Search results for: overarching regulatory agencies
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 1561

Search results for: overarching regulatory agencies

1321 Pragmatism in Adaptive Reuse of Obsolete Industrial Land in China

Authors: Yong Li

Abstract:

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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1320 Inflammatory Changes in Postmenopausal Women including Th17 and Treg

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

Abstract:

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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1319 Assessing Economic Losses Of 2104 Flood Disaster: A Case Study on Dabong, Kelantan, Malaysia

Authors: Ahmad Hamidi Mohamed, Jamaluddin Othman, Mashitah Suid, Mohd Zaim Mohd Shukri

Abstract:

Floods are considered an annual natural disaster in Kelantan. However, the record-setting flood of 2014 was a 'tsunami-like disaster'. A study has been conducted with the objectives to assess the economic impact of the flood to the resident of Dabong area in Kelantan Darul Naim, Malaysia. This area was selected due to the severity during the flood. The impacts of flood on local people were done by conducting structured interviews with the use of questionnaires. The questionnaire was intended to acquire information on losses faced by Dabong residence. Questionnaires covered various areas of inconveniences suffered with respect to health effects, including illnesses suffered, their intensities, duration and their associated costs. Loss of productivity and quality of life was also assessed. Inquiries were made to Government agencies to obtain relevant statistical data regarding the loss due to the flood tragedy. The data collected by giving formal request to the governmental agencies and formal meetings were done. From the study a staggering amount of losses were calculated. This figure comes from losses of property, Farmers/Agriculture, Traders/Business, Health, Insurance and Governmental losses. Flood brings hardship to the people of Dabong and these losses of home will cause inconveniences to the society. The huge amount of economic loss extracted from this study shows that federal and state government of Kelantan need to find out the cause of the major flood in 2014. Fast and effective measures have to be planned and implemented in flood prone area to prevent same tragedy happens in the future.

Keywords: economic impact, flood tragedy, Malaysia, property losses

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1318 Alternate Approaches to Quality Measurement: An Exploratory Study in Differentiation of “Quality” Characteristics in Services and Supports

Authors: Caitlin Bailey, Marian Frattarola Saulino, Beth Steinberg

Abstract:

Today, virtually all programs offered to people with intellectual and developmental disabilities tout themselves as person-centered, community-based and inclusive, yet there is a vast range in type and quality of services that use these similar descriptors. The issue is exacerbated by the fields’ measurement practices around quality, inclusion, independent living, choice and person-centered outcomes. For instance, community inclusion for people with disabilities is often measured by the number of times person steps into his or her community. These measurement approaches set standards for quality too low so that agencies supporting group home residents to go bowling every week can report the same outcomes as an agency that supports one person to join a book club that includes people based on their literary interests rather than disability labels. Ultimately, lack of delineation in measurement contributes to the confusion between face value “quality” and true quality services and supports for many people with disabilities and their families. This exploratory study adopts alternative approaches to quality measurement including co-production methods and systems theoretical framework in order to identify the factors that 1) lead to high-quality supports and, 2) differentiate high-quality services. Project researchers have partnered with community practitioners who are all committed to providing quality services and supports but vary in the degree to which they are actually able to provide them. The study includes two parts; first, an online survey distributed to more than 500 agencies that have demonstrated commitment to providing high-quality services; and second, four in-depth case studies with agencies in three United States and Israel providing a variety of supports to children and adults with disabilities. Results from both the survey and in-depth case studies were thematically analyzed and coded. Results show that there are specific factors that differentiate service quality; however meaningful quality measurement practices also require that researchers explore the contextual factors that contribute to quality. These not only include direct services and interactions, but also characteristics of service users, their environments as well as organizations providing services, such as management and funding structures, culture and leadership. Findings from this study challenge researchers, policy makers and practitioners to examine existing quality service standards and measurements and to adopt alternate methodologies and solutions to differentiate and scale up evidence-based quality practices so that all people with disabilities have access to services that support them to live, work, and enjoy where and with whom they choose.

