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The guidance states, "These preventative measures can include steps to prepare personnel such as: * "Educating employees on topics such as, in the case of a pandemic, personal hygiene (hand washing and coughing and sneezing etiquette), social distancing, and appropriate use of sick leave * "Encouraging employees to get immunized as appropriate by providing information on local vaccination services or by offering on-site vaccination services, if reasonable * "Providing information for and encouraging employees to develop family emergency preparedness plans * "Reviewing CGMP [current good manufacturing practice] regulations regarding appropriate sanitation practices and restriction of ill or sick employees from production areas (see 21 CFR [Code of Federal Regulations] 211.28)" (2). Examples include: * "Production equipment routine maintenance * "Utility system performance checks and maintenance (e.g., air temperature, lighting, compressed air) * "Environmental monitoring of facilities such as cell culture, harvesting, and purification rooms during production * "Stability testing for certain drug products and components * "Periodic examinations of data and of reserve samples" (2). EMA, Guidance on the Format of the Risk Management Plan (RMP) in the EU-in Integrated Format, EMA/164014/2018 Rev.2.0.1 accompanying GVP Module V Rev.2 Human Medicines Evaluation (EMA, 31 October 2018).
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Since the COVID-19 outbreak, the scope and market size of flexible employment in sustainable enterprise development have significantly increased worldwide, yet academic literature offer little information about the outcomes and moderators of flexible employment in China. The paper advances current knowledge and empirically addresses this gap by examining the effects of flexible employment on enterprise innovation input and output, with information technology capability and labor regulation as unexplored moderators. Based on data from 1179 manufacturing enterprises in China, this paper uses the OLS method to conduct empirical tests. The results show that (1) flexible employment has positively contributed to sustainable enterprise development by facilitating innovation inputs and outputs;(2) superior enterprise information technology capabilities and strict labor regulations were significant moderating factors in this relationship. The findings provide credible evidence for enterprises to pursue flexible employment as an inexhaustible impetus for sustainable economic and enterprise development.
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Objective To explore the effect of WeChat group management on blood pressure control rate and drug compliance of hypertension patients during the epidemic of coronavirus disease 2019 (COVID-19) . Methods A total of 428 consecutive patients with essential hypertension in our outpatient department from Jan. 2020 to Dec. 2020 were enrolled and randomly divided into experimental group and control group with a ratio of 1 : 1. There were 214 patients in the experimental group, 110 males and 104 females, with an average age of (55.48+/-6.11) years. There were 214 cases in the control group, 108 males and 106 females, with an average age of (56.52+/-5.19) years. WeChat groups were established for the 2 groups separately. Information on education, supervised medication and lifestyle of hypertension was provided to the patients in the experimental group through WeChat, while no active intervention was given to the control group. The blood pressure control rate and medication possession ratio (MPR) were calculated at 1, 3, 6 and 12 months of intervention, and the differences between the 2 groups were compared. Results There were no significant differences in the blood pressure control rate (91.12%195/214 vs 90.65% 194/214, 86.67%182/210vs 89.62%190/212or MPR (0.90+/-0.03 vs 0.90+/-0.05, 0.85+/-0.04 vs 0.88+/-0.03) between the 2 groups at 1 or 3 months of intervention (all P>0.05). At 6 and 12 months, the blood pressure control rate (81.73%170/208vs 88.57%186/210,75.12%154/205vs 85.99%178/207) and MPR (0.74+/-0.04 vs 0.87+/-0.05, 0.58+/-0.05 vs 0.85+/-0.03) of patients in the experimental group were significantly higher than those in the control group (all P<0.05). Conclusion During the COVID-19 epidemic, WeChat group management of hypertension patients by doctors could improve patients' blood pressure control rate and drug compliance and strengthen patients' self-management ability.Copyright © 2022, Second Military Medical University Press. All rights reserved.
