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1.
Recent guidance on safety monitoring during drug development, issued by regulatory authorities in the United States and European Union, indicate a shift in focus towards aggregate safety monitoring and scientific evaluation of integrated safety data. The call for program‐level reviews of accumulating safety data, including from ongoing studies, provides an opportunity to leverage the scientific expertise and medical judgment of safety management teams with (a) a multidisciplinary approach, (b) quantitative frameworks to measure level of evidence, and (c) assessments that are product‐specific and driven by medical judgment. A multidisciplinary team, regularly reviewing aggregate safety data throughout the development program, is vital not only for early signal detection but also for generating a better understanding of the accumulating data and context needed for decreasing false alarms. 相似文献
2.
ABSTRACTThe originality of this paper lies in the ways in which it explores how the depiction of organised crime within Andrey Kurkov’s novel Death and the Penguin can inform our understanding of organisational modularity. This non-orthodox approach might open up new avenues of thought in the study of organisational modularity while further illustrating how novelistic worlds can inform accounts of organisational realities. Two main research questions underlie the paper. How can Andrey Kurkov’s novel further our understanding of the complexity of organisational worlds and realities by focusing our attention on different landscapes of organising? How does Kurkov’s novel help us grasp the concept of modularity by drawing attention to new forms of modular organisation? Drawing from our reading of Kurkov’s novel, we primarily explore organisational modularity through Kurkov’s depiction of organised crime and consider the themes of alienation and isolation in the context of modular organising. 相似文献
3.
在倡导"生命至上、安全第一"的新时代,安全素质已然成为教师专业素质结构中的重要组成部分。但目前我国中小学教师安全素质水平较低,其主要原因在于校内安全教育的低效与共性化、职后安全培训的不足以及自主学习途径的缺乏。针对当前存在的主要问题,教师安全素质培养路径的优化和培养体系的构建可以从三个方面展开:首先,在职前修订师范教育人才培养标准,重建教师专业素质结构,同时调整安全教育的课程设置,协同第二课堂提升教师安全素质;其次,在职后扩大教师安全培训对象,建立"分层进阶"新模式,对安全考试合格者发放教师安全培训合格证书,调整和完善中小学校岗位安全工作指南;第三,在日常工作期间,逐步改善教师自主学习条件,积极开展安全专题类校本课程研究。 相似文献
4.
Brianna Keogh Poorna Kushalnagar Alina Engelman 《Journal of American college health : J of ACH》2020,68(1):1-5
AbstractObjective: The purpose of the study was to investigate whether peer support and demographic characteristics predicted food security among deaf college students. Participants: The sample included 166 deaf college students at Gallaudet University. Methods: Participants completed a bilingual online survey in American Sign Language (ASL) and English. This survey included USDA’s 6-item food security survey, questions about peer support and socio-demographic characteristics. Results: Out of 166 students (mean age =23; SD?=?6), 60.7% were food secure. About 26.4% were at-risk for low food security and another 12.9% had very low food security. The sample included respondents who identified as people of color (54%) and women (52%). Binary logistic regression revealed that compared to people who reported always receiving peer support, people who never received peer support were 16.3 times more likely to experience food insecurity (adj OR: 16.325, 95% CI 1.824–146.107). Conclusions: This study demonstrates a strong relationship between peer support and deaf college students' food security experiences. 相似文献
5.
Iñaki HERAS-SAIZARBITORIA Olivier BOIRAL Ander IBARLOZA 《International labour review / International Labour Office》2020,159(3):397-421
This article analyses the genesis of the ISO 45001 standard on occupational health and safety, a new initiative of transnational private regulation. The authors draw a picture of controversy from interviews with stakeholders involved in its design, approval and initial dissemination, and from a qualitative content analysis of the internal documentation of the committee responsible for its approval. Like its predecessors relating to environmental management – ISO 14001 – and corporate social responsibility – ISO 26000 – this new standard raises serious concerns among stakeholders given that it deals with substantive political, social and legal issues. 相似文献
6.
