This panel will explore available regulatory guidance for Real-World Data (RWD) quality assessments and how available implementing tools and frameworks may be applied for different types of RWD and use cases to help drug developers meet regulator expectations.
Learning Objectives
Understand expectations for real-world data (RWD) quality assessments in studies intended for regulatory submissions; Identify available tools and frameworks for implementing RWD quality assessments; Incorporate RWD quality assessments into internal workflows using practical approaches discussed in the session.