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Reusing What You Wrote the First Time: Deja Vu All Over Again
Session Chair(s)
Steve Sibley, MS
Vice President, Global Submissions and Submissions Leadership
Certara , United States
Increases in regulatory requirements and expectations for follow-on submissions have expanded the opportunities - and complexities - for content re-use. The value of structured authoring, natural language processing (NLP), and artificial intelligence (AI) will only be realized once these have been defined. In this session, we'll look at the underlying questions to be addressed in achieving real benefits in content re-use (and creation), as well as a real-world example of NLP/AI tools that have been implemented an in use for several years at a large pharma company.
Learning Objective : Identify factors that impact content re-use; Define opportunities for document generation through structured authoring and artificial intelligence (AI); Outline how to plan for document generation, select tools, and integrate these into your own documentation plans.
Speaker(s)
How Did We Get Here? Understanding the Drivers for Artificial Intelligence in Regulatory Writing
Steve Sibley, MS
Certara , United States
Vice President, Global Submissions and Submissions Leadership
Automated Production of In-Text Tables and Accelerating the Preparation of Quality Documents
Kenneth Lord, PhD
GlaxoSmithKline, United States
Medical Writing and Clinical Submission Planning Director
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