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
Close this folder5. SPECIAL ISSUES IN REPORTING
View the document5.1 Central or decentralised reporting?
View the document5.2 Stimulation of reporting
View the document5.3 Under-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
 

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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