Tuesday, 24 February 2026 | 11:40 - 12:10
HUMAN IN THE LOOP AI FOR PHARMACOVIGILANCE CASE INTAKE: FROM RAW EMAILS TO VALIDATED E2B(R3) WITH MEASURABLE QC TIME SAVINGS
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Workflow Architecture: Automated parsing, E2B(R3) XML generation, and two-tier QC with “back compare” for continuous learning and traceability.
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Implementation & IT Enablement: SaaS/AWS setup, SSO integration, and EU data residency considerations.
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Results & Lessons Learned: Early time study suggests case processing time reduction from ~90 minutes to ~15 minutes per case, pending formal validation.
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Regulatory & Compliance: Maintaining audit trails, GDPR compliance, and human oversight for regulatory accountability.
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Scalability: Multilingual intake, MedDRA consistency, and global regulatory readiness.
1 speaker
Head of Global Pharmacovigilance, QPPVEU
Worwag Pharma
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