Advanced Clinical Trials and Clinical Research

AI-Powered Pharmacovigilance

AI-powered pharmacovigilance is transforming how safety data is detected, analyzed, and reported in real time. This session focuses on the use of machine learning and natural language processing tools to automate adverse event detection, signal prioritization, and risk assessment. Topics include integration with spontaneous reporting systems, literature screening, and social media mining. Attendees will learn about model validation, explainability, and compliance with ICH E2E and FDA regulations. The session also explores AI's role in predictive safety modeling, enabling earlier identification of potential risks. Real-world applications in post-marketing surveillance and clinical trial safety monitoring will be presented, along with challenges in algorithm bias and data source variability. Whether supporting internal safety teams or regulatory submissions, this session equips attendees with practical strategies for deploying AI responsibly in pharmacovigilance workflows.