(CASE STUDY) Can we Negotiate with Regulators? Outlining Lessons Learnt from Successful Regulatory Interactions to Help Facilitate Compromise
Time: 11:00 am
day: Day 1
Details:
- A real-world example of an end-end potency assay design strategy that resulted in a regulatory approval
- Discussing how feedback from regulators was incorporated into potency assay design as the drug product moved towards commercialization
- Outlining how interactions with regulatory authority can ultimately lead to compromise in potency assay expectations
