Reviewing Regulatory Guidance for Potency Testing in Cell Therapy Products
Time: 8:30 am
day: Pre-Conference Workshop Day - Track B - AM
Details:
Potency remains a critical regulatory bottleneck when it comes to the approval of cell therapy products, with many recent examples of submission being rejected due to concerns surrounding potency.
Attend to Discuss:
• What are the key regulatory requirements regarding potency assays in the US and EU?
• How should we align cell therapy potency assay design, development, qualification/validation, and lifecycle management with FDA and EMA guidelines?
• What are the critical pain points when developing a potency bioassay?
