Risk Benefit Considerations in Regulatory Applications

Time: 8:45 am
day: Day Two


• Bridging the gap between case-by-case approach and predicting what regulators need
• With multiple considerations, continuous validation, real time release testing ect. how to prioritize and communicate in global dossier preparation
• Balancing the data with the story: Seeing the big picture to translate technical data into concise, quality control strategy