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The Use of Human Experience Data in the EU Risk Assessment Process

机译：在欧盟风险评估过程中使用人类经验数据

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The incorporation of human experience data (HD) into the risk assessment process is encouraged by various authorities with the aim of improving the robustness of the subsequent findings. HD, however, can present in many forms, ranging from epidemiological studies to the accumulated experiences from poison centers. This diversity of the human experience, combined with the manner in which it may (or may not) present, creates several challenges for risk assessors if they are to give available HD due weight in the RA process. An evaluation was made of how HD has been cited and used within the 64 human health RAs published by the EU to the end of 2005. In all RAs, HD had been cited to some degree. But there was no consistency between how cited data had subsequently been taken forward and used in the evaluation of different endpoints, either between the RAs authored by the same or different EU Member States. The lack of any accepted guidance for addressing the role that HD can play within the RA process appears to lead to this situation. Recommendations are provided on the scope and focus such guidance could usefully be expected to take.
机译：各种权威机构都鼓励将人类经验数据（HD）纳入风险评估过程，以提高后续发现结果的可靠性。然而，高清可以多种形式出现，从流行病学研究到毒物中心的累积经验。人类经验的这种多样性，加上可能（或可能不）表现的方式，给风险评估者带来了一些挑战，如果他们要在RA流程中给予可用的HD适当的权重。对欧盟在2005年底之前发布的64种人类健康RA中如何引用和使用HD进行了评估。在所有RA中，HD在某种程度上都被引用。但是，在相同或不同欧盟成员国签署的RA之间，随后如何继续使用引用的数据并将其用于评估不同的终点之间，并不一致。缺乏解决高清可以在RA流程中扮演的角色的公认指南似乎导致了这种情况。提供了有关范围的建议，并希望可以有效地预期此类指导的重点。

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