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Session 8, Track 2: Wake Up to Calmer Submissions: Bust Bottlenecks, Build Adoption, Strengthen Content Processes
Session Chair(s)
Theresa Pinnell, MLS
Director of Regulatory Solutions, Kivo, United States
Explore practical ways to remove submission bottlenecks, reduce manual effort, and strengthen regulatory content processes—without creating new headaches for your team. Through candid practitioner lessons and real-world examples, examine how content strategy, targeted automation, cross-functional coordination, and training work together to build adoption and improve execution. Learn to avoid common implementation pitfalls and measure whether process changes actually reduce rework rather than shift it elsewhere.
Learning Objective : - Identify submission assembly bottlenecks and evaluate how automated consistency checks, validation, and readiness assessment can reduce manual effort
- Apply practitioner lessons in content strategy, implementation, training, and change management to strengthen content processes and build adoption
- Evaluate process improvements using measures that distinguish genuine reductions in rework from effort shifted to other teams or workflows
Speaker(s)
Stop Hand-Assembling eCTD Packages: Scaling Submission Operations Without Scaling Headcount
Kristen Sauter, MBA
President & GM, Life Sciences, Adlib Software, United States
Lessons from the Field: Optimizing Regulatory Content Processes from Strategy Through Implementation and Training
Murali Menon, MS
CRO, Docuvera, United States
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