P112: The Digital Policy Architect: A Global Harmonization Framework for AI-Augmented Compliance in Post-Market Surveillance
Poster Presenter
Alex Raju
Founder & Lead Researcher
Chatmedsafe | MS Candidate, LIU United States
Objectives
To present the Global Harmonization Framework (GHF), a validated roadmap for resolving the "Regulatory Chasm"—the high-risk misalignment between global safety data retention mandates (FDA/EMA) and digital privacy laws (GDPR) in AI-augmented pharmacovigilance intake systems.
Method
The study utilized a two-phase methodology: 1) A systematic divergence analysis to map 12 Critical Digital Decision Points (DDPs) within the AI-augmented PV lifecycle, and 2) A Delphi-Lite Policy Consensus Protocol to validate 6 Harmonized Regulatory Requirements (HRRs) for global compliance.
Results
The research identified and validated three primary pillars for the future of digital pharmacovigilance:
1) Mapping the "Regulatory Chasm": The study identified 12 Critical Digital Decision Points (DDPs) where current AI intake systems fail to meet concurrent global standards. The most significant friction point (DDP 9) occurs where GDPR’s "Right to Erasure" (Article 17) directly contradicts GVP and CFR mandates for 10-year safety data retention.
2) Validation of the "Highest Common Denominator": Through the Delphi-Lite Protocol, 6 Harmonized Regulatory Requirements (HRRs) were established. Key finding HRR 7.1 (Explicit Consent for Retention) provides a viable legal mechanism to satisfy both PV safety mandates and privacy laws within a digital interface, effectively "pre-empting" legal friction.
3) The Explainability Mandate: For AI-augmented seriousness classification, a standard audit trail is insufficient. The Explainability Log (HRR 2.3) was validated as the only mechanism to satisfy "Human Oversight" requirements of the emerging EU AI Act while maintaining compliance with FDA 21 CFR Part 11.
Initial expert consensus data confirms that by implementing these HRRs, organizations can move from "paper-form" SOPs to AI-native workflows with a 4.4/5.0 validation score for the proposed policy solutions.
Conclusion
The research concludes that the industry bottleneck in adopting AI for medication safety is a policy-governance gap, not a technological failure. The primary conclusion is that Global Harmonization is achievable through a "Highest Common Denominator" approach. By implementing the GHF and its associated HRRs, Marketing Authorization Holders (MAHs) can resolve the conflict between privacy "erasure" and safety "retention" through pre-emptive digital consent logic.
Furthermore, this study demonstrates that the role of the Regulatory Affairs professional must evolve into a "Digital Policy Architect." The GHF provides the first validated, auditable blueprint for this evolution, ensuring that as we move toward "The Death of the Form," the replacement systems are patient-centric, clinically robust, and legally defensible across all major jurisdictions (US, EU, and Global).
