Juhaeri Juhaeri is an epidemiologist with over thirty years of experience in real-world evidence and epidemiology in academia and in the pharmaceutical industry. Currently, he is Vice President and Global Head of Epidemiology and Benefit – Risk at Sanofi. He has implemented new innovative approaches to real-world evidence, signal detection, and structured benefit – risk evaluation, and has built and led various teams in Pharmacovigilance and Patent Safety. He has contributed to various public-private collaborations between pharmaceutical industry, academia, and regulatory agencies. He was a member of the Editorial Committee of the CIOMS Working Group XIII on “Real-World Data and Real-World Evidence in Regulatory Decision Making.” Currently, he is the industry co-lead of the European Innovative Health Initiative Real-World Evidence project to generate, pilot-test, and disseminate evidence-based guidance and tools for the use of real-world evidence to inform the development and evaluation of medicines, medical devices, and drug-device combinations. Prior to that, he was the industry lead of Methods Working Group in the IMI project on patient preference in benefit-risk evaluation in the whole drug life cycle.
For many years, real-world data — e.g., administrative claims and electronic health records — have played a critical role in medical product safety through traditional Post-Approval Safety Studies. With advances in real-world data availability, methods, and tools, real-world evidence is increasingly being used as part of routine pharmacovigilance activities in the signal management process. While less well established, there is growing interest in using secondary real-world data for signal detection to identify new safety observations. Covering multiple stakeholder perspectives, this panel will discuss the current state and future potential of real-world data in signal detection