Search results for: T regulatory

Authors: Qingxin Chen, Liben Jiang, Andrew Smith, Karim Hadjri

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Since 2007, the Chinese food industry has undergone serious food contamination in the baby dairy industry, especially milk powder contamination. One of the milk powder products was found to contain melamine and a significant number (294,000) of babies were affected by kidney stones. Due to growing concerns among consumers about food safety and protection, and high pressure from central government, companies must take radical action to ensure food quality protection through the use of an appropriate quality management system. Previously, though researchers have investigated the health and safety aspects of food industries and products, quality issues concerning food products in China have been largely over-looked. Issues associated with baby dairy products and their quality issues have not been discussed in depth. This paper investigates the impact of quality management systems on the Chinese baby dairy product industry. A literature review was carried out to analyse the use of quality management systems within the Chinese milk power market. Moreover, quality concepts, relevant standards, laws, regulations and special issues (such as Melamine, Flavacin M1 contamination) have been analysed in detail. A qualitative research approach is employed, whereby preliminary analysis was conducted by interview, and data analysis based on interview responses from four selected Chinese baby dairy product companies was carried out. Through the analysis of literature review and data findings, it has been revealed that for quality management system that has been designed by many practitioners, many theories, models, conceptualisation, and systems are present. These standards and procedures should be followed in order to provide quality products to consumers, but the implementation is lacking in the Chinese baby dairy industry. Quality management systems have been applied by the selected companies but the implementation still needs improvement. For instance, the companies have to take measures to improve their processes and procedures with relevant standards. The government need to make more interventions and take a greater supervisory role in the production process. In general, this research presents implications for the regulatory bodies, Chinese Government and dairy food companies. There are food safety laws prevalent in China but they have not been widely practiced by companies. Regulatory bodies must take a greater role in ensuring compliance with laws and regulations. The Chinese government must also play a special role in urging companies to implement relevant quality control processes. The baby dairy companies not only have to accept the interventions from the regulatory bodies and government, they also need to ensure that production, storage, distribution and other processes will follow the relevant rules and standards.

Keywords: baby dairy product, food quality, milk powder contamination, quality management system

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Authors: Thanusha D. Abeywickrama, Inoka C. Perera, Genji Kurisu

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Tuberculosis, considered being as the ninth leading cause of death worldwide, cause from a single infectious agent M. tuberculosis and the drug resistance nature of this bacterium is a continuing threat to the world. Therefore TB preventing treatment is expanding, where this study designed to analyze the regulatory mechanism of GntR transcriptional regulator gene Rv0792c, which lie between several genes codes for some hypothetical proteins, a monooxygenase and an oxidoreductase. The gene encoding Rv0792c was cloned into pET28a and expressed protein was purified to near homogeneity by Nickel affinity chromatography. It was previously reported that the protein binds within the intergenic region (BS region) between Rv0792c gene and monooxygenase (Rv0793). This resulted in binding of three protein molecules with the BS region suggesting tight control of monooxygenase as well as its own gene. Since monooxygenase plays a key role in metabolism, this gene may have a global regulatory role. The natural ligand for this regulator is still under investigation. In relation to the Rv0792 protein structure, a Circular Dichroism (CD) spectrum was carried out to determine its secondary structure elements. Percentage-wise, 17.4% Helix, 21.8% Antiparallel, 5.1% Parallel, 12.3% turn and 43.5% other were revealed from CD spectrum data under room temperature. Differential Scanning Calorimetry (DSC) was conducted to assess the thermal stability of Rv0792, which the melting temperature of protein is 57.2 ± 0.6 °C. The graph of heat capacity (Cp) versus temperature for the best fit was obtained for non-two-state model, which concludes the folding of Rv0792 protein occurs through stable intermediates. Peak area (∆HCal ) and Peak shape (∆HVant ) was calculated from the graph and ∆HCal / ∆HVant was close to 0.5, suggesting dimeric nature of the protein.

Keywords: CD spectrum, DSC analysis, GntR transcriptional regulator, protein structure

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Authors: Ian Kingsbury

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The rapid expansion of charter schools (public schools that receive government but do not face the same regulations as traditional public schools) over the preceding two decades has raised concerns over the potential for graft and fraud. These concerns are largely justified: Incidents of financial crime and mismanagement are not unheard of, and the charter sector has become a darling of hedge fund managers. In response, several states have strengthened their charter school regulatory regimes. Imposing regulations and attempting to increase accountability seem like sensible measures, and perhaps they are necessary. However, increased regulation may come at the cost of imposing barriers to entry. Specifically, increased regulation often entails evidence for a high likelihood of fiscal solvency. That should theoretically entail access to capital in the short-term, which may systematically preclude Black or Hispanic applicants from opening charter schools. Moreover, increased regulation necessarily entails more red tape. The institutional wherewithal and the number of hours required to complete an application to open a charter school might favor those who have partnered with an education service provider, specifically a charter management organization (CMO) or education management organization (EMO). These potential barriers to entry pose a significant policy concern. Just as policymakers hope to increase the share of minority teachers and principals, they should sensibly care whether individuals who open charter schools look like the students in that school. Moreover, they might be concerned if successful applications in states with stringent regulations are overwhelmingly affiliated with education service providers. One of the original missions of charter schools was to serve as a laboratory of innovation. Approving only those applications affiliated with education service providers (and in effect establishing a parallel network of schools rather than a diverse marketplace of schools) undermines that mission. Data and methods: The analysis examines more than 2,000 charter school applications from 15 states. It compares the outcomes of applications from states with a strong regulatory environment (those with high scores) from NACSA-the National Association of Charter School Authorizers- to applications from states with a weak regulatory environment (those with a low NACSA score). If the hypothesis is correct, applicants not affiliated with an ESP are more likely to be rejected in high-regulation states compared to those affiliated with an ESP, and minority candidates not affiliated with an education service provider (ESP) are particularly likely to be rejected. Initial returns indicate that the hypothesis holds. More applications in low NASCA-scoring Arizona come from individuals not associated with an ESP, and those individuals are as likely to be accepted as those affiliated with an ESP. On the other hand, applicants in high-NACSA scoring Indiana and Ohio are more than 20 percentage points more likely to be accepted if they are affiliated with an ESP, and the effect is particularly pronounced for minority candidates. These findings should spur policymakers to consider the drawbacks of charter school accountability and consider accountability regimes that do not impose barriers to entry.

Keywords: accountability, barriers to entry, charter schools, choice

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Authors: Yiling Shao, Megan Dai

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This paper attempts to explore whether the cultural infrastructure supported by the Chinese government is still subject to a logic of “strict regulation”.Previous studies have pointed out that the "paternalism" tendency of China's cultural policy always leads to excessive government intervention in cultural development, while Chinese cultural practitioners can only seek cultural autonomy in the cracks of supervision. This can also explain why Chinese cultural policies sometimes have different effects than the official expectations.But this only reflects one aspect of China's cultural policy. In fact, the welfare cultural infrastructure funded by the government seems to highlight the principles of "safeguarding citizens' cultural rights" and "citizens' voluntary" rather than "indoctrination" and "enlightenment", What new features of China's cultural policy are reflected behind this policy orientation that is completely different from the logic of "regulation", which has also become an important issue in this paper. Based on the field survey of a cultural infrastructure (Gao ming District Cultural Center) in Gao ming District, Fo shan City, Guangdong Province, China, for nearly one year, the authors have obtained many text and picture materials.The paper discusses the dual role of cultural centers in China's cultural policy -both as a formal commitment by the state to protect citizens' basic cultural rights and as a social space for citizens to use preferential policies to obtain cultural capital. All in all, the author have conclued three operational logics of the cultural infrastructure currently supported by the Chinese government (at least in developed areas): first, the cultural center has become a versatile cultural space; second, grass-roots cultural cadres can be described as "policy entrepreneurs"; third, ordinary citizens will use the officially supported cultural infrastructure to increase cultural capital. This paper argues that, in comparison to the common “regulatory hand” in the field of cultural industries, in cultural infrastructure supported by state, the authorities and citizens are not in conflict. On the contrary, authorities must adopt a de-regulatory "pleasing" strategy to gain the support of citizens.

