ENCEPP CONSIDERATIONS ON THE DEFINITION OF NON-INTERVENTIONAL TRIALS UNDER THE CURRENT LEGISLATIVE FRAMEWORK (“CLINICAL TRIALS DIRECTIVE” 2001/20/EC) Agreed by the European Network of Centres for Pharmacoepidemiology

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology (Revision 2)

Comment of the Network of Coordinating Centers for Clinical Trials (KKS-Network), Germany on the Concept Paper Submitted for Public Consultation on 09/02/2011 Revision of the Clinical Trials Directive 2001/20/EC

The KKS-Network, which is the German network of academic clinical trial units, welcomes the Public Consultation Paper of the European Commission concerning the Revision of the Clinical Trials Directive 2001/20/EC. We are grateful to be able to provide input into the current discussion process. Furthermore, we very much appreciate, that the comments of the academic clinical research community wh...

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology (Revision 1)

Proposed revisions to the EU clinical trials directive--comments from the European Resuscitation Council.

An editorial written by Fritz Stertz et al. in 2002 and pubished in this journal was one of the first to highlight concerns bout the introduction of a new European Union (EU) clinical trils directive (Clinical Trials Directive 2001/20/EC) particularly for esearch in emergency settings.1 The directive sought “to simplify nd harmonize the administrative provisions governing clinical rials in the ...