Signal Detection in Pharmacovigilance Explained: Ultimate Guide to Regulatory Compliance and Best Practices Mastering Signal Detection: Compliance-Ready Guide for Pharmacovigilance Systems Introduction to Signal Detection and Its Importance Signal detection in pharmacovigilance refers to the process of identifying potential safety issues or new adverse drug reactions (ADRs) from various data sources, including spontaneous adverse event reports, clinical trial data, literature, and real-world evidence (RWE). Regulatory agencies such as the EMA, FDA, and CDSCO mandate structured signal detection as part of Good Pharmacovigilance Practices (GVP), particularly under GVP Module IX (Signal Management). Signal detection is critical because it allows timely identification…