Search results for: regulatory bodies
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 1628

Search results for: regulatory bodies

1568 The Readiness of Bodies Corporate in South Africa for Third Generation Sectional Title Legislation: An Accountancy Perspective

Authors: Leandi Steenkamp

Abstract:

After being in effect since the late 1970s, first generation sectional title legislation in South Africa was completely overhauled in recent years into what is now commonly referred to as third generation sectional title legislation. The original Sectional Titles Act was split into three separate statutes, namely the Sectional Titles Schemes Management Act No. 8 of 2011, the Sectional Titles Amendment Act No. 33 of 2013 and the Community Schemes Ombud Service Act No. 9 of 2011, with various Regulations detailing how the different acts should be applied in practice. Even though some of the changes effected by the new legislation is simply technical adjustments and replications of the original first generation legislation, the new acts introduce a number of significant changes that will have an effect on accountancy and financial management aspects of sectional title schemes in future. No academic research has been undertaken on third generation sectional title legislation in South Africa from an accountancy and financial management perspective as yet. The aim of this paper is threefold: Firstly, to discuss the findings of a literature review on the new third generation sectional title legislation, with specific reference to accountancy-related aspects. Secondly, the empirical findings of accountancy-related aspects from the results of a quantitative study on a sample of bodies corporate will be discussed. The sample of bodies corporate was selected from four different municipal areas in South Africa. Specific reference will be made to the readiness of bodies corporate regarding the provisions of the new legislation. Thirdly, practical recommendations will be made on how bodies corporate can prepare for the new legislative aspects, and further research opportunities in this regard will be discussed.

Keywords: accountancy, body corporate, sectional title, third generation sectional title legislation

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1567 Proposed Model to Assess E-Government Readiness in Jordan

Authors: Hadeel Abdulatif, Maha Alkhaffaf

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E-government is the use of Information and Communication Technology to enrich the access to and delivery of government services to citizens, business partners and employees, Policy makers and regulatory bodies have to be cognizant of the degree of readiness of a populace in order to design and implement efficient e-government programs. This paper aims to provide a transparent situation analyses for the case of e-government official website in Jordan, it focuses on assessing e-government in Jordan; web site assessment by using international criteria for assessing e-government websites, However, the study analyses the environmental factor consisting of cultural and business environment factors. By reviewing the literature the researchers found that government's efforts towards e-government may vary according to the country's readiness and other key implementation factors which will lead to diverse e-government experience; thus, there is a need to study the impact of key factors to implement e-government in Jordan.

Keywords: e-government, environmental factors, website assessment, readiness

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1566 Role of Pro-Inflammatory and Regulatory Cytokines in Pathogenesis of Graves’ Disease in Association with Autoantibody Thyroid and Regulatory FoxP3 T-Cells

Authors: Dwitya Elvira, Eryati Darwin

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Background: Graves’ disease (GD) is an autoimmune thyroid disease. Imbalance of Th1/Th2 cells and T-regulatory (Treg)/Th17 cells was thought to play pivotal role in the pathogenesis of GD. Treg FoxP3 produced TGF-β to maintain regulatory function, and Th17 cells produced IL-17 as cytokines that were thought in mediating several autoimmune diseases. The aim of this study is to assess the role of IL-17 and TGF-β in the pathogenesis of GD and to investigate its correlation with Thyroid Stimulating Hormone Receptor Antibody (TRAb) and Treg FoxP3 expression. Method: 30 GD patients and 27 age and sex-matched controls were enrolled in this study. Diagnosis of GD was based on clinical and biochemical of GD. Serum IL-17, TGF-β, TRAb, and FoxP3 were measured by enzyme-linked immunosorbent assay (ELISA). Data were analyzed by using SPSS 21.0 (SPSS Inc.). Spearman rank correlation test was used for assessment of correlation. The statistical significance was accepted as P<0.05. Result: There was no significant correlation between IL-17 and TGF-β serum with expression of FoxP3 level in GD, but there was significant correlation between TGF-β and TRAb serum level (P<0.05). Serum levels of IL-17 and TGF-β were found to be elevated in patient group compared to control, where mean values of IL-17 were 14.43±2.15 pg/mL and TGF-β were 10.44±3.19 pg/mL in patients group; and in control group, level of IL-17 were 7.1±1.45 pg/mL and TGF-β were 4.95±1.35 pg/mL. Conclusion: Serum Il-17 and TGF-β were elevated in GD patients that reflect the role of inflammatory and regulatory cytokines activation in pathogenesis of GD. There was significant correlation between TGF-β and TRAb, revealing that Treg cytokines may play a role in pathogenesis of GD.

Keywords: IL-17, TGF-B, FoxP3, TRAb, Graves’ disease

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1565 Simulation of Elastic Bodies through Discrete Element Method, Coupled with a Nested Overlapping Grid Fluid Flow Solver

Authors: Paolo Sassi, Jorge Freiria, Gabriel Usera

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In this work, a finite volume fluid flow solver is coupled with a discrete element method module for the simulation of the dynamics of free and elastic bodies in interaction with the fluid and between themselves. The open source fluid flow solver, caffa3d.MBRi, includes the capability to work with nested overlapping grids in order to easily refine the grid in the region where the bodies are moving. To do so, it is necessary to implement a recognition function able to identify the specific mesh block in which the device is moving in. The set of overlapping finer grids might be displaced along with the set of bodies being simulated. The interaction between the bodies and the fluid is computed through a two-way coupling. The velocity field of the fluid is first interpolated to determine the drag force on each object. After solving the objects displacements, subject to the elastic bonding among them, the force is applied back onto the fluid through a Gaussian smoothing considering the cells near the position of each object. The fishnet is represented as lumped masses connected by elastic lines. The internal forces are derived from the elasticity of these lines, and the external forces are due to drag, gravity, buoyancy and the load acting on each element of the system. When solving the ordinary differential equations system, that represents the motion of the elastic and flexible bodies, it was found that the Runge Kutta solver of fourth order is the best tool in terms of performance, but requires a finer grid than the fluid solver to make the system converge, which demands greater computing power. The coupled solver is demonstrated by simulating the interaction between the fluid, an elastic fishnet and a set of free bodies being captured by the net as they are dragged by the fluid. The deformation of the net, as well as the wake produced in the fluid stream are well captured by the method, without requiring the fluid solver mesh to adapt for the evolving geometry. Application of the same strategy to the simulation of elastic structures subject to the action of wind is also possible with the method presented, and one such application is currently under development.

