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Abstract

The COVID-19 pandemic requires robust risk control strategies; these should be multi-layered, science-based and subjected to effectiveness checks and formal reviews, to identify any unintended consequences. They should be supported by communications informed by an understanding of biases and risk perception. While developing such strategies for COVID-19 is difficult, given the scale of the problem and the diversity of stakeholders, the approach to Quality Risk Management (QRM) used by the pharmaceutical industry provides governments and public health officials with a ready-made framework to arrive at such control strategies. This approach is set out in the ICH Guideline on Quality Risk Management (ICH Q9). This globally adopted guideline provides a structured QRM framework based on four key process elements - Risk Assessment, Risk Control, Risk Communication and Risk Review. This paper demonstrates how each of these elements can be used when developing robust and sciencebased risk control strategies for COVID-19.

DOI

https://doi.org/10.21427/f5hn-9436

Creative Commons License

Creative Commons Attribution-Noncommercial 4.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 4.0 License.

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