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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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At present, due to the COVID-19, China's social and economic development has slowed down. Some life service e-commerce platforms have successively launched "contactless delivery" services, which can effectively curb the spread of the epidemic. Robot distribution is the current mainstream, but robots are different from people and need to have accurate program settings. Both path planning and obstacle avoidance are currently top issues. This requires the mobile robot to successfully arrive at the destination while minimizing the impact on the surrounding environment and pedestrians, and avoiding encroachment on the movement space of pedestrians. Therefore, the mobile robot needs to be able to actively avoid moving pedestrians in a dynamic environment, in addition to avoiding static obstacles, and safely and efficiently integrate into the pedestrian movement environment. In this paper, the path planning problem of unmanned delivery robot is studied, and the path of mobile robot in the crowd is determined by global planning and local planning, and the matlab simulation is used for verification. © The Authors. Published under a Creative Commons Attribution CC-BY 3.0 License.
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The epidemic caused by the infection of severe acute respiratory syndrome coronavirus 2 omicron variant broke out in Shanghai in Mar. 2022. Omicron variant has characteristics such as strong concealment and rapid transmission, resulting in significant differences between the current round of epidemic and that in Wuhan. The number of infected patients (mainly asymptomatic infected patients) increased rapidly in a short term. Based on dynamic zero policy, shelter hospitals were set up in time in Shanghai to treat the patients. It is suggested that medical resources and patient characteristics should be taken into account in the independent cabin of a shelter hospital with more than 10 000 beds, and the clinical medical practice should be divided to 5 modes (universal education and management, community outpatient clinic, ward duty, emergency rescue, and temporary observation and transport) to optimize the allocation of medical resources, so as to further enhance the treatment capacity and efficiency of shelter hospitals.Copyright © 2022, Second Military Medical University Press. All rights reserved.
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As cruise ships call at many ports and passengers come from all over the world, it is very easy to carry viruses on cruise ships. Under the control of the epidemic situation on board, the solid waste generated by them should be scientifically treated to prevent the spread of infectious diseases such as COVID-19 pneumonia. Therefore, Reasonable selection of waste disposal ports and formulation of unloading plans are directly related to the resumption of cruise operations. This study considers the cost and risk of waste disposal, uses robust optimization to deal with waste volume, increases the scenarios of port service interruption due to epidemics and other reasons, and proposes a variety of emergency strategies. Finally, the relevant strategies are selected according to the decision-maker's preference for cost and risk;By solving the relevant examples, the optimal choice of the cruise ship waste disposal port under the epidemic situation is given, which verifies the validity and feasibility of the model. The research helps to improve the management of cruise waste during the post-epidemic period, and has practical value and guiding significance for the normal operation and development of the global cruise market. © 2023 SPIE.
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[...]many sponsors have implemented alternative ways to conduct trials or components of them, incorporating remote and virtual activities, which aim to bring studies directly to patients via a range of technologies. Every clinical investigation begins with the development of a protocol that describes h.ow a clinical trial will be conducted-encompassing the objective(s), design, methodology, statistical considerations, and organization of the study-and ensures the safety of the trial subjects and integrity of the data collected. [...]of the pandemic, we will see more hybrid trials that combine site and remote patient visits. In forcing the research community to be more open to using different tools to ensure vital research continues, the pandemic is driving the beginning of a new era of patient and site engagement-one in which a more proactive and efficient approach ensures the lines of communication remain open and data is collected appropriately and with greater speed.
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This paper is a personal attempt to rethink critically the social impact of the Covid-19 pandemic, trying to discuss about some changes, which came out in that tragic period, in the way of living time and space. There are several ways in which the COVID-19 pandemic has affected these two main structural dimensions of society and the response strategies used by people, groups, and social organizations, depending on the geographical area. There are trends that have had a highly differentiated impact, which have shown that the concept of time is not the same for everyone. Other trends have had a transversal impact, reconfiguring the ideas of present and future. Precariousness and uncertainty, that coincide with an existential specific condition of our contemporary, now take on a new meaning. Before the pandemic, the neoliberal development model seemed to have no alternative. Now, the possibility of an alternative model is imaginable, not only for the critics of it, but also for a large part of public opinion, which now even considers it necessary. The possibility of an alternative becomes concrete and achievable due to the impact that the Covid-19 pandemic has had on the structural dimensions of time and space in social life.