Keywords: computational fluid dynamics, discrete element method, fishnets, nested overlapping grids

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1564 Shark Cartilage Modulate IL-23/IL-17 Axis by Increasing IFN-γ and Decreasing IL-4 in Patients with Gastric Cancer

Authors: Razieh Zareia, Hassan ZMB, Darush Moslemic, Amrollah Mostafa-Zaded

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Introduction: Shark is a murine organism and its cartilage has antitumor peptides to prevent angiogenesis, at least, in vitro. The purpose of our research was to evaluate the immune-effectiveness on imbalance between IL-23/IL-17 axis, as an inflammatory pathway and TGF/Foxp3 T regulatory as a inhibitory pathway of commercial shark cartilage that is available as a non-common dietary supplement in IRAN. Materials and Methods: First investigated an imbalanced supernatant of cytokines exist in patients with gastric cancer by ELISA. Associated with cytokines measuring such as IL-23, IL-17, TGF-β, IL-4, and γ-IFN, then flow cytometry was employed to determine whether the peripheral blood mononuclear cells such as CD4+CD25+Foxp3highT regulatory cells in patients with gastric cancer were changed correspondingly. Results: The simultaneously presented up-regulation IL-17A indicated, at least cytokine level without changing in TGF-β amount or CD4+CD25+Foxp3 T regulatory cells, that there are not a direct correlation between IL-23/IL-17 axis and Treg/TGF-β pathway in patients with gastric cancer treated by shark cartilage, but IL-23 was not expressed differentially in this group. So, accompany these changes, an imbalance between Th1 immunity (γ-IFN production) and TH2 immunity (IL-4 secretion) evaluated in patients with gastric cancer treated by shark cartilage. Conclusion: On the basis of results, we propose that shark cartilage, by reducing IL-4, decreasing IL-17 a central cytokine in angiogenesis and increasing γ-IFN amplify anti-tumor immune responses in patients with gastric cancer.

Keywords: IL-23/IL17 axis, TGF-β/CD4+CD25+Foxp3high T regulatory pathway, γ-IFN, IL-4, shark cartilage, gastric cancer

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1563 Male Bodies and Philosophy of Sexual Difference: A Sketch for an Impossible 'Becoming-Man'

Authors: Ovidiu Anemtoaicei

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This paper offers a possible answer to the question of what it means to think about men and masculinities through the philosophy of sexual difference as developed by Luce Irigaray, employing Gilles Deleuze’s concept of 'critique' and arguing, at the same time, for a concept of 'becoming-man' as an expression of this answer. First, while examining the nature of the role of male bodies underlying the theorizing of men and masculinities in the field of the Critical Studies of Men and Masculinities, the paper argues for a turn to sexual difference theory as an answer to the 'gap' between the representations on male bodies and their participation in thought and masculine subjective production. Secondly, sharing Luce Irigaray’s critique of Western thought, the paper explores alternative morphological bodily 'locations' for rethinking male imaginary in relation to male embodiments, on the one hand, and in relation to the maternal and the feminine, on the other hand. Thirdly, the paper develops the idea that a phenomenologically-influenced approach towards male bodies might be productive, especially when thought through Irigaray’s sexual difference as a relational and experiential ontology. Finally, while showing that Irigaray and Deleuze share a similar critique of Western philosophical thought and of the masculine historical subject, it proposes a rethinking of the concept of 'becoming-man' as an assemblage meeting between Irigaray’s theory of sexual difference and Deleuze and Guattari’s nomadologic project, as a possibility of thinking change in men’s masculine subjective constitution in relation to both women and other men. As far as the ethical implications of such rethinking are concerned, the paper urges for the cultivation of a masculine culture of stepping back and its constitutive political, social and cultural practices so as to make possible the construction of new spaces that would allow for the becoming of at least two subjects based on the respect for their differences.

Keywords: feminist philosophy, male bodies, masculinities, phenomenology, sexual difference

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1562 Legislator’s Liability – Sovereign Immunity and Rule of Law

Authors: Isabel Mousinho de Figueiredo

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Traditionally it was held that the king can do no wrong. History has proved otherwise, and both the rule of law and the open society call for a diversification of checks and balances, including civil liability in tort. Most jurisdictions are right to fear the excessive cost of such liability for the innocent taxpayer. There are notwithstanding extreme instances where refusing compensation is perceived to be outrageous. Many public bodies end up handing out on a voluntary basis, which leaves room to question its legality and merit. Instead, some criteria can shed light on the fairness of an underlying rationale of such compensation and cordon it off within reasonable limits.

