European Drug Safety & AI 2026

24–25 Feb 2026 | Barcelona, Spain

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

Location:Gloria B, C, D
  • Workflow Architecture: Automated parsing, E2B(R3) XML generation, and two-tier QC with “back compare” for continuous learning and traceability. 

  • Implementation & IT Enablement: SaaS/AWS setup, SSO integration, and EU data residency considerations.

  • Results & Lessons Learned: Early time study suggests case processing time reduction from ~90 minutes to ~15 minutes per case, pending formal validation. 

  • Regulatory & Compliance: Maintaining audit trails, GDPR compliance, and human oversight for regulatory accountability. 

  • Scalability: Multilingual intake, MedDRA consistency, and global regulatory readiness.

1 speaker

  • Head of Global Pharmacovigilance, QPPVEU

    Worwag Pharma

Location image

Session location Gloria B, C, D