Talk Data Science, RWE & Artificial Intelligence track
S0306 - International Harmonization and Convergence in RWD
Thu, Mar 20, 2025 · 8:30–9:40 AM CET Kairo 1-2 Room, Congress Center Basel
About this session
How can we achieve global harmony in the use of real-world data (RWD) and real-world evidence (RWE)? This session will address the critical need for harmonization and convergence in RWD/RWE terminology and guidelines. Discussions will begin with the importance of a common language, as exemplified by ICH initiatives, and move on to harmonizing data quality frameworks across regulatory perspectives.
Programme:
- 2. “You Say Tomato, I Say Tomato”? Finding Regulatory Harmony in RWD/RWE Terminology and Guidelines — Bart Barefoot
- Panel Discussion — Melissa Kampman, Rachael Williams
- 3. Harmonizing Data Quality Attributes: A Comparative Analysis of EMA, FDA, and ICH M14 Guidelines — Elena Popa
- 1. Setting the scene — Patrice Verpillat, Bart Barefoot
- 4. Characteristics Impacting Authority Consideration of RWE for Effectiveness: Evidence from North America, Europe and Australia — Gianmario Candore
Speakers
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Head of Epidemiology · Medicines and Healthcare products Regulatory Agency
Panelist
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Manager and Senior Epidemiologist, Marketed Health Products Directorate · Health Canada
Panelist
