Peer Review

同行评审
  • 文章类型: Journal Article
    报告了欧洲食品安全局(EFSA)在报告员成员国主管当局对荷兰农药活性物质1-甲基环丙烯进行的初步风险评估进行同行审查后得出的结论。同行评审的背景是欧洲议会和理事会第1107/2009号条例(EC)所要求的批准条件修正案。目前对1-甲基环丙烯的批准包括具体规定,“只有在可密封仓库中作为收获后储存的植物生长调节剂的用途才可获得授权”。申请人AgroFreshHoldingFranceSAS提交,根据Reg的第7条。(EC)1107/2009,删除该特定规定的申请,以允许成员国授权在户外作物收获前使用含有1-甲基环丙烯的产品。结论是基于对1-甲基环丙烯作为植物生长调节剂的代表性用途的评估,该用途通过喷雾施用在pome果实上而得出的。可靠的端点,适用于监管风险评估。列出了监管框架所需的缺失信息。在确定的地方报告了担忧。
    The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State The Netherlands for the pesticide active substance 1-methylcyclopropene are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council for an amendment in approval conditions. The current approval of 1-methylcyclopropene includes the specific provision \'Only uses as plant growth regulator for post-harvest storage in sealable warehouse may be authorised\'. The applicant AgroFresh Holding France SAS submitted, in accordance with Article 7 of Reg. (EC) 1107/2009, an application to remove this specific provision in order to allow member states to authorise the use of products containing 1-methylcyclopropene on outdoor crops pre-harvest. The conclusions were reached on the basis of the evaluation of the representative use(s) of 1-methylcyclopropene as a plant growth regulator via spray application on pome fruit. The reliable endpoints, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.
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  • 文章类型: News
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  • 文章类型: Journal Article
    欧洲食品安全局(EFSA)在对报告员成员国主管当局进行的初步风险评估进行同行审查后得出的结论,据报道,荷兰对农药活性物质黄藻颗粒病毒进行了报道。同行评审的背景是欧洲议会和理事会法规(EC)1107/2009所要求的。结论是在评估了通过喷洒(拖拉机牵引或背负式喷雾器)或高架灌溉在番茄(田间和温室用途)和马铃薯(田间用途)上作为杀虫剂的代表性用途的基础上得出的。可靠的端点,适用于监管风险评估。列出了监管框架所需的缺失信息。
    The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, The Netherlands for the pesticide active substance Phthorimaea operculella granulovirus are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of Phthorimaea operculella granulovirus as an insecticide on tomato (field and greenhouse uses) and on potato (field use) via spraying (tractor drawn or knapsack sprayers) or overhead irrigation. The reliable endpoints, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed.
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  • 文章类型: Journal Article
    报告了欧洲食品安全局(EFSA)在报告员成员国波兰和共同报告员成员国匈牙利的主管当局对农药活性物质三氯吡喃(变体三氯吡喃-丁tototyl)进行的初步风险评估的同行审查后得出的结论,以及对最大残留水平(MRL)的申请的评估。同行评审的背景是委员会执行条例(EU)第844/2012号所要求的,由委员会执行条例(EU)第2018/1659号修订。结论是在评估了三氯吡喃(变体三氯吡喃-丁tototyl)作为除草剂在既定牧场和非休闲设施草地上的代表性用途(田间使用)的基础上得出的。在水稻中评估MRL。可靠的终点,适用于监管风险评估和拟议的MRL,被呈现。列出了监管框架所需的缺失信息。在确定的地方报告了担忧。
    The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Poland and co-rapporteur Member State Hungary for the pesticide active substance triclopyr (variant triclopyr-butotyl) and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of triclopyr (variant triclopyr-butotyl) as a herbicide on established pasture and non-recreational amenity grassland (field use). MRLs were assessed in rice. The reliable end points, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.
