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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
 

10. OTHER SOURCES OF INFORMATION

Spontaneous Reporting is especially useful in picking up signals of relatively rare, serious and unexpected adverse reactions. For less rare adverse reactions several other methods may be used, e.g. clinical trials or cohort studies. In addition to spontaneous reporting several other methods have become available to provide data relevant to pharmacovigilance. Examples are: Prescription Event Monitoring, Case-Control Surveillance and linkage of records from multipurpose databases. In addition, drug utilisation data is of value in safety assessment.

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