The Regulatory Expectations For Acceptance Criteria And For Demonstrating Extended Characterization Of Gene Therapy Products

Time: 9:00 am
day: Day One


  • 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