Understanding the Changes in Regulatory Scrutiny Throughout the EarlyLate Stage Transition in Order to Optimise Phase-Appropriate Assay Design Strategy

Time: 4:30 pm
day: Day One


  • Discussing ICH guidelines during progression towards clinical trials
  • Establishing regulatory perspectives on late-phase cGMP
  • Ensuring appropriate data integrity and instrument qualification through the early-late stage transition to suit regulatory demands
  • What are the most important factors to show regulators during AAV extended characterisation