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T2S4: AI-Driven Regulatory Writing: Balancing Innovation with Compliance
Session Chair(s)
Nomita S Saxena
Independent Regulatory Writing Consultant, India
AI is transforming regulatory writing by enhancing speed, accuracy, and consistency. Yet, its adoption raises concerns around compliance, data integrity, and regulatory acceptance. This session will explore practical applications of AI in regulatory writing, share industry experiences, and discuss strategies to balance innovation with compliance. Attendees will gain key insights to navigate this evolving space responsibly and effectively.
Speaker(s)
Streamlining GenAI-Augmented Structured Content Authoring of Regulatory Documents
Shruti Diggavi, MSC
Freelance Consultant, India
Quality Assurance, QC and GenAI structured content authoring in Medical writing,
AI-Assisted Medical Writing: Tools for Efficiency and the Need for Oversight
Lalit Doshi
Novo Nordisk, India
Medical Writing Specialist
AI Driven Structured Content Authoring: Navigating Compliance, Risk, Ethical Standards And Upskilling For The Future
Tapasya Bhardwaj, DDS, MHA
Syneos, India
Director Innovation & Technology
With the Additional Presence of
Dev Bhaskar Baruah
AstraZeneca, India
Associate Director, Clinical Regulatory Writing