Keywords: co-production, inclusion, independent living, quality measurement, quality supports

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1317 Framing the Dynamics and Functioning of Different Variants of Terrorist Organizations: A Business Model Perspective

Authors: Eisa Younes Alblooshi

Abstract:

Counterterrorism strategies, to be effective and efficient, require a sound understanding of the dynamics, the interlinked organizational elements of the terrorist outfits being combated, with a view to having cognizance of their strong points to be guarded against, as well as the vulnerable zones that can be targeted for optimal results in a timely fashion by counterterrorism agencies. A unique model regarding the organizational imperatives was evolved in this research through likening the terrorist organizations with the traditional commercial ones, with a view to understanding in detail the dynamics of interconnectivity and dependencies, and the related compulsions facing the leaderships of such outfits that provide counterterrorism agencies with opportunities for forging better strategies. It involved assessing the evolving organizational dynamics and imperatives of different types of terrorist organizations, to enable the researcher to construct a prototype model that defines the progression and linkages of the related organizational elements of such organizations. It required detailed analysis of how the various elements are connected, with sequencing identified, as any outfit positions itself with respect to its external environment and internal dynamics. A case study focusing on a transnational radical religious state-sponsored terrorist organization was conducted to validate the research findings and to further strengthen the specific counterterrorism strategies. Six different variants of the business model of terrorist organizations were identified, categorized based on their outreach, mission, and status of any state sponsorship. The variants represent vast majority of the range of terrorist organizations acting locally or globally. The model shows the progression and dynamics of these organizations through various dimensions including mission, leadership, outreach, state sponsorship status, resulting in the organizational structure, state of autonomy, preference divergence in its fold, recruitment core, propagation avenues, down to their capacity to adapt, resulting critically in their own life cycles. A major advantage of the model is the utility of mapping terrorist organizations according to their fits to the sundry identified variants, allowing for flexibility and differences within, enabling the researchers and counterterrorism agencies to observe a neat blueprint of the organization’s footprint, along with highlighting the areas to be evaluated for focused target zone selection and timing of counterterrorism interventions. Special consideration is given to the dimension of financing, keeping in context the latest developments regarding cryptocurrencies, hawala, and global anti-money laundering initiatives. Specific counterterrorism strategies and intervention points have been identified for each of the respective model variants, with a view to efficient and effective deployment of resources.

Keywords: terrorism, counterterrorism, model, strategy

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1316 Legal Considerations in Fashion Modeling: Protecting Models' Rights and Ensuring Ethical Practices

Authors: Fatemeh Noori

Abstract:

The fashion industry is a dynamic and ever-evolving realm that continuously shapes societal perceptions of beauty and style. Within this industry, fashion modeling plays a crucial role, acting as the visual representation of brands and designers. However, behind the glamorous façade lies a complex web of legal considerations that govern the rights, responsibilities, and ethical practices within the field. This paper aims to explore the legal landscape surrounding fashion modeling, shedding light on key issues such as contract law, intellectual property, labor rights, and the increasing importance of ethical considerations in the industry. Fashion modeling involves the collaboration of various stakeholders, including models, designers, agencies, and photographers. To ensure a fair and transparent working environment, it is imperative to establish a comprehensive legal framework that addresses the rights and obligations of each party involved. One of the primary legal considerations in fashion modeling is the contractual relationship between models and agencies. Contracts define the terms of engagement, including payment, working conditions, and the scope of services. This section will delve into the essential elements of modeling contracts, the negotiation process, and the importance of clarity to avoid disputes. Models are not just individuals showcasing clothing; they are integral to the creation and dissemination of artistic and commercial content. Intellectual property rights, including image rights and the use of a model's likeness, are critical aspects of the legal landscape. This section will explore the protection of models' image rights, the use of their likeness in advertising, and the potential for unauthorized use. Models, like any other professionals, are entitled to fair and ethical treatment. This section will address issues such as working conditions, hours, and the responsibility of agencies and designers to prioritize the well-being of models. Additionally, it will explore the global movement toward inclusivity, diversity, and the promotion of positive body image within the industry. The fashion industry has faced scrutiny for perpetuating harmful standards of beauty and fostering a culture of exploitation. This section will discuss the ethical responsibilities of all stakeholders, including the promotion of diversity, the prevention of exploitation, and the role of models as influencers for positive change. In conclusion, the legal considerations in fashion modeling are multifaceted, requiring a comprehensive approach to protect the rights of models and ensure ethical practices within the industry. By understanding and addressing these legal aspects, the fashion industry can create a more transparent, fair, and inclusive environment for all stakeholders involved in the art of modeling.

