Essential medicines and health products

Meetings & Activities

Training on signal detection and causality assessment

5-6 December 2016, Mombasa (Kenya)

The WHO strategy to strengthen pharmacovigilance (PV) systems and practices involves improving the qualitative and quantitative aspects of PV information and analysis of the information collected. In line with this strategy, WHO Safety and Vigilance team organized a training session on quality grading of Individual Case Safety Reports (ICSRs), causality assessment and signal detection from 5 to 6 December 2016 in Mombasa, Kenya with the Kenya Pharmacy and Poisons Board as the local host.
The course content was based on the assumption that knowledge of the clinical significance of reported values within an ICSR would improve the quality of ADR reports over time and ultimately, the capacity to detect PV signals in countries. The quality of reports will be compared over time, to study the impact of this and similar training courses.

The two-day training consisted of presentations and, hands on exercises on causality assessments, and interactive sessions on quality of reporting and signal detection and models of work-sharing among countries. The session was led by WHO and experts from the WHO Collaborating Centres in Morocco and Sweden; and from the National Pharmacovigilance Centre in Cape Verde. Consultants with an interest in pharmacovigilance whose focus is on drug safety issues in the African setting participated in the training. Representatives came from Burundi, Cabo Verde, Ethiopia, Kenya, Liberia, Nigeria, Rwanda, Sierra Leone, Tanzania, Uganda, Zanzibar and Zimbabwe. Further support by WHO and a follow-up of quality of ICSRs is planned in 2017.