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EMA consults on risk-based auditing of pharmacovigilance systems, communicating safety info

This article was originally published in Scrip

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Executive Summary

The European Medicines Agency is seeking feedback on two draft modules to be included in its good pharmacovigilance practice guideline (GVP). The latest modules pertain to pharmacovigilance audits and communication of safety information.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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