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Harmonizing Data Quality Frameworks: Bridging Regulatory Perspectives
Session Chair(s)
Elena Popa, MPharm
Chief of Staff, Global Regulatory Affairs
Bayer, Switzerland
This session will explore the ways in which the data quality criteria within the EMA, FDA and ICH M14 guidelines converge or diverge, and propose some definitive actions for consideration to achieve harmonization of terminology.
Learning Objective : Examine the current fragmentation in RWD/RWE data quality standards and its impact on research and regulatory decisions; Identify the key stakeholders and their varying data quality criteria within the pharmaceutical landscape; Explore potential strategies for developing a unified data quality framework to enhance consistency and reliability in data-driven research.
Speaker(s)
Panelist
Representative Invited
European Medicines Agency, Netherlands
Pursuing Opportunities for Harmonization in Using Real-World Data: ICH Update
Representative Invited
Health Canada, Canada
A Comparative Analysis of Data Quality Frameworks
Simon Bennett, MSc
Biogen, United Kingdom
Director, EU Regulatory Policy
Panelist
Rachele Hendricks-Sturrup, DrSc, MA, MSc
Duke-Robert J. Margolis, MD, Institute For Health Policy, United States
Research Director, Real-World Evidence
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