SW-2D - The Future of Pharmacovigilance: Accelerating Signal Identification With Electronic Healthcare Data

Background: The integration of large, population-based electronic healthcare data (EHD) into pharmacovigilance presents a potentially transformative opportunity to identify drug safety signals to complement traditional spontaneous reporting systems (SRS). However, the performance of EHD-based signal detection methods is not well established, raising concerns about their reliability and practical utility.

Objectives: In this special symposium, we will: (1) review state-of-the-art methods for signal detection with EHD, including their strengths and methodological challenges; (2) evaluate the performance of EHD-based signal detection techniques (e.g., sensitivity and specificity), while highlighting their adoption in the life sciences or regulatory agencies; and (3) explore how to augment existing pharmacovigilance systems with these novel approaches. The symposium is tailored for academicians, regulators and life science professionals committed to advancing pharmacovigilance with EHD-based methods.

Description: The symposium features expert presentations and discussions on key aspects of EHD-based signal detection: (1) Evolving methods for EHD-based signal detection: techniques and performance measures (Judith Maro, Patrick Ryan); (2) Regulatory perspectives: insights from U.S. Food and Drug Administration and European Medicines Agency on EHD-based signal detection (FDA/EMA participants); (3) Comparisons with traditional SRS, challenges in adopting EHD-based methods within the life sciences companies, opportunities for integration within existing pharmacovigilance systems (Juhaeri Juhaeri); (4): Panel discussion (Moderators: Jian-Yu E, G. Caleb Alexander). Attendees, who are familiar with signal detection methods, will gain a nuanced understanding of how EHD data can enhance pharmacovigilance, as well as actionable insights regarding how to institute and assess the performance of these methods. The symposium will provide practical insights into implementing challenges, ensuring scalability, and maximizing the value of EHD in identifying drug safety signals.

By addressing both the theoretical and practical dimensions of EHD-based signal detection, this symposium will advance pharmacovigilance and equip academicians, regulators and life science professionals with tools to optimize drug safety.