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Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre
(2000; 28 pages) [French]
Table of Contents
View the documentINTRODUCTION
View the document1. WHY PHARMACOVIGILANCE?
View the document2. DEFINITION AND AIMS
Open this folder and view contents3. HOW TO START A PHARMACOVIGILANCE CENTRE
Open this folder and view contents4. REPORTING OF ADVERSE DRUG REACTIONS
Open this folder and view contents5. SPECIAL ISSUES IN REPORTING
Open this folder and view contents6. PRACTICALITIES IN THE ORGANISATION OF A PHARMACOVIGILANCE CENTRE
Open this folder and view contents7. ASSESSMENT OF CASE REPORTS
Open this folder and view contents8. USE OF THE DATA
Open this folder and view contents9. RELATIONS WITH OTHER PARTIES
View the document10. OTHER SOURCES OF INFORMATION
View the document11. FUNDING
View the documentREFERENCES
View the documentGLOSSARY
View the documentCAUSALITY CATEGORIES
View the documentWHO 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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