Search results for: regulatory compliance

Authors: Veronika Zivicova, Petr Broz, Zdenek Fik, Alzbeta Mifkova, Jan Plzak, Zdenek Cada, Herbert Kaltner, Jana Fialova Kucerova, Hans-Joachim Gabius, Karel Smetana Jr.

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The possibility to determine genome-wide expression profiles of cells and tissues opens a new level of analysis in the quest to define dysregulation in malignancy and thus identify new tumor markers. Toward this long-term aim, we here address two issues on this level for head and neck cancer specimen: i) defining profiles in different regions, i.e. the tumor, the transition zone and normal control and ii) comparing complete data sets for seven individual patients. Special focus in the flanking immunohistochemical part is given to adhesion/growth-regulatory galectins that upregulate chemo- and cytokine expression in an NF-κB-dependent manner, to these regulators and to markers of differentiation, i.e. keratins. The detailed listing of up- and down-regulations, also available in printed form (1), not only served to unveil new candidates for testing as marker but also let the impact of the tumor in the transition zone become apparent. The extent of interindividual variation raises a strong cautionary note on assuming uniformity of regulatory events, to be noted when considering therapeutic implications. Thus, a combination of test targets (and a network analysis for galectins and their downstream effectors) is (are) advised prior to reaching conclusions on further perspectives.

Keywords: galectins, genome scale sequencing, squamous cell carcinoma, transition zone

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Authors: Tripta Dixit, Smita Sahu, William Selvamurthy, Sadhana Srivastava

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The translation of healthcare technologies is an expensive, complex affair, current healthcare challenges in Asian countries and their efforts to meet Millennium Development Goals (MDGs), necessitates continuous technology advancement to save countless lives, improve the quality of life and for socio-economic development. India’s consistently improving global innovation index (57) demonstrates its innovation potential, but access to health care is asymmetric and lacks priority in India. Therefore, there is utmost need of a robust translation system for point-of-care (POC) solutions, inexpensive, low-maintenance, reliable, and easy-to-use diagnostic technologies. Few cases of POC technologies viz. Elisa based diagnostic kits for regional viral disease, a device for detection of cancerous lesions were studied to understand the process and challenges involved in their translation. Accordingly, the entire translation ecosystem was summarized proposing a nexus of various actors such as technology developer, technology transferor technology receiver, funding entities, government/regulatory bodies and their effect on translation of different medical technologies. This study highlights the role and concerns pertaining to these actors for POC such as unsystematic and unvalidated research roadmap, low profit preposition, unfocused approach of up-scaling, low market acceptability and multiple window regulatory framework, etc. This provides an opportunity to devise solutions to overcome problem areas in translation path.

Keywords: healthcare technologies, point-of-care solutions, public health, translation

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Authors: Katerina Balounova, Jiri Pacha, Peter Ergang, Martin Vodicka, Pavlina Kvapilova

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MicroRNAs are small non-coding RNAs involved in a wide range of physiological processes. Post-transcriptional regulation of gene expression by microRNAs gives the organism a further level of control of the gene-expression program and the disruption of this microRNA regulatory mechanism seems to increase the risk of various pathophysiological conditions including tumorigenesis. To the present day, microRNAs were shown to participate in the mayor signalization pathways leading to tumorigenesis, including proliferation, cell cycle, apoptosis and metastasis formation. In addition, microRNAs have been found to play important roles in the generation and maintenance of circadian clock. These clocks generate circadian rhythms, which participate in a number of regulatory pathways. Disruption of the circadian signals seems to be associated with the development and the progression of tumours including colorectal cancer. We investigated therefore whether the diurnal profiles of miRNAs linked to tumorigenesis and regulation of circadian clock are changed during tumorigenesis. Based on published data we chose 10 microRNAs linked to tumorigenesis or circadian clock (let-7b-5p, miR 1 3p, miR 106b 5p, miR 141 3p, miR 191 5p, miR 20a 5p, miR 25 3p, miR 29a 3p, miR 34a 5p and miR 93 5p) and compared their 24-hr expression profiles in healthy and in chemically induces primary colorectal tumours of 52week-old mice. Using RT-qPCR we proved circadian rhythmicity in let-7b-5p, miR 106b 5p, miR 141 3p, miR 191 5p, miR 20a 5p, miR 25 3p, miR 29a 3p and miR 93 5p in healthy colon but not in tumours. The acrophases of miR 106b 5p, miR 141 3p, miR 191 5p, miR 20a 5p, miR 25 3p and miR 93 5p were reached around CT 24, the acrophases of let-7b-5p and miR-29a-3p were slightly shifted and reached around CT 21. In summary, our results show that circadian regulation of some colonic microRNAs is greatly affected by neoplastic transformation.

Keywords: circadian rhythm, colon, colorectal cancer, microRNA, tumorigenesis

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Authors: Mateen A. Khan, Elizabeth J. Theil, Dixie J. Goss

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Cellular iron homeostasis is accomplished by the coordinated regulated expression of iron uptake, storage, and export. Iron regulate the translation of ferritin and mitochondrial aconitase iron responsive element (IRE)-mRNA by interaction with an iron regulatory protein (IRPs). Iron increases protein biosynthesis encoded in iron responsive element. The noncoding structure IRE-mRNA, approximately 30-nt, folds into a stem loop to control synthesis of proteins in iron trafficking, cell cycling, and nervous system function. Fluorescence anisotropy measurements showed the presence of one binding site on IRP1 for ferritin and mitochondrial aconitase IRE-mRNA. Scatchard analysis revealed the binding affinity (Kₐ) and average binding sites (n) for ferritin and mitochondrial aconitase IRE-mRNA were 68.7 x 10⁶ M⁻¹ and 9.2 x 10⁶ M⁻¹, respectively. In order to understand the relative importance of equilibrium and stability, we further report the contribution of electrostatic interactions in the overall binding of two IRE-mRNA with IRP1. The fluorescence quenching of IRP1 protein was measured at different ionic strengths. The binding affinity of IRE-mRNA to IRP1 decreases with increasing ionic strength, but the number of binding sites was independent of ionic strength. Such results indicate a differential contribution of electrostatics to the interaction of IRE-mRNA with IRP1, possibly related to helix bending or stem interactions and an overall conformational change. Selective destabilization of ferritin and mitochondrial aconitase RNA/protein complexes as reported here explain in part the quantitative differences in signal response to iron in vivo and indicate possible new regulatory interactions.

