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Clinical Trial Events
SCOPE Summit for Clinical Ops Executives

Talk AI for Clinical Trials track

Transforming Regulatory Document Authoring: The Promise of Human-Led Generative AI

Tue, Feb 4, 2025 · 3:45–4:05 PM EST Rosen Shingle Creek

About this session

The presentation will explore how Generative AI is revolutionizing the entire spectrum of regulatory document authoring, from protocols to clinical study reports, promoting standardization, ensuring compliance, and maximizing efficiency. It will highlight the paradigm shift in how these critical regulatory documents are drafted, emphasizing the transformative impact of Gen AI on the pharmaceutical industry. While showcasing how Gen AI accelerates the process, the presentation will also stress the essential role of human oversight in maintaining accuracy and regulatory standards, advocating for a collaborative "human-led" Generative AI approach that delivers the best outcomes.

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