Risk mitigation

Biological risk Mitigation of risk handling procedures, packaging for transit, minimization of inhalation of particulates or aerosols. 

Those parameters that are not directly evaluated by system suitability testing during routine analysis must be checked periodically or the risk mitigated in some other way to ensure that the instrument is maintained in a qualified state. However for some critical parameters evaluation as part of the system suitability testing may not be sufficient and specific periodic testing may also be required. 

FIGURE 8.1 The risk curve lines shown represent thresholds between different types of decisions (based on ECOFRAM 1999a and 1999b). These thresholds would be determined by decision makers and may move location subject to other factors that affect the decision (e.g., pesticide benefits). The bottom graph shows an example risk curve with uncertainty bounds. The curve clearly fits within the acceptable risk category however the upper uncertainty bound does not, indicating a need for risk mitigation or further refinement of the risk assessment. 

The PAT framework and ICH Q8 will provide a basis for risk mitigation. Risk management principles and tools being developed under ICH Q9 will be necessary to describe and communicate the level of risk-mitigation achieved through quality by design and process understanding. 

The quality of design (product and its manufacturing process)—the ability to reliably predict quality and performance, process monitoring and controls, process capability and appropriate risk-mitigation strategies—provides an opportunity to achieve real time quality assurance (the ultimate level of efficiency). This also provides an excellent opportunity to develop efficient and effective quality assurance systems as an alternative to market or public standards (18). 

PAT Tools There are many tools available that enable process understanding. These tools, when used within a system, can provide effective and efficient means for acquiring information to facilitate process understanding, continuous improvement, and development of risk mitigation strategies. Such tools are categorized as follows ... 

Keywords Oil and gas pipeline economics, pipeline investment risks, risk mitigation... 

The next section provides an analysis of contractual structures and risk mitigation instruments in transborder pipelines. 

The development of the HySPP is a crucial step in the scale-up of the HyS technology. This will build on the HyS component development and R D project. The HySPP is also an important risk mitigation tool as supplier (and supply chain) evaluation, system integration, human capital development, scale-up verification, proof of concept, materials of construction verification and various other risks will be mitigated before proceeding with basic and detail design of the commercial HyS plant. 

Brock TCM. 2001. Risk assessment and mitigation measures for pesticides are all patches of freshwater habitat equal In Streloke M, editor. Workshop on risk assessment and risk mitigation measures in the context of the authorization of plant protection products (WORMM). Volume 383. Berlin (Germany) Mitteilungen aus der Biologischen Bundesanstalt fur Land- und Forstwirtschaft, p 68-72. 

Schulz R. 2004. Field studies on exposure, effects, and risk mitigation of aquatic nonpoint-source insecticide pollution a review. J Environ Qual 33 419-448. 

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],... 

Risk mitigation—take small steps within the current infrastructure. 

It must be determined whether the risk mitigation options selected are feasible and provide a realistic use pattern, and whether compliance can be enforced. Another significant consideration is that options are cost-sensitive and are unlikely to be accepted if their cost exceeds the economic valne of the commodity on which the pesticide is to be used. 

Some regulatory agencies also require the reporting of adverse effects. Such post-registration monitoring data can supplement and validate risk assessments for pesticides under re-evaluation and provide useful information for further risk mitigation and management. 

COMPONENTS OF RISK MITIGATION - CONSIDERATION OF PERSONAL PROTECTIVE EQUIPMENT... 

Components of Risk-Mitigation section above). Thus, it would be desirable... 

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