Keywords: IRE-mRNA, IRP1, binding, ionic strength

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Authors: Efua Ehiaguina, Haruna Moda

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Interest in the development of appropriate safety culture in the oil and gas industry has taken centre stage among stakeholders in the industry. Human behaviour has been identified as a major contributor to occupational accidents, where abnormal activities associated with safety management are taken as normal behaviour. Poor safety culture is one of the major factors that influence employee’s safety behaviour at work, which may consequently result in injuries and accidents and strengthening such a culture can improve workers safety performance. Nigeria oil and gas industry has contributed to the growth and development of the country in diverse ways. However, in terms of safety and health of workers, this industry is a dangerous place to work as workers are often exposed to occupational safety and health hazard. To ascertain the impact of employees’ safety and how it impacts health and safety compliance within the local industry, online safety culture survey targeting frontline workers within the industry was administered covering major subjects that include; perception of management commitment and style of leadership; safety communication method and its resultant impact on employees’ behaviour; employee safety commitment and training needs. The preliminary result revealed that 54% of the participants feel that there is a lack of motivation from the management to work safely. In addition, 55% of participants revealed that employers place more emphasis on work delivery over employee’s safety on the installation. It is expected that the study outcome will provide measures aimed at strengthening and sustaining safety culture in the Nigerian oil and gas industry.

Keywords: oil and gas safety, safety behaviour, safety culture, safety compliance

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Authors: Tsu-Yun Chiu, Tsung-Hsueh Lu, Tain-Junn Cheng

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Background: Traditional chronic disease management did not pay attention to effects of geographic factors on the compliance of treatment regime, which resulted in geographic inequality in outcomes of chronic disease management. This study aims to examine the geographic distribution and clustering of quality indicators of diabetes care. Method: We first extracted address, demographic information and quality of care indicators (number of visits, complications, prescription and laboratory records) of patients with diabetes for 2014 from medical information system in a medical center in Tainan City, Taiwan, and the patients’ addresses were transformed into district- and village-level data. We then compared the differences of geographic distribution and clustering of quality of care indicators between districts and villages. Despite the descriptive results, rate ratios and 95% confidence intervals (CI) were estimated for indices of care in order to compare the quality of diabetes care among different areas. Results: A total of 23,588 patients with diabetes were extracted from the hospital data system; whereas 12,716 patients’ information and medical records were included to the following analysis. More than half of the subjects in this study were male and between 60-79 years old. Furthermore, the quality of diabetes care did indeed vary by geographical levels. Thru the smaller level, we could point out clustered areas more specifically. Fuguo Village (of Yongkang District) and Zhiyi Village (of Sinhua District) were found to be “hotspots” for nephropathy and cerebrovascular disease; while Wangliau Village and Erwang Village (of Yongkang District) would be “coldspots” for lowest proportion of ≥80% compliance to blood lipids examination. On the other hand, Yuping Village (in Anping District) was the area with the lowest proportion of ≥80% compliance to all laboratory examination. Conclusion: In spite of examining the geographic distribution, calculating rate ratios and their 95% CI could also be a useful and consistent method to test the association. This information is useful for health planners, diabetes case managers and other affiliate practitioners to organize care resources to the areas most needed.

Keywords: catchment area of healthcare, chronic disease management, Geographic information system, quality of diabetes care

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Authors: Eugene Mashapa

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The age of information has witnessed countless unprecedented technological developments, which signal the articulation of succinct technological capabilities that can match these cutting-edge technological trends. These changes have impacted patterns in the production, distribution, and consumption of media content, a space that the Film and Publication Board (FPB) is concerned with. Consequently, the FPB is keen to understand the nature and impact of these technological changes on media content regulation. This exploratory study sought to investigate how content regulators in high and middle-income economies have adapted to the changes in this space, seeking insights into innovations, technological and operational, that facilitate continued relevance during this fast-changing environment. The study is aimed at developing recommendations that could assist and inform the organisation in regulating media content as it evolves. Thus, the overall research strategy in this analysis is applied research, and the analytical model adopted is a mixed research design guided by both qualitative and quantitative research instruments. It was revealed in the study that the FPB was significantly impacted by the unprecedented technological advancements in the media regulation space. Additionally, there exists a need for the FPB to understand the current and future penetrations of 4IR technology in the industry and its impact on media governance and policy implementation. This will range from reskilling officials to align with the technological skills to developing technological innovations as well as adopting co-regulatory or self-regulatory arrangements together with content distributors, where more content is distributed in higher volumes and with increased frequency. Importantly, initiating an interactive learning process for both FPB employees and the general public can assist the regulator and improve FPB’s operational efficiency and effectiveness.

Keywords: media, regulation, technology, film and publications board

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Authors: Tapiwa Shumba, Nyaradzo D. T. Karubwa

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Dispute resolution is the plinth of regional integration initiatives anchored on the rule of law and compliance with obligations. Without effective and reliable despite resolution mechanisms, it may be difficult to foster deeper integration. Within the Southern African Development Community (SADC) legal and institutional framework exists an apparent recognition that dispute resolution is an integral part of the regional integration. Almost all legal instruments of SADC include some provision for dispute resolution. Institutionally, the somewhat now defunct SADC Tribunal is meant to be the fulcrum for resolving disputes that arise under SADC instruments. However, after a closer analysis of the substance of these legal provisions and the attendant procedural mechanisms for addressing disputes, an argument can be made that dispute resolution in SADC is somewhat scant, fragmented and neglected. In most instruments, the common provision on dispute resolution appears to be a ‘mid-night clause’. In other instruments which have specialised provisions and procedures, questions of practicality and genius cannot be avoided. Worse still there now appears to be a lack of magnanimity between the substantive provisions in various instruments and the role of the transformed Tribunal. This scant, fragmented and neglected dispute resolution system may have an impact on the observance of the rule of law and compliance with obligations in the rules-based SADC system. This all, in turn, has an effect on the common agenda for deeper regional integration. This article seeks to expose this scant, fragmented and neglected SADC dispute resolution system and to propose a harmonised system that addresses these challenges. A ‘one stop shop’ system under a strengthened SADC tribunal is proposed as a responsive solution.

Keywords: regional integration, harmonisation, SADC tribunal, dispute resolution

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Authors: Esam El Gohary

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— The companies’ ability to survive and compete in the fierce competition is determined by its competitiveness level. With the spread of information technology use and appearance of online shopping, it became crucial for companies to adopt e-commerce system to increase its competitiveness. This paper was conducted with the purpose of determine how increasing the service value through e-commerce factors (competitive strategy, ICT infrastructures, logistics, security, human resources and innovation) can enhance companies' competitiveness. The problem of this paper is summarized in the absence of the thorough awareness of e-commerce benefits for business owners and customers, as well as how to reduce the intangibility attributes of e-commerce. For this purpose this paper describes the e-commerce in Egypt and its success factors (infrastructures, legal and regulatory environment, human resources and innovation), as well as displays the barriers of such factor, to investigate the significant of these factors on increasing service value and enhance companies' competitiveness. This paper revealed that e-commerce companies have many opportunities to enhance its competitiveness in Egypt, which is enhanced by several factors. The most important factors are “strong ICT infrastructure, qualified and skilled human resources, in addition to the distinctive logistics that distinguish Egypt due to its location, strong legal and regulatory environment and Innovation, as well as the competitive strategy. As well as, companies encounter several threats such as; the lack of infrastructures and logistics in rural areas, the absence of the inclusive understanding and awareness of e-commerce, fear from e-payment transactions and fraud, the ambiguity and burdensome of customs. Through the research findings several recommendations were introduced to both government and companies to overcome threats and exploit opportunities to improve performance and enhance companies' competitiveness.

