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Is Europe ready to define quality standards for Real World Data (RWD) sources?
Session Chair(s)
Anja Langeneckert, PhD, RPh, RAC
Head EU Regulator Affairs, Product Development
F. Hoffmann-La Roche Ltd., Switzerland
When discussing challenges with the use of Real World Data (RWD) and Real World Evidence (RWE) in the context of regulatory decision-making, one of the challenges most often raised is the lack of reliably high quality sources of data. While there is no universally accepted guidance -such as GCP for clinical trials- , issues like representatives, standard outcomes measurement, missing data/completeness of data, reliability of imputations, timeliness and a full view of the patient journey have been mentioned as important quality attributes. Questions remain here - are these the right measures given RWD use is very context specific? Do we have a good case study of a data source, which could represent these measures already? Are these measures applicable to all RWD sources (EHRs, Registry data, Claims/billing? And is it realistic to expect that regulators globally can adopt the same set of standards and measures? These questions will be debated through a round of presentations and panel discussion during this session with representation from regulators, the pharmaceutical industry and the health data company space.
Speaker(s)
Data from Electronic Medical Records -data quality standards?
Rachael Sorg, MPH
Flatiron Health, Inc., United States
Senior Quantitative Scientist
Data from Disease Registries
Xavier Kurz, MD, PhD, MSc
European Medicines Agency, Netherlands
Head of Data Analytics Workstream
Panelist
Anja Van Biezen
EBMT, Netherlands
Business Development Manager
Panelist
Eoin McGrath
EBMT, Spain
JACIE OPERATIONS MANAGER
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