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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; Describe potential strategies for developing a unified data quality framework to enhance consistency and reliability in data-driven research.
Speaker(s)
Donna Rivera, PHARMD, MSC, FISPE
Executive Vice President-Clinical Evidence Modernization, Canal Row Advisors, United States
Panelist
Rachele Hendricks-Sturrup, MA
Research Director, Real-World Evidence, Duke-Margolis Institute For Health Policy (DMI), United States
Harmonizing Data Quality Through an International Convergence and Applying Best Practices Through a United States Lens
Simon Bennett, MS
Director, EU Regulatory Policy, Biogen, United Kingdom
A Comparative Analysis of Data Quality Frameworks
Kelly Robinson, MSC
Director General, Pharmaceutical Drugs Directorate, Health Canada, Canada
Pursuing Opportunities for Harmonization in Using Real-World Data: ICH Update
Patrice Verpillat, DrMed, MD, PHD, MPH
Head of Real World Evidence, European Medicines Agency, Netherlands
Panelist
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