Risk based quality management in clinical trials workshop

• Date:
  Monday, 2 December 2013, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

Workshop on risk-based quality management in clinical trials 2-3 December 2013: Summaries of the presentations

Reference Number: EMA/84016/2014

Agenda - Risk-based quality management in clinical trials workshop

Draft Reference Number: EMA/314826/2013 Summary:

Workshop organised by the European Medicines Agency 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. The workshop will be held at the European Medicines Agency (EMA).