Cell & Gene Therapy: Risk Management Processes

Newly approved cell and genetic therapies are showing impressive results for patients who, otherwise, would have exhausted all treatment options.

As with all product development processes, risk management is an important part of that process. In this article we discuss the application of Risk Management Processes to Cell & Gene Therapies.

In it you will find out:

  • A summary of the FDA guidelines for Cell & Gene Therapies

  • A discussion on the relevant aspects of Risk Management Process for Cell & Gene Therapies

  • Our recommendations towards a solid application of risk management principles


How does 4TE handle Risk Management in Cell & Gene Therapy?

4TE’s expertise in pharmaceutical risk management consistently shows us that a strong risk and knowledge management culture is key for a successful product development.

In our work we deliver iRISK™ to our clients, a Risk Management Platform for the Life Sciences industry to identify, quantify and prioritise risks, enabling the formulation of the risk mitigation strategy throughout the processes and products lifecycle.


4Tune Engineering provides 4.0 Intelligent & Integrated solutions to support Pharma and Biopharma Industries' Digital Transformation. Focused on operational excellence, we assist companies improve decisively the entire life cycle of their products and processes. Founded in 2004 with offices in Lisbon and São Paulo.


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