Keywords: comparative law, liability of legislators, public bodies, tort law

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1561 Predictors of Post-marketing Regulatory Actions Concerning Hepatotoxicity

Authors: Salwa M. Almomen, Mona A. Almaghrabi, Saja M. Alhabardi, Adel A. Alrwisan

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Background: Hepatotoxicity is a major reason for medication withdrawal from the markets. Unfortunately, serious adverse hepatic effects can occur after marketing with limited indicators during clinical development. Therefore, finding possible predictors for hepatotoxicity might guide the monitoring program of various stakeholders. Methods: We examined the clinical review documents for drugs approved in the US from 2011 to 2016 to evaluate their hepatic safety profile. Predictors: we assessed whether these medications meet Hy’s Law with hepatotoxicity grade ≥ 3, labeled hepatic adverse effects at approval, or accelerated approval status. Outcome: post-marketing regulatory action related to hepatotoxicity, including product withdrawal or updates to warning, precaution, or adverse effects sections. Statistical analysis: drugs were included in the analysis from the time of approval until the end of 2019 or the first post-marketing regulatory action related to hepatotoxicity, whichever occurred first. The hazard ratio (HR) was estimated using Cox-regression analysis. Results: We included 192 medications in the study. We classified 48 drugs as having grade ≥ 3 hepatotoxicities, 43 had accelerated approval status, and 74 had labeled information about hepatotoxicity prior to marketing. The adjusted HRs for post-marketing regulatory action for products with grade ≥ 3 hepatotoxicity was 0.61 (95% confidence interval [CI], 0.17-2.23), 0.92 (95%CI, 0.29-2.93) for a drug approved via accelerated approval program, and was 0.91 (95%CI, 0.33-2.56) for drugs with labeled hepatotoxicity information at approval time. Conclusion: This study does not provide conclusive evidence on the association between post-marketing regulatory action and grade ≥ 3 hepatotoxicity, accelerated approval status, or availability of labeled information at approval due to sampling size and channeling bias.

Keywords: accelerated approvals, hepatic adverse effects, drug-induced liver injury, hepatotoxicity predictors, post-marketing withdrawal

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1560 Exposure Analysis of GSM Base Stations in Industrial Area

Authors: A. D. Usman, W. F. Wan Ahmad, H. H. Danjuma

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Exposure due to GSM frequencies is subject of daily debate. Though regulatory bodies provide guidelines for exposure, people still exercise fear on the possible health hazard that may result due to long term usage. In this study, exposure due to electromagnetic field emitted by GSM base stations in industrial areas was investigated. The aimed was to determine whether industrial area exposure is higher as compared to residential as well as compliance with ICNIRP guidelines. Influence of reflection and absorption with respect to inverse square law was also investigated. Measurements from GSM base stations were performed at various distances in far field region. The highest measured peak power densities as well as the calculated values at GSM 1.8 GHz were 6.05 and 90 mW/m2 respectively. This corresponds to 0.07 and 1% of ICNIRP guidelines. The highest peak power densities as well as the calculated values at GSM 0.9 GHz were 11.92 and 49.7 mW/m2 respectively. These values were 0.3 and 1.1% of ICNIRP guidelines.

Keywords: Global System for Mobile Communications (GSM), Electromagnetic Field (EMF), far field, power density, Radiofrequency (RF)

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1559 Multithreading/Multiprocessing Simulation of The International Space Station Multibody System Using A Divide and Conquer Dynamics Formulation with Flexible Bodies

Authors: Luong A. Nguyen, Elihu Deneke, Thomas L. Harman

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This paper describes a multibody dynamics algorithm formulated for parallel implementation on multiprocessor computing platforms using the divide-and-conquer approach. The system of interest is a general topology of rigid and elastic articulated bodies with or without loops. The algorithm is an extension of Featherstone’s divide and conquer approach to include the flexible-body dynamics formulation. The equations of motion, configured for the International Space Station (ISS) with its robotic manipulator arm as a system of articulated flexible bodies, are implemented in separate computer processors. The performance of this divide-and-conquer algorithm implementation in multiple processors is compared with an existing method implemented on a single processor.

Keywords: multibody dynamics, multiple processors, multithreading, divide-and-conquer algorithm, computational efficiency, flexible body dynamics

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1558 The Valuation of Equity Book Value and Net Income of Financial Firms in Times of Financial Crisis

Authors: Sami Adwan, Alaa Alhaj Ismail, Claudia Girardone

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This paper examines the changes in the value relevance of book value of equity and net income of financial firms over the crisis period. It also examines how these changes vary with three variables, namely, fair value exposure, ownership concentration, and regulatory capital ratios. Using a sample of financial firms operating in the European Economic Area over 2005-2011, our findings suggest that the value relevance of book value of equity increases while that of net income decreases during the financial crisis. We find that more exposure to fair value accounting mitigates the impact of the crisis on the value relevance of book value of equity and net income. We also find that more concentrated ownership appears to have a mitigating impact on the changes in the value relevance of both book value of equity and net income in times of financial crisis. Finally, we find evidence that the level of regulatory capital ratios tends to have an attenuating effect on the changes in the value relevance of net income (but not book value of equity) in times of financial crisis.

Keywords: value relevance, financial crisis, financial firms, fair value, ownership concentration, regulatory capital

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1557 A Decade of Creating an Alternative Banking System in Tanzania: The Current State of Affairs of Islamic Banks

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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1556 IIROC's Enforcement Performance: Funnel in, Funnel out, and Funnel away

Authors: Mark Lokanan

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The paper analyzes the processing of complaints against investment brokers and dealer members through the Investment Industry Regulatory Organization of Canada (IIROC) from 2008 to 2017. IIROC is the self-regulatory organization (SRO) that is responsible for policing investment dealers and brokerage firms that trade in Canada’s securities market. Data from the study came from IIROC's enforcement annual reports for the years examined. The case processing is evaluated base on the misconduct funnel that was originally designed for street crime and applies to the enforcement of investment fraud. The misconduct funnel is used as a framework to examine IIROC’s claim that it brought in more complaints (funnel in) than government regulators and shows how these complaints are funneled out and funneled away as they are processed through IIROC’s enforcement system. The results indicate that IIROC is ineffective in disciplining its members and is unable to handle the more serious quasi-criminal and improper sales practices offenses. It is hard not to see the results of the paper being used by the legislator in Ottawa to show the importance of a federal securities regulatory agency such as the Securities and Exchange Commission (SEC) in the United States.

