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Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre
(2000; 28 pages) [French]
Abrégé
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 des matières
Afficher le documentINTRODUCTION
Afficher le document1. WHY PHARMACOVIGILANCE?
Afficher le document2. DEFINITION AND AIMS
Ouvrir ce répertoire et afficher son contenu3. HOW TO START A PHARMACOVIGILANCE CENTRE
Ouvrir ce répertoire et afficher son contenu4. REPORTING OF ADVERSE DRUG REACTIONS
Ouvrir ce répertoire et afficher son contenu5. SPECIAL ISSUES IN REPORTING
Ouvrir ce répertoire et afficher son contenu6. PRACTICALITIES IN THE ORGANISATION OF A PHARMACOVIGILANCE CENTRE
Ouvrir ce répertoire et afficher son contenu7. ASSESSMENT OF CASE REPORTS
Ouvrir ce répertoire et afficher son contenu8. USE OF THE DATA
Ouvrir ce répertoire et afficher son contenu9. RELATIONS WITH OTHER PARTIES
Afficher le document10. OTHER SOURCES OF INFORMATION
Afficher le document11. FUNDING
Afficher le documentREFERENCES
Afficher le documentGLOSSARY
Afficher le documentCAUSALITY CATEGORIES
Afficher le 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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Tel: +44 (0)20 7274 8724
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Le Portail d'information - Médicaments essentiels et produits de santé a été conçu et est maintenu par l'ONG Human Info. Dernière mise à jour: le 5 novembre 2014