Keywords: e-commerce competitiveness, e-commerce factors, e-commerce in Egypt, information technology

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Authors: Saikiran Subbagari, Avinash Malladhi

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Anti Money Laundering (AML) regulations are designed to prevent money laundering and terrorist financing activities worldwide. Financial institutions around the world are legally obligated to identify, assess and mitigate the risks associated with money laundering and report any suspicious transactions to governing authorities. With increasing volumes of data to analyze, financial institutions seek to automate their AML processes. In the rise of financial crimes, optical character recognition (OCR), in combination with machine learning (ML) algorithms, serves as a crucial tool for automating AML processes by extracting the data from documents and identifying suspicious transactions. In this paper, we examine the utilization of OCR for AML and delve into various OCR techniques employed in AML processes. These techniques encompass template-based, feature-based, neural network-based, natural language processing (NLP), hidden markov models (HMMs), conditional random fields (CRFs), binarizations, pattern matching and stroke width transform (SWT). We evaluate each technique, discussing their strengths and constraints. Also, we emphasize on how OCR can improve the accuracy of customer identity verification by comparing the extracted text with the office of foreign assets control (OFAC) watchlist. We will also discuss how OCR helps to overcome language barriers in AML compliance. We also address the implementation challenges that OCR-based AML systems may face and offer recommendations for financial institutions based on the data from previous research studies, which illustrate the effectiveness of OCR-based AML.

Keywords: anti-money laundering, compliance, financial crimes, fraud detection, machine learning, optical character recognition

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Authors: Valentina Marutyan

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Healthcare data mining is a rapidly developing field at the intersection of technology and medicine that has the potential to change our understanding and approach to providing healthcare. Healthcare and data mining is the process of examining huge amounts of data to extract useful information that can be applied in order to improve patient care, treatment effectiveness, and overall healthcare delivery. This field looks for patterns, trends, and correlations in a variety of healthcare datasets, such as electronic health records (EHRs), medical imaging, patient demographics, and treatment histories. To accomplish this, it uses advanced analytical approaches. Predictive analysis using historical patient data is a major area of interest in healthcare data mining. This enables doctors to get involved early to prevent problems or improve results for patients. It also assists in early disease detection and customized treatment planning for every person. Doctors can customize a patient's care by looking at their medical history, genetic profile, current and previous therapies. In this way, treatments can be more effective and have fewer negative consequences. Moreover, helping patients, it improves the efficiency of hospitals. It helps them determine the number of beds or doctors they require in regard to the number of patients they expect. In this project are used models like logistic regression, random forests, and neural networks for predicting diseases and analyzing medical images. Patients were helped by algorithms such as k-means, and connections between treatments and patient responses were identified by association rule mining. Time series techniques helped in resource management by predicting patient admissions. These methods improved healthcare decision-making and personalized treatment. Also, healthcare data mining must deal with difficulties such as bad data quality, privacy challenges, managing large and complicated datasets, ensuring the reliability of models, managing biases, limited data sharing, and regulatory compliance. Finally, secret code of data mining in healthcare helps medical professionals and hospitals make better decisions, treat patients more efficiently, and work more efficiently. It ultimately comes down to using data to improve treatment, make better choices, and simplify hospital operations for all patients.

Keywords: data mining, healthcare, big data, large amounts of data

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Authors: Yanqing Yi, Maria Cristina Lavagnolo, Alessandro Manzardo

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Construction and demolition waste (C&DW) represents a pressing concern within the European Union, underscoring the urgent need for effective waste management strategies. The selection of these solutions constitutes a complex task, entailing the identification of efficient C&DW management strategies that balance appropriate practices, regulatory compliance, resource conservation, economic viability, and environmental considerations. Techniques for evaluating different types of criteria enable the application of multi-criteria analysis in life cycle assessment (LCA). LCA is widely utilized to assess environmental impact, yet the economic aspect has not been adequately incorporated into the LCA process in the field of C&DW management. The life cycle costing (LCC) methodology has been tailored to assess economic performance in conjunction with LCA. The selection of an appropriate multi-criteria decision-making (MCDM) method is vital for the C&DW system. This study seeks to propose a model that employs MCDM to integrate the LCA and LCC results, thereby augmenting both environmental and economic sustainability. A widely used compensatory MCDM technique, TOPSIS, has been chosen to identify the most effective C&DW management scheme by comparing and ranking various scenarios. Our study introduces a framework for C&DW management by integrating LCA and LCC factors into MCDM, using AHP for weight determination, and applying TOPSIS for alternative ranking. Four waste management alternatives were examined in the Lombardy region of Italy, namely, (i) landfill; (ii) recycling for concrete production and road construction, incineration with energy recovery; (iii) recycling for road construction; (iv) recycling for concrete production and road construction. We determine that, with the implementation of various scenarios, the most suitable scenario emerges to be recycled for concrete production and road construction, with a score of 0.711/1; recycling for road construction, with a final score of 0.291/1, ranks second; recycling for concrete production and road construction, incineration with energy recovery scores 0.002/1, ranks third; and landfill (scores: 0/1) is the worst choice, signifying it has the highest environmental impacts and the least economic benefits. Lastly, recommendations were formulated to enhance the environmental performance of the system.

Keywords: life cycle assessment, construction and demolition waste, TOPSIS, multi-criteria decision making

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Authors: Yong Li

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Major cities in China has experienced a shift from production based on manufacturing industry to tertiary industry. How to make a better use of existing obsolete industrial land within urban cores has become a difficult problem for many policymakers. City governments regard old manufacturing industrial land as an important source of land to facilitate the development of the cities. Despite the announcement of policies in promoting that, a large portion of industrial land is still not properly redeveloped and most of them became obsolete. The study uses the project of Xinyi International Club as a case to examine the process of adaptive reuse of obsolete industrial space in Guangzhou, China. It attempts to elucidate the underlying mechanisms by identifying the key forces from both the government and the private sectors in influencing the process. The study found that market forces in transforming industrial space are exerting a strong impact on the existing land use planning system in Chinese cities. Pragmatic relaxation of the formal land use the regulatory framework and government supportive land-use intervention have also been crucial towards achieving successful implementation of the restructuring project and making it a showcase. This study questions whether these extraordinary measures, in particular, the use of temporary land use permit, are sustainable in facilitating the transformation of derelict industrial land, and in informing future industrial land-use restructuring policies. It concludes that, while the land use regulatory system in China is becoming increasingly dynamic and flexible, it remains ill-equipped in responding positively to the market, which is characterized by an increasing bargaining power of the private sector. A comprehensive appraisal of the overall impacts of these adaptive re-uses on society is wanting.

