Lynne Ensor

Company: Independent Expert

Job title: President

Seminars:

Bringing Clarity to Regulatory Interactions: Proactive Strategies & FDA Updates to Align Analytical Expectations 9:30 am

Gain insight into recent FDA leadership and organizational changes, as well as how they influence evolving policy development and its practical enforcement in analytical development Explore tactics for presenting data and negotiating assay specifications that reflect real-world manufacturing capabilities and clinical realities Learn how early, well-structured engagement with regulators can help align on assay expectations, minimize rework, and support…Read more

day: Conference Day 1 Morning