Keywords: fashion modeling contracts, image rights in modeling, labor rights for models, ethical practices in fashion, diversity and inclusivity in modeling

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1315 Molecular Characterization of Arginine Sensing Response in Unravelling Host-Pathogen Interactions in Leishmania

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

Abstract:

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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1314 Kitchenary Metaphors in Hindi-Urdu: A Cognitive Analysis

Authors: Bairam Khan, Premlata Vaishnava

Abstract:

The ability to conceptualize one entity in terms of another allows us to communicate through metaphors. This central feature of human cognition has evolved with the development of language, and the processing of metaphors is without any conscious appraisal and is quite effortless. South Asians, like other speech communities, have been using the kitchenary [culinary] metaphor in a very simple yet interesting way and are known for bringing into new and unique constellations wherever they are. This composite feature of our language is used to communicate in a precise and compact manner and maneuvers the expression. The present study explores the role of kitchenary metaphors in the making and shaping of idioms by applying Cognitive Metaphor Theories. Drawing on examples from a corpus of adverts, print, and electronic media, the study looks at the metaphorical language used by real people in real situations. The overarching theme throughout the course is that kitchenary metaphors are powerful tools of expression in Hindi-Urdu.

Keywords: cognitive metaphor theories, kitchenary metaphors, hindi-urdu print, and electronic media, grammatical structure of kitchenary metaphors of hindi-urdu

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1313 Cybersecurity Challenges in the Era of Open Banking

Authors: Krish Batra

Abstract:

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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1312 Association of Antibiotics Resistance with Efflux Pumps Genes among Multidrug-Resistant Klebsiella pneumonia Recovered from Hospital Waste Water Effluents in Eastern Cape, South Africa

Authors: Okafor Joan, Nwodo Uchechukwu

Abstract:

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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1311 Regulating Issues concerning Data Protection in Cloud Computing: Developing a Saudi Approach

Authors: Jumana Majdi Qutub

Abstract:

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

Procedia PDF Downloads 236
1310 Kitchenary Metaphors In Hindi-urdu: A Cognitive Analysis

Authors: Bairam Khan, Premlata Vaishnava

Abstract:

The ability to conceptualize one entity in terms of another allows us to communicate through metaphors. This central feature of human cognition has evolved with the development of language, and the processing of metaphors is without any conscious appraisal and is quite effortless. South Asians, like other speech communities, have been using the kitchenary [culinary] metaphor in a very simple yet interesting way and are known for bringing into new and unique constellations wherever they are. This composite feature of our language is used to communicate in a precise and compact manner and maneuvers the expression. The present study explores the role of kitchenary metaphors in the making and shaping of idioms by applying Cognitive Metaphor Theories. Drawing on examples from a corpus of adverts, print, and electronic media, the study looks at the metaphorical language used by real people in real situations. The overarching theme throughout the course is that kitchenary metaphors are powerful tools of expression in Hindi-Urdu.

Keywords: cognitive metaphor theory, source domain, target domain, signifier- signified, kitchenary, ethnocultural elements of south asia and hindi- urdu language

Procedia PDF Downloads 59
1309 Rating Agreement: Machine Learning for Environmental, Social, and Governance Disclosure

Authors: Nico Rosamilia

Abstract:

The study evaluates the importance of non-financial disclosure practices for regulators, investors, businesses, and markets. It aims to create a sector-specific set of indicators for environmental, social, and governance (ESG) performances alternative to the ratings of the agencies. The existing literature extensively studies the implementation of ESG rating systems. Conversely, this study has a twofold outcome. Firstly, it should generalize incentive systems and governance policies for ESG and sustainable principles. Therefore, it should contribute to the EU Sustainable Finance Disclosure Regulation. Secondly, it concerns the market and the investors by highlighting successful sustainable investing. Indeed, the study contemplates the effect of ESG adoption practices on corporate value. The research explores the asset pricing angle in order to shed light on the fragmented argument on the finance of ESG. Investors may be misguided about the positive or negative effects of ESG on performances. The paper proposes a different method to evaluate ESG performances. By comparing the results of a traditional econometric approach (Lasso) with a machine learning algorithm (Random Forest), the study establishes a set of indicators for ESG performance. Therefore, the research also empirically contributes to the theoretical strands of literature regarding model selection and variable importance in a finance framework. The algorithms will spit out sector-specific indicators. This set of indicators defines an alternative to the compounded scores of ESG rating agencies and avoids the possible offsetting effect of scores. With this approach, the paper defines a sector-specific set of indicators to standardize ESG disclosure. Additionally, it tries to shed light on the absence of a clear understanding of the direction of the ESG effect on corporate value (the problem of endogeneity).