Keywords: investment fraud, securities regulation, compliance, enforcement

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1555 The Various Bodies of a Person and How to Cleanse Them Spiritually

Authors: J. B. Athavale, Sean Clarke

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Introduction According to ancient Indian scriptures, a person’s consciousness includes the physical body, the vital energy sheath (Pranshakti), the mental body (which includes one’s feelings and emotions), the intellectual body (which refers to one’s decision-making ability), and the Soul (which is the God Principle that resides in every person). Apart from the physical body, all the other aspects are subtle in nature. In today’s world, much attention is given to one’s physical appearance and intellectual prowess. While there have been improvements in the attention given to mental health, its complete nature is not understood, and in many cultures, mental ill health is considered taboo and looked down upon. Regarding the spiritual well-being of a person, our spiritual research has shown that people’s understanding and efforts are mostly lacking and superficial as they do not conform to Universal Spiritual Principles. Also, true well-being occurs only when all the bodies are healthy. Methodology The spiritual research team at the University has found that the spiritual aspect of a person’s life affects all the physical, psychological, and intellectual bodies of a person resulting in ill health. Cleansing these bodies at a spiritual level is essential to regain well-being. Using Aura and Energy Scanners and advanced sixth sense, we studied what causes spiritual impurity in various bodies and how to cleanse them. We measured the spiritual vibrations of a person and how they get affected due to various daily activities. For example, we studied the difference in a person’s aura before and after applying chemical-based makeup vs. natural makeup. Key Findings From the various spiritual research experiments we conducted, we found that: • All our actions and our thoughts affect our various bodies and have the potential to change the aura for the better or worse. • When there is an increase in negative vibrations around a person, negative energies from the subtle dimension are more likely to affect a person. • As the person’s spiritual level increases, the positivity in their aura also increases, and it is much easier to cleanse the various bodies spiritually. • Spiritual practice is like a general spiritual tonic that increases the positivity in one’s aura. The benefits of this are that it leads to mental stability and intellectual clarity. • Spiritual healing remedies augment any spiritual practice to obtain a faster healing effect. Conclusion Taking care of oneself spiritually has a positive halo effect on all one’s bodies. Spiritual cleansing is required regularly if one wants to attain a state of well-being. Spiritual practice and spiritual healing lead to spiritual growth, stability of mind, and less stress and reactions. Spiritually purer people affect the environment positively, and there is less unrest and more harmony between man and nature.

Keywords: body, spirituality, cleansing, consciousness

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1554 A Regulatory Analysis on Legal Problems of BitCoin

Authors: Fady Tawakol

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BitCoin is a decentralized cryptocurrency that can be used without the need of traditional central banks to accomplish any e-commerce trade. The use of such currency could facilitate new economic interactions and linkages. However, without effective and efficient regulations, cryptocurrency transactions are mostly used by criminals to commit crimes such as money laundering, theft, and blackmailing. And because law is one step behind technological developments, this paper discusses the importance of regulations and supervision for the BitCoin-system, to provide unified regulatory solutions for our digital future in the Middle East. It will provide a detailed analysis of the legal nature of BitCoin along with, its regulation with respect to criminal and civil law.

Keywords: BitCoin, financial protection, crypto currency, money laundering

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1553 A Resource-Based Understanding of Health and Social Care Regulation

Authors: David P. Horton, Gary Lynch-Wood

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Western populations are aging, prone to various lifestyle health problems, and increasing their demand for health and social care services. This demand has created enormous fiscal and regulatory challenges. In response, government institutions have deployed strategies of behavior modification to encourage people to exercise greater personal responsibility over their health and care needs (i.e., welfare responsibilisation). Policy strategies are underpinned by the assumption that people if properly supported, will make better health and lifestyle selections. Not only does this absolve governments of the responsibility for meeting all health and care needs, but it also enables government institutions to assert fiscal control over welfare spending. Looking at the regulation of health and social care in the UK, the authors identify and outline a suite of regulatory tools that are designed to extract and manage the resources of health and social care services users and to encourage them to make (‘better’) use of these resources. This is important for our understanding of how health and social care regulation is responding to ongoing social and economic challenges. It is also important because there has been a failure to systematically examine the relevance of resources for regulation, which is surprising given that resources are crucial to how and whether regulation succeeds or fails. In particular, drawing from the regulatory welfare state concept, the authors analyse the key legal and regulatory changes and mechanisms that have been introduced since the 2008 financial crisis, focusing on critical measures such as the Health and Social Care Act and regulations introduced under the National Health Service Act. The authors show how three types of user resources (i.e., tangible, labor, and data) are being used to assert fiscal control and increase welfare responsibilisation. Amongst other things, the paper concludes that service users have become more than rule followers and targets of behavioral modification; rather, they are producers of resources that regulatory systems have come to rely on.

Keywords: health care, regulation, resources, social care

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1552 The Need for a Consistent Regulatory Framework for CRISPR Gene-Editing in the European Union

Authors: Andrew Thayer, Courtney Rondeau, Paraskevi Papadopoulou

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The Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) gene-editing technologies have generated considerable discussion about the applications and ethics of their use. However, no consistent guidelines for using CRISPR technologies have been developed -nor common legislation passed related to gene editing, especially as it is connected to genetically modified organisms (GMOs) in the European Union. The recent announcement that the first babies with CRISPR-edited genes were born, along with new studies exploring CRISPR’s applications in treating thalassemia, sickle-cell anemia, cancer, and certain forms of blindness, have demonstrated that the technology is developing faster than the policies needed to control it. Therefore, it can be seen that a reasonable and coherent regulatory framework for the use of CRISPR in human somatic and germline cells is necessary to ensure the ethical use of the technology in future years. The European Union serves as a unique region of interconnected countries without a standard set of regulations or legislation for CRISPR gene-editing. We posit that the EU would serve as a suitable model in comparing the legislations of its affiliated countries in order to understand the practicality and effectiveness of adopting majority-approved practices. Additionally, we present a proposed set of guidelines which could serve as a basis in developing a consistent regulatory framework for the EU countries to implement but also act as a good example for other countries to adhere to. Finally, an additional, multidimensional framework of smart solutions is proposed with which all stakeholders are engaged to become better-informed citizens.

