Isobel Searing

Company: Replimune

Job title: Director - Quality Control

Seminars:

From Bench to Bedside: Mastering QC & CMC Alignment to Meet Evolving Regulatory Standards 1:00 pm

Ensuring QC readiness and CMC alignment is critical to the successful development and regulatory approval of gene therapies. As regulatory standards evolve, especially with the complexities of viral vector production, maintaining consistency and meeting compliance requirements at each stage—from early development to clinical trials-is essential. Timing & Implementation of QC Assays: Identifying the optimal stages…Read more

day: Pre-Conference QC Readiness Track B - PM