Keywords: ESG ratings, non-financial information, value of firms, sustainable finance

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1308 A Cloud-Based Mobile Auditing Tools for Muslim-Friendly Hospitality Services

Authors: Mohd Iskandar Illyas Tan, Zuhra Junaida Mohamad Husny, Farawahida Mohd Yusof

Abstract:

The potentials of Muslim-friendly hospitality services bring huge opportunities to operators (hoteliers, tourist guides, and travel agents), especially among the Muslim countries. In order to provide guidelines that facilitate the operations among these operators, standards and manuals have been developing by the authorities. Among the challenges is the applicability and complexity of the standard to be adopted in the real world. Mobile digital technology can be implemented to overcome those challenges. A prototype has been developed to help operators and authorities to assess their readiness in complying with MS2610:2015. This study analyzes the of mobile digital technology characteristics that are suitable for the user in conducting sharia’ compliant hospitality audit. A focus group study was conducted in the state of Penang, Malaysia that involves operators (hoteliers, tourist guide, and travel agents) as well as agencies (Islamic Tourism Center, Penang Islamic Affairs Department, Malaysian Standard) that involved directly in the implementation of the certification. Both groups were given the 3 weeks to test and provide feedback on the usability of the mobile applications in order to conduct an audit on their readiness towards the Muslim-friendly hospitality services standard developed by the Malaysian Standard. The feedbacks were analyzed and the overall results show that three criteria (ease of use, completeness and fast to complete) show the highest responses among both groups for the mobile application. This study provides the evidence that the mobile application development has huge potentials to be implemented by the Muslim-friendly hospitality services operator and agencies.

Keywords: hospitality, innovation, audit, compliance, mobile application

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1307 Collaborative Environmental Management: A Case Study Research of Stakeholders' Collaboration in the Nigerian Oil-Producing Region

Authors: Favour Makuochukwu Orji, Yingkui Zhao

Abstract:

A myriad of environmental issues face the Nigerian industrial region, resulting from; oil and gas production, mining, manufacturing and domestic wastes. Amidst these, much effort has been directed by stakeholders in the Nigerian oil producing regions, because of the impacts of the region on the wider Nigerian economy. Research to date has suggested that collaborative environmental management could be an effective approach in managing environmental issues; but little attention has been given to the roles and practices of stakeholders in effecting a collaborative environmental management framework for the Nigerian oil-producing region. This paper produces a framework to expand and deepen knowledge relating to stakeholders aspects of collaborative roles in managing environmental issues in the Nigeria oil-producing region. The knowledge is derived from analysis of stakeholders’ practices – studied through multiple case studies using document analysis. Selected documents of key stakeholders – Nigerian government agencies, multi-national oil companies and host communities, were analyzed. Open and selective coding was employed manually during document analysis of data collected from the offices and websites of the stakeholders. The findings showed that the stakeholders have a range of roles, practices, interests, drivers and barriers regarding their collaborative roles in managing environmental issues. While they have interests for efficient resource use, compliance to standards, sharing of responsibilities, generating of new solutions, and shared objectives; there is evidence of major barriers which includes resource allocation, disjointed policy and regulation, ineffective monitoring, diverse socio- economic interests, lack of stakeholders’ commitment and limited knowledge sharing. However, host communities hold deep concerns over the collaborative roles of stakeholders for economic interests, particularly, where government agencies and multi-national oil companies are involved. With these barriers and concerns, a genuine stakeholders’ collaboration is found to be limited, and as a result, optimal environmental management practices and policies have not been successfully implemented in the Nigeria oil-producing region. A framework is produced that describes practices that characterize collaborative environmental management might be employed to satisfy the stakeholders’ interests. The framework recommends critical factors, based on the findings, which may guide a collaborative environmental management in the oil producing regions. The recommendations are designed to re-define the practices of stakeholders in managing environmental issues in the oil producing regions, not as something wholly new, but as an approach essential for implementing a sustainable environmental policy. This research outcome may clarify areas for future research as well as to contribute to industry guidance in the area of collaborative environmental management.

