Name: Harmonizing Data Quality Frameworks: Bridging Regulatory Perspectives
Start: 2025-06-17T13:45:00-0400
End: 2025-06-17T14:45:00-0400

Tuesday June 17, 2025 1:45pm - 2:45pm EDT

TBD

Component Type: Session
Level: Intermediate

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 Objectives

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.

Chair

Elena Popa, MPharm

Speakers

Elena Popa

Regulatory Policy and Innovation Lead, Bayer, Switzerland

Elena is a pharmacist by training with a master in drug safety & pharmacovigilance. She is the Chief of Staff for Global Regulatory Affairs at Bayer. Elena joined Bayer as a Regulatory Policy & Innovation Lead in 2022, a role which focused on the regulatory use and acceptance of RWD/RWE... Read More →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Format Session
Level Intermediate
Level Intermediate
format csv
Tags Session

DIA 2025 Global Annual Meeting

Elena Popa

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