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Under the influence of the novel coronavirus epidemic, some negative social events, such as separation of family or friends and home isolation have increased. These events can cause negative emotion experiences similar to physical pain, thus they are called social pain. Placebo effect refers to the positive response to the inert treatment with no specific therapeutic properties, which has been shown to be one of the effective ways to alleviate social pain. Studies have shown that the dorsolateral prefrontal cortex (DLPFC) plays a key role in placebo effect. Therefore, this study aimed to explore whether activating DLPFC by using transcranial magnetic stimulation (TMS) could improve the ability of placebo effects to regulate social pain. Besides, we also combined neuroimaging and neuromodulation techniques to provide bidirectional evidence for the role of the DLPFC on placebo effects. We recruited a total of 100 participants to finish the task of negative emotional rating of the social exclusion images. Among them, 50 participants were stimulated by TMS at the right DLPFC (rDLPFC), while the others were assigned to the sham group. This study contained two independent variables. The between-subject variable was TMS group (rDLPFC-activated group or sham group) and the within-subject variable was placebo type (no-placebo and placebo). All participants received nasal spray in two blocks. In the no-placebo condition, participants were instructed that they would receive a saline nasal spray which helped to improve physiological readings;in placebo block, participants were told to administrate an intranasal fluoxetine spray (saline nasal spray in fact) that could reduce unpleasantness within 10 minutes. To strengthen the expectation of intranasal fluoxetine, participants viewed a professional introduction to fluoxetine's clinical and academic usage including downregulating negative emotion, such as fear, anxiety, and disgust. Participants who received the placebo block first would be reminded that fluoxetine's effect was over before the next block to reduce the carry-over for the following block. Self-reported negative emotional and electroencephalogram data were recorded. There was a significant two-way interaction of TMS group and placebo type. Results showed that compared with the sham group, participants in the rDLPFC-activated group reported less negative emotional feeling and had a lower amplitude of the late positive potential (LPP) in placebo condition, a component that reflects the emotional intensity, suggesting that activating rDLPFC can improve the ability of placebo effect to regulate social pain. The above finding suggested that activating DLPFC can improve the placebo effect of regulating negative emotion. Moreover, this study is the first attempt to investigate the enhancement of placebo effects by using TMS on emotion regulation. The findings not only support the critical role of DLPFC on placebo effect using neuroimaging and neuromodulation techniques, but also provide a potential brain target for treating emotional regulation deficits in patients with psychiatric disorders. © 2023 WANG Mei.
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In December 2019, a novel coronavirus broke out in Wuhan City, Hubei Province, and, as the center of the coronavirus disease 2019 (COVID-19) epidemic, the economy and production throughout Hubei Province suffered huge temporary impacts. Based on the input–output and industrial pollution emissions data of 33 industrial industries in Hubei from 2010 to 2019, this article uses the non-parametric frontier analysis method to calculate the potential production losses and compliance costs caused by environmental regulations in Hubei's industrial sector by year and industry. Research has found that the environmental technology efficiency of the industrial sector in Hubei is showing a trend of increasing year-on-year, but the overall efficiency level is still not high, and there is great room for improvement. The calculation results with and without environmental regulatory constraints indicate that, generally, production losses and compliance costs may be encountered in the industrial sector in Hubei, and there are significant differences by industry. The potential production losses and compliance costs in pollution-intensive industries are higher than those in clean production industries. On this basis, we propose relevant policy recommendations to improve the technological efficiency of Hubei's industrial environment, in order to promote the high-quality development of Hubei's industry in the post-epidemic era.
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The debate about tackling online misinformation and disinformation is not unique to the COVID-19 pandemic. However, the health crisis has elevated the danger of misleading information circulated on social media. Labelled as 'infodemic', the problem of COVID-19-related misinformation and disinformation prompted governments and social media platforms around the globe to impose various speech restrictions. The public and private policy frameworks aiming to curb the spread of the infodemic were adopted in a state of emergency and without proper scrutiny. Yet, they are shaping the future of content regulation, possibly affecting freedom of speech and other democratic values for years to come. This chapter looks at the key problematic aspects of actions taken by governments and social media platforms to address COVID-19-related misinformation and disinformation and discusses the possible long-term effects of these measures. © 2023 the authors.
