Yu Qian

Company: Novartis AG

Job title: Director & Head of Analytical Project Leads & Cell Therapies

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