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Session 8, Track 2:
Session Chair(s)
Theresa Pinnell, MLS
Director of Regulatory Solutions, Kivo, United States
Session 8, Track 2:
Learning Objective : Describe where manual eCTD assembly and cross-module reconciliation create bottlenecks as submission volume and portfolio complexity grow. Evaluate readiness-scoring and automated consistency checks as levers for reducing submission cycle time. Apply a framework for measuring whether a process change actually reduced rework, not just shifted it.
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
Donna Fritz
CMO, Docuvera, United States
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