EMA Reflection Paper on risk based Quality Management in Clinical Trials

The European Medicines Agency EMA has recently released a draft reflection paper on risk based quality management in clinical trials.

The purpose of this reflection paper is to facilitate the development of a more systematic, prioritised, risk-based approach to quality management of clinical trials, to support the principles of Good Clinical Practice and to complement existing quality practices, requirements and standards.

Please also see the reflection paper available for consultation for further details.

Comments related to this reflection paper should be provided using this template. The completed comments form should be sent to GCP@ema.europa.eu.

Please note that the deadline for comments for this reflection paper is 15 February 2012.