Keywords: collaborative environmental management framework, case studies, document analysis, multinational oil companies, Nigerian oil producing regions, Nigerian government agencies, stakeholders analysis

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1306 Examining Risk Based Approach to Financial Crime in the Charity Sector: The Challenges and Solutions, Evidence from the Regulation of Charities in England and Wales

Authors: Paschal Ohalehi

Abstract:

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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1305 Navigating the Future: Evaluating the Market Potential and Drivers for High-Definition Mapping in the Autonomous Vehicle Era

Authors: Loha Hashimy, Isabella Castillo

Abstract:

In today's rapidly evolving technological landscape, the importance of precise navigation and mapping systems cannot be understated. As various sectors undergo transformative changes, the market potential for Advanced Mapping and Management Systems (AMMS) emerges as a critical focus area. The Galileo/GNSS-Based Autonomous Mobile Mapping System (GAMMS) project, specifically targeted toward high-definition mapping (HDM), endeavours to provide insights into this market within the broader context of the geomatics and navigation fields. With the growing integration of Autonomous Vehicles (AVs) into our transportation systems, the relevance and demand for sophisticated mapping solutions like HDM have become increasingly pertinent. The research employed a meticulous, lean, stepwise, and interconnected methodology to ensure a comprehensive assessment. Beginning with the identification of pivotal project results, the study progressed into a systematic market screening. This was complemented by an exhaustive desk research phase that delved into existing literature, data, and trends. To ensure the holistic validity of the findings, extensive consultations were conducted. Academia and industry experts provided invaluable insights through interviews, questionnaires, and surveys. This multi-faceted approach facilitated a layered analysis, juxtaposing secondary data with primary inputs, ensuring that the conclusions were both accurate and actionable. Our investigation unearthed a plethora of drivers steering the HD maps landscape. These ranged from technological leaps, nuanced market demands, and influential economic factors to overarching socio-political shifts. The meteoric rise of Autonomous Vehicles (AVs) and the shift towards app-based transportation solutions, such as Uber, stood out as significant market pull factors. A nuanced PESTEL analysis further enriched our understanding, shedding light on political, economic, social, technological, environmental, and legal facets influencing the HD maps market trajectory. Simultaneously, potential roadblocks were identified. Notable among these were barriers related to high initial costs, concerns around data quality, and the challenges posed by a fragmented and evolving regulatory landscape. The GAMMS project serves as a beacon, illuminating the vast opportunities that lie ahead for the HD mapping sector. It underscores the indispensable role of HDM in enhancing navigation, ensuring safety, and providing pinpoint, accurate location services. As our world becomes more interconnected and reliant on technology, HD maps emerge as a linchpin, bridging gaps and enabling seamless experiences. The research findings accentuate the imperative for stakeholders across industries to recognize and harness the potential of HD mapping, especially as we stand on the cusp of a transportation revolution heralded by Autonomous Vehicles and advanced geomatic solutions.

Keywords: high-definition mapping (HDM), autonomous vehicles, PESTEL analysis, market drivers

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1304 Dietary N-6/N-3 PUFA Ratios Affect the Homeostasis of CD4+ T Cells in Mice with Dextran Sulfate Sodium-Induced Colitis

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

Abstract:

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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1303 Characterization of Polymorphic Forms of Rifaximin

Authors: Ana Carolina Kogawa, Selma Gutierrez Antonio, Hérida Regina Nunes Salgado

Abstract:

