Safety Surveillance

The goal of the signal management process is to identify, evaluate, and communicate drug safety risks as early as possible.

Safety signals are evaluated to determine if they represent a drug-related risk, and if so, to better understand the seriousness and frequency of the risk. Safety surveillance leads to the detection and analysis of potential risk factors whose confirmation helps prevent or mitigate risk in the whole or special population. A safety "signal" is a report or reports of an event with an unknown causal relationship to treatment that is recognized as worthy of further exploration and continued surveillance.

Lilly actively searches for safety signals from numerous relevant sources of safety data by using both qualitative and quantitative methodologies. Once a signal has been detected, it is evaluated to assess the possibility of a causal association between the product and the adverse event. Safety signals are assessed and evaluated, using all relevant sources of safety data, based on clinical and medical factors such as the potential public health impact and the strength of the signal.