Keywords: CRISPR, ethics, regulatory framework, European legislation

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1551 New Advanced Medical Software Technology Challenges and Evolution of the Regulatory Framework in Expert Software, Artificial Intelligence, and Machine Learning

Authors: Umamaheswari Shanmugam, Silvia Ronchi

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Software, artificial intelligence, and machine learning can improve healthcare through innovative and advanced technologies that can use the large amount and variety of data generated during healthcare services every day; one of the significant advantages of these new technologies is the ability to get experience and knowledge from real-world use and to improve their performance continuously. Healthcare systems and institutions can significantly benefit because the use of advanced technologies improves the efficiency and efficacy of healthcare. Software-defined as a medical device, is stand-alone software that is intended to be used for patients for one or more of these specific medical intended uses: - diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease, any other health conditions, replacing or modifying any part of a physiological or pathological process–manage the received information from in vitro specimens derived from the human samples (body) and without principal main action of its principal intended use by pharmacological, immunological or metabolic definition. Software qualified as medical devices must comply with the general safety and performance requirements applicable to medical devices. These requirements are necessary to ensure high performance and quality and protect patients' safety. The evolution and the continuous improvement of software used in healthcare must consider the increase in regulatory requirements, which are becoming more complex in each market. The gap between these advanced technologies and the new regulations is the biggest challenge for medical device manufacturers. Regulatory requirements can be considered a market barrier, as they can delay or obstacle the device's approval. Still, they are necessary to ensure performance, quality, and safety. At the same time, they can be a business opportunity if the manufacturer can define the appropriate regulatory strategy in advance. The abstract will provide an overview of the current regulatory framework, the evolution of the international requirements, and the standards applicable to medical device software in the potential market all over the world.

Keywords: artificial intelligence, machine learning, SaMD, regulatory, clinical evaluation, classification, international requirements, MDR, 510k, PMA, IMDRF, cyber security, health care systems

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1550 Sustainability in Tourism and Hospitality Industry in China: Best Practices and Challenges

Authors: Mkhitaryan Davit

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The tourism and hospitality industry plays a significant role in China's economy, but it also poses environmental, social, and economic challenges. This paper examines the concept of sustainability within the context of China's tourism and hospitality industry, exploring best practices from 26 Hotels in 15 cities and identifying key challenges. Drawing upon a comprehensive review of existing literature, case studies, and interviews with industry experts, the paper highlights successful sustainability initiatives implemented by various stakeholders, including government bodies, businesses, and non-governmental organizations. Additionally, it discusses the barriers and obstacles hindering the widespread adoption of sustainable practices in the sector, such as lack of awareness, financial constraints, and regulatory issues. The findings provide insights for policymakers, industry practitioners, and researchers to develop strategies and solutions for promoting sustainable tourism and hospitality practices in China, ultimately contributing to the long-term viability and resilience of the industry.

Keywords: sustainability, waste management, renewable energy, hospitality

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1549 IL-23, an Inflammatory Cytokine, Decreased by Shark Cartilage and Vitamin A Oral Treatment in Patient with Gastric Cancer

Authors: Razieh Zarei, Hassan zm, Abolghasem Ajami, Darush Moslemi, Narges Afsary, Amrollah Mostafa-zade

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Introduction: IL-23 is responsible for the differentiation and expansion of Th17/ThIL-17 cells from naive CD4+ T cells. Therefore, may be IL-23/IL17 axis involve in a variety of allergic and autoimmune diseases, such as RA, MS, inflammatory bowel disease (IBD), and asthma. TGF-β is also share for the differentiation Th17 producing IL-17 and CD4+CD25+Foxp3hiT regulatory cells from naïve CD4+ T cells which are involved in the regulation of immune response, maintaining immunological self-tolerance and immune homeostasis ,and the control of autoimmunity and cancer surveillance. Therefore, T regulatory cells play a key role in autoimmunity, allergy, cancer, infectious disease, and the induction of transplantation tolerance. Vitamin A and it's derivatives (retinoids) inhibit or reverse the carcinogenic process in some types of cancers in oral cavity,head and neck, breast, skin, liver, and blood cells. Shark is a murine organism and its cartilage has antitumor peptides to prevent angiogenesis, in vitro. Our purpose is whether simultaneous oral treatment vitamin A and shark cartilage can modulate IL-23/IL-17 and CD4CD25Foxp3 T regulatory cell/TGF-β pathways and Th1/Th2 immunity in patients with gastric cancer. Materials and Methods: First investigated an imbalanced supernatant of cytokines exist in patients with gastric cancer by ELISA. Associated with cytokines measuring such as IL-23,IL-17,TGF-β,IL-4 and γ-IFN, then flow cytometry was employed to determine whether the peripheral blood mononuclear cells such as CD4+CD25+Foxp3highT regulatory cells in patients with gastric cancer were changed correspondingly. Results: An imbalance between IL-17 secretion and TGF-β/Foxp3 t regulatory cell pathway and so, Th1 immunity (γ-IFN production) and TH2 immunity (IL-4 secretion) was not seen in patients with gastric cancer treated by vitamin A and shark cartilage. But, the simultaneously presented down-regulation of IL-23 indicated, at least cytokine level. Conclusion: Il-23, as a pro-angiogenesis cytokine, probably, help to tumor growth. Hence, suggested that down-regulation of IL-23, at least cytokine level, is useful for anti-tumor immune responses in patients with gastric cancer.

