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Thursday, June 18 • 11:30am - 12:30pm
#423 L: Reusing What You Wrote the First Time: Deja Vu All Over Again

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-737-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Steve Sibley, MS


How Did We Get Here? Understanding the Drivers for Artificial Intelligence in Regulatory Writing
Steve Sibley, MS

Automated Production of In-Text Tables and Accelerating the Preparation of Quality Documents
Kenneth Lord, PhD

avatar for Steve Sibley

Steve Sibley

Vice President, Global Submissions and Submission Leadership, Certara Synchrogenix, United States
With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles. He has successfully supported projects from discovery through approval and life cycle management... Read More →

Kenneth Lord

Medical Writing and Clinical Submission Planning Director, GlaxoSmithKline
Ken Lord earned a PhD degree in Biochemistry from the University of Pennsylvania and then did post-doctoral research in molecular and cellular biology in myeloid leukemia. He entered the pharmaceutical industry in Discovery with Sterling-Winthrop, followed by SmithKline Beecham and... Read More →

Thursday June 18, 2020 11:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  04: MedAffairs-SciComm, Session