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Session 6: Digitization, AI and Automation in Medical Writing & Scientific- From Structured Protocols to Implementation Strategy
Session Chair(s)
Priyanka Tiwari
Associate Director, Global Medical Writing, Thermofisher Scientific, India
Session Overview: This session examines how artificial intelligence (AI) and digitization are transforming medical writing across the regulatory lifecycle, with a focus on practical, scalable, and compliant implementation. The session will begin with a protocol-first approach enabled by ICH M11, demonstrating how structured, machine-readable protocols can serve as a single source of truth to improve traceability, consistency, and downstream automation. It will then explore the application of AI and digitization in aggregate safety reporting, highlighting how reducing manual compilation burden can enhance scientific interpretation, strengthen benefit–risk evaluation, and improve overall report quality. The session will also address strategic considerations for AI integration in medical and plain language writing, including governance, quality, and sustainability. The session will conclude with a panel discussion bringing together diverse perspectives on governance, capability building, and real-world implementation challenges in scaling AI-enabled medical writing. Together, these presentations provide an end-to-end perspective—from data foundations to implementation strategy—equipping attendees with actionable frameworks to responsibly adopt AI and improve efficiency, quality, and regulatory confidence.
Speaker(s)
Deepali Chaku, MSC
Regulatory writer, Novartis, India
Fixing Backward Automation: A Protocol-First Strategy for Regulatory submissions
Nalin Taneja, MSC
Senior Manager Patient Safety Medical Writing, Parexel International, India
Faster to Smarter: Using Digitization and AI to Reduce Compilation Burden and Elevate Quality of Aggregate Safety Reports
Vidhi Vashisht, MS
Vice President, Head of Plain Language Services, Krystelis Ltd, India
Cutting Through the AI Fog: How to Choose the Right Integration Strategy for Plain Language Writing
Sonali Parmar, MPHARM
Director, Medical Writing, Syneos Health Company, India
Panel Discussion with Q&A: AI in Medical Writing: From Automation to Accountable Intelligence Participating Panelist
Raina Agarwal, MPHARM
Associate Director, Geninvo, India
Participating Panelist
Pallavi Dasgupta, PHD, MSC
Manager, Medical Communications and Content Solutions - Vaccines, Pfizer, India
Participating Panelist
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