Module 3 - Strategic case studies in practice

ICH Q3D(R1) Guideline

The decision to accept risk. (ISO Guide 73)

Risk Analysis: The estimation of the risk associated with the identified hazards. (ICH Q9) Risk Assessment: A systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards. (ICH Q9)

Risk Control: Actions implementing risk management decisions. (ISO Guide 73)

Risk Identification: The systematic use of information to identify potential sources of harm (hazards) referring to the risk question or problem description. (ICH Q9) Risk Management: The systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating, and reviewing risk. (ICH Q9) Safety: Practical certainty that adverse effects will not result from exposure to an agent under defined circumstances. (Ref. 2) Safety Assessment: An approach that focuses on the scientific understanding and measurement of chemical hazards as well as chemical exposures, and ultimately the risks associated with them. This term is often (and in this guideline) used synonymously with risk assessment. (Ref. 2) Safety Factor: A composite (reductive) factor applied by the risk assessment experts to the NOAEL or other reference point, such as the benchmark dose or benchmark dose lower confidence limit, to derive a reference dose that is considered safe or without appreciable risk, such as an acceptable daily intake or tolerable daily intake (the NOAEL or other reference point is divided by the safety factor to calculate the reference dose). The value of the safety factor depends on the nature of the toxic effect, the size and type of population to be protected, and the quality of the toxicological information available. See related terms: Assessment factor, Uncertainty factor. (Ref. 2) TLV: Threshold Limit Value: The concentration in air to which it is believed that most workers can be exposed daily without an adverse effect (i.e., effectively, the threshold between safe and dangerous concentrations). The values were established (and are revised annually) by the ACGIH and are time-weighted concentrations (TWA) for a 7- or 8-hour workday and 40-hour workweek, and thus related to chronic effects. (IUPAC ） TWA: Time Weighted Average: As defined by ACGIH, time-weighted average concentration for a conventional 8-hour workday and a 40-hour workweek. (IUPAC) Severity: A measure of the possible consequences of a hazard. (ICH Q9)

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