Clinical Case Study: Lessons Learned in Phase 1
Time: 12:00 pm
day: Conference Day Two - Track B - AM
Details:
- A step-by-step guide on preparing and submitting an IND application: Regulatory requirements for IND submission and best practices for engaging with regulatory agencies during the IND filing process
- Sharing lessons learned from being in the clinic, addressing unexpected regulatory challenges in the clinic and incorporating lessons learned into future development strategies