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Bethesda North Marriott Hotel and Conference Center

2025 年 02 月 03 日 7:45 上午 - 2025 年 02 月 05 日 12:45 下午

5701 Marinelli Road, North Bethesda, MD 20852

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Session 9, Track 1: Gaining Efficiency: Using Automation across Writing, Hyperlinking, and Rendering

Session Chair(s)

Nimesh  Patel

Nimesh Patel

Director of Global Regulatory Systems

Eisai Co., Ltd., United States

In the ever-evolving regulatory landscape, gaining efficiency through automation is paramount. This session delves into transformative strategies and technologies to optimize critical processes such as content creation, hyperlinking, and rendering. With a focus on leveraging AI, automation, and advanced rendering, attendees will learn practical approaches to streamline submission workflows, reduce redundancy, and improve compliance.

From crafting AI-ready source content to automating document authoring and hyperlinking, and exploring process improvements in advanced rendering, this session offers actionable insights and best practices to enhance regulatory efficiency. Attendees will gain a comprehensive understanding of how these innovations can revolutionize their document management processes and drive industry progress.

Writing Quality Source Content for AI-Driven Regulatory Submissions - Regina Lynn Preciado, Content Rules, Inc.

Streamlining Submission Processing Through Automation of Document Authoring and Hyperlinking - Alishay Pringle, Biogen

Exploring Process Improvement in Document Management through Advanced Rendering - Paul Richard Ireland, DocShifter

Learning Objective : At the conclusion of this activity, participants should be able to:
  • Evaluate and prepare regulatory submission content for AI-driven processes
  • Integrate automated solutions to optimize submission timelines, reduce manual efforts, and ensure quality compliance
  • Explore advanced rendering techniques to identify process improvements and enhance efficiency across document management lifecycles

Speaker(s)

Alishay  Pringle, MS

Streamlining Submission Processing Through Automation of Document Authoring and Hyperlinking

Alishay Pringle, MS

Biogen, United States

Global Deliver Manager

Regina Lynn  Preciado

Writing Quality Source Content for AI-Driven Regulatory Submissions

Regina Lynn Preciado

Content Rules, Inc., United States

VP, Content Strategy Solutions

Paul Richard Ireland

Exploring Process Improvement in Document Management through Advanced Rendering

Paul Richard Ireland

DocShifter, Belgium

VP Life Sciences & Product Owner

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