Keywords: China, land alteration, obsolete industrial properties, urban planning

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Authors: Esam Roshdy, Saleh AlRashdi, Turki Alharbi, Rawan Eskandarani, Zurina Cabilo

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Introduction/ background: Consultation in the Emergency Department constitute a major part of the work flow every day. Any delay in the consultation process have a major impact on the length of stay and patient disposition and thus affect the total waiting time of patients in the ED. King Fahad medical City in Riyadh City, Saudi Arabia is considered a major Tertiary hospital where there is high flow of patients of different categories visiting the ED. The importance of decreasing consultation time and decision for final disposition of patients was recognized and interpreted in this project to find ways to improve the patient flow in the department and thus the total patient disposition and outcome. Aim / Objectives: 1. To monitor the time of consultation for patients in the Emergency department and its impact on the length of stay of patients in the ED. 2. To detect and assess the problems that lead to long consultation times in the ED, and reach a targeted time of 2 hours for final disposition of patients, according to recognized international and our institutional consultation policy, to reach the final goal of decreasing total length of stay and thus improve the patient flow in the ED. Methods: Data was collected retrospectively for a 92 charts of consultations done in the ED over 2 month’s period. The data was analyzed to get the median of Total Consultation Time. A survey was conducted among all ED staff to determine the level of knowledge about the total consultation time and the compliance to the institutional policy target of 2 hours. A second Data sample of 168 chart was collected after awareness campaign and education of all ED staff about the importance of reaching the target consultation time and compliance to the institutional policy. Results: We have found that there is room for improvement in our overall consultation time. This was found to be more frequent with certain specialties. Our surveys have showed that many ED staff are not familiar or not compliant with our consultation policy which was not clear for everyone. Post-intervention data have showed that awareness of the importance to decrease the total consultation time and compliance alone to the targeted goal have had a huge impact on overall improvement and decreasing the time of final decision and disposition of the patient and the overall patient length of stay in the ED. Conclusion: Working on improving Consultation time in the Emergency Department is a major factor in improving overall length of stay and patient flow. This improvement helps in the overall patient disposition and satisfaction. Plan: As a continuation of our project we are planning to focus on the conflict of admission cases where more than one specialty is involved in the care of patients. We are planning to collect data on the time it takes to resolve and reach final disposition of those patients, and its impact on the length of stay and our department flow and the overall patient outcome and satisfaction.

Keywords: consultation time, impact, length of stay, in the ED

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Authors: Brandon Takahashi, Marielle Hanley, Gerry Hanley

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The large-scale quick-service restaurant industry is a complex business to manage optimally. With over 40 suppliers providing different ingredients for food preparation and thousands of restaurants serving over 50 unique food offerings across a wide range of regions, the company must implement a quality assurance process. Businesses want to deliver quality food efficiently, reliably, and successfully at a low cost that the public wants to buy. They also want to make sure that their food offerings are never unsafe to eat or of poor quality. A good reputation (and profitable business) developed over the years can be gone in an instant if customers fall ill eating your food. Poor quality also results in food waste, and the cost of corrective actions is compounded by the reduction in revenue. Product compliance evaluation assesses if the supplier’s ingredients are within compliance with the specifications of several attributes (physical, chemical, organoleptic) that a company will test to ensure that a quality, safe to eat food is given to the consumer and will deliver the same eating experience in all parts of the country. The technical component of the evaluation includes the chemical and physical tests that produce numerical results that relate to shelf-life, food safety, and organoleptic qualities. The psychological component of the evaluation includes organoleptic, which is acting on or involving the use of the sense organs. The rubric for product compliance evaluation has four levels: (1) Ideal: Meeting or exceeding all technical (physical and chemical), organoleptic, & psychological specifications. (2) Deviation from ideal but no impact on quality: Not meeting or exceeding some technical and organoleptic/psychological specifications without impact on consumer quality and meeting all food safety requirements (3) Acceptable: Not meeting or exceeding some technical and organoleptic/psychological specifications resulting in reduction of consumer quality but not enough to lessen demand and meeting all food safety requirements (4) Unacceptable: Not meeting food safety requirements, independent of meeting technical and organoleptic specifications or meeting all food safety requirements but product quality results in consumer rejection of food offering. Sampling of products and consumer tastings within the distribution network is a second critical element of the quality assurance process and are the data sources for the statistical analyses. Each finding is not independently assessed with the rubric. For example, the chemical data will be used to back up/support any inferences on the sensory profiles of the ingredients. Certain flavor profiles may not be as apparent when mixed with other ingredients, which leads to weighing specifications differentially in the acceptability decision. Quality assurance processes are essential to achieve that balance of quality and profitability by making sure the food is safe and tastes good but identifying and remediating product quality issues before they hit the stores. Comprehensive quality assurance procedures implement human factors methodologies, and this report provides recommendations for systemic application of quality assurance processes for quick service restaurant services. This case study will review the complex decision rubric and evaluate processes to ensure the right balance of cost, quality, and safety is achieved.

Keywords: decision making, food safety, organoleptics, product compliance, quality assurance

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Authors: Ae Ra Han, Seoung Eun Huh, Ji Yeon Kim, Joanne Kwak-Kim, Sung Ki Lee

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Objective: Prevalence of osteoporosis, cardiovascular disorders, and Alzheimer's disease rapidly increase after menopause. Immune activation and inflammation are suggested as an important pathogenesis of these serious diseases. Several pro-inflammatory cytokines are increased in women with surgical or natural menopause. However, the little is known about IL-17 producing T cells and Foxp3+ regulatory T (Treg) cells in post-menopause. Methods: A total of 34 postmenopausal women, who had no active cardiovascular, endocrine and infectious disorders were recruited as study group and healthy premenopausal women participated as controls. Peripheral blood mononuclear cells were isolated. Immuno-morphologic (CD3, CD4, CD8, CD19, CD56/CD16), intracellular cytokine (TNF-alpha, IFN-gamma, IL-10, IL-17), and Treg cell (Foxp3) studies were carried out using flow cytometry. The proportion of peripheral lymphocytes, including IL-17 producing and Foxp3+ Treg cells immune cell in each group were statistically analyzed. Results: The proportion of NK cells was significantly increased in menopausal women as compared to that of controls (P=.005). The ratios of TNF-alpha/IL-10 producing CD3+CD4+ T cells were increased in postmenopausal women. CD3+IL-17+ T cell level was higher in postmenopausal women and CD4+ Foxp3+ Treg cells was lower than that of controls. The ratios of CD3+IL-17+ T cell to CD3+Foxp3+ and to CD4+Foxp3+ Treg cells were significantly increased in postmenopausal women (P=.001). Conclusions: We found enhanced innate immunity and Th1- and Th17-mediated adaptive immunity in postmenopausal women. This may explain increasing prevalence of chronic inflammatory diseases after menopause. Further studies are needed to elucidate what factors contribute to this inflammatory shift in the postmenopause.

