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Symposium 1: Privacy-Preserving Federated AI-Enabled Analytics for Regulatory Decision-Making: Bridging Innovation and Decision-Grade Evidence

Tracks
Track 1
Saturday, October 31, 2026
10:30 - 12:00
Lecture Theatre 3

Details

Cross-country real-world evidence (RWE) is increasingly needed, but privacy and data governance constraints often limit centralized data sharing. Federated, privacy-preserving analytics can support collaborative evidence generation across distributed healthcare data systems, while advances in AI and causal machine learning may improve scalability and heterogeneity assessment. A key question is whether these approaches can generate transparent, reproducible, and decision-grade evidence for regulatory and HTA use. This symposium will examine how privacy-preserving, federated analytics may bridge methodological innovation and decision-grade evidence for regulatory and HTA decision-making. It will review distributed data networks, federated learning, causal AI, and federated target trial emulation, with attention to transparency, validation, and evidence standards. The session will also address implementation challenges, including privacy-preserving workflows, cross-border data constraints, and the diversity of healthcare and data governance environments across Asia. Presentations will reflect complementary perspectives from academia, regulatory science, industry, and applied evidence generation. Discussion will focus on methodological standards, study design, AI validation, and documentation to support trustworthy federated RWE for regulatory and HTA use, and broader adoption of scalable, privacy-preserving, AI-enabled evidence approaches. • Assess how privacy-preserving, federated, and AI-enabled approaches may support RWE across distributed data networks. • Identify considerations for translating methodological innovation into transparent, reproducible, decision-grade evidence for regulatory and HTA use. • Recognize methodological and operational challenges affecting the credibility and acceptability of federated RWE. • Apply lessons from emerging examples to inform decision-grade evidence generation. Relevant to pharmacoepidemiologists, RWE scientists, biostatisticians, regulators, HTA stakeholders, and researchers interested in privacy-preserving evidence generation.


Speaker

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Dr. Hsu-Wen Chou
RWE/Epi Scientist
Pfizer

Symposium Moderator

Biography

Hsu-Wen Chou is a Medical Oncology Real-World Evidence (RWE) and Epidemiology Scientist based in Taipei, Taiwan. She supports regional evidence generation across Asia-Pacific, with a focus on hematologic malignancies, particularly multiple myeloma. Her work spans study design, protocol and statistical analysis plan development, and the translation of real-world data into actionable insights to inform clinical and regulatory decision-making. Hsu-Wen has extensive experience working with large healthcare databases across Japan and other APAC markets, and actively contributes to cross-functional collaborations for abstract submissions and scientific publications at major international congresses. She is also engaged in advancing innovative RWE methodologies and exploring AI-enabled analytics to enhance evidence generation. Through close partnership with global and local stakeholders, she helps align evidence strategies with unmet clinical needs and supports the delivery of high-quality, policy-relevant research.
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Dr K Arnold Chan
Senior VP
TriNetX

Symposium Presenter

Biography

K. Arnold Chan is a pharmacoepidemiologist with almost 40 years of global research experience in North America and East Asia. He received medical training at National Taiwan University and advanced epidemiology training at Harvard School of Public Health. He subsequently served as faculty in both institutions. His private sector experience includes positions in a global pharmaceutical company and a service provider. He has authored or co-authored more than 160 original research articles and co-edited a textbook on Pharmacoepidemiology and Therapeutic Risk Management, with an H-index of 62 according to Google Scholar (August 2026). He is a member of the first cohort of FISPEs, who were inducted in 2003. Dr. Chan is currently a Senior Vice President at TriNetX LLC.
Dr Mary Beth Ritchey
Principal And Owner
Med Tech Epi

Symposium Presenter

Biography

Angela Yin
IQVIA

Symposium Presenter

Biography

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