Roundtable Discussion: Successes and Setbacks with IND Submissions
Time: 12:30 pm
day: Conference Day Two
Details:
Roundtable discussions place a larger focus on group discussion. A moderator will introduce the session topic and attendees then split into groups to discuss a series of assigned questions. At the end, all groups report back on their discussions, and findings are collated.
- Highlighting areas of CMC and nonclinical testing most commonly met with regulatory feedback
- Sharing experiences with on- and off- targeting assessment
- What level of sensitivity and specificity do I need to demonstrate to the regulators?
