Vilma Jimenez
Seminars
Wednesday 3rd December 2025
Panel Discussion: Balancing Risk & Benefit When Making Late-Stage Analytical Changes
12:00 pm
- 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
Wednesday 3rd December 2025
Lessons Learned in Navigating Late-Stage Changes in Analytical Methods
11:30 am
- Share lessons learned from supporting quality control in latestage and commercial programs
- The role of analytical development in comparability planning and regulatory engagement when making changes in late commercialization and post BLA
