New European clinical trials directive

European Commission considers revisions to clinical trials directive.

T he cancer community is hoping for important revisions to how clinical trials are run in Europe as the European Commission (EC) sets about overhauling the much-criticized Clinical Trials Directive. Adopted in 2001 and implemented by all EU member states in 2004, the directive aimed to create a harmonized framework for clinical research, as well as to improve patient safety and procedures for e...

Harmful impact of EU clinical trials directive.

Clinical Trials Legislation - preparing for the revision of the European Directive Scheduled for 2011.

The aim of the Round Table was to make recommendations with regard to the imminent revision of the European Directive on clinical drug trials (2001/20/CE). While recognising the importance of compliance with this Directive, which is not optimal in some member states of the European Union, it would be constructive to simplify further and harmonise its application in every country. Without necess...

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 ...

The European vibration directive.

The European Union adopted a Directive in 2002 on minimum requirements for the health and safety of workers exposed to vibration. This is known as the Physical Agents (Vibration) Directive. It builds on existing general employers' duties to manage risks to health and safety, and introduces exposure action and limit values for both hand-arm vibration and whole-body vibration, setting minimum sta...