Panel Discussion: Producing a Comprehensive Drug Comparability Framework
Time: 4:00 pm
day: Day Two PM
Details:
• Creating a consistent impurity profile across manufacturing and vendors through a robust comparability assessment
• Taking a proactive approach to comparability submission packages- thinking beyond just your manufacturing steps
• Developing strategies for effectively managing and documenting any changes in compliance with agency guidelines,
while proactively engaging with regulatory bodies to ensure the drug’s continued effectiveness and adherence to quality
standards
