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
Details:
- 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