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Besides the widespread harm and dreadful impact COVID-19 has caused, it brought about change. Interpreting the pandemic as a 'change agent', it is possible to observe how it accelerated the use of digital technologies, facilitating the migration of many activities to the virtual sphere and thus changing the interaction between the physical and virtual worlds. Although the pandemic accelerated the diffusion and adoption of digital technologies, allowing many to avoid or reduce the harms caused by the pandemic, not everyone benefitted to the same extent. The pandemic exacerbated existing digital divides while creating new ones, simultaneously elevating important policy debates regarding digital infrastructure and inclusion policies. © 2023 the authors.
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Aims: Children and adolescents were affected in various ways by the measures due to COVID-19 pandemic. The aims of this study were to investigate and compare the effects on mental health across age, to identify latent class trajectories of emotional and behavioural problems over 12-months and to examine the association of classes of trajectories with baseline demographic and clinical predictors. Method(s): Children (n = 1854) and adolescents (n = 1243) from the general population were assessed baseline, at 6-, 9-, and 12-month follow-up. They were eligible if they were residents in Austria, Germany, or Switzerland, were parents/caregivers of a child aged between 7 and 10 years or adolescents >=11 years, had sufficient German language skills and provided informed consent. Results and Conclusion(s): Significant age-effects were found regarding type and frequency of problems. While children had the largest increase in aggressive behaviours, adolescents reported the largest increase in emotional problems. Sociodemographic variables, exposure to and appraisal of COVID-19, psychotherapy before COVID-19 and parental mental health significantly predicted change in problemscores (F >= 3.69, p <= .001). Using growth mixture modelling, a oneclass solution was detected for the trajectory of aggressive behaviours and a two- and three-class solution for withdrawn/depression and anxiety/depression. A substantial proportion of children and adolescents experienced age-related mental health problems during the different stages of the COVID-19 pandemic. These results suggest that psychological problems of specific sub-groups should be monitored over the longer-term and interventions to improve communication, emotion regulation, and appraisal style should be offered to risk groups.
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Objectives: Glycogen Storage Disease Type Ia (GSDIa) is a rare inherited disorder resulting in acute hypoglycemia due to impaired release of glucose from glycogen. Despite dietary management practices to prevent hypoglycemia in patients with GSDIa, complications still occur in children and throughout adulthood. This retrospective cohort study compared the prevalence of complications in adults and children with GSDIa. Method(s): Using ICD-10 diagnosis codes, the IQVIA Pharmetrics Plus database was searched for patients with >=2 GSDI claims (E74.01) from January 2016 through February 2020, with >=12 months continuous enrollment beginning prior to March 2019 (for one year of follow-up before COVID-19), and no inflammatory bowel disease diagnoses (indicative of GSDIb). Complication prevalence in adults and children with GSDIa was summarized descriptively. Result(s): In total, 557 patients with GSDIa were identified (adults, 67%;male, 63%), including 372 adults (median age, 41 years) and 185 children (median age, 7 years). Complications occurring only in adults were atherosclerotic heart disease (8.6%), pulmonary hypertension (3.0%), primary liver cancer (1.9%), dialysis (0.8%), and focal segmental glomerulosclerosis (0.3%). Other complications with the greatest prevalence in adults/children included gout (11.8%/0.5%), insomnia (10.0%/1.1%), osteoarthritis (22.0%/2.7%), severe chronic kidney disease (4.3%/0.5%), malignant neoplasm (10.8%/1.6%), hypertension (49.7%/8.7%), acute kidney failure (15.3%/2.7%), pancreatitis (3.0%/0.5%), gallstones (7.8%/1.6%), benign neoplasm (37.4%/8.1%), hepatocellular adenoma (7.0%/1.6%), neoplasm (41.1%/9.7%), and hyperlipidemia (45.2%/10.8%). Complications with the greatest prevalence in children/adults included poor growth (22.2%/1.9%), gastrostomy (29.7%/3.2%), kidney hypertrophy (2.7%/0.8%), seizure (1.6%/0.5%), hypoglycemia (27.0%/11.3%), hepatomegaly (28.7%/15.9%), kidney transplant (1.6%/1.1%), diarrhea (26.5%/18.6%), nausea and/or vomiting (43.8%/35.8%), acidosis (20.0%/17.2%), and anemia due to enzyme disorders (43.8%/40.6%). Conclusion(s): GSDIa is associated with numerous, potentially serious complications. Compared with children, adults with GSDIa had a greater prevalence of chronic complications, potentially indicating the progressive nature of disease. Children with GSDIa had more acute complications related to suboptimal metabolic control.Copyright © 2023
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This chapter looks at current and perspective legislative and regulatory scenario, identifying rules governing the use of Artificial Intelligence in the health sector at European Union level with a focus on the impact of AI on pharmacovigilance activities. After some preliminary considerations on definitory issues, attention will be paid to the challenges posed by AI to pharmaceutical industry in developing medicinal products and monitoring their quality, safety and efficacy. The European strategy addressing the use of AI in pursuing a better health policy will then be outlined, followed by some caveat concerning ethical implications and protection of personal data. © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2022.
