Risk management plans – one year on from the EMEA guidelines

被引：0
|
作者：
R Stather
机构：
来源：
Reactions Weekly | 2006年 / 1130卷 / 1期
关键词：
Risk Management; Marketing Authorisation; Safety Specification; Risk Management Plan; Pharmacovigilance Activity;
D O I：
10.2165/00128415-200611300-00005
中图分类号：
学科分类号：
摘要：
In November 2005, the European Medicines Agency, the EMEA, published its guidelines on risk management plans (RMPs). Just under a year later, in order to aid consistency of the format and content of such plans, the EMEA released a template for companies to use when submitting what have become known as 'EU-RMPs'. It was therefore timely that the topic of one of this year's pre-conference training sessions at the 6th Annual Meeting of the International Society of Pharmacovigilance [Liege, Belgium; October 2006] was RMPs.1,2
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页数：1
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