Keywords: cultural infrastructure, cultural capital, deregulation, policy entrepreneur

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Authors: S. Lemoussu, J. C. Chaudemar, R. A. Vingerhoeds

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The aeronautics sector is currently living an unprecedented growth largely due to innovative projects. In several cases, such innovative developments are being carried out by Small and Medium sized-Enterprises (SMEs). For instance, in Europe, a handful of SMEs are leading projects like airships, large civil drones, or flying cars. These SMEs have all limited resources, must make strategic decisions, take considerable financial risks and in the same time must take into account the constraints of safety, cost, time and performance as any commercial organization in this industry. Moreover, today, no international regulations fully exist for the development and certification of this kind of projects. The absence of such a precise and sufficiently detailed regulatory framework requires a very close contact with regulatory instances. But, SMEs do not always have sufficient resources and internal knowledge to handle this complexity and to discuss these issues. This poses additional challenges for those SMEs that have system integration responsibilities and that must provide all the necessary means of compliance to demonstrate their ability to design, produce, and operate airships with the expected level of safety and reliability. The final objective of our research is thus to provide a methodological framework supporting SMEs in their development taking into account recent innovation and institutional rules of the sector. We aim to provide a contribution to the problematic by developing a specific Model-Based Systems Engineering (MBSE) approach. Airspace regulation, aeronautics standards and international norms on systems engineering are taken on board to be formalized in a set of models. This paper presents the on-going research project combining Systems Engineering and Project Management process modeling and taking into account the metamodeling problematic.

Keywords: aeronautics, certification, process modeling, project management, SME, systems engineering

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Authors: Pradeep Kulshrestha, Maulana Ayoub Ali

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The concept of financial inclusion has been tabled in the whole world where practitioners, academicians, policy makers and economists are working hard to look for the best possible opportunities in order to enable the whole society to be in the banking cycle. The Islamic banking system is considered to be one of the said opportunities. Countries like the United Kingdom, United States of America, Malaysia, Saudi Arabia, the whole of the United Arab Emirates and many African countries have accommodated the aspect of Islamic banking in the conventional banking system as one of the financial inclusion strategies. This paper tries to analyse the current state of affairs of the Islamic Banking system in Tanzania in order to understand the improvement of the provision of Islamic banking products and services in the said country. The paper discusses the historical background of the banking system in Tanzania, the level of penetration of banking products and services and the coming of the Islamic banking system in the country. Furthermore, the paper discusses banking regulatory bodies, legal instruments governing banking operations as well as number of legal challenges facing Islamic banking operations in the country. Following a critical literature review, the paper discovered that there is no legal instrument which talks about the introduction and provision of Islamic banking system in Tanzania. Furthermore, the Islamic banking system was considered as a banking product which is absolutely incorrect because Islamic banking is considered to be as a banking system of its own. In addition to that, it has been discovered that lack of a proper regulatory system and legal instruments to harmonize the conventional and Islamic banking systems has resulted in the closure of one Islamic window in the country, which in the end affects the credibility of the newly introduced banking system. In its conclusive remarks, the paper suggests that Tanzania should work on all legal challenges affecting the smooth operations of the Islamic banking system. This can be in a way of adopting various Islamic banking legal models which are used in countries like Malaysia and others, or a borrowing legal harmonization process which has been adopted by the UK, Uganda, Nigeria and Kenya.

Keywords: Islamic banking, Islamic windows, regulations, banks

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Authors: Anurag Devkota

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Foreign employment serves to be the strongest pillar in engendering employment options for a large number of the young Nepali population. Nepali workers are forced to leave the comfort of their homes and are exposed to precarious conditions while on a journey to earn enough money to live better their lives. The exponential rise in foreign labour migration has produced a snowball effect on the economy of the nation. The dramatic variation in the economic development of the state has proved to establish the fact that migration is increasingly significant for livelihood, economic development, political stability, academic discourse and policy planning in Nepal. The foreign employment practice in Nepal largely incorporates the role of individual agents in the entire process of migration. With the fraudulent acts and false promises of these agents, the problems associated with every Nepali migrant worker starts at home. The workers encounter tremendous pre-departure malpractice and exploitation at home by different individual agents during different stages of processing. Although these epidemic and repetitive ill activities of intermediaries are dominant and deeply rooted, the agents have been allowed to walk free in the absence of proper laws to curb their wrongdoings and misconduct. It has been found that the existing regulatory mechanisms have not been utilised to their full efficacy and often fall short in addressing the actual concerns of the workers because of the complex legal and judicial procedures. Structural changes in the judicial setting will help bring perpetrators under the law and victims towards access to justice. Thus, a qualitative improvement of the overall situation of Nepali migrant workers calls for a proper 'regulatory' arrangement vis-à-vis these brokers. Hence, the author aims to carry out a doctrinal study using reports and scholarly articles as a major source of data collection. Various reports published by different non-governmental and governmental organizations working in the field of labour migration will be examined and the research will focus on the inductive and deductive data analysis. Hence, the real challenge of establishing a pro-migrant worker regime in recent times is to bring the agents under the jurisdiction of the court in Nepal. The Gulf Visit Study Report, 2017 prepared and launched by the International Relation and Labour Committee of Legislature-Parliament of Nepal finds that solving the problems at home solves 80 percent of the problems concerning migrant workers in Nepal. Against this backdrop, this research study is intended to determine the ways and measures to curb the role of agents in the foreign employment and labour migration process of Nepal. It will further dig deeper into the regulatory mechanisms of Nepal and map out essential determinant behind the impunity of agents.

Keywords: foreign employment, labour migration, human rights, migrant workers

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Authors: Ogunlana Olarewaju Fatai, Kelani Fatai Adeshina

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The interplay of corruption and institutional quality determines how effective and efficient an economy progresses. An efficient institutional quality is a key requirement for economic stability. Institutional quality in most cases has been used interchangeably with Governance and these have given room for proxies that legitimized Governance as measures for institutional quality. A poorly-tailored institutional quality has a penalizing effect on corruption and economic growth, while defective institutional quality breeds corruption. Corruption is a hydra-headed phenomenon as it manifests in different forms. The most celebrated definition of corruption is given as “the use or abuse of public office for private benefits or gains”. It also denotes an arrangement between two mutual parties in the determination and allocation of state resources for pecuniary benefits to circumvent state efficiency. This study employed Barro (1990) type augmented model to analyze the nexus among corruption, institutional quality and economic growth in Nigeria using annual time series data, which spanned the period 1996-2019. Within the analytical framework of Johansen Cointegration technique, Error Correction Mechanism (ECM) and Granger Causality tests, findings revealed a long-run relationship between economic growth, corruption and selected measures of institutional quality. The long run results suggested that all the measures of institutional quality except voice & accountability and regulatory quality are positively disposed to economic growth. Moreover, the short-run estimation indicated a reconciliation of the divergent views on corruption which pointed at “sand the wheel” and “grease the wheel” of growth. In addition, regulatory quality and the rule of law indicated a negative influence on economic growth in Nigeria. Government effectiveness and voice & accountability, however, indicated a positive influence on economic growth. The Granger causality test results suggested a one-way causality between GDP and Corruption and also between corruption and institutional quality. Policy implications from this study pointed at checking corruption and streamlining institutional quality framework for better and sustained economic development.

