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Session 5, Track 2: Demystifying Digital Submissions: Successful Journey to Automation, AI, Content & Data Transformation
Session Chair(s)
Maria Sagoua, MHA
Chief Operating Officer
Breaking Barriers, United States
The shift from document-driven to data-centric submissions is upon us and it is redefining how organizations prepare, manage, and deliver regulatory content. This session explores what it truly takes to enable a connected, end-to-end data journey that unlocks automation, AI, and digital efficiencies within the regulatory function.
Drawing from real-world use cases and lessons learned, expert panelists will share practical insights on how regulatory and cross-functional teams are laying the foundation for sustainable digital transformation. The discussion will highlight both the strategic vision and the operational realities behind this evolution, offering a grounded look at the people, processes, and data required to make digital regulatory transformation work.
Key themes include:
Participants will leave with actionable insights, guidance and tactics to accelerate progress toward data-driven submissions and digital-first operations. The discussion will emphasize what can be done to move transformation forward within your organization spanning data curation, process alignment, and workforce capability building.
This session is designed for regulatory and RIM professionals, data and information managers, and transformation leaders who are driving or supporting modernization efforts within their organizations. Whether you’re just beginning your digital journey or advancing toward AI-enabled capabilities, this conversation will provide practical strategies to advance your organization’s readiness and success.
By sharing tangible examples and hard-won lessons from industry peers, this session will help attendees understand how regulatory data strategy serves as both a foundation and a catalyst for broader enterprise innovation—ultimately enabling faster, more intelligent, and globally harmonized regulatory submissions.
The Digital Knowledge Transformation Journey
Kathy Vieson, Sage Content Solutions
End to End: From Data to Publication at Scale
Kevin O'Leary, Dassault Systemes
Understanding and Improving Your Data Readiness
Justin Porth, Amgen
Learning Objective : - Illustrate the organization-wide change coordination required to align a strategy between regulatory, data management, operations, & other functions to transform knowledge flow
- Distinguish the criticality of designing proper data models: key element to this strategy
- Define a scalable & achievable implementation framework to mitigate key barriers to the shift from document to data driven practice
Speaker(s)
End to End: From Data to Publication at Scale
Kevin O'Leary
Dassault Life Sciences, Ireland
VP of R&D, Quality and Regulatory
The Digital Knowledge Transformation Journey
Kathleen Vieson, PHARMD
Sage Content Solutions, United States
Principal
Understanding and Improving Your Data Readiness
Justin Porth, MBA
Amgen, United States
Principle Data Engineer (Senior Manager Information Systems)
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