×
Don't Miss Out!
Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA!
Back to Agenda
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 : 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.
Speaker(s)
Data Holder and Patient Advocacy Perspectives
Jennifer Farmer, MS
Friedreich's Ataxia Research Alliance (FARA), United States
Chief Executive Officer
Health Technology Perspective
Ulka B Campbell, PhD
Aetion Inc, United States
Head of Scientific Strategy
Regulatory Perspective
Representative Invited
European Medicines Agency, Netherlands
Sponsor Perspective
Pamela Dobay, PhD, MSc
Biogen, Switzerland
Director
Have an account?