Keywords: institutional quality, corruption, economic growth, public policy

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Authors: Mayada Mazher, Ahmed Moustafa, Ahmed Abdellatif

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Background: Autophagy is a eukaryotic, highly conserved catabolic process implicated in many pathophysiologies such as wound healing. Autophagy-associated genes serve as a scaffolding platform for signal transduction of macrophage polarization during the inflammatory phase of wound healing and tissue repair process. In the current study, we report a model for the interplay between autophagy-associated genes and macrophages polarization associated genes. Methods: In silico analysis was performed on 249 autophagy-related genes retrieved from the public autophagy database and gene expression data retrieved from Gene Expression Omnibus (GEO); GSE81922 and GSE69607 microarray data macrophages polarization 199 DEGS. An integrated protein-protein interaction network was constructed for autophagy and macrophage gene sets. The gene sets were then used for GO terms pathway enrichment analysis. Common transcription factors for autophagy and macrophages' polarization were identified. Finally, microRNAs enriched in both autophagy and macrophages were predicated. Results: In silico prediction of common transcription factors in DEGs macrophages and autophagy gene sets revealed a new role for the transcription factors, HOMEZ, GABPA, ELK1 and REL, that commonly regulate macrophages associated genes: IL6,IL1M, IL1B, NOS1, SOC3 and autophagy-related genes: Atg12, Rictor, Rb1cc1, Gaparab1, Atg16l1. Conclusions: Autophagy and macrophages' polarization are interdependent cellular processes, and both autophagy-related proteins and macrophages' polarization related proteins coordinate in tissue remodelling via transcription factors and microRNAs regulatory network. The current work highlights a potential new role for transcription factors HOMEZ, GABPA, ELK1 and REL in wound healing.

Keywords: autophagy related proteins, integrated network analysis, macrophages polarization M1 and M2, tissue remodelling

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Authors: Ankan Roy, Niharika, Samir Kumar Patra

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Anomalous nexus of complex topological assemblies and spatiotemporal epigenetic choreography at chromosomal territory may forms the most sophisticated regulatory layer of gene expression in cancer. Colon cancer is one of the leading malignant neoplasms of the lower gastrointestinal tract worldwide. There is still a paucity of information about the complex molecular mechanisms of colonic cancerogenesis. Bioinformatics prediction and analysis helps to identify essential genes and significant pathways for monitoring and conquering this deadly disease. The present study investigates and explores potential hub genes as biomarkers and effective therapeutic targets for colon cancer treatment. Colon cancer patient sample containing gene expression profile datasets, such as GSE44076, GSE20916, and GSE37364 were downloaded from Gene Expression Omnibus (GEO) database and thoroughly screened using the GEO2R tool and Funrich software to find out common 2 differentially expressed genes (DEGs). Other approaches, including Gene Ontology (GO) and KEGG pathway analysis, Protein-Protein Interaction (PPI) network construction and hub gene investigation, Overall Survival (OS) analysis, gene correlation analysis, methylation pattern analysis, and hub gene-Transcription factors regulatory network construction, were performed and validated using various bioinformatics tool. Initially, we identified 166 DEGs, including 68 up-regulated and 98 down-regulated genes. Up-regulated genes are mainly associated with the Cytokine-cytokine receptor interaction, IL17 signaling pathway, ECM-receptor interaction, Focal adhesion and PI3K-Akt pathway. Downregulated genes are enriched in metabolic pathways, retinol metabolism, Steroid hormone biosynthesis, and bile secretion. From the protein-protein interaction network, thirty hub genes with high connectivity are selected using the MCODE and cytoHubba plugin. Survival analysis, expression validation, correlation analysis, and methylation pattern analysis were further verified using TCGA data. Finally, we predicted COL1A1, COL1A2, COL4A1, SPP1, SPARC, and THBS2 as potential master regulators in colonic cancerogenesis. Moreover, our experimental data highlights that disruption of lipid raft and RAS/MAPK signaling cascade affects this gene hub at mRNA level. We identified COL1A1, COL1A2, COL4A1, SPP1, SPARC, and THBS2 as determinant hub genes in colon cancer progression. They can be considered as biomarkers for diagnosis and promising therapeutic targets in colon cancer treatment. Additionally, our experimental data advertise that signaling pathway act as connecting link between membrane hub and gene hub.

Keywords: hub genes, colon cancer, DNA methylation, epigenetic engineering, bioinformatic predictions

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Authors: Maria Krambia-Kapardis, Andreas Kapardis

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The paper discusses regulatory and legislative measures implemented by various nations in an effort to avert another financial crisis. More specifically, to address the financial crisis, the European Commission followed the practice of other developed countries and implemented a European Economic Recovery Plan in an attempt to overhaul the regulatory and supervisory framework of the financial sector. In 2010 the Commission introduced the European Systemic Risk Board and in 2011 the European System of Financial Supervision. Some experts advocated that the type and extent of financial regulation introduced in the European crisis in the wake of the 2008 crisis has been excessive and counterproductive. In considering how different countries responded to the financial crisis, global regulators have shown a more focused commitment to combat industry misconduct and to pre-empt abusive behavior. Regulators have also increased funding and resources at their disposal; have increased regulatory fines, with an increasing trend towards action against individuals; and, finally, have focused on market abuse and market conduct issues. Financial regulation can be effected, first of all, through legislation. However, neither ex ante or ex post regulation is by itself effective in reducing systemic risk. Consequently, to avert a financial crisis, in their endeavor to achieve both economic efficiency and financial stability, governments need to balance the two approaches to financial regulation. Fiduciary duty is another means by which the behavior of actors in the financial world is constrained and, thus, regulated. Furthermore, fiduciary duties extend over and above other existing requirements set out by statute and/or common law and cover allegations of breach of fiduciary duty, negligence or fraud. Careful analysis of the etiology of the 2008 financial crisis demonstrates the great importance of corporate governance as a way of regulating boardroom behavior. In addition, the regulation of professions including accountants and auditors plays a crucial role as far as the financial management of companies is concerned. In the US, the Sarbanes-Oxley Act of 2002 established the Public Company Accounting Oversight Board in order to protect investors from financial accounting fraud. In most countries around the world, however, accounting regulation consists of a legal framework, international standards, education, and licensure. Accounting regulation is necessary because of the information asymmetry and the conflict of interest that exists between managers and users of financial information. If a holistic approach is to be taken then one cannot ignore the regulation of legislators themselves which can take the form of hard or soft legislation. The science of averting a financial crisis is yet to be perfected and this, as shown by the preceding discussion, is unlikely to be achieved in the foreseeable future as ‘disaster myopia’ may be reduced but will not be eliminated. It is easier, of course, to be wise in hindsight and regulating unreasonably risky decisions and unethical or outright criminal behavior in the financial world remains major challenges for governments, corporations, and professions alike.

