Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre
(2000; 28 pages) [French]
Índice de contenido
Ver el documentoINTRODUCTION
Ver el documento1. WHY PHARMACOVIGILANCE?
Ver el documento2. DEFINITION AND AIMS
Abrir esta carpeta y ver su contenido3. HOW TO START A PHARMACOVIGILANCE CENTRE
Abrir esta carpeta y ver su contenido4. REPORTING OF ADVERSE DRUG REACTIONS
Abrir esta carpeta y ver su contenido5. SPECIAL ISSUES IN REPORTING
Cerrar esta carpeta6. PRACTICALITIES IN THE ORGANISATION OF A PHARMACOVIGILANCE CENTRE
Ver el documento6.1 Staff
Ver el documento6.2 Useful equipment (includes)
Ver el documento6.3 Continuity
Ver el documento6.4 Advisory Committees
Ver el documento6.5 Information service
Ver el documento6.6 Communications
Ver el documento6.7 Poison Control and Drug Information Centres
Abrir esta carpeta y ver su contenido7. ASSESSMENT OF CASE REPORTS
Abrir esta carpeta y ver su contenido8. USE OF THE DATA
Abrir esta carpeta y ver su contenido9. RELATIONS WITH OTHER PARTIES
Ver el documento10. OTHER SOURCES OF INFORMATION
Ver el documento11. FUNDING
Ver el documentoREFERENCES
Ver el documentoGLOSSARY
Ver el documentoCAUSALITY CATEGORIES
Ver el documentoWHO 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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