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Session 6, Track 2: Moving Beyond Fragmentation through Integrated Data and Content for Modern Regulatory Processes
Session Chair(s)
Rachel Bombara
Sr. Regulatory Services Manager, Veristat, United States
Under pressure to meet today’s regulatory demands, many pharmaceutical organizations struggle with inefficiencies from outdated manual processes or rush to implement the latest technology without the requisite key foundations. This session will focus on how to successfully move beyond the fragmented legacy processes of the past to enable modern, data-centric frameworks for improvements across regulatory. Ways to apply content governance, structured data, automation, and more will be shared along with their practical uses and prospective benefits.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Identify the risks of fragmented or improperly implemented processes on regulatory
- • Formulate a practical next step for improving governance maturity using session frameworks and examples
- Discuss the strategic approaches and technological practices to bolster regulatory affairs for the future
Speaker(s)
Beyond the Spreadsheet: The Silent Cost of Data Chaos in Regulatory Affairs
John Popp, PhD
Senior Manager - Regulatory Information Management, Celegence, Netherlands
Data + Content Governance: The Missing Foundation for Scalable-AI in Regulatory Affairs
Vanni Carapetian, MPH
CMC RA, Strategy and Operations, Executive Director , Gilead Sciences, United States
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