ROUNDTABLE: Unpacking the Details of the New FDA Guidance: “Potency Assurance for Cellular & Gene Therapy Products” – Changes, Learnings & Implications
Time: 12:00 pm
day: Day 1
Details:
Roundtable discussions include a larger focus on group discussion. A moderator will introduce the session topic and attendees then split into groups to discuss a series of predetermined agenda points. At the end, all groups report back on their discussions, and findings are collated.
This roundtable will cover:
- Outlining the major changes made to the new FDA guidance to understand the reasoning behind the updates
- Making comparisons with the previous guidance and identifying significant shifts or emphasis changes
- Discussing how the new guidelines should be interpreted and implemented to guide novel assay design approaches
- Introducing case-study examples of the new guidance in practice
- Discussing potential hurdles and opportunities in implementing revised guidelines
- Outlining how the new guidance may influence your potency assay strategy going forward