Keywords: inflammation, immune cell, menopause, Th17, regulatory T cell

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Authors: Loukou Amoin Marie Djedri

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Financing is important for all terrorists – from the largest organizations in control of territories, to the smallest groups – not only for spreading fear through attacks, but also to finance the expansion of terrorist dogmas. These organizations pose serious threats to the international community. The disruption of terrorist financing aims to create a hostile environment for the growth of terrorism and to limit considerably the terrorist groups capacities. The World Bank (WB), together with the International Monetary Fund (IMF), decided to include in their scope the Fight against the money laundering and the financing of terrorism, in order to assist Member States in protecting their internal financial system from terrorism use and abuse and reinforcing their legal system. To do so, they have adopted the Anti-Money Laundering /Combating Financing of Terrorism (AML/CFT) standards that have been set up by the Financial Action Task Force. This set of standards, recognized as the international standards for anti-money laundering and combating the financing of terrorism, has to be implemented by States Members in order to strengthen their judicial system and relevant national institutions. However, we noted that, to date, some States Members still have significant AML/CFT deficiencies, which can constitute serious threats not only to the country’s economic stability but also for the global financial system. In addition, studies stressed out that repressive measures are more implemented by countries than preventive measures, which could be an important weakness in a state security system. Furthermore, we noticed that the AML/CFT standards evolve slowly, while techniques used by terrorist networks keep developing. The goal of the study is to show how to enhance the AML/CFT global compliance through the work of the IMF and the WB, to help member states to consolidate their financial system. To encourage and ensure the effectiveness of these standards, a methodology for assessing the compliance with the AML/CFT standards has been created to follow up the concrete implementation of these standards and to provide accurate technical assistance to countries in need. A risk-based approach has also been adopted as a key component of the implementation of the AML/CFT Standards, with the aim of strengthening the efficiency of the standards. Instead, we noted that the assessment is not efficient in the process of enhancing AML/CFT measures because it seems to lack of adaptation to the country situation. In other words, internal and external factors are not enough taken into account in a country assessment program. The purpose of this paper is to analyze the AML/CFT regime in the fight against the financing of terrorism and to find lasting solutions to achieve the global AML/CFT compliance. The work of all the organizations involved in this combat is imperative to protect the financial network and to lead to the disintegration of terrorist groups in the future.

Keywords: AML/CFT standards, financing of terrorism, international financial institutions, risk-based approach

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Authors: Adam Aboalkaz, Rana Shamoon, Duncan Meikle, James Lewis

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Background and aims: In orthopaedic theatres, radiological screening during operations is a commonly used and useful technique to visualise and guide the operating surgeon. Within any theatre using ionising radiation, it is imperative that the use of protective equipment and the wearing of a dosimeter at all times. 1. To assess compliance with use of protective equipment during orthopaedic procedures involving ionising radiation. 2. To assess the radiation risk knowledge of staff members regularly present in an orthopaedic theatre of a national major trauma centre, in accordance to the ionising radiation regulation (2000) guidelines. Method: We conducted an Observational study of 21 operations at the University Hospital of Wales, which is a major trauma centre, recording the compliance with use of protective equipment (lead aprons and thyroid shields) and dosimeters. The observations were performed sporadically over a two week period to ensure that all staff in monitored operating theatres were not aware of the ongoing study, as to avoid bias. A questionnaire testing the knowledge of trainees and staff within the orthopaedic department was given following completion of the initial phase of the study, with 19 responses. The questions were based on knowledge of ionising radiation exposure and monitoring. The questions also tested the general staff knowledge of what equipment should be worn and where to locate such equipment. Results: This study found that only 25% of staff members were wearing thyroid protectors when less than 1 meter from the radiation source and only 50% were wearing appropriate lead aprons whilst in this same vicinity. The study also showed that 0% of all staff members used a dosimeter whilst in an area of radiation exposure. From the distributed questionnaires, only 40% of staff understood where to stand whilst radiation was being used, and only 25% of staff knew where to find protective equipment. Conclusion: Overall our audit showed poor compliance with regards to the National and local policies, due to lack of awareness of the policy and lack of basic ionising radiation exposure knowledge. It was evident from the observational study and questionnaire that staff were not fully aware of what equipment should be worn, where to find such equipment and did not appreciate that the distance from the ionising radiation source altered its exposure effect. This lack of knowledge may affect the staff health and safety after long term exposure. Changes to clinical practice: From the outcome of this study, we managed to drastically increase awareness of ionising radiation within the orthopaedic department. A mandatory teaching session on the safety of ionising radiation has been incorporated into the orthopaedic induction week for all staff. The dosimeters have been moved to a visible location within the trauma operating theatre and all staff made aware of where to find protective equipment.

Keywords: audit, ionising radiation, observational study, protection

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Authors: Aisha Maroof

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Introduction: Coronavirus Disease 2019 (COVID-19) is spreading rapidly around the world with devastating consequences on patients, health care workers and health systems. Severe 2019 novel coronavirus infectious disease (COVID-19) with pneumonia is associated with high rates of admission to the intensive care unit (ICU) and they are at high risk to obtain the hospital acquire bloodstream infection (HAIs) such as central line associated bloodstream infection (CLABSI), catheter associated urinary tract infections (CAUTI) and laboratory confirm bloodstream infection (LCBSI). The chances of infection transmission increase when healthcare worker’s (HCWs) practice is inappropriate. Risk related to hand hygiene (HH) and personal protective equipment (PPE) as regards multidrug-resistant organism transmission: use of multiple gloving instead of HH and incorrect use of PPE can lead to a significant increase of device-related infections. As it reaches low- and middle-income countries, its effects could be even more, because it will be difficult for them to react aggressively to the pandemic. HAIs are one of the biggest medical concerns, resulting in increased mortality rates. Objective: To assess the effect of intervention on compliance of hand hygiene and PPE among HCWs reduce the rate of HAI in COVID-19 patients. Method: An interventional study was done between July to December, 2020. CLABSI, CAUTI and LCBSI data were collected from the medical record and direct observation. There were total of 50 Nurses, 18 doctors and all patients with laboratory-confirmed severe COVID-19 admitted to the hospital were included in this research study. Respiratory tract specimens were obtained after the first 48 h of ICU admission. Practices were observed after and before intervention. Education was provided based on WHO guidelines. Results: During the six months of study July to December, the rate of CLABSI, CAUTI and LCBSI pre and post intervention was reported. CLABSI rate decreasedd from 22.7 to 0, CAUTI rate was decreased from 1.6 to 0, LCBSI declined from 3.3 to 0 after implementation of intervention. Conclusion: HAIs are an important cause of morbidity and mortality. Most of the device related infections occurs due to lack of correct use of PPE and hand hygiene compliance. Hand hygiene and PPE is the most important measure to protect patients, through education it can be improved the correct use of PPE and hand hygiene compliance and can reduce the bacterial infection in COVID-19 patients.