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Since the early 2000s, emerging markets have become the heart of global supply chains hosting a large volume of industrial productions. The second article looked into the barriers to attaining sustainability in supply chain of the Bangladeshi pharmaceutical sector and developed a hierarchical structure of those barriers using interpretive structural modeling and MICMAC analysis. The eleventh article explored a new way to assess suppliers' suitability by considering pseudo-resilience factors to achieve SSC in the post-COVID-19 era using an analytical hierarchy process and R. It also provided a case study of three smartphone processor suppliers (Jessin et al., 2023).
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With the upgrading and innovation of the logistics industry, the requirements for the level of transportation smart technologies continue to increase. The outbreak of the COVID-19 has further promoted the development of unmanned transportation machines. Aimed at the requirements of intelligent following and automatic obstacle avoidance of mobile robots in dynamic and complex environments, this paper uses machine vision to realize the visual perception function, and studies the real-time path planning of robots in complicated environment. And this paper proposes the Dijkstra-ant colony optimization (ACO) fusion algorithm, the environment model is established by the link viewable method, the Dijkstra algorithm plans the initial path. The introduction of immune operators improves the ant colony algorithm to optimize the initial path. Finally, the simulation experiment proves that the fusion algorithm has good reliability in a dynamic environment. © 2022 IEEE.
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In this interview, Sujay Jadhav, global vice president, study start-up, Oracle Health Sciences, touches on how COVID has affected study start-up and what new perspectives it has forced the industry to have on its own challenges. [...]assessing site ability to leverage telehealth will be a factor in site selection. Andy Studna is an Assistant Editor for Applied Clinical Trials Sujay Jadhav Global Vice President, Study Start-Up, Oracle Health Sciences Problems with startup, more than any other phase of a clinical trial, have the greatest potential to increase timelines and budgets.
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PurposeThe purpose of this paper is to "identify”, "analyze” and "construct” a framework to quantify the relationships between several determinants of organizational preparedness for change in the start-ups during the COVID-19 emergencies.Design/methodology/approachTotal interpretive structural modelling (TISM) is used to find characteristics that assist in analyzing the readiness or preparedness level before initiating a change deployment process in start-ups. A cross-impact matrix multiplication applied to classification (MICMAC) analysis is performed to determine the driving and dependent elements of change in start-ups.FindingsFrom literature research and an expert interview, this study selected ten variables of change preparedness to explore inner interconnections and comprehend the inner connections factors. The findings depict that clarity of mission and goals, reward system, technological advancement and motivational readiness have been considered the most important readiness factor for deploying organizational change in start-ups during the COVID-19 emergencies.Practical implicationsThis research will aid the management and researchers gain a better understanding of the factors that influence change preparedness. Constant observation of current changes in the start-ups and the external environment will aid in improving the quality of products or services provided by the start-ups during the COVID-19. The start-ups can use these criteria linked to change readiness. The priority of each element is determined using MICMAC analysis and ranking using the TISM technique, which assists start-ups in ordering the enablers from highest to lowest priority.Originality/valueThere is no research regarding factors influencing organizational readiness for change in start-ups during the COVID-19 emergencies. This research gap is filled by analyzing aspects linked to organizational readiness for change in start-ups. This gap inspired the present study, which uses the "Total Interpretive Structural Modelling (TISM)” technique to uncover change determinants and investigate hierarchical interconnections among factors influencing organizational readiness to change in start-ups during the COVID-19 emergencies.
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Many best practices and lessons learned have emerged in recent years as pharma/life sciences companies, along with their third-party logistics partners and vendors that supply specialized packaging and monitoring solutions, have all weathered the COVID-19 pandemic together and continued to support ongoing growth in the pipeline of therapeutic products that must be continuously maintained at refrigerated, frozen, or ultra-frozen temperatures. Cold chain planning and execution "... continues to be impacted by not only the pandemic but by other factors, such as air cargo capacity being down, instability related to inflation, the Russia/Ukraine conflict, and more, but despite it all, you still have patients depending on what you're delivering," notes Rob Coyle, senior vice president, healthcare strategy, Kuehne+Nagel. "With careful planning, we're often able to replace active shippers with passive units by leveraging existing infrastructure, ongoing advances in insulation materials, phase-change materials (PCM), and container designs, using advanced GPS and other monitoring devices to ensure continuous access to real-time location, temperature, and other data," adds Scott Ohanesian, senior vice president, commercial operations, QuickStat, a Kuehne+Nagel company. Technology advances "The Holy Grail for the pharma cold chain is 'how do I get perfect service at a more economical price?'" says Dan Gagnon, vice president of global strategy for UPS Healthcare.
