Implementation of the Clinical Trials Directive: Pitfalls and Benefits
European Journal of Health Law 2002 March; 9(1): 31-47
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Baeyens, A.J. (2004)With the adoption of the Clinical Trials Directive it was Europe's intention to make the performance of multi-national clinical trials in Europe easier through the harmonization of the regulatory procedures. As the Directive ...
'(More) Trials and Tribulations': The Effect of the EU Directive on Clinical Trials in Intensive Care and Emergency Medicine, Five Years After Its Implementation Robinson, Katy; Andrews, Peter J D (2010-06)The European Clinical Trials Directive was issued in 2001 and aimed to simplify and harmonise the regulatory framework of clinical trials throughout Europe, thus stimulating European research. However, significant complexity ...
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Relating to the Implementation of Good Clinical Practice in The Conduct of Clinical Trials on Medicinal Products for Human Use Unknown author (European Parliament; Council of the European Union, 2002-03)