Rifaximin is an oral antimicrobial, gut - selective and not systemic with adverse effects compared to placebo. It is used for the treatment of hepatic encephalopathy, travelers diarrhea, irritable bowel syndrome, Clostridium difficile, ulcerative colitis and acute diarrhea. The crystalline form present in the rifaximin with minimal systemic absorption is α, being the amorphous form significantly different. Regulators are increasingly attention to polymorphisms. Polymorphs can change the form by altering the drug characteristics compromising the effectiveness and safety of the finished product. International Conference on Harmonization issued the ICH Guidance Q6A, which aim to improve the control of polymorphism in new and existing pharmaceuticals. The objective of this study was to obtain polymorphic forms of rifaximin employing recrystallization processes and characterize them by thermal analysis (thermogravimetry - TG and differential scanning calorimetry - DSC), X-ray diffraction, scanning electron microscopy and solubility test. Six polymorphic forms of rifaximin, designated I to VI were obtained by the crystallization process by evaporation of the solvent. The profiles of the TG curves obtained from polymorphic forms of rifaximin are similar to rifaximin and each other, however, the DTG are different, indicating different thermal behaviors. Melting temperature values of all the polymorphic forms were greater to that shown by the rifaximin, indicating the higher thermal stability of the obtained forms. The comparison of the diffractograms of the polymorphic forms of rifaximin with rifaximin α, β and γ constant in patent indicate that forms III, V and VI are formed by mixing polymorph β and α and form III is formed by polymorph β. The polymorphic form I is formed by polymorph β, but with a significant amount of amorphous material. Already, the polymorphic form II consists of polymorph γ, amorphous. In scanning electron microscope is possible to observe the heterogeneity of morphological characteristics of crystals of polymorphic forms among themselves and with rifaximin. The solubility of forms I and II was greater than the solubility of rifaximin, already, forms III, IV and V presented lower solubility than of rifaximin. Similarly, the bioavailability of the amorphous form of rifaximin is considered significantly higher than the form α, the polymorphic forms obtained in this work can not guarantee the excellent tolerability of the reference medicine. Therefore, studies like these are extremely important and they point to the need for greater requirements by the regulatory agencies competent about polymorphs analysis of the raw materials used in the manufacture of medicines marketed globally. These analyzes are not required in the majority of official compendia. Partnerships between industries, research centers and universities would be a viable way to consolidate researches in this area and contribute to improving the quality of solid drugs.

Keywords: electronic microscopy, polymorphism, rifaximin, solubility, X-ray diffraction

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1302 Examining Postcolonial Corporate Power Structures through the Lens of Development Induced Projects in Africa

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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1301 Enhancing Teachers’ Professional Development Programmes by the Implementation of Flipped Learning Instruction: A Qualitative Study

Authors: Badriah Algarni

Abstract:

The pedagogy of ‘flipped learning’ is a form of blended instruction which is gaining widespread attention throughout the world. However, there is a lack of research concerning teachers’ professional development (TPD) in teachers who use flipping. The aim of this study was, therefore, to identify teachers’ perspectives on their experience of flipped PD. The study used a qualitative approach. Purposive sampling recruited nineteen teachers who participated in semi-structured, in-depth interviews. Thematic analysis was used to analyse the interview data. Overall, the teachers reported feeling more confident in their knowledge and skills after participating in flipped TPD. The analysis of the interview data revealed five overarching themes:1) increased engagement with the content; 2) better use of resources; 3) a social, collaborative environment; 4) exchange of practices and experiences; and 5) valuable online activities. These findings can encourage educators, policymakers, and trainers to consider flipped TPD as a form of PD to promote the building of teachers’ knowledge and stimulate reflective practices to improve teaching and learning practices.

Keywords: engagement, flipped learning, teachers’ professional development, collaboration

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1300 Improved Regression Relations Between Different Magnitude Types and the Moment Magnitude in the Western Balkan Earthquake Catalogue

Authors: Anila Xhahysa, Migena Ceyhan, Neki Kuka, Klajdi Qoshi, Damiano Koxhaj

Abstract:

The seismic event catalog has been updated in the framework of a bilateral project supported by the Central European Investment Fund and with the extensive support of Global Earthquake Model Foundation to update Albania's national seismic hazard model. The earthquake catalogue prepared within this project covers the Western Balkan area limited by 38.0° - 48°N, 12.5° - 24.5°E and includes 41,806 earthquakes that occurred in the region between 510 BC and 2022. Since the moment magnitude characterizes the earthquake size accurately and the selected ground motion prediction equations for the seismic hazard assessment employ this scale, it was chosen as the uniform magnitude scale for the catalogue. Therefore, proxy values of moment magnitude had to be obtained by using new magnitude conversion equations between the local and other magnitude types to this unified scale. The Global Centroid Moment Tensor Catalogue was considered the most authoritative for moderate to large earthquakes for moment magnitude reports; hence it was used as a reference for calibrating other sources. The best fit was observed when compared to some regional agencies, whereas, with reports of moment magnitudes from Italy, Greece and Turkey, differences were observed in all magnitude ranges. For teleseismic magnitudes, to account for the non-linearity of the relationships, we used the exponential model for the derivation of the regression equations. The obtained regressions for the surface wave magnitude and short-period body-wave magnitude show considerable differences with Global Earthquake Model regression curves, especially for low magnitude ranges. Moreover, a conversion relation was obtained between the local magnitude of Albania and the corresponding moment magnitude as reported by the global and regional agencies. As errors were present in both variables, the Deming regression was used.

