Signal management remains a cornerstone of ensuring patient safety. The release of the revised Good Pharmacovigilance Practices (GVP) Module IX – Signal Management on 16th October 2017, which updates the June 2012 version, brings further clarification and additional regulatory requirements for the marketing authorisation holder (MAH). From 22nd February 2018, MAHs with an active substance on the EMA pilot additional monitoring list are obliged to monitor the EudraVigilance Data Analysis System (EVDAS) for new and existing signals with a frequency proportionate to the identified risk, potential risks and need for additional information. 

This whitepaper summarises the changes in the Module IX revision and provides insights on how industry can seize the opportunity to meet the associated challenges through improvement of signal management processes and technology.