Alicja Fiedorowicz

Company: Association of the British Pharmaceutical Industry

Job title: ATMP Working Group Scientific Lead

Seminars:

Navigating Late-Stage Changes in Analytical Development to Ensure Regulatory Compliance & Mitigate Risks 1:20 pm

Explore the technical and regulatory hurdles faced when making changes to gene therapy products at late development stages, including changes to the viral vector, formulation, or assay systems, and how these can affect product consistency and regulatory compliance Discuss strategies for assessing and mitigating risks when making late-stage changes, particularly regarding how those changes might…Read more

day: Day Two