Keywords: hospital acquire infection, healthcare workers, hand hygiene, personal protective equipment

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Authors: Evanka Madan, Madhu Puri, Dan Zilberstein, Rohini Muthuswami, Rentala Madhubala

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The extensive interaction between the host and pathogen metabolic networks decidedly shapes the outcome of infection. Utilization of arginine by the host and pathogen is critical for determining the outcome of pathogenic infection. Infections with L. donovani, an intracellular parasite, will lead to an extensive competition of arginine between the host and the parasite donovani infection. One of the major amino acid (AA) sensing signaling pathways in mammalian cells are the mammalian target of rapamycin complex I (mTORC1) pathway. mTORC1, as a sensor of nutrient, controls numerous metabolic pathways. Arginine is critical for mTORC1 activation. SLC38A9 is the arginine sensor for the mTORC1, being activated during arginine sufficiency. L. donovani transport arginine via a high-affinity transporter (LdAAP3) that is rapidly up-regulated by arginine deficiency response (ADR) in intracellular amastigotes. This study, to author’s best knowledge, investigates the interaction between two arginine sensing systems that act in the same compartment, the lysosome. One is important for macrophage defense, and the other is essential for pathogen virulence. We hypothesize that the latter modulates lysosome arginine to prevent host defense response. The work presented here identifies an upstream regulatory role of LdAAP3 in regulating the expression of SLC38A9-mTORC1 pathway, and consequently, their function in L. donovani infected THP-1 cells cultured in 0.1 mM and 1.5 mM arginine. It was found that in physiological levels of arginine (0.1 mM), infecting THP-1 with Leishmania leads to increased levels of SLC38A9 and mTORC1 via an increase in the expression of RagA. However, the reversal was observed with LdAAP3 mutants, reflecting the positive regulatory role of LdAAP3 on the host SLC38A9. At the molecular level, upon infection, mTORC1 and RagA were found to be activated at the surface of phagolysosomes which was found to form a complex with phagolysosomal localized SLC38A9. To reveal the relevance of SLC38A9 under physiological levels of arginine, endogenous SLC38A9 was depleted and a substantial reduction in the expression of host mTORC1, its downstream active substrate, p-P70S6K1 and parasite LdAAP3, was observed, thereby showing that silencing SLC38A9 suppresses ADR. In brief, to author’s best knowledge, these results reveal an upstream regulatory role of LdAAP3 in manipulating SLC38A9 arginine sensing in host macrophages. Our study indicates that intra-macrophage survival of L. donovani depends on the availability and transport of extracellular arginine. An understanding of the sensing pathway of both parasite and host will open a new perspective on the molecular mechanism of host-parasite interaction and consequently, as a treatment for Leishmaniasis.

Keywords: arginine sensing, LdAAP3, L. donovani, mTORC1, SLC38A9, THP-1

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Authors: Krish Batra

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The advent of open banking has revolutionized the financial services industry by fostering innovation, enhancing customer experience, and promoting competition. However, this paradigm shift towards more open and interconnected banking ecosystems has introduced complex cybersecurity challenges. This research paper delves into the multifaceted cybersecurity landscape of open banking, highlighting the vulnerabilities and threats inherent in sharing financial data across a network of banks and third-party providers. Through a detailed analysis of recent data breaches, phishing attacks, and other cyber incidents, the paper assesses the current state of cybersecurity within the open banking framework. It examines the effectiveness of existing security measures, such as encryption, API security protocols, and authentication mechanisms, in protecting sensitive financial information. Furthermore, the paper explores the regulatory response to these challenges, including the implementation of standards such as PSD2 in Europe and similar initiatives globally. By identifying gaps in current cybersecurity practices, the research aims to propose a set of robust, forward-looking strategies that can enhance the security and resilience of open banking systems. This includes recommendations for banks, third-party providers, regulators, and consumers on how to mitigate risks and ensure a secure open banking environment. The ultimate goal is to provide stakeholders with a comprehensive understanding of the cybersecurity implications of open banking and to outline actionable steps for safeguarding the financial ecosystem in an increasingly interconnected world.

Keywords: open banking, financial services industry, cybersecurity challenges, data breaches, phishing attacks, encryption, API security protocols, authentication mechanisms, regulatory response, PSD2, cybersecurity practices

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Authors: Okafor Joan, Nwodo Uchechukwu

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Klebsiella pneumoniae (K. pneumoniae) is a significant pathogen responsible for opportunistic and nosocomial infection. One of the most significant antibiotic resistance mechanisms in K. pneumoniae isolates is efflux pumps. Our current study identified efflux genes (AcrAB, OqxAB, MacAB, and TolC) and regulatory genes (RamR and RarA) in multidrug-resistant (MDR) K. pneumoniae isolated from hospital effluents and investigated their relationship with antibiotic resistance. The sum of 145 K. pneumoniae isolates was established by PCR and screened for antibiotic susceptibility. PCR detected efflux pump genes, and their link with antibiotic resistance was statistically examined. However, 120 (83%) of the confirmed isolated were multidrug-resistant, with the largest percentage of resistance to ampicillin (88.3%) and the weakest rate of resistance to imipenem (5.5%). Resistance to the other antibiotics ranged from 11% to 76.6%. Molecular distribution tests show that AcrA, AcrB, MacA, oqxB oqxA, TolC, MacB were detected in 96.7%, 85%, 76.7%, 70.8%, 55.8%, 39.1%, and 29.1% respectively. However, 14.3% of the isolates harboured all seven genes screened. Efflux pump system AcrAB (83.2%) was the most commonly detected in K. pneumonia isolated across all the antibiotics class-tested. In addition, the frequencies of RamR and RarA were 46.2% and 31.4%, respectively. AcrAB and OqxAB efflux pump genes were significantly associated with fluoroquinolone, beta-lactam, carbapenem, and tetracycline resistance (p<0.05). The high rate of efflux genes in this study demonstrated that this resistance mechanism is the dominant way in K. pneumoniae isolates. Appropriate treatment must be used to reduce and tackle the burden of resistant Klebsiella pneumonia in hospital wastewater effluents.

