Risk management - A European regulatory perspective

被引：7
|
作者：
Moseley, JNS [1 ]
机构：
[1] Med & Healthcare Prod Regulatory Agcy, Pharmacoepidemiol Res Team, London SW8 5NQ, England
来源：
DRUG SAFETY | 2004年 / 27卷 / 08期
关键词：
European Union; Medicinal Product; Marketing Authorisation; Orphan Medicinal Product; Marketing Authorisation Application;
D O I：
10.2165/00002018-200427080-00003
中图分类号：
R1 [预防医学、卫生学];
学科分类号：
1004 ; 120402 ;
摘要：
Risk management for European regulators means the detection and assessment of risks, the development and selection of measures to reduce risk, and monitoring of the effectiveness of risk control; all aspects of pharmacovigilance intended to minimise risk to European Union citizens associated with use of medicinal substances. This incorporates earlier and better planning of pharmacovigilance through formal product risk-management plans, better use of information tools to protect public health and routine audit of effectiveness of regulatory action.
引用
收藏
页码：499 / 508
页数：10
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