Deirdre Harwood

Company: Ultragenyx Pharmaceutical Inc

Job title: Sr. Director, Regulatory Affairs CMC

Seminars:

Refining Process Control Strategy & PPQ for Successful Pivotal-Led Pre-BLA & Pre-MAA Submissions 12:00 pm

Development of an aligned pre-PPQ position in Phase 3 Explore real-world case studies of pivotal-led BLA submissions and MAA engagement with FDA and EMA Highlight best practices leading to regulatory success and expedited approval pathways for gene therapy productsRead more

day: Conference Day Two