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Session 7 Track 4: Pairing Strategic Vision With Innovation To Support Regulatory Processes
Session Chair(s)
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)
FDA Technology Case Study: Leveraging AI and ML to Verify Accuracy in Data Submitted for Regulatory Review
Bryan Reynolds
Docxonomy, United States
Founder & CEO
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
Content Authoring Automation for Productivity Gains, Improved Quality and Lesser Submission Delays
Siva Thiagarajan, MBA
ZS Associates, United States
Associate Partner
Igniting Innovation in Regulatory Operations
Kevin Tompkins, MBA
Bristol Myers Squibb, United States
Executive Director, Regulatory Information & Submission Management