Vilma Jimenez

Company: BlueRock Therapeutics

Job title: Director, Quality Control & Consultant

Seminars:

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…Read more

day: Day 2 - Track B - Morning

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 BLARead more

day: Day 2 - Track B - Morning