DIA 2025 Global Annual Meeting

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-596-L04-P; CME 1.00; RN 1.00

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

Recognize expectations for real-world data (RWD) quality assessments in studies intended for regulatory submissions; Identify available tools and frameworks for implementing RWD quality assessments; Explain ways to incorporate RWD quality assessments into internal workflows using practical approaches.

Chair

Eleanor Caplan, PharmD, PhD

Speaker

Regulatory Perspective
Luis Pinheiro, PharmD, MSc

Balancing Patient Centricity with Data Quality Requirements and Standards
Jennifer Farmer, MS

Learnings About Meeting RWD Fitness Standards From FDA Use Cases
Ulka B Campbell, PhD

Can we Separate Relevance From Reliability in Data Quality Assessments? Quality-by-Design in Secondary use of Health Data
Pamela Dobay, PhD, MSc