Pharmacovigilance Legislation

Abstract

Pharmaceutical companies, regulatory agencies, and contract service organizations are managing substantial and ongoing changes to pharmacovigilance legislation in the European Economic Area, and penalties for noncompliance are potentially large. Given that the majority of pharmaceutical companies and contract service organizations have global reach, the impact of this change is being felt far beyond the boundaries of the European Economic Area.

Keywords

pharmacovigilance Europe legislation Good Pharmacovigilance Practice

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References

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