Panel Discussion: Balancing Risk & Benefit When Making Late-Stage Analytical Changes
Time: 12:00 pm
day: Day 2 - Track B - Morning
Details:
- How to assess the scientific, regulatory, and operational risks of modifying assays or specifications after pivotal trials begin
- When is it worth changing a method late-stage and what data is needed to justify the decision to regulators and internal teams?
- Best practices for building a comparability and bridging strategy that supports product integrity without delaying timelines