Keywords: Klebsiella pneumonia, efflux pumps, regulatory genes, multidrug-resistant, hospital, PCR

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Authors: Jumana Majdi Qutub

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Rationale: Cloud computing has rapidly developed the past few years. Because of the importance of providing protection for personal data used in cloud computing, the role of data protection in promoting trust and confidence in users’ data has become an important policy priority. This research examines key regulatory challenges rose by the growing use and importance of cloud computing with focusing on protection of individuals personal data. Methodology: Describing and analyzing governance challenges facing policymakers and industry in Saudi Arabia, with an account of anticipated governance responses. The aim of the research is to describe and define the regulatory challenges on cloud computing for policy making in Saudi Arabia and comparing it with potential complied issues rose in respect of transported data to EU member state. In addition, it discusses information privacy issues. Finally, the research proposes policy recommendation that would resolve concerns surrounds the privacy and effectiveness of clouds computing frameworks for data protection. Results: There are still no clear regulation in Saudi Arabia specialized in legalizing cloud computing and specialty regulations in transferring data internationally and locally. Decision makers need to review the applicable law in Saudi Arabia that protect information in cloud computing. This should be from an international and a local view in order to identify all requirements surrounding this area. It is important to educate cloud computing users about their information value and rights before putting it in the cloud to avoid further legal complications, such as making an educational program to prevent giving personal information to a bank employee. Therefore, with many kinds of cloud computing services, it is important to have it covered by the law in all aspects.

Keywords: cloud computing, cyber crime, data protection, privacy

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Authors: Paschal Ohalehi

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Purpose - The purpose of this paper, which is part of a PhD thesis is to examine the role of risk based approach in minimising financial crime in the charity sector as well as offer recommendations to improving the quality of charity regulation whilst still retaining risk based approach as a regulatory framework and also making a case for a new regulatory model. Increase in financial crimes in the charity sector has put the role of regulation in minimising financial crime up for debates amongst researchers and practitioners. Although previous research has addressed the regulation of charities, research on the role of risk based approach to minimising financial crime in the charity sector is limited. Financial crime is a concern for all organisation including charities. Design/methodology/approach - This research adopts a social constructionist’s epistemological position. This research is carried out using semi structured in-depth interviews amongst randomly selected 24 charity trustees divided into three classes: 10 small charities, 10 medium charities and 4 large charities. The researcher also interviewed 4 stakeholders (NFA, Charity Commission and two different police forces in terms of size and area of coverage) in the charity sector. Findings - The results of this research show that reliance on risk based approach to financial crime in the sector is weak and fragmented with the research pointing to a clear evidence of disconnect between the regulator and the regulated leading to little or lack of regulation of trustees’ activities, limited monitoring of charities and lack of training and awareness on financial crime in the sector. Originality – This paper shows how regulation of charities in general and risk based approach in particular can be improved in order to meet the expectations of the stakeholders, the public, the regulator and the regulated.

Keywords: risk, risk based approach, financial crime, fraud, self-regulation

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Authors: Cyoung-Huei Huang, Chiu-Li Yeh, Man-Hui Pai, Sung-Ling Yeh

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This study evaluated the effect of different dietary n-6/n-3 polyunsaturated fatty acid (PUFA) ratios on modulating helper T (Th) and regulatory T (Treg) lymphocytes in mice with dextran sulfate sodium (DSS)-induced colitis. There were 3 control and 3 colitis groups in this study. Mice were fed for 24 d with an AIN-93G diet either with soybean oil (S), a mixture of soybean oil and low fish oil content (LF) or high fish oil content (HF). The ratio of n-6/n-3 PUFA in the LF diet was 4:1, and that in the HF diet was 2:1. The control groups drank distilled water while colitis groups provided 2% DSS in drinking water during day 15-19. All mice drank distilled water from day 20-24 for recovery and sacrificed on day 25. The results showed that colitis resulted in higher Th1, Th2, and Th17 and lower Treg percentages in the blood. Also, plasma haptoglobin and proinflammatory chemokines were elevated in colon lavage fluid. Colitic groups with fish oil had lower inflammatory mediators in the plasma and colon lavage fluid. Further, the percentages of Th1, Th2, and Th17 cells in the blood were lower, whereas Treg cell percentages were higher than those in the soybean oil group. The colitis group with n-6/n-3 PUFA ratio 2:1 had more pronounce effects than ratio 4:1. These results suggest that diets with an n-6/n-3 PUFA ratio of 2:1 or 4:1 regulate the Th/Treg balance and attenuate inflammatory mediator production in colitis. Compared to the n-6/n-3 PUFA ratio 4:1, the ratio of 2:1 was more effective in reducing inflammatory reactions in DSS-induced colitis.

Keywords: inflammatory bowel disease, n-3 polyunsaturated fatty acids, helper T lymphocyte, regulatory T lymphocyte

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Authors: K. P. Fasalu Rahman

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The financial services industry of Islam include large number of institutions, such as investment banks and commercial banks, investment companies and mutual insurance companies. All types of these financial institutions should have to deal with many issues and risks in their field of work. Islamic banks should expect to face two types of risks: risks that are similar to those faced by conventional financial intermediaries and risks that are unique to the Islamic Banks due to their compliance with the Shariah. The use of financial services and products that comply with the Shariah principles cause special issues for supervision and risk management. Risks are uncertain future events that could influence the achievement of the bank’s objectives, including strategic, operational, financial and compliance objectives. In Islamic banks, effective risk management deserves special attention. As an operational problem, risk management is the classification and identification of methods, processes, and risks in banks to supervise, monitor and measure them. In comparison to conventional banks, Islamic banks face big difficulties in identifying and managing risks due to bigger complexities emerging from the profit loss sharing (PLS) concept and nature of particular risks of Islamic financing. As the developing of managing risks tool becomes very essential, especially in Islamic banking as most of the products are depending on PLS principle, identifying and measuring each type of risk is highly important and critical in any Islamic finance based systems. This paper highlights the special and general risks surrounding Islamic banking. And it investigates in detail the need for risk management in Islamic banks. In addition to analyzing the effectiveness of risk management strategies adopted by Islamic financial institutions at present, this research is also suggesting strategies for improving risk management process of Islamic banks in future.

