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RSSThe ENCePP Steering Group has adopted revision 2 of the ENCePP Checklist for Study Protocols.
The ENCePP Steering Group has adopted the network's new two-year work plan.
The European Medicines Agency (EMA) will establish and maintain an EU PAS Register for registration of non-interventional PASS, as described in GVP chapter VIII.B.4.
The 10th ENCePP Plenary meeting will be taking place at the premises of the European Medicines Agency on Thursday, 11 October 2012.
On 13 June 2012 the ENCePP Steering Group adopted the first revision of the Guide on Methodological Standards in Pharmacoepidemiology.
The European Medicines Agency has published information on research activities on medicine safety that may be funded by the European Commission's Seventh Framework Programme (FP7).
The purpose of this call is to enable the EMA to obtain fast and reliable answers to questions on safety or benefit:risk concerns, and ultimately facilitating regulatory decision-making.
The first meeting of the new ENCePP Steering Group took place on 21 March 2012 at the European Medicines Agency in London.
The European Medicines Agency has released the first batch of modules on good pharmacovigilance practice (GVP) for public consultation.
On 21 November 2011 the ENCePP Steering Group adopted the 2nd revision of the Code of Conduct 1 year after its initial launch.
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 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.