Keywords: financial crisis, legislation, regulation, financial regulation

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Authors: Maria Ashitko

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The Constitution of the Republic of Belarus is based on the principle of the unity of rights and obligations, including those of the child. The constitutional status of the child is aspecific system of constitutional elements established and guaranteed by the state through the current legislation and regulatory acts that ensure the special legal status of the child, his or her constitutional legal capacity, implementation of the principles of the constitutional and legal status of the child, constitutional rights of the child and their safeguards. Under the principles of the constitutional status of the child, we consider the general, normative, social-volitional rules of behavior established by the Constitution of the Republic of Belarus, laws and other regulatory acts that determine the content and social purpose of the legal status of the child. The constitutional and legal status of the child is characterized by the following special principles, which form a feature of the state legal system:1) Ensuring the interests of the child means providing for the child in accordance with his or her age, state of health, characteristics of development, life experience, family life, cultural traditions, ethnicity. 2) The principle of equal responsibility of both parents or their substitutes characterized by caring for the next generation as one of the priority tasks of the state and society, and all issues related to the implementation of children’s rights should be addressed at the constitutional level. 3) We would like to highlight such a special principle as the subprinciple of safeguards, which is the principle of ensuring the safety of the child. It is also worth noting that in legal studies, there is no relationship between safety and constitutional rights as general safeguards of individual rights and freedoms, and as special safeguards for the right to life. 4) The principle of justice is expressed by the fact that in modern conditions, the quality of life is determined not only by material wealth but also by the ability of the state to ensure the harmonization of social relations and social harmony on the basis of humanism and justice. Thus, the specificity of the constitutional status of the child is the age boundary between adulthood and minority; therefore, we propose to highlight the age characteristics of the child as an additional element. It is advisable to highlight such a special principle as the subprinciple of safeguards, which is the principle of ensuring the safety of the child.

Keywords: children’s rights, constitutional status, constitutional principles, constitutional rights

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Authors: Liya Abraham

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Eritrea is located along the Red Sea, north of the Horn of Africa, between Djibouti and Sudan and has a population of about 3.2 million as of 2010. It has six administrative regions; Anseba, Debub, Debubawi K’eyih Bahri, Gash-Barka, Ma'akel, and Semenawi K’eyih Bahri. Eritrea has got its independence in 1991 after 30 years war of liberation. The country is blessed with various medicinal flora and fauna, and marine and terrestrial biodiversity. Traditional Medicine (TM) has been an integral part of the Eritrean culture for centuries. So far, more than 19 TM modalities have been recognized, and are broadly categorized as; herbal, procedure-based and spiritual. Despite the availability of modern medicine to the majority of the population, TM is still widely practiced. The rationale behind widespread use is accessibility, affordability and cultural acceptability. Hence, TM is of great contribution to the Eritrean health care system. As a matter of fact, harnessing the potential contribution of effective and safe TM in order to attain Universal Health Coverage (UHC) has been emphasized in the WHO TM strategy 2014-2023. The Eritrean TM, however, was operating without regulation and reliable scientific justification behind its safety and efficacy. Thus, the Ministry of Health (MoH), in recognition of the role of TM in primary healthcare and safeguard public health, established a regulatory body for TM so-called as Traditional Medicine Unit (TMU) in 2012. The mission of the unit is to ensure rational TM use through an integrated health service delivery system and contribute to the country’s economic and social development. The unit has established its national TM policy in 2017. The activities of the unit are guided by the National TM Advisory Committee (TMAC), responsible for the provision of technical assistance and advisory role. Moreover, the Legal Framework and Code of Ethics and Practice which provide a legal basis for the regulation of TM have also been drafted. In recognition of the importance of TM research and development, the unit launched a nationwide TM survey in 2017 and had surveyed two zones (Gash-Barka and Debub). The findings of the survey were subjected to a research dissemination workshop and publication in international journals. Furthermore, TM-related adverse events reporting tool (Green Form) aiming to guide regulatory interventions and researches have been established by the unit, and ever since reports are flowing. The unit has also been offering training to THPs, pharmacy students and health care professionals regarding TM and its regulatory activities. In addition, as part of the establishment of the national medicinal plants' database and herbal monograph, more than 329 and 30 medicinal plants, have been compiled respectively. In conclusion, TM is still widely accepted and practiced in Eritrea. The TMU ever since its establishment is endeavoring to ensure the safety and efficacy of the TM, and its integration in the mainstream health service delivery system.

Keywords: efficacy, regulation, safety, traditional medicine, traditional medicine unit, universal health coverage

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Authors: Chrysthia Papacleovoulou

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The era of de-regulation, off-shore and tax haven jurisdictions, and shelf companies has come to an end. The usage of complex corporate structures involving trust instruments, special purpose vehicles, holding-subsidiaries in offshore haven jurisdictions, and taking advantage of tax treaties is soaring. States which raced to introduce corporate friendly legislation, tax incentives, and creative international trust law in order to attract greater FDI are now faced with regulatory challenges and are forced to revisit the corporate form and its tax treatment. The fiduciary services industry, which dominated over the last 3 decades, is now striving to keep up with the new regulatory framework as a result of a number of European and international legislative measures. This article considers the challenges to the company and the corporate form as a result of the legislative measures on tax planning and tax avoidance, CRS reporting, FATCA, CFC rules, OECD’s BEPS, the EU Commission's new transparency rules for intermediaries that extends to tax advisors, accountants, banks & lawyers who design and promote tax planning schemes for their clients, new EU rules to block artificial tax arrangements and new transparency requirements for financial accounts, tax rulings and multinationals activities (DAC 6), G20's decision for a global 15% minimum corporate tax and banking regulation. As a result, states are found in a race of over-regulation and compliance. These legislative measures constitute a global up-side down tax-harmonisation. Through the adoption of the OECD’s BEPS, states agreed to an international collaboration to end tax avoidance and reform international taxation rules. Whilst the idea was to ensure that multinationals would pay their fair share of tax everywhere they operate, an indirect result of the aforementioned regulatory measures was to attack private clients-individuals who -over the past 3 decades- used the international tax system and jurisdictions such as Marshal Islands, Cayman Islands, British Virgin Islands, Bermuda, Seychelles, St. Vincent, Jersey, Guernsey, Liechtenstein, Monaco, Cyprus, and Malta, to name but a few, to engage in legitimate tax planning and tax avoidance. Companies can no longer maintain bank accounts without satisfying the real substance test. States override the incorporation doctrine theory and apply a real seat or real substance test in taxing companies and their activities, targeting even the beneficial owners personally with tax liability. Tax authorities in civil law jurisdictions lift the corporate veil through the public registries of UBO Registries and Trust Registries. As a result, the corporate form and the doctrine of limited liability are challenged in their core. Lastly, this article identifies the development of new instruments, such as funds and private placement insurance policies, and the trend of digital nomad workers. The baffling question is whether industry and states can meet somewhere in the middle and exit this over-regulation frenzy.

