SIGNAL MANAGEMENT: Let’s Get Real!

Signal Management is Core to Pharmacovigilance: It plays a central role in identifying, assessing, and acting on safety signals to protect patients effectively. 

Embrace of New Technologies: The integration of AI, big data analytics, wearables, and predictive modeling can dramatically enhance the speed and accuracy of signal detection. 

Real-time Monitoring is the Future: Continuous, real-time data from clinical trials, post-marketing surveillance, and wearables can revolutionize safety monitoring. 

Need for Regulatory Harmonization and Standardization: Variability across regulators, academia, and industry calls for unified methods and global standards like READUS-PV. 

Call for a PV Mindset Shift: The presentation urges a redefinition of pharmacovigilance practices—moving from reactive to proactive, integrated, and tech-enabled signal and risk management.