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PV.S2. – Harnessing AI and Real-World Data in PV And How Regulators View Automation And AI
Session Chair(s)
Fahd Khan
Head Business Development - APAC
Emmes, India
As pharmacovigilance (PV) functions evolve to manage increasing data volumes and complexity, AI and Real-World Data (RWD) are becoming essential tools in the day-to-day operations of safety teams. This session is designed for PV professionals who are directly engaged in case processing, signal management, compliance, and safety analytics—and are navigating the challenges of integrating advanced technologies into routine workflows.
The discussion will focus on measurable efficiencies, implementation considerations, and lessons learned from real-world deployments.
In parallel, the session will delve into how global regulatory bodies view the use of AI and automation in PV. Attendees will gain clarity on current expectations for validation, audit readiness, and algorithm transparency, as well as updates from recent guidance issued by EMA, FDA, and other health authorities.
Speaker(s)
Intelligent Pharmacovigilance: The Role of AI in Signal Detection And Safety Surveillance
Speaker Invited
India
Real World Data And Digital Health in PV
John Praveen
Accenture Services Pvt. Ltd., India
With Additional Participation Of:
Syed Firasatullah
Oracle Life Sciences, India
Principal Solutions Consultant
With Additional Participation Of:
Siva Kumar Buddha
Indegene, India
Director, Head of Signal and Risk
Vivek Kalagara
Datafoundry, India
Founder & CEO
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