Panel Discussion: Understanding The Nuances in Comparability Package Expectations at a Market Level
Time: 9:00 am
day: Day One
- How are regulatory authorities aligning expectations to prevent market specific disparities in comparability criteria?
- What are the ‘need to know’ differences in comparability requirements globally that need to be considered?
- Why are the specifications for product release changing and how are the acceptance criteria for comparability tests deviating? Are there any leniencies provided for variable quality attributes?
- What is the guidance when it comes to overcoming the bottleneck of material retention?