Keywords: company, regulation, TAX, corporate structure, trust vehicles, real seat

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Authors: A. Md. Bayejid Hosen, B. M Zakir Hossain Howlader, C. Yearul Kabir

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Contamination of soil and agricultural products by heavy metals resulting from rapid industrial development has caused major concern. Dietary exposure to heavy metals has been associated with toxic and adverse health effects. The main threats to human health from heavy metals are associated with exposure to Pb, Cd and Hg. The aim of this study was to monitor the presence of heavy metals in cereals collected from different wholesale markets of Dhaka City. One hundred and sixty cereal samples were collected and analyzed for determination of heavy metals. Heavy metals were analyzed by inductively coupled plasma mass spectrometry (ICP-MS). A total of six heavy metals– lead, chromium, cadmium, mercury, arsenic and antimony were estimated. The average concentrations of heavy metals in cereals fall within the safe limit established by regulatory organizations except for Pb (152.4 μg/100g) and Hg (15.13 μg/100g) which exceeded the safe limits. BARI gom-26 was the highest source of Pb (304.1 μg/100g) whereas Haski-29 rice variety contained the highest amount of Hg (60.85 μg/100g). Though all the cereal varieties contained approximately same amount of Cr the naizer sail varieties contained huge amount of Cr (171.8 μg/100g). Among all the cereal samples miniket rice varieties contained the least amount of heavy metals. The concentration of Cr (63.24 μg/100g), Cd (5.54 μg/100g) and As (3.26 μg/100g) in all cereals were below the safe limits. The daily intake of heavy metals was determined using the total weight of cereals consumed each day multiplied by the concentrations of heavy metals in cereals. The daily intake was compared with provisional maximum tolerable daily intake set by different regulatory organizations. The daily intake of Cd (23.0 μg), Hg (63.0 μg) and as (13.6 μg) through cereals were below the risk level except for Pb (634.0 μg) and Cr (263.1 μg). As the main meal of average Bangladeshi people is boiled rice served with some sorts of vegetables, our findings indicate that the residents of Dhaka City are at risk from Pb and Cr contamination. Potential health risks from exposure to heavy metals in self-planted cereals need more attention.

Keywords: contamination, dietary exposure, heavy metals, human health, ICP-MS

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Authors: Mengjia Zhi, Xingmei Wei, Xiang Gao, Shiyang Liu, Zhiran Huang, Li Yang, Jing Sun

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Background: To understand the consumption trend of opioid analgesics and the consumption adequacy of opioid analgesic treatment for moderate to severe pain in China, as well as the pain control level of China with international perspective. Importance: To author’s best knowledge, this is the first study in China to measure the adequacy of opioid analgesic treatment for moderate to severe pain considering disease pattern and with the standardized pain treatment guideline. Methods: A retrospective analysis was carried out to show the consumption frequency (daily defined doses, DDDs) of opioid analgesics and its trend in China from 2006 to 2016. Adequacy of consumption measure (ACM) was used to measure the number of needed morphine equivalents and the overall adequacy of opioid analgesic treatment of moderate to severe pain in China, and compared with international data. Results: The consumption frequency of opioid analgesics (DDDs) in China increased from 13,200,000 DDDs in 2006 to 44,200,000 DDDs in 2016, and showed an increasing trend. The growth rate was faster at first, especially in 2013, then slowed down, decreased slightly in 2015. The ACM of China increased from 0.0032 in 2006 to 0.0074 in 2016, with an overall trend of growth. The ACM level of China has been always a very poor level during 2006-2016. Conclusion: The consumption of opioid analgesics for the treatment of moderate to severe pain in China has always been inadequate. There is a huge gap between China and the international level. There are many reasons behind this problem, which lie in different aspects, including medical staff, patients and the public, health systems and social & cultural aspects. It is necessary to strengthen the training and education of medical staff and the patients, to use mass media to disseminate scientific knowledge of pain management, to encourage communications between doctors and patients, to improve regulatory system for the controlled medicines and the overall health systems, and to balance the regulatory goal for avoidance of abuse, and the social goal of meeting the increasing needs of the people for better life.

Keywords: opioid analgesics, adequate consumption measure, pain control, China

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Authors: M. Miljkovic, A. Urakpo, M. Simic-Koumoutsaris

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Benefit-risk assessment (BRA) is a valuable tool that takes place in multiple stages during a medicine's lifecycle, and this assessment can be conducted in a variety of ways. The aim was to summarize current BRA methods used during approval decisions and in post-approval settings and to see possible future directions. Relevant reviews, recommendations, and guidelines published in medical literature and through regulatory agencies over the past five years have been examined. BRA implies the review of two dimensions: the dimension of benefits (determined mainly by the therapeutic efficacy) and the dimension of risks (comprises the safety profile of a drug). Regulators, industry, and academia have developed various approaches, ranging from descriptive textual (qualitative) to decision-analytic (quantitative) models, to facilitate the BRA of medicines during the product lifecycle (from Phase I trials, to authorization procedure, post-marketing surveillance and health technology assessment for inclusion in public formularies). These approaches can be classified into the following categories: stepwise structured approaches (frameworks); measures for benefits and risks that are usually endpoint specific (metrics), simulation techniques and meta-analysis (estimation techniques), and utility survey techniques to elicit stakeholders’ preferences (utilities). All these approaches share the following two common goals: to assist this analysis and to improve the communication of decisions, but each is subject to its own specific strengths and limitations. Before using any method, its utility, complexity, the extent to which it is established, and the ease of results interpretation should be considered. Despite widespread and long-time use, BRA is subject to debate, suffers from a number of limitations, and currently is still under development. The use of formal, systematic structured approaches to BRA for regulatory decision-making and quantitative methods to support BRA during the product lifecycle is a standard practice in medicine that is subject to continuous improvement and modernization, not only in methodology but also in cooperation between organizations.

Keywords: benefit-risk assessment, benefit-risk profile, product lifecycle, quantitative methods, structured approaches

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Authors: Livia Calcagni

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Most of the largest cities in the world are located in areas that are vulnerable to coastal erosion and flooding, both linked to climate change and rising sea levels (RSL). Nevertheless, more and more people are moving to these vulnerable areas as cities keep growing. Architects, engineers and policy makers are called to rethink the way we live and to provide timely and adequate responses not only by investigating measures to improve the urban fabric, but also by developing strategies capable of planning change, exploring unusual and resilient frontiers of living, such as floating architecture. Since the beginning of the 21st century we have seen a dynamic growth of water-based architecture. At the same time, the shortage of land available for urban development also led to reclaim the seabed or to build floating structures. In light of these considerations, time is ripe to consider floating architecture not only as a full-fledged building typology but especially as a full-fledged adaptation solution for RSL. Currently, there is no global international legal framework for urban development on water and there is no structured performance based building design (PBBD) approach for floating architecture in most countries, let alone national regulatory systems. Thus, the research intends to identify the technological, morphological, functional, economic, managerial requirements that must be considered in a the development of the PBBD framework conceived as a meta-design tool. As it is expected that floating urban development is mostly likely to take place as extension of coastal areas, the needs and design criteria are definitely more similar to those of the urban environment than of the offshore industry. Therefor, the identification and categorization of parameters takes the urban-architectural guidelines and regulations as the starting point, taking the missing aspects, such as hydrodynamics, from the offshore and shipping regulatory frameworks. This study is carried out through an evidence-based assessment of performance guidelines and regulatory systems that are effective in different countries around the world addressing on-land and on-water architecture as well as offshore and shipping industries. It involves evidence-based research and logical argumentation methods. Overall, this paper highlights how inhabiting water is not only a viable response to the problem of RSL, thus a resilient frontier for urban development, but also a response to energy insecurity, clean water and food shortages, environmental concerns and urbanization, in line with Blue Economy principles and the Agenda 2030. Moreover, the discipline of architecture is presented as a fertile field for investigating solutions to cope with climate change and its effects on life safety and quality. Future research involves the development of a decision support system as an information tool to guide the user through the decision-making process, emphasizing the logical interaction between the different potential choices, based on the PBBD.

