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 This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

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

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With kind regards,

Alessandro Camera | Medical Information Sector
European Medicines Agency | 7 Westferry Circus | Canary Wharf | London E14 4HB | United Kingdom
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