Change is in the air for the European Clinical Trials Directive
May 1st 2010Though many advantages are associated with the European Clinical Trials Directive, complexities have emerged since its introduction in 2004. Since 2007, efforts have been made to raise the issues and address the negative impact of the Directive.
The changing face of European regulatory affairs
April 1st 2010In 1995, pharmaceutical regulation in Europe underwent a dramatic change with the emergence of the European Medicines Agency. The agency's 15-year history has been eventful, with it having to adapt to a changing regulatory landscape and new expectations from those relying on it for guidance.