Keywords: adaptation measures, floating architecture, performance based building design, resilient architecture, rising sea levels

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Authors: Komal Saini, S. K. Sahoo, B. S. Bajwa

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The Laser Fluorimetery Technique has been used for the microanalysis of uranium content in water samples collected from different sources like the hand pumps, tube wells in the drinking water samples of SW & NE Punjab, India. The geographic location of the study region in NE Punjab is between latitude 31.21º- 32.05º N and longitude 75.60º-76.14º E and for SW Punjab is between latitude 29.66º-30.48º N and longitude 74.69º-75.54º E. The purpose of this study was mainly to investigate the uranium concentration levels of ground water being used for drinking purposes and to determine its health effects, if any, to the local population of these regions. In the present study 131 samples of drinking water collected from different villages of SW and 95 samples from NE, Punjab state, India have been analyzed for chemical and radiological toxicity. In the present investigation, uranium content in water samples of SW Punjab ranges from 0.13 to 908 μgL−1 with an average of 82.1 μgL−1 whereas in samples collected from NE- Punjab, it ranges from 0 to 28.2 μgL−1 with an average of 4.84 μgL−1. Thus, revealing that in the SW- Punjab 54 % of drinking water samples have uranium concentration higher than international recommended limit of 30 µgl-1 (WHO, 2011) while 35 % of samples exceeds the threshold of 60 µgl-1 recommended by our national regulatory authority of Atomic Energy Regulatory Board (AERB), Department of Atomic Energy, India, 2004. On the other hand in the NE-Punjab region, none of the observed water sample has uranium content above the national/international recommendations. The observed radiological risk in terms of excess cancer risk ranges from 3.64x10-7 to 2.54x10-3 for SW-Punjab, whereas for NE region it ranges from 0 to 7.89x10-5. The chemical toxic effect in terms of Life-time average Daily Dose (LDD) and Hazard Quotient (HQ) have also been calculated. The LDD for SW-Punjab varies from 0.0098 to 68.46 with an average of 6.18 µg/ kg/day whereas for NE region it varies from 0 to 2.13 with average 0.365 µg/ kg/day, thus indicating presence of chemical toxicity in SW Punjab as 35% of the observed samples in the SW Punjab are above the recommendation limit of 4.53 µg/ kg/day given by AERB for 60 µgl-1 of uranium. Maximum & Minimum values for hazard quotient for SW Punjab is 0.002 & 15.11 with average 1.36 which is considerably high as compared to safe limit i.e. 1. But for NE Punjab HQ varies from 0 to 0.47. The possible sources of high uranium observed in the SW- Punjab will also be discussed.

Keywords: uranium, groundwater, radiological and chemical toxicity, Punjab, India

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Authors: Sevil Yildiz

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In this study, we will touch upon the legal arrangements issued in Turkey for prevention of condensation and for ensuring pluralism in the media. We will mention the legal arrangements concerning the regulatory and supervisory authority, namely the Radio and Television Supreme Council, for the visual and auditory media. In this context; the legal arrangements, which have been introduced by the Law No 6112 on the Establishment of Radio and Television Enterprises and Their Media Services in relation to the media ownership, will be reviewed through comparison with the Article 29 of the repealed Law No 3984.

Keywords: media ownership, legal arrangements, the case for Turkey, pluralism

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Authors: Jeena Gupta

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In the today’s world of pharmaceutical products, one should not forget the healing properties of inexpensive food materials especially spices. They are known to possess hidden pharmaceutical ingredients, imparting them the qualities of being anti-microbial, anti-oxidant, anti-inflammatory and anti-carcinogenic. Further aberrant epigenetic regulatory mechanisms like DNA methylation, histone modifications or altered microRNA expression patterns, which regulates gene expression without changing DNA sequence, contribute significantly in the development of various diseases. Changing lifestyles and diets exert their effect by influencing these epigenetic mechanisms which are thus the target of dietary phytochemicals. Bioactive components of plants have been in use since ages but their potential to reverse epigenetic alterations and prevention against diseases is yet to be explored. Spices being rich repositories of many bioactive constituents are responsible for providing them unique aroma and taste. Some spices like curcuma and garlic have been well evaluated for their epigenetic regulatory potential, but for others, it is largely unknown. We have evaluated the biological activity of phyto-active components of Fennel, Cardamom and Fenugreek by in silico molecular modeling, in vitro and in vivo studies. Ligand-based similarity studies were conducted to identify structurally similar compounds to understand their biological phenomenon. The database searching has been done by using Fenchone from fennel, Sabinene from cardamom and protodioscin from fenugreek as a query molecule in the different small molecule databases. Moreover, the results of the database searching exhibited that these compounds are having potential binding with the different targets found in the Protein Data Bank. Further in addition to being epigenetic modifiers, in vitro study had demonstrated the antimicrobial, antifungal, antioxidant and cytotoxicity protective effects of Fenchone, Sabinene and Protodioscin. To best of our knowledge, such type of studies facilitate the target fishing as well as making the roadmap in drug design and discovery process for identification of novel therapeutics.

Keywords: epigenetics, spices, phytochemicals, fenchone

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Authors: Robert Vanderburg, Michael Cowling, Nicholas Gibson

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Mathematics is one of the core subjects taught in the Australian K-12 education system and is considered an important component for future studies in areas such as engineering and technology. In addition to this, Australia has been a world leader in distance education due to the vastness of its geographic landscape. Despite this, research is still needed on distance math instruction. Even though delivery of curriculum has given way to online studies, and there is a resultant push for computer-based (PC, tablet, smartphone) math instruction, much instruction still involves practice problems similar to those original curriculum packs, without the ability for students to self-regulate their learning using the full interactive capabilities of these devices. Given this need, this paper addresses issues students have during online instruction. This study consists of 32 students struggling with mathematics enrolled in a math tutorial conducted in an online setting. The study used a case study design to understand some of the blockades hindering the students’ success. Data was collected by tracking students practice and quizzes, tracking engagement of the site, recording one-on-one tutorials, and collecting data from interviews with the students. Results revealed that when students have cognitively straining tasks in an online instructional setting, the first thing to dissipate was their ability to self-regulate. The results also revealed that instructors could ameliorate the situation and provided useful data on strategies that could be used for designing future online tasks. Specifically, instructors could utilize cognitive dissonance strategies to reduce the cognitive drain of the tasks online. They could segment the instruction process to reduce the cognitive demands of the tasks and provide in-depth self-regulatory training, freeing mental capacity for the mathematics content. Finally, instructors could provide specific scheduling and assignment structure changes to reduce the amount of student centered self-regulatory tasks in the class. These findings will be discussed in more detail and summarized in a framework that can be used for future work.

