Presented at the EUPV CONGRESS 2023 in Milan, this talk by Thomas Debray explores the critical role of the European Health Data & Evidence Network (EHDEN) in advancing pharmacovigilance. EHDEN, launched under the Innovative Medicines Initiative, aims to standardize and harmonize health data across Europe through the OMOP Common Data Model. This network integrates over 187 data partners and more than 850 million anonymized health records, significantly enhancing the ability to generate real-world evidence and improve regulatory decision-making in healthcare.

The presentation highlights key examples, including studies on the safety and effectiveness of COVID-19 treatments like remdesivir and tocilizumab, showcasing EHDEN's capability to provide timely insights into drug safety. The talk also addresses the challenges of small sample sizes and the need for more diverse and comprehensive data sources in pharmacovigilance research.

Benefits for Participants:

• Insight into EHDEN's Infrastructure: Learn how EHDEN’s data harmonization and federated network can enhance your pharmacovigilance studies.
• Case Studies: Gain knowledge from real-world examples demonstrating the application of EHDEN in assessing drug safety during the COVID-19 pandemic.
• Networking Opportunities: Connect with experts in the field of real-world evidence generation and explore collaborative opportunities.
• Regulatory Insights: Understand how EHDEN supports regulatory decision-making and the potential to improve healthcare outcomes through better data utilization.

About the Presenters:

Thomas Debray, PhD: Thomas Debray is the founder of Smart Data Analysis and Statistics B.V., specializing in the development and application of innovative statistical methods. With extensive experience in risk prediction and meta-analysis, he has significantly contributed to advancing real-world evidence generation in healthcare.