Signal Management Process

The Signal Management Process encompasses a comprehensive sequence of tasks, including signal detection, signal validation, signal confirmation, signal analysis and prioritization, signal assessment, and ultimately, the formulation of recommended actions.

This process is designed to systematically ascertain whether, through a meticulous evaluation of individual case safety reports (ICSRs), aggregated data stemming from active surveillance systems or research endeavors, literature findings, or other pertinent data sources, there emerges evidence of novel risks causally linked to an active substance or medicinal product.

Additionally, this process examines whether established risks have undergone any alterations in their characteristics or significance. Through these activities, the Signal Management Process provides a structured approach to staying abreast of potential safety concerns within the realm of pharmaceuticals.