Roundtable Discussion: Gene Therapy Comparability Regulatory Engagement Strategies and Navigating International Regulatory Variances for Global Comparability

Time: 4:00 pm
day: Conference Day One


  • Delve into the regulatory tools available for managing comparability in the dynamic world of gene therapy, including the strategic roles of meetings, comparability protocols, and staggered filing approaches amidst rapid development and changes
  • Examine the implications of the evolving FDA comparability guidance for gene therapy products, emphasizing key aspects amid ongoing public comment periods
  • Analyze the differences in comparability requirements across international regulatory agencies, gaining a nuanced understanding of the global landscape
  • Learn effective strategies to ensure that gene therapy products meet diverse standards for comparability on an international scale
  • Gain insights into building robust communication channels with various regulatory bodies, fostering collaboration and ensuring successful approvals worldwide