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RSSThe Clinical Trials Regulation was published on 27 May 2014 in the Official Journal of the European Union (EU). The new legislation will not come into force until the necessary IT platforms to support the exchange of information are in place (see Articles 80 and 81).
On 21 February 2014 the ENCePP Steering Group adopted the 3rd revision of the ENCePP Code of Conduct.
The most recent version of the Declaration of Helsinki was adopted by the 64th World Medical Association (WMA) General Assembly in October 2013.
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.
The 12th ENCePP plenary meeting will be taking place at the premises of the European Medicines Agency in London on Tuesday, 12 November 2013.
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).
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.
A report of the meeting between ENCePP and industry associations which took place on 22 May 2013 is now available.
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.
The 11th ENCePP plenary meeting will be taking place at the premises of the European Medicines Agency in London on Tuesday, 18 June 2013.
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 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).
The 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.