Keywords: IL-23/IL17 axis, TGF-β/CD4CD25Foxp3 T regulatory pathway, γ-IFN, IL-4, shark cartilage and gastric cancer

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1548 Legislating for Public Participation and Environmental Justice: Whether It Solves or Prevent Disputes

Authors: Deborah A. Hollingworth

Abstract:

The key tenets associated with ‘environmental justice’, were first articulated in a global context in Principle 10 of the United Nations Declaration on Environment and Development at Rio de Janeiro in 1992 (the Rio Declaration). The elements can be conflated to require: public participation in decision-making; the provision of relevant information to those affected about environmental hazards issues; access to judicial and administrative proceeding; and the opportunity for redress where remedy where required. This paper examines the legislative and regulatory arrangements in place for the implementation these elements in a number of industrialised democracies, including Australia. Most have, over time made regulatory provision for these elements – even if they are not directly attributed Principle 10 or the notion of environmental justice. The paper proposes, that of these elements the most critical to the achievement of good environmental governance, is a legislated recognition and role of public participation. However, the paper considers that notwithstanding sound legislative and regulatory practices, environmental regulators frequently struggle, where there is a complex decision-making scenario or long-standing enmity between a community and industry to achieve effective engagement with the public. This study considers the dilemma confronted by environmental regulators to given meaningful effect to the principles enshrined in Principle 10 – that even when the legislative expression of Principle 10 is adhered to – does not prevent adverse outcomes. In particular, it considers, as a case study a prominent environmental incident in 2014 in Australia in which an open-cut coalmine located in the regional township of Morwell caught fire during bushfire season. The fire, which took 45 days to be extinguished had a significant and adverse impact on the community in question, but compounded a complex, and sometime antagonistic history between the mine and township. The case study exemplifies the complex factors that will often be present between industry, the public and regulatory bodies, and which confound the concept of environmental justice, and the elements of enshrined in the Principle 10 of the Rio Declaration. The study proposes that such tensions and complex examples will commonly be the reality of communities and regulators. However, to give practical effect to outcomes contemplated by Principle 10, the paper considers that regulators will may consider public intervention more broadly as including early interventions and formal opportunities for “conferencing” between industry, community and regulators. These initiatives help to develop a shared understanding and identification of issues. It is proposed that although important, options for “alternative dispute resolution” are not sufficiently preventative, as they come into play when a dispute has arise. Similarly “restorative justice” programs, while important once an incident or adverse environmental outcome has occurred, are post event and therefore necessarily limited. The paper considers the examples of how public participation at the outset – at the time of a proposal, before issues arise or eventuate to ensure, is demonstrably the most effective way for building commonality and an agreed methodology for working to resolve issues once they occur.

Keywords: environmental justice, alternative dispute resolution, domestic environmental law, international environmental law

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1547 Ethnographic Studies of the Choreographic Exploration Unveiling the Black Caribbean Female Body

Authors: Elle Nielsen

Abstract:

Festival time on the island of St. Croix is an annual celebration of a melting pot of rich culture and heritage. All your senses are amplified by the colorful bodies that paint the streets with swaying hips commemorating the ancestors who didn’t have the voice to express themselves, let alone the bodily authority through movement. Within this atmosphere of jubilee, you will become a witness to how the melodies of Calypso and Soca music take full control of the body. As a result, the waist and hips in a trance follow the polyrhythmic patterns birthing the shunned movement practices of whining and wukkin up. Spectators on the sidelines of the festival events will either frown upon this spectacle of the whining bodies or gaze in awe at the performative history in a public space. The historical value of the Caribbean Carnival is being defaced by the transnational spectatorship using body politics to push more of a Eurocentric-influenced atmosphere. The themes within this investigation are the stereotypes of over-sexualization and resistance to assimilation to how black female bodies are being viewed in Carnival.

Keywords: women equity, West Indian movement vocabulary, critical dance studies, humanitarianism in dance academia

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1546 Consumer Protection: An Exploration of the Role of the State in Protecting Consumers Before and During Inflation

Authors: Fatimah Opebiyi

Abstract:

Economic growth promotion, inflation reduction and consumer protection are among the core public interest aims of governments. Nevertheless, higher rates of default by consumers in relation to credit card loans and mortgages in recent times illustrate that government’s performance in balancing the protection of the economy and consumer is subpar. This thereby raises an important question on the role of government in protecting consumers during prolonged spells of inflation, particularly when such inflationary trends may be traceable to the acts of the government. Adopting a doctrinal research methodology, this article investigates the evolution of the concept of consumer protection in the United Kingdom and also brings to the fore the tensions and conflicts of interests in the aims and practices of the main regulators within the financial services industry. Relying on public interest theories of regulation and responsive regulatory theory, the article explores the limitations in the state’s ability to strike the right balance in meeting regulatory aims of the regulatory agencies at the opposite ends of the spectrum.

Keywords: financial regulation, consumer protection, prudential regulation, public interest theories of regulation, central bank

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1545 Physical and Mechanical Performance of Mortars with Ashes from Straw and Bagasse Sugarcane

Authors: Débora C. G. Oliveira, Julio D. Salles, Bruna A. Moriy, João A. Rossignolo, Holmer Savastano Jr.

Abstract:

The objective of this study was to identify the optimal level of partial replacement of Portland cement by the ashes originating from burning straw and bagasse from sugar cane (ASB). Order to this end, were made five series of flat plates and cylindrical bodies: control and others with the partial replacement in 20, 30, 40, and 50% of ASB in relation to the mass of the Ordinary Portland cement, and conducted a mechanical testing of simple axial compression (cylindrical bodies) and the four-point bending (flat plates) and determined water absorption (WA), bulk density (BD) and apparent void volume (AVV) on both types of specimens. Based on the data obtained, it may be noted that the control treatment containing only Portland cement, obtained the best results. However, the cylindrical bodies with 20% ashes showed better results compared to the other treatments. And in the formulations plates, the treatment which showed the best results was 30% cement replacement by ashes.

Keywords: modulus of rupture, simple axial compression, waste, bagasse sugarcane

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1544 From Private Bodies to a Shareable Body Politic. A Theological Solution to a Foundational Political Problem.

