Back to Agenda
Session 3: Quality, Compliance, and Risk Management in Medical Writing
Session Chair(s)
Sherin Babykutty
Associate Director – Scientific Writing, Global Scientific Communications, Eli Lilly and Company, India
Session Overview: As AI rapidly accelerates medical writing workflows, the focus is shifting from speed and efficiency to accountability, control, and compliance. AI-enabled tools offer significant gains in productivity and consistency, but they also introduce critical risks, including data integrity concerns, hallucinations, limited traceability, and intensifying regulatory scrutiny that demand careful governance. This session will explore how organizations can move beyond experimentation to establish robust, compliant, AI-enabled medical writing practices. Experts will discuss governance frameworks, including human-in-the-loop review, AI validation strategies, and audit-ready documentation aligned with global regulatory expectations. Attendees will gain actionable insights into implementing responsible AI practices, enabling teams to improve efficiency while ensuring transparency, accountability, and inspection readiness in this new paradigm.
Speaker(s)
Neha Tickoo, MPHARM
Associate Director, Syneos Health, India
Exploring the Role of Medical Writers in Validation of Disclosure Platforms
Have an account?