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Harmonizing Data Quality Frameworks: Bridging Regulatory Perspectives
Session Chair(s)
Elena Popa, MPharm
Chief of Staff, Global Regulatory Affairs
Bayer AG, 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)
Panelist
Donna Rivera, PharmD, MSc, FISPE
FDA, United States
Associate Director for Pharmacoepidemiology, Oncology Center of Excellence
Harmonizing Data Quality Through an International Convergence and Applying Best Practices Through a United States Lens
Rachele Hendricks-Sturrup, DrSc, MA, MSc
Duke-Margolis Institute For Health Policy, United States
Research Director, Real-World Evidence
A Comparative Analysis of Data Quality Frameworks
Simon Bennett, MSc
Biogen, United Kingdom
Director, EU Regulatory Policy
Pursuing Opportunities for Harmonization in Using Real-World Data: ICH Update
Kelly Robinson, MSc
Health Canada, Canada
Director General, Pharmaceutical Drugs Directorate
Panelist
Patrice Verpillat, DrMed, MD, PhD, MPH
European Medicines Agency, Netherlands
Head of Real World Evidence
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