Siobhan Cowley

Company: FDA/CBER/OVRR/DBPAP

Job title: Biological Regulatory Review Specialist

Seminars:

Best Practices for Assay Development for Live Biotherapeutics 1:30 pm

How can sponsors better align processes to meet regulatory body quality expectations? What are todays’ best practice for implementing robust analytical methods which meet regulatory scrutiny and support approval of material quality?  What industry successes can others learn from to plan efficient pathways towards regulatory clearance?Read more

day: Day One Track B (PM)