March 10th, 2022 | 32:26

The Risk Based Approach to Advanced Therapies Manufacturing

The use of living cells and tissues (or blood derivatives) as raw material in the manufacturing process, for advanced cell and gene therapies impose additional risks and makes developing a risk-based approach much more difficult. Not only that, but recent data suggests that the risk associated with cell and gene therapies drastically increases cost to manufacturing, delays market access and complicates regulatory approval.

Join us discuss how to set up a proper risk mitigation strategy and how to integrate basic quality management principles to ensure the reliability, traceability, safety and effectiveness of advanced therapies.

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