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

页码：499 / 508

页数：10