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Drug Safety Operations: Good Pharmacovigilance Practice in the EU

Drug Safety Operations: Good Pharmacovigilance Practice in the EU

Jutta Syha, Klaus Syha

ISBN: 978-3-527-67361-2

Jun 2019

350 pages

Select type: E-Book

$108.99

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Description

An indispensable step by step practical guide on the regulatory environment of pharmacovigilance focusses on EU regulations, incorporating each draft of the new EMA framework and putting them in a global context.
Introduction
1 Strategic Aspects
2 Operational Aspects
3 Quality management
4 Human Capital
5 Culture
6 Knowledge Management
7 Financial Aspects
8 Impact of Pharmacovigilance on the perfomance of the Company