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.

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Comments related to this reflection paper should be provided using this template. The completed comments form should be sent to Cette adresse email est protégée contre les robots des spammeurs, vous devez activer Javascript pour la voir. .

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

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Alessandro Camera | Medical Information Sector
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