Keywords: digital education, distance education, mathematics education, self-regulation

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Authors: Thomais Tsoulia, Arvind Y. M. Sundaram, Stine Braaen, Øyvind Haugland, Espen Rimstad, Øystein Wessel, Maria K. Dahle

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Fish red blood cells (RBC) are nucleated, and in addition to their function in gas exchange, they have been characterized as mediators of immune responses. Salmonid RBC are the major target cells of Piscineorthoreovirus (PRV), a virus associated with heart and skeletal muscle inflammation (HSMI) in farmed Atlantic salmon. The activation of antiviral response genesin RBChas previously been described in ex vivo and in vivo PRV-infection models, but not explored in the initial virus encounter phase. In the present study, mRNA transcriptome responses were explored in erythrocytes from individual fish, kept ex vivo, and exposed to purified PRV for 24 hours. The responses were compared to responses in macrophage-like salmon head kidney (SHK-1) and endothelial-like Atlantic salmon kidney (ASK) cells, none of which support PRV replication. The comparative analysis showed that the antiviral response to PRV was strongest in the SHK-1 cells, with a set of 80 significantly induced genes (≥ 2-fold upregulation). In RBC, 46 genes were significantly upregulated, while ASK cells were not significantly responsive. In particular, the transcriptome analysis of RBC revealed that PRV significantly induced interferon regulatory factor 1 (IRF1) and interferon-induced protein with tetratricopeptide repeats 5-like (IFIT9). However, several interferon-regulated antiviral genes which have previously been reported upregulated in PRV infected RBC in vivo (myxovirus resistance (Mx), interferon-stimulated gene 15 (ISG15), toll-like receptor 3 (TLR3)), were not significantly induced after 24h of virus stimulation. In contrast to RBC, these antiviral response genes were significantly upregulated in SHK-1. These results confirm that RBC are involved in the innate immune response to viruses, but with a delayed antiviral response compared to SHK-1. A notable difference is that interferon regulatory factor 1 (IRF-1) is the most strongly induced gene in RBC, but not among the significantly induced genes in SHK-1. Putative differences in the binding, recognition, and response to PRV, and any link to effects on the ability of PRV to replicate remains to be explored.

Keywords: antiviral responses, atlantic salmon, piscine orthoreovirus-1, red blood cells, RNA-seq

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Authors: G. Lambe, D. Mansukhani, A. Shetty, S. Khodaiji, C. Rodrigues, F. Kapadia

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Introduction: Sepsis is known to cause impairment of both innate and adaptive immunity and involves an early uncontrolled inflammatory response, followed by a protracting immunosuppression phase, which includes decreased expression of cell receptors, T cell anergy and exhaustion, impaired cytokine production, which may cause high risk for secondary infections due to reduced response to antigens. Although human cytomegalovirus (CMV) is widely recognized as a serious viral pathogen in sepsis and immunocompromised patients, the incidence of CMV reactivation in patients with sepsis lacking strong evidence of immunosuppression is not well defined. Therefore, it is important to determine an association between CMV reactivation and sepsis-induced immunosuppression. Aim: To determine the association between incidence of CMV reactivation and immune modulation in sepsis-induced immunosuppression with time. Material and Methods: Ten CMV-seropositive adult patients with severe sepsis were included in this study. Blood samples were collected on Day 0, and further weekly up to 21 days. CMV load was quantified by real-time PCR using plasma. The expression of immunosuppression markers, namely, HLA-DR, PD-1, and regulatory T cells, were determined by flow cytometry using whole blood. Results: At Day 0, no CMV reactivation was observed in 6/10 patients. In these patients, the median length for reactivation was 14 days (range, 7-14 days). The remaining four patients, at Day 0, had a mean viral load of 1802+2599 copies/ml, which increased with time. At Day 21, the mean viral load for all 10 patients was 60949+179700 copies/ml, indicating that viremia increased with the length of stay in the hospital. HLA-DR expression on monocytes significantly increased from Day 0 to Day 7 (p = 0.001), following which no significant change was observed until Day 21, for all patients except 3. In these three patients, HLA-DR expression on monocytes showed a decrease at elevated viral load (>5000 copies/ml), indicating immune suppression. However, the other markers, PD-1 and regulatory T cells, did not show any significant changes. Conclusion: These preliminary findings suggest that CMV reactivation can occur in patients with severe sepsis. In fact, the viral load continued to increase with the length of stay in the hospital. Immune suppression, indicated by decreased expression of HLA-DR alone, was observed in three patients with elevated viral load.

Keywords: CMV reactivation, immune suppression, sepsis immune modulation, CMV viral load

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Authors: Dong-Gi Lee, Suyeon Cha, Yong-Sun Bahn

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Sterol lipid is essential for cell membrane structure in eukaryotic cells. In mammalian cells, sterol regulatory element binding proteins (SREBPs) act as principal regulators of cellular cholesterol which is essential for proper cell membrane fluidity and structure. SREBP and sterol regulation are related to levels of cellular oxygen because it is a major substrate for sterol synthesis. Upon cellular sterol and oxygen levels are depleted, SREBP is translocated to the Golgi where it undergoes proteolytic cleavage of N terminus, then it travels to the nucleus to play a role as transcription factor. In yeast cells, synthesis of ergosterol is also highly oxygen consumptive, and Sre1 is a transcription factor known to play a central role in adaptation to growth under low oxygen condition and sterol homeostasis in Cryptococcus neoformans. In this study, we observed phenotypes in other strains of Cryptococcus species by constructing hob1Δ and sre1Δ mutants to confirm whether the functions of both genes are conserved in most serotypes. As a result, hob1Δ showed no noticeable phenotype under treatment of antifungal drugs and most environmental stresses in R265 (C. gattii) and XL280 (C. neoformans), suggesting that Hob1 is related to sterol regulation only in H99 (serotype A). On the other hand, the function of Sre1 was found to be conserved in most serotypes. Furthermore, mating experiment of hob1Δ or sre1Δ showed dramatic defects in serotype A (H99) and D (XL280). It revealed that Hob1 and Sre1 related to mating ability in Cryptococcus species, especially cell fusion efficiency. In conclusion, HOB1 and SRE1 play crucial role in regulating sterol-homeostasis and differentiation in C. neoformans, moreover, Hob1 is specific gene in Cryptococcus neoformans. It suggests that Hob1 is considered as potent factor-targeted new safety antifungal drug.

Keywords: cryptococcus neoformans, Hob1, Sre1, sterol regulatory element binding proteins

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Authors: Anushtha Saxena

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This paper examines the process of data monetisation bye-commerce companies operating in India. Data monetisation is collecting, storing, and analysing consumers’ data to use further the data that is generated for profits, revenue, etc. Data monetisation enables e-commerce companies to get better businesses opportunities, innovative products and services, a competitive edge over others to the consumers, and generate millions of revenues. This paper analyses the issues and challenges that are faced due to the process of data monetisation. Some of the issues highlighted in the paper pertain to the right to privacy, protection of data of e-commerce consumers. At the same time, data monetisation cannot be prohibited, but it can be regulated and monitored by stringent laws and regulations. The right to privacy isa fundamental right guaranteed to the citizens of India through Article 21 of The Constitution of India. The Supreme Court of India recognized the Right to Privacy as a fundamental right in the landmark judgment of Justice K.S. Puttaswamy (Retd) and Another v. Union of India . This paper highlights the legal issue of how e-commerce businesses violate individuals’ right to privacy by using the data collected, stored by them for economic gains and monetisation and protection of data. The researcher has mainly focused on e-commerce companies like online shopping websitesto analyse the legal issue of data monetisation. In the Internet of Things and the digital age, people have shifted to online shopping as it is convenient, easy, flexible, comfortable, time-consuming, etc. But at the same time, the e-commerce companies store the data of their consumers and use it by selling to the third party or generating more data from the data stored with them. This violatesindividuals’ right to privacy because the consumers do not know anything while giving their data online. Many times, data is collected without the consent of individuals also. Data can be structured, unstructured, etc., that is used by analytics to monetise. The Indian legislation like The Information Technology Act, 2000, etc., does not effectively protect the e-consumers concerning their data and how it is used by e-commerce businesses to monetise and generate revenues from that data. The paper also examines the draft Data Protection Bill, 2021, pending in the Parliament of India, and how this Bill can make a huge impact on data monetisation. This paper also aims to study the European Union General Data Protection Regulation and how this legislation can be helpful in the Indian scenarioconcerning e-commerce businesses with respect to data monetisation.

