@Regulatory: March 2013
Quality systems that support EMA good pharmacovigilance practices
The regulatory environment around safety is beginning to change. The European Medicines Agency (EMA) published its first set of seven Good Pharmacovigilance (GVP) modules in June 20121 , after a public consultation period that went from February to April 2012. In total, EMA anticipates 16 modules with the remainder expected to be released for consultation in 2013.
While corporate quality and safety departments have long had standing relationships and interactions across multiple processes, the collaboration has usually been centered around the identification and remediation of safety concerns arising during the manufacturing process. The design of a comprehensive but efficient GVP system should promote and enhance the monitoring and remediation of safety issues beyond the manufacturing process.
This month’s edition features insights on quality systems that support EMA good pharmacovigilance practices and the impact that this will have on a comprehensive design of an efficient GVP system
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1.Guideline on good pharmacovigilance practices (GVP), European Medicines Agency, Effective July 2, 2012