AbstractNudge theory describes how indirect suggestions and positive reinforcement can influence decision-making. We used nudge theory to implement a traffic-light labeling and choice architecture (modifying product placement) intervention at Harvard University cafeterias, but found no significant change in sales. Survey and focus group data showed that some students thought the labeling may exacerbate eating disorders, however, there is extremely limited research on potential negative consequences of labeling. One way to describe these findings is through 20th century philosopher Michel Foucault’s concept of biopower. Biopower manipulates cultural norms and nudges individuals to engage in self-surveillance and self-discipline, de facto subjugating themselves to certain ways of being. Biopower may lead to the creation of an in-group and an out-group based on who can adopt the new behaviors, such as healthy eating. Those in the out-group may face additional unintended consequences, highlighting the need for mixed-methods research to better evaluate public health interventions. 相似文献
7.
Although there has been a growing literature on the effects of culture on the cross-national variation of homicide, this literature remains limited in the operationalization of national culture as well as in the modeling of the cultural effects. Adopting a multidimensional measure of national culture developed in the World Values Survey, this study examines the effects of various aspects of national culture, as well as their interaction, on the cross-national variation of homicide. The findings of this study provide evidence for the effect of national culture on homicide variation across countries while painting a more complex picture about the potential mechanisms of these effects. 相似文献
8.
9.
This article presents a discourse on the incorporation of organizational factors into probabilistic risk assessment (PRA)/probabilistic safety assessment (PSA), a topic of debate since the 1980s that has spurred discussions among industry, regulatory agencies, and the research community. The main contributions of this article include (1) identifying the four key open questions associated with this topic; (2) framing ongoing debates by considering differing perspectives around each question; (3) offering a categorical review of existing studies on this topic to justify the selection of each question and to analyze the challenges related to each perspective; and (4) highlighting the directions of research required to reach a final resolution for each question. The four key questions are: (I) How significant is the contribution of organizational factors to accidents and incidents? (II) How critical, with respect to improving risk assessment, is the explicit incorporation of organizational factors into PRA? (III) What theoretical bases are needed for explicit incorporation of organizational factors into PRA? (IV) What methodological bases are needed for the explicit incorporation of organizational factors into PRA? Questions I and II mainly analyze PRA literature from the nuclear domain. For Questions III and IV, a broader review and categorization is conducted of those existing cross-disciplinary studies that have evaluated the effects of organizational factors on safety (not solely PRA-based) to shed more light on future research needs. 相似文献
10.
Alberto Garre Geraldine Boué Pablo S. Fernández Jeanne-Marie Membré Jose A. Egea 《Risk analysis》2020,40(2):336-351
Decision making in food safety is a complex process that involves several criteria of different nature like the expected reduction in the number of illnesses, the potential economic or health-related cost, or even the environmental impact of a given policy or intervention. Several multicriteria decision analysis (MCDA) algorithms are currently used, mostly individually, in food safety to rank different options in a multifactorial environment. However, the selection of the MCDA algorithm is a decision problem on its own because different methods calculate different rankings. The aim of this study was to compare the impact of different uncertainty sources on the rankings of MCDA problems in the context of food safety. For that purpose, a previously published data set on emerging zoonoses in the Netherlands was used to compare different MCDA algorithms: MMOORA, TOPSIS, VIKOR, WASPAS, and ELECTRE III. The rankings were calculated with and without considering uncertainty (using fuzzy sets), to assess the importance of this factor. The rankings obtained differed between algorithms, emphasizing that the selection of the MCDA method had a relevant impact in the rankings. Furthermore, considering uncertainty in the ranking had a high influence on the results. Both factors were more relevant than the weights associated with each criterion in this case study. A hierarchical clustering method was suggested to aggregate results obtained by the different algorithms. This complementary step seems to be a promising way to decrease extreme difference among algorithms and could provide a strong added value in the decision-making process. 相似文献