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  • 文章类型: Journal Article
    同行评审是放射治疗质量保证的重要组成部分。据我们所知,没有研究报告在MR直线加速器(MR-Linac)上进行磁共振(MR)引导放射治疗(MRgRT)的同行评审过程的可行性和结果,尽管涉及计划的复杂性及其不断发展的临床适应症.这项研究旨在量化同行评审后治疗计划的变化率以及所需的时间和资源。
    前瞻性地收集了2023年6月8日至9月21日在两个中心每周一次的MR-Linac同行评审会议上提出的55例病例。根据澳大利亚和新西兰皇家放射科医师学院(RANZCR)开发的放射肿瘤学同行评审审核工具(PRAT),对病例进行了分析,以确定计划变更的速率和程度。
    同行评审导致更改了36.4%的治疗计划(n=20),3.6%(n=2)有重大变化,需要推迟治疗。最常见的变化是涉及轮廓和增加的OAR保留的危险器官(OAR)体积(16.4%,n=9),总剂量和分级(10.9%,n=6)和目标体积剂量覆盖率(5.5%,n=3)。有SBRT计划的患者(39.1%参见22.2%),寡转移/寡进展部位(38.1%cf30.7%)和再照射病例(41.2%cf34.2%)的变化率更高。病例平均需要7分钟(范围2-15分钟)来讨论。
    计划变更的高比率支持MRgRT中同行评审的价值。我们建议,在可能的情况下,所有MRgRT病例,特别是那些涉及SBRT计划的,寡转移/寡进展位点,和/或再辐照,要接受同行评审。
    UNASSIGNED: Peer review is an important component of quality assurance in radiotherapy. To our knowledge, there are no studies reporting on the feasibility and outcomes of the peer review process for magnetic resonance (MR) guided radiotherapy (MRgRT) on the MR linear accelerator (MR-Linac) despite the planning complexity involved and its evolving clinical indications. This study aimed to quantify the rate of change in treatment plans post-peer review and the time and resources required.
    UNASSIGNED: Fifty-five cases presented at weekly MR-Linac peer review meetings across two centres from 8 June to 21 September 2023 were prospectively collected. Cases were analysed to determine the rate and extent of plan changes based on the Peer Review Audit Tool for radiation oncology (PRAT) developed by the Royal Australian and New Zealand College of Radiologists (RANZCR).
    UNASSIGNED: Peer review resulted in changes to 36.4 % of treatment plans (n = 20), with 3.6 % (n = 2) having major changes requiring deferment of treatment. The most frequent changes were to organs at risk (OAR) volumes involving both delineation and increased OAR sparing (16.4 %, n = 9), total dose and fractionation (10.9 %, n = 6) and target volume dose coverage (5.5 %, n = 3). Patients with SBRT plans (39.1 % cf 22.2 %), oligometastatic/oligoprogressive sites (38.1 % cf 30.7 %) and reirradiation cases (41.2 % cf 34.2 %) had higher rates of change. Cases took a mean of 7 min (range 2-15 minutes) to discuss.
    UNASSIGNED: The high rates of plan changes support the value of peer review in MRgRT. We recommend, where possible that all MRgRT cases, particularly those involving SBRT plans, oligometastatic/oligoprogressive sites, and/or reirradiation, be subject to peer review.
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  • 文章类型: Editorial
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    报告了EFSA在报告员成员国比利时的主管当局对农药活性物质低聚腐霉菌株B301进行的初步风险评估的同行审查后得出的结论,以及关于将该物质纳入法规(EC)第396/2005号附件IV的考虑因素。同行评审的背景是欧洲议会和理事会法规(EC)1107/2009所要求的。结论是在评估寡生腐霉菌株B301作为抗性诱导剂/激发剂控制葡萄树树干病的代表性用途的基础上得出的。可靠的端点,适用于监管风险评估,被呈现。列出了监管框架所需的缺失信息。在确定的地方报告了担忧。
    The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Belgium for the pesticide active substance Pythium oligandrum strain B301 and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of Pythium oligandrum strain B301 as a resistance inducer/elicitor to control trunk diseases on grapevines. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.
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  • 文章类型: Editorial
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  • 文章类型: Letter
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