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[...]what could that look like? "In an ideal world, I'd like to see life sciences supply chains break down the linear and functional siloed approach that exists today to become a dynamically connected ecosystem that integrates the full supply chain network in a collaborative and optimized way," says Stephanie David, vice president, Pariveda. In addition to inherent flaws in the foundational setup of the supply chain and the need for fewer manual processes, there are functional shortcomings as well-particularly with regards to cold chain storage and distribution. [...]more importantly, I believe that the supply chain's robustness will depend on the appetite for innovation and the ability of life sciences supply chain leaders and the skills of their organization (people) to drive the acceleration and adoption of digital capabilities required to effect change across the end-to-end supply chain," says David. "Because the supply chain is the operational backbone of life sciences companies, it is important that supply chain leaders can connect and clearly articulate the value and business outcomes of these initiatives to the wider enterprise-sales, marketing, operations, finance, etc."
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The popularity of Petra, Jordan, as a tourist destination has surged among international visitors since the 1980s. This has led to the tourism sector's emergence as a major source of income for indigenous communities living adjacent to the ancient city's ruins. Rapidly expanding visitor numbers and business activity-both licensed and unlicensed-exposed the need for government to play an active role in organizing Petra's tourism industry. Drawing upon a thematic analysis of interviews I conducted in three tourism-reliant, tribal communities in Petra's vicinity in 2022, this case study examines relations between the Petra Development and Tourism Region Authority (PDTRA) and indigenous stakeholders in the local economy. Focusing on the period extending from 2019-just before the COVID-19 pandemic's onset-to 2022, I explore local perspectives towards PDTRA policies impacting indigenous work in the tourism sector. I find that legality, size, and internal organization of stakeholder groups affect their capacity to influence political decisions that impact their lives and livelihoods.
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PurposeThis paper aims to predict the post-pandemic intention of Indian consumers to participate in tourism and hospitality T&H events by incorporating the perception of Covid-19 (PCOV) into the theory of planned behavior (TPB). It also examines the relationship among attitude, subjective norm, perceived behavioral control, behavioral intention and PCOV.Design/methodology/approachThis research employed a quantitative research technique, with data collected using an online questionnaire-based survey from August 23 to October 29, 2021. The sampling approach is convenient, and the sample of this study is comprised of individuals who follow events pages on social networking sites.FindingsThe findings of SEM revealed that the proposed model has better explanatory and predictive power. The path analysis showed that all the variables of the TPB are significantly and positively associated with the post-pandemic intention to participate in the T&H events. However, the PCOV is negatively associated with the post-pandemic intention.Research limitations/implicationsThe results of this study give an idea about the post-pandemic intention of Indian consumers to participate in T&H events. The results of this study revealed important practical implications for event management organizations, travel agencies that deal in events, the T&H industry, tourism planners and other stakeholders, as these findings may be used to develop effective marketing strategies.Originality/valueThere has been a lot of research on TPB in the context of coronavirus, but to the best of the authors' knowledge, there is a gap in the literature regarding the intention to participate in T&H events. Hence, this research fills that gap.
