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Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre
(2000; 28 pages) [French]
Resumen
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...
Índice de contenido
Ver el documentoINTRODUCTION
Ver el documento1. WHY PHARMACOVIGILANCE?
Ver el documento2. DEFINITION AND AIMS
Abrir esta carpeta y ver su contenido3. HOW TO START A PHARMACOVIGILANCE CENTRE
Abrir esta carpeta y ver su contenido4. REPORTING OF ADVERSE DRUG REACTIONS
Abrir esta carpeta y ver su contenido5. SPECIAL ISSUES IN REPORTING
Abrir esta carpeta y ver su contenido6. PRACTICALITIES IN THE ORGANISATION OF A PHARMACOVIGILANCE CENTRE
Abrir esta carpeta y ver su contenido7. ASSESSMENT OF CASE REPORTS
Abrir esta carpeta y ver su contenido8. USE OF THE DATA
Abrir esta carpeta y ver su contenido9. RELATIONS WITH OTHER PARTIES
Ver el documento10. OTHER SOURCES OF INFORMATION
Ver el documento11. FUNDING
Ver el documentoREFERENCES
Ver el documentoGLOSSARY
Ver el documentoCAUSALITY CATEGORIES
Ver el documentoWHO 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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