Risk mitigation labeling

Importantly, appropriate labeling is critical to communicating potential human risk and also when appropriate should be supported with a risk mitigation plan. As most assessments of carcinogenic risk are made on individual products, additional consideration may also be needed when patients are exposed to multiple products for treating the intended disease. The need for a prospectively defined pharmacovigilance plan is a final imperative for ensuring the availability of safe medicines [36],... 

Evaluate options to mitigate risks in individual projects and the overaU portfoHo through diversification. This may include analyzing opportunities for label... 

Employers must furnish the tools needed for safe electrical work, such as insulated voltagerated hand tools and voltage sensing devices. Warning labels on eqnipment In some cases required by law, visible labels on electrical equipment with PPE Hazard/Risk Category, incident energy, boundary distances and other data reinforce safety awareness and help mitigate liability claims. 

Risk Analysis takes all inputs and products to produce a list of risk items to be properly dealt with the appropriate measures. As a general rule, risks in medical devices are usually avoided or mitigated. On the contrary, direct acceptance of a risk is not an option except for cases of highly beneficial medical devices. Even in that case, it shall be possible only for the most superficial, harmless and improbable risks that can hardly be reduced or mitigated. Mitigation and avoidance can be achieved by means of additional requirements, safety checks, boundary control, labelling, etc. Furthermore, software can hardly reduce the severity of a risk, instead it can reduce its probability to happen and/or increase its visibility should it happen. In the end, all risk items should have been brought to an acceptable level of residual risk. 

This group usually consists of a set of design, documentation or labelling requirements focused on mitigating risk from other requirements. This is usually an out-... 

Exposure. With the establishment of cumulative risk assessment requirements of the FQPA, there is much more of a need to focus on exposure. Prior to FQPA registrants could often live with the worst case result of an individual exposure assessment. Hazards could be mitigated with additional testing and/or label recommendations for additional personal protective equipment. Cumulative assessment and a certain total allowable risk shows that worst-case exposure analyses soon cause the risk cup to overflow. Prudent long-term strategy for a... 

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