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Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre
(2000; 28 pages) [French]
Abstract
This booklet aims to provide practical guidelines and information for the setting up of new Pharmacovigilance Centres...Criteria for this development are not only the functioning of the centre in question itself, but also the presence of an effective drug regulatory body in the country that has the will and the potential to react to signals emanating from the centre and to take proper regulatory measures. WHO considers this point as vital: a pharmacovigilance system must be backed up by the regulatory body...
Table of Contents
View the documentINTRODUCTION
View the document1. WHY PHARMACOVIGILANCE?
View the document2. DEFINITION AND AIMS
Open this folder and view contents3. HOW TO START A PHARMACOVIGILANCE CENTRE
Open this folder and view contents4. REPORTING OF ADVERSE DRUG REACTIONS
Open this folder and view contents5. SPECIAL ISSUES IN REPORTING
Open this folder and view contents6. PRACTICALITIES IN THE ORGANISATION OF A PHARMACOVIGILANCE CENTRE
Open this folder and view contents7. ASSESSMENT OF CASE REPORTS
Open this folder and view contents8. USE OF THE DATA
Open this folder and view contents9. RELATIONS WITH OTHER PARTIES
View the document10. OTHER SOURCES OF INFORMATION
View the document11. FUNDING
View the documentREFERENCES
View the documentGLOSSARY
View the documentCAUSALITY CATEGORIES
View the documentWHO CONTACTS
 

Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre


World Health Organization

Published by

the Uppsala Monitoring Centre
(the UMC), WHO Collaborating Centre for
International Drug Monitoring
Stora Torget 3, S-75320 Uppsala,
Sweden

Tel: +46 18 65 60 60
Fax: +46 18 65 60 80
E-mail: info@who-umc.org
Internet: www.who-umc.org

Copyright © 2000 the Uppsala Monitoring Centre

ISBN 91-630-9004-X

This document is not a formal publication of the World Health Organization (WHO) and all rights are reserved by the WHO Collaborating Centre for International Drug Monitoring (the UMC). The document may nevertheless be freely reviewed, abstracted, reproduced or translated into any other language (but not for sale) provided that full acknowledgement is given to the source.

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