Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre
(2000; 28 pages) [French]
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
Cerrar esta carpeta5. SPECIAL ISSUES IN REPORTING
Ver el documento5.1 Central or decentralised reporting?
Ver el documento5.2 Stimulation of reporting
Ver el documento5.3 Under-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
 

5.1 Central or decentralised reporting?

As a rule spontaneous monitoring aims at country-wide reporting and the use of one central pharmacovigilance database to obtain a national overview. The collection of data may nevertheless be more successful in number and quality if reporting is organised regionally, especially when countries are large or have regional cultural differences. Regional centres with short lines of communication to healthcare professionals may improve communications and feedback. When regional centres are used, good collaboration and data-exchange with the national centre needs to be ensured. Regionalisation requires more staff and facilities and can therefore be more expensive.

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