achieving these objectives in a timely manner. T