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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)
Shruti Diggavi, MSC
Quality Assurance, QC and GenAI structured content authoring in Medical writing,, Freelance Consultant, India
Streamlining GenAI-Augmented Structured Content Authoring of Regulatory Documents
Lalit Doshi
Medical Writing Specialist, Novo Nordisk, India
AI-Assisted Medical Writing: Tools for Efficiency and the Need for Oversight
Tapasya Bhardwaj, DDS, MHA
Director Innovation & Technology, Syneos, India
AI Driven Structured Content Authoring: Navigating Compliance, Risk, Ethical Standards And Upskilling For The Future
Dev Bhaskar Baruah, MPHARM
Associate Director -II, Clinical Regulatory Writing, Astrazeneca India Pvt Ltd, India
With the Additional Presence of
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