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The LEARN-COVID pilot study collected data on infants and their parents during the COVID-19 pandemic. Assessments took place between April and July 2021. Parents (N = 357) from Switzerland (predominantly), Germany, and Austria answered a baseline questionnaire on their behaviour related to the pandemic, social support, infant nutrition, and infant regulation. Subsequently, parents (n = 222) answered a 10- day evening diary on infant nutrition, infant regulation, parental mood, and parental soothing behaviour. Data and documentation are stored on Zenodo, https://doi. org/10.5281/zenodo.6946048. These data may be valuable to researchers interested in infant development and parenting during the pandemic as well as to researchers interested in daily variability in infant behaviour, parenting, and nutrition. (PsycInfo Database Record (c) 2023 APA, all rights reserved)
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The article calls for the public health community to examine who deter the issuance of deficiently supported recommendations by holding accountable public health officials who promote such recommendations. Topics discussed include advice public health advice that contradicts prevailing scientific evidence, mechanisms for accountability, and the need for self-regulation.
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Background and Objectives: Fear of COVID-19 is common among older adults and negatively impacts on their physical and mental health. Self-regulation is an essential factor for controlling or managing excitement and anxiety. So, this study aimed to determine the relationship between fear of COVID-19 and death anxiety with the moderator role of self-regulation among the elderly residing in Qazvin. Method(s): This descriptive and cross-sectional study was performed on 430 elderly aged 60 and over living in Qazvin in 2021. Samples were selected by cluster sampling method. The demographic checklist, Templer death anxiety scale, fear of COVID-19 questionnaire, and Self-Regulation Inventory were used for collecting the data. The data were analyzed using the Path Analyze test. Result(s): The mean age of the elder participants in the study was 66.88 +/- 6.40 years old. The results showed a significant and positive relationship between fear of COVID-19 and death anxiety (beta=0.60, P<0.001) and an inverse association between fear of COVID-19 (beta=-0.24, P=0.021) and death anxiety (beta=-0.10, P=0.021) with self-regulation. Furthermore, the results of the Path analysis confirmed the moderator role of self-regulation in the association between fear of Covid-19 and death anxiety among the elderly residing in Qazvin, Iran. Conclusion(s): Given the mediator role of self-regulation in the relationship between fear of COVID-19 and death anxiety, it is suggested to use teaching strategies to the older adults to improve self-regulation to control and mitigate the negative impacts of the fear of COVID-19 in this vulnerable population.Copyright © 2022 The Authors.
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The revised NIS-2 Directive has been assigned to the Committee on Industry, Research, and Energy (ITRE), within the European Parliament, and is intended to form one of the baselines for the European cybersecurity framework, as well as act as a central tool in advancing Europe's strategic autonomy and the Digital Europe Programme (3). The intention is that cyber resilience must be considered a priority at board and senior management level rather than be confined to the remit of technical teams. European Parliament Adopts New Draft Directive," Technology Law Dispatch, Reed Smith LLP, 20 Jan. 2022.
