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Previews 3031444 Pre by miguel.chipana is a document available to read on EtoBox.
The ISPE Guide on Advanced Therapy Medicinal Products (ATMPs) provides comprehensive guidance on validation methods and controls throughout the cell and gene therapy product lifecycle. It addresses the unique challenges and risks associated with ATMPs, emphasizing the importance of a risk-based approach to ensure regulatory compliance and expedite patient access to innovative therapies. The guide includes insights into validation activities, regulatory considerations, and lifecycle management to aid stakeho
- Author
- miguel.chipana
- Language
- EN