Authors: Patrick Downey

Abstract:

The political problem besetting all nations, tribes, and families, as illuminated by Plato in the fifth book of his Republic, is the problem of our own private body with its own particular pleasures and pains. This problem we might label the “irrational love of one’s own.” The reasonable philosopher loves reality just because it is, but we love things only if we can convince ourselves that they are “ours” or an imaginative extension of “ours.” The resulting problem, that can only be medicated, but not cured, is that the “body private,” whether our own, our family, tribe, or nation, always lies underneath any level of “body politic” and threatens the bloodshed and disintegration of civil war. This is also the political problem the Bible deals with throughout, beginning with Adam and Eve’s fall from rationally shareable bodies (“the two were one flesh”) into unshareable bodies whose now shameful “privacy” must be hid behind a bloody rather than bloodless veil. The blood is the sign of always threatening civil war, whether murder between brothers, feuds within tribes, or later, war between nations. The scarlet thread of blood tying the entire Bible together, Old and New Testament, reminds us that however far our loves are pushed out beyond our private body to family, tribe or nation, they remain irrational because unshareable. Only by loving the creator God who first loved us, can we rationally love anything of our own, but it must be loved as gift rather than as a possession. Such a love renders all bodies and nations truly shareable, and achieving this shareability is the paradoxical plot of the Bible, wherein the Word becomes flesh in a particular body amidst a particular people and nation. Yet even with His own nation and His own Son, this Lord is not “partial” and demands justice towards widows, orphans, and sojourners, because the irrational love of only our own can become rational solely through the resurrection of this particular body, king of this particular nation and these particular people. His body, along with all other bodies, can thus now retain their particular wounds and history, while yet remaining shareable. Likewise, all nations will share in the nation of Israel, in the same way all distinct languages will share an understanding through the inner rational word that we see illustrated in Pentecost. Without the resurrection, however, this shareability of bodies and nations remains merely a useful fiction, as Plato saw, and the equally fictitious “rationality” of some sort of deductive universalism will not go away. Reading Scripture in terms of Plato’s “irrational love of one’s own” therefore raises questions for both a Protestant and Catholic understanding of nations, questions that neither can answer adequately without this philosophical and exegetical attention.

Keywords: body private, nations, shareability, body politic

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1543 Disagreement among the United Nations Human Rights Bodies over the Legality of Deprivation of Liberty on the Grounds of Mental Disability

Authors: Ravan Samadov

Abstract:

Mentally disabled people are the most discriminated against among other disabled people and face much stronger negative attitudes across many cultures. The most complex and severe form of exclusion of these people is deprivation of liberty on the grounds of their disability. This problem was for many years overlooked to a great extent by the core human rights instruments. However, the United Nations (UN) Convention on the Rights of Persons with Disabilities (CRPD), adopted in 2006, is considered a potential tool to successfully fill the gap. It is especially vital for the developing countries with the vast majority of disabled people of the world and the CRPD is presumed to be able to trigger drastic positive changes. Article 14 of the mentioned human rights treaty has brought into the international forum a new notion, as prohibits deprivation of liberty on the grounds of disability. It is to be understood as an absolute prohibition of deprivation of liberty on the grounds of disability, including mental disability, which manifests in the form of non-consensual psychiatric hospitalisation. The interpretation by the CRPD Committee indicates that this prohibition well embraces all types of non-consensual psychiatric hospitalisation – whether it is based on illness, impairment or disability. This prohibition also extends to such justifications as ‘dangerousness’, ‘need for treatment’ and ‘diminished capacity’. Moreover, providing due substantive and/or procedural safeguards does not render any legitimacy to application of deprivation of liberty on the grounds of mental disability. Logically, this new prohibition form was to be duly considered by different UN human rights bodies, and was subsequently to bring changes to their practices. However, the analyses of post-CRPD work of those bodies allows for asserting the contrary, as they have continued displaying the position which recognises deprivation of liberty on the grounds of disability to be legitimate. While such a position could be justified in the pre-CRPD time as stemming from the silence of human rights documents about it, the continuation of this course after the CRPD entered into force may call the integrity and coherence of the UN human rights treaty system into question. The non-coherent approaches of different UN bodies to this novelty give grounds for misinterpretation thereof, and hinder its due implementation by the States Parties. The paper will discuss the nature of the mentioned new prohibition and the controversial approaches to that notion by different UN human rights bodies.

Keywords: CRPD, deprivation of liberty, mental disability, non-consensual psychiatric hospitalisation, UN bodies

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1542 Finding the Right Regulatory Path for Islamic Banking

Authors: Meysam Saidi

Abstract:

While the specific externalities and required regulatory measures in relation to Islamic banking are fairly uncertain, the business is growing across the world. Unofficial data indicate that the Islamic Finance market is growing with annual rate of 15% and it has reached 1.3 $ trillion size. This trend is associated with inherent systematic connection of Islamic financial institutions to other entities and different sectors of economies. Islamic banking has been subject of market development policies in major economies, most notably the UK. This trend highlights the need for identification of distinct risk features of Islamic banking and crafting customized regulatory measures. So far there has not been a significant systemic crisis in this market which can be attributed to its distinct nature. However, the significant growth and spread of its products worldwide necessitate an in depth study of its nature for customized congruent regulatory measures. In the post financial crisis era some market analysis and reports suggested that the Islamic banks fairly weathered the crisis. As far as heavily blamed conventional financial products such as subprime mortgage backed securities and speculative credit default swaps were concerned the immunity claim can be considered true, as Islamic financial institutions were not directly exposed to such products. Nevertheless, similar to the experience of the conventional banking industry, it can be only a matter of time for Islamic banks to face failures that can be specific to the nature of their business. Using the experience of conventional banking regulations and identifying those peculiarities of Islamic banking that need customized regulatory approach can aid to prevent major failures. Frank Knight has stated that “We perceive the world before we react to it, and we react not to what we perceive, but always to what we infer”. The debate over congruent Islamic banking regulations might not be an exception to Frank Knight’s statement but I will try to base my discussion on concrete evidences. This paper first analyzes both theoretical and actual features of Islamic banking in order to ascertain to its peculiarities in terms of market stability and other externalities. Next, the paper discusses distinct features of Islamic financial transactions and banking which might require customized regulatory measures. Finally, the paper explores how a more transparent path for the Islamic banking regulations can be drawn.