Keywords: data monetization, e-commerce companies, regulatory framework, GDPR

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Authors: Prisecaru Diana-Sorina

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The paper will show that, while the EU legislator tackled a series of UX patterns used in e-commerce to induce the consumers take actions that they would not normally undertake, it leaves out many other aspects related to misuse or poor UX design that adversely affect EU consumers. Further, the paper proposes a reevaluation of the regulatory addressability of the issue and hand and focuses on explaining why a joint strategy, based on the interplay between provisions aiming consumer protection and personal data protection is the key approach to this matter.

Keywords: algorithms, consumer protection, European Union, user experience design

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Authors: Vijaya Madhuri Devraj, Swarnalatha Guditi, Kiran Kumar Bokara, Gangadhar Taduri

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Cell-based strategies may open therapeutic approaches that promote tolerance through manipulation of macrophages to increase long-term transplant survival rates and minimize side effects of the current immune suppressive regimens. The aim of the present study was, therefore, to test and compare the therapeutic potential of MSC and Tregs on macrophage polarization to develop an alternate cell-based treatment option in kidney transplantation. In the current protocol, macrophages from kidney transplant recipients with graft dysfunction were co-cultured with MSCs and Treg cells with and without cell-cell contact on transwell plates, further to quantitatively assess macrophage polarization in response to MSC and Treg treatment over time, M1 and M2 cell surface markers were used. Additionally, multiple soluble analytes were analyzed in cell supernatant by using bead-based immunoassays. Furthermore, to confirm our findings, gene expression analysis was done. MSCs induced the formation of M2 macrophages more than Tregs when macrophages M0 were cultured in transwell without cell contact. From this, we deduced the mechanism that soluble factors present in the MSCs condition media are involved in skewing of macrophages towards type 2 macrophages; similarly, in co-culture with cell-cell contact, MSCs resulted in more M2 type macrophages than Tregs. And an important finding of this study is the combination of both MSC-Treg showed significantly effective and consistent results in both with and without cell contact setups. Hence, it is suggestive to prefer MSCs over Tregs for secretome-based therapy and a combination of both for either therapy for effective transplantation outcomes. Our findings underline a key role of Tregs and MSCs in promoting macrophage polarization towards anti-inflammatory type. The study has great importance in prolongation of allograft and patient survival without any rejection by cell-based therapy, which induce self-tolerance and controlling infection.

Keywords: graft rejection, graft tolerance, macrophage polarization, mesenchymal stem cells, regulatory T cells, transplant immunology

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Authors: Mitchell J. Baum, Badin Gibbes, Greg Collecutt

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This study details a three-dimensional field-scale numerical investigation conducted for the Gold Coast Desalination Plant (GCDP) offshore multiport brine diffuser. Quantitative assessment of diffuser performance with regard to trajectory, dilution and mapping of seafloor concentration distributions was conducted for 100% plant operation. The quasi-steady Computational Fluid Dynamics (CFD) simulations were performed using the Reynolds averaged Navier-Stokes equations with a k-ω shear stress transport turbulence closure scheme. The study compliments a field investigation, which measured brine plume characteristics under similar conditions. CFD models used an iterative mesh in a domain with dimensions 400 m long, 200 m wide and an average depth of 24.2 m. Acoustic Doppler current profiler measurements conducted in the companion field study exhibited considerable variability over the water column. The effect of this vertical variability on simulated discharge outcomes was examined. Seafloor slope was also accommodated into the model. Ambient currents varied predominantly in the longshore direction – perpendicular to the diffuser structure. Under these conditions, the alternating port orientation of the GCDP diffuser resulted in simultaneous subjection to co-propagating and counter-propagating ambient regimes. Results from quiescent ambient simulations suggest broad agreement with empirical scaling arguments traditionally employed in design and regulatory assessments. Simulated dynamic ambient regimes showed the influence of ambient crossflow upon jet trajectory, dilution and seafloor concentration is significant. The effect of ambient flow structure and the subsequent influence on jet dynamics is discussed, along with the implications for using these different simulation approaches to inform regulatory decisions.

Keywords: computational fluid dynamics, desalination, field-scale simulation, multiport brine diffuser, negatively buoyant jet

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Authors: X. Simon, D. Copena, M. Montero

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The last decades have witnessed a significant increase in renewable energy, especially wind energy, to achieve sustainable development. Specialized literature in this field has carried out interesting case studies to extensively analyze both the environmental benefits of this energy and its social acceptance. However, to the best of our knowledge, work to date makes no analysis of the role of private owners of lands with wind potential within a broader territory of strong wind implantation, nor does it estimate their economic incomes relating them to social acceptance. This work fills this gap by focusing on Galicia, territory housing over 4,000 wind turbines and almost 3,400 MW of power. The main difficulty in getting this financial information is that it is classified, not public. We develop methodological techniques (semi- structured interviews and work groups), inserted within the Participatory Research, to overcome this important obstacle. In this manner, the work directly compiles qualitative and quantitative information on the processes as well as the economic results derived from implementing wind energy in Galicia. During the field work, we held 106 semi-structured interviews and 32 workshops with owners of lands occupied by wind farms. The compiled information made it possible to create the socioeconomic database on wind energy in Galicia (SDWEG). This database collects a diversity of quantitative and qualitative information and contains economic information on the income received by the owners of lands occupied by wind farms. In the Galician case, regulatory framework prevented local participation under the community wind farm formula. The possibility of local participation in the new energy model narrowed down to companies wanting to install a wind farm and demanding land occupation. The economic mechanism of local participation begins here, thus explaining the level of acceptance of wind farms. Land owners can receive significant income given that these payments constitute an important source of economic resources, favor local economic activity, allow rural areas to develop productive dynamism projects and improve the standard of living of rural inhabitants. This work estimates that land owners in Galicia perceive about 10 million euros per year in total wind revenues. This represents between 1% and 2% of total wind farm invoicing. On the other hand, relative revenues (Euros per MW), far from the amounts reached in other spaces, show enormous payment variability. This signals the absence of a regulated market, the predominance of partial agreements, and the existence of asymmetric positions between owners and developers. Sustainable development requires the replacement of conventional technologies by low environmental impact technologies, especially those that emit less CO₂. However, this new paradigm also requires rural owners to participate in the income derived from the structural transformation processes linked to sustainable development. This paper demonstrates that regulatory framework may contribute to increasing sustainable technologies with high social acceptance without relevant local economic participation.

Keywords: regulatory framework, social acceptance, sustainable development, wind energy, wind income for landowners

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