Keywords: Islamic banking, management, risk, risk management

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Authors: Omogboyega Abe

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This paper examines the relationships between socio-economic inequalities of power, race, wealth engendered by corporate structure, and domination in postcolonial Africa. The paper further considers how land as an epitome of property and power for the locals paved the way for capitalist accumulation and control in the hands of transnational corporations. European colonization of Africa was contingent on settler colonialism, where properties, including land, were re-modified as extractive resources for primitive accumulation. In developing Africa's extractive resources, transnational corporations (TNCs) usurped states' structures and domination over native land. The usurpation/corporate capture that exists to date has led to remonstrations and arguably a counter-productive approach to development projects. In some communities, the mention of extractive companies triggers resentment. The paradigm of state capture and state autonomy is simply inadequate to either describe or resolve the play of forces or actors responsible for severe corporate-induced human rights violations in emerging markets. Moreover, even if the deadly working conditions are conceived as some regulatory failure, it is tough to tell whose failure. The analysis in this paper is that the complexity and ambiguity evidenced by the multiple regimes and political and economic forces shaping production, consumption, and distribution of socio-economic variables are not exceptional in emerging markets. Instead, the varied experience in developing countries provides a window for seeing what we face in understanding and theorizing the structure and operation of the global economic and regulatory order in general.

Keywords: colonial, emerging markets, business, human rights, corporation

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Authors: Neslihan Cetin

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In this study, we will aim to analyze how the period of the state of emergency in Turkey lead to gaps in law and the formation of areas in which there was a complete lack of supervision. The state of emergency that was proclaimed following the coup attempt of July 15, 2016, continued until July 18, 2018, that is to say, 2 years, without taking into account whether the initial circumstances persisted. As part of this work, we claim that the state of emergency provided the executive power with important tools for governing, which it took constant use. We can highlight how the concern for security at the center of the basic considerations of the people in a city was exploited as a foundation by the military power in Turkey to interfere in the political, legal, and social spheres. The constitutions of 1924, 1961, and 1982 entrusted the army with the role of protector of the integrity of the state. This became an instrument at the hands of the military to legitimize their interventions in the name of public security. Its interventions in the political field are indeed politically motivated. The constitution, the legislative, and regulatory systems are modified and monopolized by the military power that dominates the legislative, regulatory, and judicial power, leading to a state of exception. With the political convulsions over a decade, the government was able to usurp the instrument called the state of exception. In particular, the decree-laws of the state of emergency, which the executive makes frequent and generally abusive use, became instruments in the hands of the government to take measures that it wishes to escape from the rules and the pre-established control mechanisms. Thus the struggle against the political opposition becomes more unbalanced and destructive. To this must also be added the ineffectiveness of ex-post controls and domestic remedies. This research allows us to stress how a legal concept, such as ‘the state of emergency’ can be politically exploited to make it a legal weapon that continues to produce victims.

Keywords: constitutional law, state of emergency, rule of law, instrumentalization of law

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Authors: S. Shakibaei, P. Alpkokin

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The railway network is one of the major components of a transportation system in a country which may be an indicator of the country’s level of economic improvement. Since 2000s on, revival of national railways and development of High Speed Rail (HSR) lines are one of the most remarkable policies of Turkish government in railway sector. Within this trend, the railway age is to be revived and coming decades will be a golden opportunity. Indubitably, major infrastructures such as road and railway networks require sizeable investment capital, precise maintenance and reparation. Traditionally, governments are held responsible for funding, operating and maintaining these infrastructures. However, lack or shortage of financial resources, risk responsibilities (particularly cost and time overrun), and in some cases inefficacy in constructional, operational and management phases persuade governments to find alternative options. Financial power, efficient experiences and background of private sector are the factors convincing the governments to make a collaboration with private parties to develop infrastructures. Public-Private Partnerships (PPP or 3P or P3) and related regulatory issues are born considering these collaborations. In Turkey, PPP approaches have attracted attention particularly during last decade and these types of investments have been accelerated by government to overcome budget limitations and cope with inefficacy of public sector in improving transportation network and its operation. This study mainly tends to present a comprehensive overview of PPP concept, evaluate the regulatory procedure in Europe and propose a general framework for Turkish State Railways (TCDD) as an outlook on privatization, liberalization and deregulation of railway network.

Keywords: deregulation, high-speed railway, liberalization, privatization, public-private partnership

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Authors: Ponshano Kaselekela, Simooya O. Oscar, Lunshano Boyd

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The Copperbelt University Health Services (CBUHS) was designated by the Zambia Medicines Regulatory Authority (ZAMRA), formally the Pharmaceutical Regulatory Authority (PRA) as a regional pharmacovigilance centre to carryout activities of drug safety monitoring in four provinces in Zambia. CBUHS’s mandate included stimulating the reporting of adverse drug reactions (ADRs), as well as collecting and collating ADR reports from health institutions in the four provinces. This report covers the researchers’ experiences from May 2008 to September, 2016. The main objectives are 1) to monitor ADRs in the Zambian population, 2) to disseminate information to all health professionals in the region advising that the CBU health was a centre for reporting ADRs in the region, 3) to monitor polypharmacy as well as the benefit-risk profile of medicines, 4) to generate independent, evidence based recommendations on the safety of medicines, 5) to support ZAMRA in formulating safety related regulatory decisions for medicines, and 6) to communicate findings with all key stakeholders. The methodology involved monthly visits, beginning in early May 2008 to September, 2016, by the CBUHS to health institutions in the programme areas. Activities included holding discussions with health workers, distribution of ADR forms and collection of ADRs reports. These reports, once collected, were documented and assessed at the CBUHS. A report was then prepared for ZAMRA on quarterly basis. At ZAMRA, serious ADRs were noted and recommendations made to the Ministry of Health of the Republic of Zambia. The results show that 2,600 ADRs reports were received at the pharmacovigilance regional centre. Most of the ADRs reports that received were due to antiretroviral drugs, as well as a few from anti-malarial drugs like Artemether/Lumefantrine – Coartem®. Three hundred and twelve ADRs were entered in the Uppsala Monitoring Centre WHO Vigiflow for further analysis. It was concluded that in general, 2008-16 were exciting years for the pharmacovigilance group at CBUHS. From a very tentative beginning, a lot of strides were made and contacts established with healthcare facilities in the region. The researchers were encouraged by the support received from the Copperbelt University management, the motivation provided by ZAMRA and most importantly the enthusiasm of health workers in all the health care facilities visited. As a centre for drug safety in Zambia, the results show it achieves its objectives for monitoring ADRs, Pharmacovigilance (drug safety monitoring), and activities of monitoring ADRs as well as preventing them. However, the centre faces critical challenges caused by erratic funding that prevents the smooth running of the programme.

Keywords: adverse drug reactions, drug safety, monitoring, pharmacovigilance

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