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Bethesda North Marriott Hotel and Conference Center

Feb 13, 2023 11:30 AM - Feb 15, 2023 2:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Session 7 Track 4: Pairing Strategic Vision With Innovation To Support Regulatory Processes

Session Chair(s)

Sandra  Krogulski, MA

Sandra Krogulski, MA

Director, GRSO Innovation and Business Operations Lead

Bristol-Myers Squibb Company, United States

This session will examine innovation using a wide lens. Artificial intelligence (AI), technology, and process improvements will be studied as they relate to the submission process and will include a case study with the FDA. The panel will discuss ways to automate tasks like content authoring, and how the implementation of AI can lead to fast and accurate submissions. Ensuring innovation is explored comprehensively, this session will also review process improvements as simple, budget-friendly solutions that can save teams tremendous time and cost. The session will also feature a case study with the FDA, one that walks through using AI to solve problems efficiently, while reducing manual work.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Apply practical aspects of implementing content authoring automation for regulatory submission documents
  • Generate and implement process improvements that lead to streamlined submission processes
  • Identify problems where AI would be a feasible solution
  • Understand how to approach and engage teams with process changes

Speaker(s)

Bryan  Reynolds

FDA Technology Case Study: Leveraging AI and ML to Verify Accuracy in Data Submitted for Regulatory Review

Bryan Reynolds

Docxonomy, United States

Founder & CEO

Jason  Cober, MPA

FDA Technology Case Study: Leveraging AI and ML to Verify Accuracy in Data Submitted for Regulatory Review

Jason Cober, MPA

OPDP | OMP | CDER | FDA, United States

Lead Project Manager

Siva  Thiagarajan, MBA

Content Authoring Automation for Productivity Gains, Improved Quality and Lesser Submission Delays

Siva Thiagarajan, MBA

ZS Associates, United States

Associate Partner

Kevin  Tompkins, MBA

Igniting Innovation in Regulatory Operations

Kevin Tompkins, MBA

Bristol Myers Squibb, United States

Executive Director, Regulatory Information & Submission Management

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