New sources of evidence, such as big data in healthcare, offer opportunities to improve decision-making for better outcomes. However, uncertainties may exist around the quality of the data and the evidence being generated. In the EU, medicine regulators find that access to health care data is limited by different conditions (e.g. regulatory, data structure, governance, language, etc.) and often involves complex and slow processes for the analysis of multiple, heterogeneous data sources.
To help solve these issues, the European Medicine Agency (EMA) established the Data Analysis and Real World Interrogation Network (DARWIN EU) to accelerate access to high-quality real-world evidence for drug use, safety, and effectiveness across the EU.
Join our special guest for a discussion on:
- EMA’s journey to DARWIN EU
- How standardization of health care data enables large-scale analysis
- Why DARWIN EU is a paradigm shift for executing observational studies for regulators
Speaker
Peter Rijnbeek
Professor of Medical Informatics and Chair of the Department of Medical Informatics of the Erasmus MC and Executive Director of DARWIN EU Coordination Centre
Source: https://www.iqvia.com/events/2022/08/darwin-eu-a-transformation-in-the-use-of-real-world-health-data-for-regulatory-purposes-in-the-eu