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Session 3: Data Sources of the Future
Session Chair(s)
Michael Seewald
Head Real World Evidence, Novartis Pharma AG, Switzerland
Real-world data can support to develop, evaluate, and monitor the safety and effectiveness of medicines and medical devices, especially once inherent limitations such as biases, gaps in coverage, outcomes are addressed with appropriate methodology. However, many hurdles have to be overcome in areas like data access, transfer, interoperability and quality before real-world data sources can be considered adequate for a given evidence generation purpose. This session will explore the long-term creation of data assets in the real-world, including the role of trusted, multi-stakeholder collaborations, the need to agree on data formats and standards, promoting the wider use of data to continuously enhance the data asset in a long-term, sustainable fashion. A panel discussion in conclusion shall help to raise a call to action in support of broader collaboration and focusing on approaching data as a strategic asset.
Speaker(s)
Michael Seewald
Head Real World Evidence, Novartis Pharma AG, Switzerland
The Value of Trusted Partnerships between Pharma and Healthcare Facilitated by Real-world Data
Nikolai Constantin Brun, MD
Co-Chair, EMA-MHA Big Data Task Force; Dir, Div for Medical Eval & Biostatistics, Danish Medicines Agency, Denmark
EU-Funded Initiatives for Real-World Evidence: Relevance for Regulatory Decision-Making And Proposal for the Future
Nigel Hughes, MSc
Scientific Director, Observational Health Data Analytics/Epidemiology, Janssen Research and Development, Belgium
IMI EHDEN: Building a Trusted Observational Research Ecosystem to Enable Better Health Decisions, Outcomes and Care
Madis Tiik
Senior Lecturer, Tallinn University of Technology, Estonia
E-Health in Estonia: Digital Healthcare Will Revolutionise Industry – If We Let It
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