Keywords: regression, seismic catalogue, local magnitude, tele-seismic magnitude, moment magnitude

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1299 State of Emergency in Turkey (July 2016-July 2018): A Case of Utilization of Law as a Political Instrument

Authors: Neslihan Cetin

Abstract:

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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1298 Mobile Device Applications in Physical Education: Investigating New Pedagogical Possibilities

Authors: Danica Vidotto

Abstract:

Digital technology is continuing to disrupt and challenge local conventions of teaching and education. As mobile devices continue to make their way into contemporary classrooms, educators need new pedagogies incorporating information communication technology to help reform the learning environment. In physical education, however, this can seem controversial as physical inactivity is often related to an excess of screen-time. This qualitative research project is an investigation on how physical educators use mobile device applications (apps) in their pedagogy and to what end. A comprehensive literature review is included to examine and engage current academic research of new pedagogies and technology, and their relevance to physical activity. Data were collected through five semi-structured interviews resulting in three overarching themes; i) changing pedagogies in physical education; ii) the perceived benefits and experienced challenges of using apps; and iii) apps, physical activity, and physical education. This study concludes with a discussion of the findings engaging the literature, discussing the implications of findings, and recommendations for future research.

Keywords: applications (apps), mobile devices, new pedagogies, physical education

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1297 Scientific Theoretical Fundamentals of Comparative Analysis

Authors: Khalliyeva Gulnoz Iskandarovna, Mannonova Feruzabonu Sherali Qizi

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A scientific field called comparative literature or literary comparative studies compares two or more literary phenomena. One of the most important scientific fields nowadays, when global social, cultural, and literary relations are growing daily, is comparative literature. Any comparative investigation reveals shared and unique characteristics of literary phenomena, which provide the cornerstone for the creation of overarching theoretical principles that apply to all literature. Comparative analysis consists of objects, and they are their constituents. For researchers, it is enough to know this. Comparative analysis, in addition to the above-mentioned actions, also focuses on comparing the components of the objects of analysis with each other. The purpose of this article is to investigate comparative analysis in literature and to identify similarities and differences between comparable objects. Students, teachers, and researchers should be able to describe comparative research techniques and their fundamental ideas when studying this topic. They should also have a basic understanding of comparative literature and their summary.

Keywords: object, natural, social, spiritual, epistemological, logical, methodological, methodological, axiological tasks, stages of comparison, environment, internal features, and typical situations

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1296 The Promotion of a Risk Culture: a Descriptive Study of Ghanaian Banks

Authors: Gerhard Grebe, Johan Marx

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The aim of the study is to assess the state of operational risk management and the adoption of an appropriate risk culture in Ghanaian banks. The Bank of Ghana (BoG) joined the Basel Consultative Group (BCG) of the Basel Committee on Bank Supervision (BCBS) in 2021 and is proceeding with the implementation of the Basel III international regulatory framework for banks. The BoG’s Directive about risk management encourages, inter alia, the creation of an appropriate risk culture by Ghanaian banks. However, it is not evident how the risk management staff of Ghanaian banks experience the risk culture and the implementation of operational risk management in the banks where they are employed. Ghana is a developing economy, and it is addressing challenges with its organisational culture. According to Transparency International, successive Ghanaian governments claim to be fighting corruption, but little success has been achieved so far. This points to a possible lack of accountability, transparency, and integrity in the environment in which Ghanaian banks operate and which could influence their risk culture negatively. Purposive sampling was used for the survey, and the questionnaire was completed byGhanaian bank personnel who specializesin operational risk management, risk governance, and compliance, bank supervision, risk analyses, as well as the implementation of the operational risk management requirements of the Basel regulatory frameworks. The respondents indicated that they are fostering a risk culture and implementing monitoring and reporting procedures; the three lines of defence (3LOD); compliance; internal auditing; disclosure of operational risk information; and receiving guidance from the bank supervisor in an attempt to improve their operational risk management practices. However, the respondents reported the following challenges with staff members who are not inside the risk management departments(in order of priority), namelydemonstrating a risk culture, training and development; communication; reporting and disclosure; roles and responsibilities; performance appraisal; and technological and environmental barriers. Recommendations to address these challenges are provided

