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Clinical Trial Events
DIA India Annual Meeting 2026

Talk Track 4 - Pharmacovigilance (PV) track

Reinventing Signal Management: From Reactive Surveillance to Predictive Safety Intelligence

Thu, Nov 19, 2026 · 2:00–3:30 PM IST Main Auditorium, CIDCO Auditorium & Convention Centre

About this session

Programme: PV.S3.T1: Integrated Safety Systems Across the Product Lifecycle; PV.S3.T2: EudraVigilance Monitoring & Signal Management: Navigating Changes Introduced by EU 2025/1466; PV.S3.T4: US FDA’s Approach to Medical Device Post-Market Safety: Advancing Patient Protection Through Modern Surveillance Systems; PV.S3.T3: FDA perspective on emerging approaches to signal detection, evaluation and benefit-risk assessment.

Speakers

  • Shubhadeep Sinha

    Senior Vice President, Head- Medical Affairs & pharmacovigilance · Alkem Laboratories Limited

    Chair

  • Isha Shukla

    Associate Director, Client Quality Management · Ergomed Clinical Research Private Limited

    Speaker

  • Krathika Bhat

    Pharmacovigilance Manager · Dr. Ebeling & Associates

    Speaker

  • Gerald J. Dal Pan

    Director, Office of Surveillance and Epidemiology (CDER) · US FDA

    Speaker

  • Stephanie Shedd

    International Policy Analyst (CDRH) · US FDA

    Speaker