Real-World Data Quality - Perspectives From Different Stakeholders

Global healthcare decision-makers require that real-world data (RWD) must be high quality and fit-for-purpose for real-world evidence (RWE) to be used in decision-making. While there is guidance available that discusses the parameters of high-quality data, such as completeness and accuracy, this guidance is often high level. This forum will focus on operationalizing data quality standards by discussing the following key topics in RWD quality:

• A brief overview of the European Medicines Agency's (EMA) data quality framework
• How to cope with data quality issues in RWE studies targeted for regulatory approval, post-approval safety, and/or health technology assessment (HTA) decision making
• What information do regulators or HTA agencies need to feel confident about data quality?
• How to collaborate with data providers to ensure data quality, trustworthiness, and transparency

This forum session will bring together analytical experts that have expertise in helping companies identify high-quality fit-for-purpose data sources, industry experts who are working to meet data quality standards in their RWE generation, and decision-makers who must judge the quality of RWD from submitted studies. Life sciences industry representatives across all segments as well as other interested stakeholders will benefit from attending this session.