(2000; 28 pages) [French]
The expertise desirable in the routines of a pharmacovigilance centre includes (see also § 7):
• clinical medicine
• toxicology, and
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.