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Examining best practices in using the functional service provider model for clinical operations, pharmacovigilance, regulatory, and other areas The COVID-19 pandemic has shown that there's a lot more flexibility in clinical trial systems than what was realized in the past. Some of these and other aspects leading to the rise of FSP outsourcing in drug development has been shared by other experts as well.3 Key functions and sub-functional areas within clinical development that have been outsourced as part of FSP model include: * Clinical monitoring (CM) * Clinical data management (CDM) * Biostatistics, statistical programming (BS&P), data standards, conversions (e.g., CDISC) * Medical writing (MW) * Pharmacovigilance/drug safety (PV) * Regulatory affairs (RA) Based on our experience in advising clients and providing FSP/CRO services over the past 20 years, we have seen the creative bundling of some of these functions as part of the extended FSP partnership model. * Combination of CDM, BS&P, and data conversions * Extension of the CDM, BS&P, and MW into a "clinical data services' package * Combination of clinical monitoring, CDM, BS&P, and medical monitoring into a "centralized monitoring team" (potential future services) * Combination of PV and regulatory activities due to regional synergies and submission/compliance requirements (potential future services) To ensure that the FSP model is strategic and provide the sustainable mode of partnership, we have shared some of the best practices ahead (and summarized in Figure 1 above) that can be leveraged and further customized as needed by sponsors: 1.Functional sourcing strategy: Sponsors must include specific criteria as part of their evaluation of service providers for the FSP sourcing plan (some of these are also typically done during a full-service CRO outsourcing process): Size and geography focus of provider that needs to be aligned with the strategic plans of the sponsor (e.g., where they plan to conduct trials to meet their regulatory needs or the size of stud ies). Team strength, capacity, and experience with both FTE and unit/deliverables-based pricing models of delivery. * Commitment to deliver year-over-year productivity gains using automation, digital/AI/ML technologies, and other approaches. * Partnership approach to play a critical role in initiating, driving/participating in innovation, and transformation initiatives of the sponsor. * Past client and employee turnover (attrition) that should be on par or below benchmark for the same function and similar type of service. * Executive commitment to participate actively in joint-governance discussions that ensures proactive monitoring and tracking of the program milestones and drive mitigatory actions, should milestones not be delivered on time, quality, and cost. 4.RFI/RFP process, joint solution development, and rigorous scoring of proposals and solutions:
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The Covid-19 pandemic and Brexit have focused attention on the resilience of key sectors and firms. This paper explores the financial resilience of the 50 largest automotive firms in the West Midlands region of the UK in their response to disruption and economic shocks. The findings demonstrate that 22 firms are at high risk due to poor current liquidity ratios, with Coventry and Birmingham emerging as locations most susceptible to firm closures. High-risk firms include key flagship original equipment manufacturers operating at the downstream end of supply chains. If these firms were to fail, there would be a significant destructive impact on both the industry and the local economy. We assert an effective subnational industrial policy is required in order to support economic resilience in regions such as the West Midlands where a few firms account for a disproportionate share of employment and value-added.
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This is the first study to examine the differential impact of Croatian and European economic policy uncertainty indices while controlling for the real effective exchange rate and industrial production on international tourist arrivals for the seven coastal counties of Croatia and the country as a whole. The Toda-Yamamoto long-run causality modeling approach with a Fourier approximation is employed to capture structural shifts. This approach is particularly useful in light of the disruption from the COVID-19 pandemic on the tourism sector. The results show unidirectional causality from both Croatian and European economic policy uncertainty indices to international tourist arrivals with the impact of the economic policy uncertainty indices negative and statistically significant across the respective coastal counties. Moreover, the findings show that European economic policy uncertainty exhibits a greater adverse impact on international tourist arrivals relative to Croatian economic policy uncertainty.
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The emergence of globalisation and the removal of obstacles between markets have heightened rivalry between territorial areas. To have a competitive advantage, the regions have to be unique. As one of the tactics used to boost their reputation on a territorial level, territories are progressively adopting environmental policies for sustainable and shared prosperity. Indeed, effective management of urban growth depends heavily on sustainable development. In this regard, the literature occasionally refers to the "green branding” of cities, a strategy that makes use of environmental aspects to boost the allure of metropolitan environments. There is currently little consensus in the literature on the measuring of environmental performance, and no statistical study has been done to confirm the efficacy of these measures in terms of territorial competitiveness. Therefore, it is important to determine whether there is a relationship between a territory's level of sustainability and competitiveness in Italy. According to the statistical analysis of the Italian provinces, the Northeast, Northwest, Centre, and Islands are the four geographical regions with the highest average scores. This unquestionably indicates a basic comprehension and supports the notion that there is a relationship between the two variables. However, it also serves as a warning about how geographical disparities in Italy represent a major issue affecting the most diverse sectors. In addition, the COVID-19 pandemic problem has drastically altered consumer demands and goals, leading consumers to seek out more sustainable travel and cities that are designed with citizens' requirements in mind. It will therefore become more and more important to research how public and private administrators, as well as policy makers, react to these changes.