The Regulatory Expectations For Acceptance Criteria And For Demonstrating Extended Characterization Of Gene Therapy Products
Time: 9:00 am
day: Day One
Details:
- Determine how regulators define what constitutes a Gene Therapy Medicinal Product (GTMP)
- Discuss how regulators are thinking around extended characterisation studies and their relevance for release testing and criteria of a GTMP
- Discuss how much data is considered ‘sufficient’ to effectively demonstrate safety, efficacy, quality and consistency of GTMPs
- Determine the regulators perspective on creating gold standard analytical methods to support with benchmarking activities
