Best Practices for Assay Development for Live Biotherapeutics
Time: 1:30 pm
day: Day One Track B (PM)
Details:
- 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?
