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Publications (20)
- Addressing Governance Gaps in Good Pharmacovigilance Practices for AI-Enabled Pharmacovigilance Systems: Development of the AI-GVP Governance Framework Save
- Who Benefits From Medical Innovation? Global Representation, Affordability, Safety and Regulatory Equity in Alzheimer's Disease and Cancer Research Save
- The Cost of Precision: Eligibility Barriers Across Alzheimer's Disease Intervention Classes Save
- Regulatory Integration of Real-World Evidence in Drug Approval and Post-Approval Decision-Making: Toward Adaptive Evidentiary Governance Through the Dynamic Adaptive Regulatory Evidence Model (DAREM) Save
- Invisible in the Evidence: Representation Information Gaps in Drug-Resistant Tuberculosis Clinical Trials and the Development of a Trial Representation Equity Index Save
- Governance of Therapeutic Uncertainty Across Expedited Regulatory Systems: Comparative Lifecycle Governance Architectures, Institutional Legitimacy, and Reform Pathways in Contemporary Pharmaceutical Regulation Save
- Defining Acceptable AI Autonomy in Pharmacovigilance: A Human-in-the-Loop Governance Framework for Individual Case Safety Report Processing Save
- Beyond the Scan: Biomarker Access, Diagnostic Equity, and the Case for a Shared Regulatory Path in Alzheimer's Disease and Cancer Save
- Beneath the Aggregate: Subtype-Level Equity Gaps in Global Cancer Clinical Trials Save
- Addressing Governance Gaps in Good Pharmacovigilance Practices for AI-Enabled Pharmacovigilance Systems: Development of the AI-GVP Governance Framework Save