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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 Group, 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)
Real World Data as a Catalyst for Early Safety Signal Detection in Pharmacovigilance
Siva Kumar Buddha
Director Global Safety Sciences, Amgen, India
The Future of Safety Operations: Preparing the Workforce for AI-Augmented Decision-Making
John Praveen
Associate Vice President - PV & MW Portfolio, Accenture Services Pvt. Ltd., India
With Additional Participation Of:
Ritu Jaswal
Vice President - Pharmacovigilance Operations, Parexel, India
With Additional Participation Of:
Syed Firasatullah
Principal Solutions Consultant, Oracle Life Sciences, India
With Additional Participation Of:
Vivek Kalagara
Founder & CEO, Datafoundry, India
With Additional Participation Of:
Aniket Patil
Senior Manager, Country Safety Lead , Pfizer India Drug Safety Unit, India
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