• Speed your regulatory approval process after hearing a report on 13 years of experience with comparability for post-approval changes from Genentech.
• Effectively manage your product's lifecycle by learning phase appropriate analytical method progression and knowledge management in support of QbD
• Understand practical ways to implement QbD including demonstration of comparability of small scale models
• Obtain flexibility to manage your product post-licensure by hearing Genentech's global submission strategy using QbD principles
• Minimize process and product variability from cell line through post-approval by learning cutting edge "omics", conjugate production, control strategy, and analytics to support process characterization and validation

View the agenda:

• Tuesday
• Wednesday