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How Do We Get from Here to There: Putting Real-World Data Quality Assessments into Practice
Session Chair(s)
Eleanor Caplan, PHARMD, PHD
Senior Principal Scientist
Johnson & Johnson Innovative Medicine, United States
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 Objective : 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.
Speaker(s)
Regulatory Perspective on Putting Real-World Data Quality Assessments into Practice
Luis Pinheiro, PHARMD, MSC
European Medicines Agency, Netherlands
Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce
Can we Separate Relevance From Reliability in Data Quality Assessments? Quality-by-Design in Secondary use of Health Data
Pamela Dobay, PHD, MSC
Biogen, Switzerland
Director
Learnings About Meeting RWD Fitness Standards From FDA Use Cases
Ulka B Campbell, PHD
Aetion Inc, United States
Head of Scientific Strategy
Balancing Patient Centricity with Data Quality Requirements and Standards
Jennifer Farmer, MS
Friedreich's Ataxia Research Alliance (FARA), United States
Chief Executive Officer
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