Risk based quality management in clinical trials workshop

Date: 02/12/2013 to 03/12/2013
Location: European Medicines Agency, London, UK
The European Medicines Agency (EMA) is holding a one-and-a-half day workshop on risk based quality management in clinical trials. This workshop is being hosted by EMA in conjunction with the Clinical Trial Transformation Initiative (CTTI), a public-private partnership founded by the U.S. Food and Drug Administration (FDA) and Duke University. This workshop follows up the recent publication of the European reflection paper on 'Risk based quality management in clinical trials' after its public consultation. It intends to further develop understanding of risk based approach to quality management of clinical trials and promote discussions among stakeholders on how to move towards a more systematic, prioritised, risk-based approach to quality management of clinical trials in order to support the principles of Good Clinical Practice and to complement existing quality practices, requirements and standards.Registration closed.

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