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22 October 2009 /Side effects and trials

Changed definition of safe contraception in clinical trials

We have updated section 5.1 Contraception in the Guideline for applications for authoristaion of clinical trials of medicine product in humans.
25 June 2009 /Side effects and trials

EudraCT has been updated to version 7

On 19 June 2009, EudraCT was updated to version 7. Please visit EudraCT's website for an overview of the new functionality.
06 May 2009 /Side effects and trials

Voluntary Harmonisation Procedure (VHP) for the assessment of multinational clinical trial applications

The Voluntary Harmonisation Procedure is a procedure which makes it possible to obtain a coordinated assessment of an application for a clinical trial that is to take place in several European countries.