Poster: A Signal Management Adaptive Model

 

Poster: A Signal Management Adaptive Model

All Marketing Authorisation Holders are required by regulation to demonstrate a systematic and documented approach to signal management, the output of which should be appropriately reflected in the benefit-risk assessment of the product. The signal management process can be defined as the set of activities performed to determine whether, based on an examination of individual case safety reports (ICSRs), aggregated data from active surveillance systems or studies, literature information or other data sources, there are new risks associated with an active substance or a medicinal product or whether risks have changed. The signal management process shall cover all steps from detecting signals (signal detection), through their validation and confirmation, analysis, prioritisation and assessment to recommending action, as well as tracking of the steps taken and any recommendations made.