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
Close this folder4. REPORTING OF ADVERSE DRUG REACTIONS
View the document4.1 Reporting form
View the document4.2 Reporting by whom?
View the document4.3 What to report?
View the document4.4 Mandatory or voluntary reporting?
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
 

4. REPORTING OF ADVERSE DRUG REACTIONS

Spontaneous reporting - a regional or country-wide system for the reporting of suspected adverse drug reactions - is currently the major source of information in pharmacovigilance.

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