Axel Ståhlbom

Axel Ståhlbom

Company: EDQM Gene Therapy Products working party

Job title: Current Member


The Regulatory Expectations For Acceptance Criteria And For Demonstrating Extended Characterization Of Gene Therapy Products 9:00 am

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…Read more

day: Day One

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