Keywords: ghana, operational risk, risk culture, risk management

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1295 Adaptation of Smart City Concept in Africa: Localization, Relevance and Bottleneck

Authors: Adeleye Johnson Adelagunayeja

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The concept of making cities, communities, and neighborhoods smart, intelligent, and responsive is relatively new to Africa and its urban renewal agencies. Efforts must be made by relevant agencies to begin a holistic review of the implementation of infrastructural facilities and urban renewal methodologies that will revolve around the appreciation and application of artificial intelligence. The propagation of the ideals and benefits of the smart city concept are key factors that can encourage governments of African nations, the African Union, and other regional organizations in Africa to embrace the ideology. The ability of this smart city concept to curb insecurities – armed robbery, assassination, terrorism, and civil disorder – is one major reason, amongst others, why African governments must speedily embrace this contemporary developmental concept whose time has come! The seamlessness to access information and virtually cross-pollinate ideas with people living in already established smart cities, when combined with the great efficiency that the emergence of smart cities brings with it, are other reasons why Africa must come up with action plans that can enable the existing cities to metamorphose into smart cities. Innovations will be required to enable Africa to develop a smart city concept that will be compatible with the basic patterns of livelihood because the essence of the smart city evolution is to make life better for people to co-exist, to be productive and to enjoy standard infrastructural facilities. This research paper enumerates the multifaceted adaptive factors that have the potentials of making the adoption of smartcity concept in Africa seamless. It also proffers solutions to potential bottlenecks capable of undermining the execution of the smart city concept in Africa.

Keywords: smartcity compactibility innovation Africa government evolution, Africa as global village member, evolution in Africa, ways to make Africa adopt smartcity, localizing smartcity concept in Africa, bottleneck to smartcity developmet in Africa

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1294 Deregulation of Turkish State Railways Based on Public-Private Partnership Approaches

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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1293 Adverse Drug Reactions Monitoring in the Northern Region of Zambia

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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1292 Ensuring Safe Operation by Providing an End-To-End Field Monitoring and Incident Management Approach for Autonomous Vehicle Based on ML/Dl SW Stack

Authors: Lucas Bublitz, Michael Herdrich

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By achieving the first commercialization approval in San Francisco the Autonomous Driving (AD) industry proves the technology maturity of the SAE L4 AD systems and the corresponding software and hardware stack. This milestone reflects the upcoming phase in the industry, where the focus is now about scaling and supervising larger autonomous vehicle (AV) fleets in different operation areas. This requires an operation framework, which organizes and assigns responsibilities to the relevant AV technology and operation stakeholders from the AV system provider, the Remote Intervention Operator, the MaaS provider and regulatory & approval authority. This holistic operation framework consists of technological, processual, and organizational activities to ensure safe operation for fully automated vehicles. Regarding the supervision of large autonomous vehicle fleets, a major focus is on the continuous field monitoring. The field monitoring approach must reflect the safety and security criticality of incidents in the field during driving operation. This includes an automatic containment approach, with the overall goal to avoid safety critical incidents and reduce downtime by a malfunction of the AD software stack. An End-to-end (E2E) field monitoring approach detects critical faults in the field, uses a knowledge-based approach for evaluating the safety criticality and supports the automatic containment of these E/E faults. Applying such an approach will ensure the scalability of AV fleets, which is determined by the handling of incidents in the field and the continuous regulatory compliance of the technology after enhancing the Operational Design Domain (ODD) or the function scope by Functions on Demand (FoD) over the entire digital product lifecycle.

Keywords: field monitoring, incident management, multicompliance management for AI in AD, root cause analysis, database approach

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