Keywords: Islamic banking, regulation, risks, capital requirements, customer protection, financial stability

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1541 Regulatory Guidelines to Support the Design of Nanosatellite Projects in Mexican Academic Contexts

Authors: Alvaro Armenta-Ramade, Arturo Serrano-Santoyo, Veronica Rojas-Mendizabal, Roberto Conte-Galvan

Abstract:

The availability and affordability of commercial off-the-shell products have brought a major impetus in the development of university projects related to the design, construction and launching of small satellites on a global scale. Universities in emerging economies as well as in least developed countries have been able to develop prototypes of small satellites (cubesats and cansats) with limited budgets. The experience gained in the development of small satellites gives rise to capacity building for designing more complex aerospace systems. This trend has significantly increased the pace and number of aerospace university projects around the world. In the case of Mexico, projects funded by different agencies have been very effective in accelerating the capacity building and technology transfer initiatives in the aerospace ecosystem. However, many of this initiatives have centered their efforts in technology development matters with minimum or no considerations of key regulatory issues related to frequency assignment, management and licensing, as well as launching requirements and measures of mitigation of space debris. These regulatory concerns are fundamental to accomplish successful missions that take into account the complete value chain of an aerospace project. The purpose of this paper is to develop a regulatory framework to support the efforts of educational institutions working on the development of small satellites in Mexico. We base our framework on recommendations from the International Telecommunications Union (ITU), the United Nations Office for Outer Space Affairs (UNOOSA) and other major actors of the Mexican regulatory ecosystem. In order to develop an integrated and cohesive framework, we draw on complexity science to identify the agents, their role and interactions. Our goal is to create a guiding instrument available both in print and online that can also be used in other regions of the world

Keywords: capacity building, complexity science, cubesats, space regulations, small satellites

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1540 Characterization of Brewery Wastewater Composition

Authors: Abimbola M. Enitan, Josiah Adeyemo, Sheena Kumari, Feroz M. Swalaha, Faizal Bux

Abstract:

With the competing demand on water resources and water reuse, discharge of industrial effluents into the aquatic environment has become an important issue. Much attention has been placed on the impact of industrial wastewater on water bodies worldwide due to the accumulation of organic and inorganic matter in the receiving water bodies. The scope of the present work is to assess the physic-chemical composition of the wastewater produced from one of the brewery industry in South Africa. This is to estimate the environmental impact of its discharge into the receiving water bodies or the municipal treatment plant. The parameters monitored for the quantitative analysis of brewery wastewater include biological oxygen demand (BOD5), chemical oxygen demand (COD), total suspended solids, volatile suspended solids, ammonia, total oxidized nitrogen, nitrate, nitrite, phosphorus, and alkalinity content. In average, the COD concentration of the brewery effluent was 5340.97 mg/l with average pH values of 4.0 to 6.7. The BOD and the solids content of the wastewater from the brewery industry were high. This means that the effluent is very rich in organic content and its discharge into the water bodies or the municipal treatment plant could cause environmental pollution or damage the treatment plant. In addition, there were variations in the wastewater composition throughout the monitoring period. This might be as a result of different activities that take place during the production process, as well as the effects of the peak period of beer production on the water usage.

Keywords: Brewery wastewater, environmental pollution, industrial effluents, physic-chemical composition

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1539 Assessing the Experiences of South African and Indian Legal Profession from the Perspective of Women Representation in Higher Judiciary: The Square Peg in a Round Hole Story

Authors: Sricheta Chowdhury

Abstract:

To require a woman to choose between her work and her personal life is the most acute form of discrimination that can be meted out against her. No woman should be given a choice to choose between her motherhood and her career at Bar, yet that is the most detrimental discrimination that has been happening in Indian Bar, which no one has questioned so far. The falling number of women in practice is a reality that isn’t garnering much attention given the sharp rise in women studying law but is not being able to continue in the profession. Moving from a colonial misogynist whim to a post-colonial “new-age construct of Indian woman” façade, the policymakers of the Indian Judiciary have done nothing so far to decolonize itself from its rudimentary understanding of ‘equality of gender’ when it comes to the legal profession. Therefore, when Indian jurisprudence was (and is) swooning to the sweeping effect of transformative constitutionalism in the understanding of equality as enshrined under the Indian Constitution, one cannot help but question why the legal profession remained out of brushing effect of achieving substantive equality. The Airline industry’s discriminatory policies were not spared from criticism, nor were the policies where women’s involvement in any establishment serving liquor (Anuj Garg case), but the judicial practice did not question the stereotypical bias of gender and unequal structural practices until recently. That necessitates the need to examine the existing Bar policies and the steps taken by the regulatory bodies in assessing the situations that are in favor or against the purpose of furthering women’s issues in present-day India. From a comparative feminist point of concern, South Africa’s pro-women Bar policies are attractive to assess their applicability and extent in terms of promoting inclusivity at the Bar. This article intends to tap on these two countries’ potential in carving a niche in giving women an equal platform to play a substantive role in designing governance policies through the Judiciary. The article analyses the current gender composition of the legal profession while endorsing the concept of substantive equality as a requisite in designing an appropriate appointment process of the judges. It studies the theoretical framework on gender equality, examines the international and regional instruments and analyses the scope of welfare policies that Indian legal and regulatory bodies can undertake towards a transformative initiative in re-modeling the Judiciary to a more diverse and inclusive institution. The methodology employs a comparative and analytical understanding of doctrinal resources. It makes quantitative use of secondary data and qualitative use of primary data collected for determining the present status of Indian women legal practitioners and judges. With respect to quantitative data, statistics on the representation of women as judges and chief justices and senior advocates from their official websites from 2018 till present have been utilized. In respect of qualitative data, results of the structured interviews conducted through open and close-ended questions with retired lady judges of the higher judiciary and senior advocates of the Supreme Court of India, contacted through snowball sampling, are utilized.

Keywords: gender, higher judiciary, legal profession, representation, substantive equality

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