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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
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
 

11. FUNDING

An estimation of the amount of money needed for pharmacovigilance can be calculated as a function of the rate of reporting required and the size of the population (see § 5.3 and 6.1). The collection of quantitatively and qualitatively good data and the careful assessment and distribution of such information obviously have a price. A pharmacovigilance centre should have some basic, regular source of funding in order to ensure continuity in its work. Such funding may be obtained as part of the drug registration fee, or through a special mandatory pharmacovigilance contribution. Both can be included in the budget of the drug regulatory authority.

Apart from the basic resources, the centre may try to get additional funding from various parties with an interest in pharmacovigilance. Institutions that may be approached include:

• health insurance companies and health insurance funds
• university departments
• professional associations
• governmental departments with an interest in drug safety.

In view of the great commercial and public health consequences of adverse reactions, the continuity of the funding of pharmacovigilance should be guaranteed and not be susceptible to possible pressure groups, political changes or economic factors.

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