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DARWIN EU: A transformation in the use of real-world health data for regulatory purposes in the EU



Wed, Aug 24, 2022 7:00 AM EDT he DARWIN EU Coordination Centre will accelerate access to high-quality real-world evidence for the use, safety and effectiveness of drugs across the EU in support of the EMA’s regulatory decision-making. By establishing a pan-European network, the DARWIN EU® will set standards for federated data analysis using a common data model to support the deeper integration of secondary data into regulatory decision-making as a complement to prospective clinical trials.

Register Free: http://www.pharmexec.com/pe_w/DARWIN_EU

Event Overview:

The European Union (EU) has a rich and diverse healthcare data landscape, but this diversity brings challenges that include:

  • Lack of a common data structure, governance, and language
  • Limited access to EU healthcare data that are distributed across different partners
  • Slow and complex processes for accessing and analyzing these data

Seeking to solve these issues and accelerate access to high-quality real-world evidence for regulatory decision-making, the European Medicines Agency (EMA) established the Data Analysis and Real World Interrogation Network (DARWIN EU). Erasmus University Medical Centre has been selected as the Coordination Centre for DARWIN EU, which IQVIA has been chosen to support.
Join our guest, Peter Rijnbeek, Executive Director of the DARWIN EU Coordination Centre, to learn:

  • 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

Peter Rijnbeek
Professor of Medical Informatics and Chair of the Department of Medical Informatics of the Erasmus MC
The Netherlands
Executive Director of the DARWIN EU Coordination Centre for the European Medicines Agency (EMA)

Peter Rijnbeek is Professor of Medical Informatics and is the Chair of the Department of Medical Informatics of the Erasmus MC, The Netherlands. He leads the research line Health Data Science (www.healthdatascience.nl). He obtained his MSc (1996) in Electrical Engineering at the Technical University Delft. His PhD thesis, received from the Erasmus University Rotterdam, was on the development of a computer program to automatically interpret pediatric electrocardiograms. The HDS team has a leading role in the Observational Health Data Sciences and Informatics (OHDSI, www.ohdsi.org) initiative that is enabling the generation of reliable evidence from observational data at an unprecedented scale. His team addresses issues that deal with the quality of data, the translation of data to other formats, and the mechanisms to access data in a federated fashion. He is the coordinator of the European Health Data and Evidence Network (EHDEN) IMI project that builds a federated network of health data bases across Europe. Once stored in the CDM, the data can be used to build and validate predictive models, perform large-scale characterisation, and population-level effect estimation studies. Furthermore, Prof Rijnbeek is the executive director of the DARWIN EU Coordination Centre for the European Medicines Agency (EMA) that will develop and manage a network of real-world healthcare data sources across the EU and to conduct scientific studies requested by medicines regulators and, at a later stage, requested by other stakeholders.

Register Free: http://www.pharmexec.com/pe_w/DARWIN_EU

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