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23 October 2015 EMA/686009/2014 Pharmacovigilance Risk Assessment Committee (PRC)Risk minimization strategy for high strength and fixed combination insulin products Addendum to the good practice guide
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How to fill out risk minimisation strategy for?

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Risk minimisation strategy is used to identify, assess, and mitigate potential risks in order to protect individuals, assets, and organizations from harm or loss.
Any individual, company, or organization that is involved in activities that pose a risk to others is required to file a risk minimisation strategy.
Risk minimisation strategy can be filled out by conducting a thorough risk assessment, identifying potential risks, implementing control measures, and regularly monitoring and reviewing the effectiveness of the strategy.
The purpose of risk minimisation strategy is to prevent accidents, injuries, and financial losses by proactively addressing potential risks and implementing preventative measures.
Information such as identified risks, control measures, responsibilities, review process, and effectiveness of the strategy must be reported on a risk minimisation strategy.
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