"Clinical Trials in Europe: a 2011 Perspective“, Presented in Princeton at the ‘Meeting on Clinical trials in Europe’, September 2011

  • Requirements for the conduct of clinical trials in the EU are provided for in "Directive 2001/20/EC (301 KB) 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" ("the Clinical Trials Directive (301 KB)").
  • The Clinical Trials Regulation aims to create an environment that is favourable for conducting clinical trials, with the highest standards of patient safety, for all EU Member States. Intrinsic to this is the simplification of current rules.
  • The presentation lays focus on clinical trials associated with skin diseases which are extremely common in Europe and becoming even more prevalent. It is estimated that at least one quarter of Europeans have a skin disease at any one time. Some 20% of pre-school children in Europe have atopic dermatitis, and 2% of Europeans suffer from psoriasis. Due to the increasing age of the population and damaging environmental factors, the frequency of skin diseases is also rapidly increasing. It is no surprise to learn then that skin diseases pose a significant burden on public health in Europe.
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