Join Dr. Mark Powell as he discusses designing a registration stability study from scratch.
The aim of this webinar is to provide guidance on the design of long-term stability studies in support of a MAA or NDA. As well as describing the general requirements for different dosage forms, differences in expectations between EU and US regulators will be highlighted. Depending on the dosage form and pack type, certain risks require mitigation prior to registration batch manufacture and stability set-down: these will be discussed. Confidence in test methods and a plan for low-level impurity data reporting are also important elements. Finally, study designs will be discussed, including different product configurations and requirements for registration in Climatic Zones III and IV.
Topics covered include:
• Regulatory expectations for different dosage forms
• Product knowledge
• Test method and data reporting considerations
• Study design
• Different strengths/primary pack configurations
• Considerations for global registration
This webinar is hosted by Q1 Scientific, a global leader in environmentally controlled stability storage and sample management.