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The regulation also sets out obligations on marketing authorization holders (MAHs) and medical devices manufacturers, authorized representatives, importers, distributors, and notified bodies duties to: * Provide information that will assist with the monitoring by the MSSG/MDSSG of shortages of medicinal products and devices contained in the critical medicines list and updating this when necessary * Provide a justification for any failure to provide the requested information by the established deadlines * Immediately provide any evidence of an actual or potential shortage of medicinal products or devices * Provide information to EMA by 2 Sep. 2022 that will enable the establishment of a Single Point of Contact (SPOC) network, and the industry Single Point of Contact (iSPOC) network, with mandates to updating this when necessary (7). Enhanced advisory role In addition to the measures designed to address medicinal and medical device shortages, an Emergency Task Force (ETF) will also be established within EMA to provide scientific advice and review evidence on medicines that have the potential to address public health emergencies, offer scientific support to facilitate clinical trials, and support existing EMA committees with their authorization and safety monitoring of medicines (8). According to the document published by EMA on Crisis Preparedness and Management, the key benefits for EMA of having these responsibilities include: * Accelerated evaluation and access to safe and effective medicines which could treat or prevent a disease causing, or likely to cause, a public health emergency * Improved quality of data and the effective use of resources through increased support at EU level towards the conducting of clinical trials in preparation for, and during a public health emergency * Improved coordination and harmonization at EU level in preparation for and during a public health emergency (7).
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[...]on 25 Nov. 2020, the European Commission (EC) announced the new Pharmaceutical Strategy for Europe, which is likely to result in significant changes to the European Union (EU) regulatory framework and will have a substantial impact on both the marketing of medicinal products and the strategic business planning of pharmaceutical companies (2). (2021), the priority areas are as follows: * The performance and adequacy of the current legislation * Unmet medical needs-with a definition or set of principles for "unmet medical needs" under discussion * Incentives for innovation, including the area of unmet needs and a reflexion on regulatory data and market exclusivity * Antimicrobial resistance that includes measures to support innovation of antibiotic development * Future-proofing the regulatory framework for novel products * Improved patient access to, and affordability of, medicines in the EU * Competitiveness of the European markets to ensure affordable medicines, including considering measures to support patients' access to affordable medicines * Encouraging the repurposing of off patent medicines * Ensuring security of supply of medicinal products in the EU * Ensuring high-quality manufacture and distribution in the EU including consideration of the need to strengthen or adapt good manufacturing practice (GMP) to reflect new manufacturing methodologies * Environmental challenges (4). Availability, accessibility, and affordability of medicinal products The section on 'Prioritising unmet medical needs' in the strategy reflects the belief within EU Bianca Piachaud-Moustakis is lead writer at PharmaVision, Pharmavision.co.uk. institutions that "current incentive models neither provide an adequate solution for unmet medical needs nor appropriately incentivise investments in innovation" (2).
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Mental health in families has been affected by COVID-19 stressors. Parental stress and emotion regulation can moderate the emotional effects on their children. This study analyzes the role of parental stress as a mediating variable between parents' emotion regulation and children's symptoms. Participants were 214 parents of youth aged 3-17 years, who completed an online survey providing information about parental variables and symptoms in their children. The results show that parental stress mediates the relationship between parental emotion regulation and children's psychological symptoms. Thus, parents who used cognitive reappraisal strategy less frequently reported more psychological symptoms in their children and higher parental stress. Parents who used expressive suppression more frequently also reported more psychological symptoms in their children and higher parental stress. The present study provides novel information by relating parental psychological variables with psychological variables in youth during a period characterized by the most significant psychological impact of the COVID-19 pandemic. © 2023. Psy, Soc & Educ.
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The COVID-19 pandemic has revealed and accelerated two trends that are now fully part of the "new normal” of work. First, the erosion of boundaries between work and life has become very salient with the normalization of work from home. Second, the quantification of organizational control, which was already present in monitoring devices and algorithmic management, has reached news levels with electronic monitoring of employees through "bossware” and Internet of Behaviours devices. This essay chapter analyses these trends and argues that active regulation of technology and its implications at work and outside of work is now an integral part of work for workers in many occupations. Specifically, the new normal of work routinely includes devising and adapting rules and behaviours around three major challenges: (a) constant connectivity (when and where workers are connected and available to work);(b) self-presentation (disclosures on video conferences, social media, and other online spaces);and (c) privacy (protecting personal information despite monitoring software, trackers, and algorithmic work). Colliding worlds and quantified algorithmic control are deep-rooted trends that must be addressed by workers, employers, unions, public policy makers, and scholars, if we are to build a new normal sustainable workplace. © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023.