Module 9 2021

23/03/2021

Reflections on COVID 19 Vaccines….

Remove Regulatory Barriers

Use these approaches

In a fast and coordinated global reliance approach

Knowledge + Risk-Based

Reference: ICH Q9 (Quality Risk Management) https://database.ich.org/sites/default/files/Q9%20Guid eline.pdf

Leading to greater supply agility and flexibility

Reliance Mechanisms

And global Covid-19 vaccine availability

COVID 19 shows why we need CONVERGENCE in requirements

And will bring wider benefits… Principles can be applied to all medicines + vaccines where similar challenges exist each day

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Regulatory view on COVID-19

New Normal?

Efficiency Gain

Old Normal

Pandemic

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