Disease surveillance as well as accurate and timely reporting for adverse events is the mainstay of pharmacovigilance (PV) programs, aiming at ensuring patient safety and enhancing patient care in relation to the use of a drug or a vaccine.
In anticipation of the possible introduction of the RTS,S/AS01E candidate malaria vaccine, GlaxoSmithKline (GSK) Biologicals will run, in a few sub-Saharan African countries, “A prospective study to estimate the incidence of diseases specified as adverse events of special interest, of other adverse events leading to hospitalization or death, and of meningitis in infants and young children in sub-Saharan Africa prior to implementation of the RTS,S/AS01E candidate vaccine (EPI-MAL-002, clinTrials.gov number NCT02374450)”, followed by “a prospective study to evaluate the safety, effectiveness and impact of the RTS,S/AS01E vaccine in infants and young children when introduced in sub-Saharan Africa (EPI-MAL-003)”.
In this context, AMP has designed and is implementing a training program in pharmacovigilance and disease surveillance that will support the accurate conduct of both studies. Moreover, AMP will build the capacity of medical and non-medical health workers from the study sites.
The training program is the result of collaboration between several partners: GSK Biologicals, AMP, Lomé University, Geneva University Hospital (HUG), Association des pédiatres du secteur privé du Bénin, principal sites investigators of the studies, and local public health authorities. It will benefit around 1,200 people.