Pharmacovigilance Legislation: The Impact of What Is Happening in Europe

被引：3

作者：

Dollen, Miranda Z. ^{[1
]}

机构：

[1] OptumInsight Canada Inc, Dundas, ON L9H 7P3, Canada

来源：

THERAPEUTIC INNOVATION & REGULATORY SCIENCE | 2014年 / 48卷 / 02期

关键词：

pharmacovigilance; Good Pharmacovigilance Practice; legislation; Europe;

D O I：

10.1177/2168479013503167

中图分类号：

R-058 [];

学科分类号：

摘要：

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.

引用

页码：190 / 199

页数：10