Module 9 2021

Risk Based Approach

Identification of risk factors ● Identification and mapping of each risk/risk factor combination ● Clinical procedures ● Manufacturing and Quality ● Product

Disease / clinical protocol Cell source (allogeneic vs autologous)

Concomitant regimens Administration route

GTMPS Insertional mutagenesis Shedding RCV

SCBMP Proliferation and oncogenicity Differentiation and trafficking Immune response

TEP Interaction/degradation of scaffolds Release of matrix / devices

MFGT Related Manipulation extension Batch to batch consisitency RCV

Novartis Pharma AG- Business use only- not for further distribution

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