Risk assessment: A transparent means by which to link the nature and extent of public health protection (risk reduction) achieved as a result of different risk management actions (or interventions). Risk analysis is composed of three activities: (1) risk assessment, (2) risk management, and (3) risk communication.

Risk characterization: The qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization, and exposure assessment.

Risk communication: The interactive exchange of information and opinions concerning risks among risk assessors, risk managers, consumers, and other interested parties.

Risk management: The process of weighing policy alternatives in the light of results of risk assessment, and, if required, selecting and implementing appropriate control options, including regulatory measures.

Standard setting: The establishment of a standard through the formulation of written rules and procedures.

Standards: Established norms or codified requirements for a product, such as material specifications or technical standards for performance. Standards may be developed by regulatory agencies, public organizations or industry associations (Marucheck et al., 2011).

Stringent regulatory authority: A national drug regulatory authority participating in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use or the Pharmaceutical Inspection Co-operation Scheme. Countries with stringent regulatory agencies include the United States, European Union member states, and Japan, but for its purposes the committee also included Australia, New Zealand, Norway, Iceland, Switzerland, and Canada in this group.

Supply chain: A system of organizations, people, technology, activities, information, and resources involved in moving a product or service from supplier to customer. Supply chain activities transform natural resources, raw materials, and components into a finished product that is delivered to the end customer.

Surveillance: A key component of epidemiology, it can be defined as the ongoing collection, analysis, interpretation, and dissemination of health-



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