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Building AI Governance Frameworks: Classification, Validation and Regulatory Alignment in Life Sciences
Session Chair(s)
Sridevi Nagarajan, PhD, MSc
AI Consortium Co Chair, Global Transformation Lead, Argenx, Ayusarogya, United Kingdom
This session presents AI consortium working group assessments on regulatory frameworks, use case classification, and validation approaches. Participants engage with practical tools while demystifying real AI deployments and regulatory requirements.
Learning Objective : Apply standardized AI use case classification frameworks to drug development and research-related scenarios; Recognize risk-based, practical assessment, governance and validation approaches for AI systems across regulatory contexts and use cases; Demonstrate utilizing aligned terminology for cross-jurisdictional AI discussions.
Speaker(s)
Julien Heidt, MS
Associate Director, Applied AI Science, IQVIA, United States
Panelist
Cecilia Almeida, JD
Associate Director for Regulatory Policy, Office of Medical Policy, CDER, FDA, FDA, United States
Panelist
Joaquim Berenguer Jornet, MS
AI Implementation lead, Digital Business Transformation Task Force, European Medicines Agency, Netherlands
Panelist
Michael Lingzhi Li, PhD
Assistant Professor, Harvard Business School, United States
Panelist
Carrie Nielson, MPH
Director of Epidemiology, Gilead Sciences, United States
Panelist
Venkatraman Balasubramanian, MBA
Healthcare and Life Sciences Strategic Advisor, VB Insights, LLC, United States
Panelist
Christina Mack, MPH
CSO RWE and SVP AAIS, IQVIA, United States
Panelist
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