Data Analysis and Real-World Interrogation Network – European Union (DARWIN EU®) – Where Are We Now and What Is in Store for the Future?
Author(s)
Moderator: Phani Veeranki, MD, DrPH, Optum LifeSciences, CYPRESS, TX, USA
Speakers: Patrice Verpillat, MD, MPH, PhD, European Medicines Agency, Amsterdam, NH, Netherlands; Shuvayu Sen, PhD, Center for Observational and Real World Evidence, Merck & Co., Inc., Kenilworth, NJ, USA; Daniel Alhambra, MD, PhD, Oxford University, London, OXF, UK
Presentation Documents
The European Medicines Agency (EMA) and the European Medicines Regulatory Network established a coordination center (DARWIN EU) to provide timely and reliable evidence on the use, safety, and effectiveness of of medicines from real world healthcare databases across the European Union (EU) to inform decisions across a medicine’s lifecycle. DARWIN EU has been working on pilot projects like European Health Data Space (EHDS) HealthData@EU Pilot which will run until September 2024 and is led by the French Health Data Hub (HDH). Pilot projects, use cases, and other developments within DARWIN EU have a significant impact on the future of medicines development, lifecycle management and access. Thus, it is critically important to understand the implications of DARWIN EU from different perspectives. This forum will provide an update on what has been done so far and what is in store for the future, discussing the implications of DARWIN EU for different stakeholders from a regulatory (Dr. Verpillat), industry (Dr. Sen), and maintenance perspective.
Conference/Value in Health Info
2024-11, ISPOR Europe 2024, Barcelona, Spain
Code
140
Topic
Real World Data & Information Systems