Document complet  |  Dérouler chapitre  |  Etendre sommaire  |  Version HTML imprimable
Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre
(2000; 28 pages) [French]
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 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


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.

vers la section précédente
vers la section suivante
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 29 octobre 2018