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
Close this folder9. RELATIONS WITH OTHER PARTIES
View the document9.1 The Drug Regulatory Authority
View the document9.2 Pharmaceutical companies
View the document9.3 Professional medical and pharmaceutical associations
View the document9.4 World Health Organization
View the document9.5 National pharmacovigilance centres
View the document9.6 Academia
View the document9.7 Media and consumer organisations
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
 

9.2 Pharmaceutical companies

Pharmaceutical companies need the same information as the regulatory authority. It will depend on the local situation whether companies are to be informed directly or via the regulatory authority.

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