Information and Guidelines of the European Medicines Agency, EMA

The European Medicines Agency 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.

The document is available for consultation by clicking here: Scientific guideline

Comments related to this reflection paper should be provided using this template.

The completed comments form should be sent to This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Deadline for comments: 15 February 2012.