Harmonizing the Expectations from Regulators & Setting Up Your Comparability Studies for Gene Therapy
Time: 9:00 am
day: Regulatory Workshop Day
Hear from regulators and sponsors in this workshop session on what the current expectations are for comparability in IND applications for gene therapy products to help you set up for your comparability assessments.
Key learnings from this workshop:
• Understanding what regulators are looking for in gene therapy comparability studies
• Clarifying what regulators consider ‘comparable’ for gene therapy
• Elucidating lessons learned from applications