(CASE STUDY) Can we Negotiate with Regulators? Outlining Lessons Learnt from Successful Regulatory Interactions to Help Facilitate Compromise

Time: 12:00 pm
day: Day 1


  • 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