Markus Hartmann and Florence Hartmann-Vareilles examine the impact of the European Union Clinical Trials Directive and argue that adopting a risk-proportionate regulatory approach could help simplify the legislative framework.
The negative impact of the European Union Clinical Trials Directive (Directive 2001/20/EC)1 on pharmaceutical clinical research has been a major source of concern for drug sponsors and academic researchers since the legislation was implemented in 2004...
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