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Session 7 Track 4: Pairing Strategic Vision With Innovation To Support Regulatory Processes
Session Chair(s)
Sandra Krogulski, MA
Senior Director, Regulatory Digital Strategy and External Engagement, Bristol Myers Squibb, 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
CEO / Founder, Docxonomy, United States
FDA Technology Case Study: Leveraging AI and ML to Verify Accuracy in Data Submitted for Regulatory Review
Jason Cober, MPA
Senior Consultant, Regulatory Affairs, Ad Promo & Digital, Compliance Forward, United States
FDA Technology Case Study: Leveraging AI and ML to Verify Accuracy in Data Submitted for Regulatory Review
Siva Thiagarajan, MBA
Associate Partner, ZS Associates, United States
Content Authoring Automation for Productivity Gains, Improved Quality and Lesser Submission Delays
Kevin Tompkins, MBA
Executive Director, Regulatory Information & Submission Management, Bristol Myers Squibb, United States
Igniting Innovation in Regulatory Operations