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Session 7, Track 3: Beyond Faster: Humans + AI and the Next Chapter of Regulatory Writing
Session Chair(s)
Aliza Nathoo
Regulatory Content Strategy, Independent, Canada
AI promises speed, but its real impact on regulatory writing goes deeper. AI is reshaping roles, responsibilities, and how humans and machines collaborate. This session will explore how writers and reviewers can adapt from authors and checkers to generators, orchestrators and validators in AI-enabled workflows. Speakers will share lessons from early implementations, discuss emerging behaviors and skills, and highlight practical steps regulatory, quality and IT teams can take to build trust, lead change, and thrive through stronger human–AI collaboration.
- Streamlining Regulatory Processes with AI Similarity Scoring System: The Future of Content Mapping, Propagation and Document: Sharon Kim, MPilotAI
- Arju Sangal, Amgen
- What it Really Takes to get AI Tech Implemented in Regulatory Space: Kruti Shah, Astrix
Learning Objective : - Evaluate examples of AI-human collaboration in regulatory writing, distinguishing between tasks suited for automation vs. those requiring human oversight
- Identify ways AI is changing roles and how readiness and role enablement can ease adoption in current workflows
- Apply practical strategies and change leadership to adapt team behaviors and skillsets within the next 12-18 months to prepare for AI-enabled regulatory writing and review
Speaker(s)
AI Similarity Scoring System: The Future of Content Mapping, Propagation and Document Management
Sharon Kim, PharmD
CEO, MPilotAI, United States
From Redlines to Risk Scores: AI-Powered QC for Regulatory Writing
Arju Sangal, MPharm
Global Safety Director, Amgen, Sweden
Implementing AI in Regulatory, Beyond the Technology
Kruti Shah, MBA, MS
Senior Consultant, Astrix, United States
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