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
Close this folder6. PRACTICALITIES IN THE ORGANISATION OF A PHARMACOVIGILANCE CENTRE
View the document6.1 Staff
View the document6.2 Useful equipment (includes)
View the document6.3 Continuity
View the document6.4 Advisory Committees
View the document6.5 Information service
View the document6.6 Communications
View the document6.7 Poison Control and Drug Information Centres
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
 

6.1 Staff

The expertise desirable in the routines of a pharmacovigilance centre includes (see also § 7):

• clinical medicine
• pharmacology
• toxicology, and
• epidemiology.

However, a new pharmacovigilance centre often starts with only a part-time expert - usually a physician or a pharmacist - and some secretarial support. It may soon become necessary to have one expert who is responsible for pharmacovigilance for most of his/her time and for secretarial assistance to be expanded (see § 6.3, Continuity). When the reporting of adverse reactions increases, staff resource requirements may be calculated by assuming that the average assessment time per case report is about one hour.

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