Search results for: regulatory changes

Authors: Umamaheswari Shanmugam, Silvia Ronchi

Abstract:

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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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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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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Authors: Sajed Sarabandi, Mostafa Rostampour Vajari

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Breast cancer is the most frequent form of cancer among women and the fifth-leading cause of cancer-related deaths. A common feature of cancer cells is their ability to survive and evade apoptosis. Understanding the mechanisms of these pathways and their regulatory factors can lead to the development of effective treatment strategies. In this study, we aim to model the effect of key miRNAs, which are significant regulatory factors in breast cancer. We designed a Petri net focusing on two crucial pathways, proliferation, and apoptosis, and identified the role of miRNAs in these pathways. Our analysis indicates that the upregulation of miRNAs 99a and 372 can effectively increase apoptosis and decrease proliferation. Moreover, we demonstrate that miRNA-600, previously reported as a potential candidate for treatment, may not be a suitable target due to its dual activity in proliferation. Therefore, further research is required to investigate the potential of this miRNA in cancer treatment. Our model shows that a combination of miRNA upregulation and knockdown can efficiently influence key genes such as MDM2 and PTEN, leading to the activation of apoptosis in cancer cells. Ultimately, our model successfully simulates the connection between regulatory miRNAs and key genes in breast cancer.

Keywords: breast cancer, microRNAs, bio-modeling, Petri net

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Authors: Shreyas Kumar, Mili Shangari

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Integrating artificial intelligence (AI) in the cyber insurance sector represents a significant advancement, offering the potential to revolutionize risk assessment, fraud detection, and claims processing. However, this integration introduces a range of regulatory and economic challenges that must be addressed to ensure responsible and effective deployment of AI technologies. This paper examines the multifaceted regulatory landscape governing AI in cyber insurance and explores the economic implications of compliance, innovation, and market dynamics. AI's capabilities in processing vast amounts of data and identifying patterns make it an invaluable tool for insurers in managing cyber risks. Yet, the application of AI in this domain is subject to stringent regulatory scrutiny aimed at safeguarding data privacy, ensuring algorithmic transparency, and preventing biases. Regulatory bodies, such as the European Union with its General Data Protection Regulation (GDPR), mandate strict compliance requirements that can significantly impact the deployment of AI systems. These regulations necessitate robust data protection measures, ethical AI practices, and clear accountability frameworks, all of which entail substantial compliance costs for insurers. The economic implications of these regulatory requirements are profound. Insurers must invest heavily in upgrading their IT infrastructure, implementing robust data governance frameworks, and training personnel to handle AI systems ethically and effectively. These investments, while essential for regulatory compliance, can strain financial resources, particularly for smaller insurers, potentially leading to market consolidation. Furthermore, the cost of regulatory compliance can translate into higher premiums for policyholders, affecting the overall affordability and accessibility of cyber insurance. Despite these challenges, the potential economic benefits of AI integration in cyber insurance are significant. AI-enhanced risk assessment models can provide more accurate pricing, reduce the incidence of fraudulent claims, and expedite claims processing, leading to overall cost savings and increased efficiency. These efficiencies can improve the competitiveness of insurers and drive innovation in product offerings. However, balancing these benefits with regulatory compliance is crucial to avoid legal penalties and reputational damage. The paper also explores the potential risks associated with AI integration, such as algorithmic biases that could lead to unfair discrimination in policy underwriting and claims adjudication. Regulatory frameworks need to evolve to address these issues, promoting fairness and transparency in AI applications. Policymakers play a critical role in creating a balanced regulatory environment that fosters innovation while protecting consumer rights and ensuring market stability. In conclusion, the integration of AI in cyber insurance presents both regulatory and economic challenges that require a coordinated approach involving regulators, insurers, and other stakeholders. By navigating these challenges effectively, the industry can harness the transformative potential of AI, driving advancements in risk management and enhancing the resilience of the cyber insurance market. This paper provides insights and recommendations for policymakers and industry leaders to achieve a balanced and sustainable integration of AI technologies in cyber insurance.

Keywords: artificial intelligence (AI), cyber insurance, regulatory compliance, economic impact, risk assessment, fraud detection, cyber liability insurance, risk management, ransomware

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Authors: Meysam Saidi

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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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Authors: Sempiga Olivier, Dominika Latusek-Jurczak

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The conflict in Ukraine has had far-reaching economic consequences, not only for the countries directly involved in it but also for their trading partners and allies, and on the global economy in general. Different European Union (EU) countries, being some of Ukraine and Russia's major trading partners, have also felt the impact of the conflict on their economy. In a special way, the energy sector has suffered the most due to the fact that Russia is a huge exporter of gas and other energy sources on which rely European countries. Energy is a locomotive of the economy and once energy prices skyrocket there is a spill over effects in other areas causing different commodities’ prices to rise thereby affecting people’s social economic lifestyles. To minimise the impact energy crisis’ socio-political and economic consequences, the EU and countries have tightened their regulatory mechanisms to stop some energy firms exploit the crisis at the expense of the vulnerable mass. The key question is to what extent these regulatory instruments put in place during the energy crisis times have an affect on citizen trust in the governing institutions. The question is of paramount importance after years of declining trust in the EU and in most countries in Europe. Earlier research have analysed how wars or global political risks relate to citizen trust in government and organizations but very few empirical research have examined the relationship between regulatory instruments during the time of crisis on citizen trust in government and institutions. Using data from INSEE (the French National Institute of Statistics and Economic Studies) and European Social Survey (ESS), it carry out a multilinear regression analysis and investigate the impact of regulation both from the EU and different countries on energy prices on citizen trust. To understand the dynamics between regulatory actions during crises and citizen trust, this study draws on the theoretical framework of institutional trust and regulatory legitimacy. Institutional trust theory posits that citizens’ trust in government and institutions is influenced by perceptions of fairness, transparency, and efficacy in governance. Regulatory legitimacy, a related concept, suggests that regulatory measures, especially in response to crises, are more effective when perceived as just, necessary, and in the public interest. Results of this cross sectional study show that regulatory frameworks strongly affect the levels of trust, the association varying from strong to moderate depending on countries and period. This study contributes to the understanding of the vital relationship between regulatory measures implemented during crises and citizen trust in government institutions. By identifying the conditions under which trust is fostered or eroded, the findings provide policymakers with valuable insights into effective strategies for enhancing public confidence, ultimately guiding interventions that can mitigate the socio-political impacts of future energy crises.

Keywords: energy crisis, price, regulation, russia-Ukraine conflict, trust

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

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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

Procedia PDF Downloads 260

Authors: Umamaheswari Shanmugam, Silvia Ronchi, Radu Vornicu

Abstract:

Software, artificial intelligence, and machine learning can improve healthcare through innovative and advanced technologies that are able to use the large amount and variety of data generated during healthcare services every day. As we read the news, over 500 machine learning or other artificial intelligence medical devices have now received FDA clearance or approval, the first ones even preceding the year 2000. One of the big advantages of these new technologies is the ability to get experience and knowledge from real-world use and to continuously improve their performance. Healthcare systems and institutions can have a great benefit because the use of advanced technologies improves the same time 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 also to protect patients’ safety. The evolution and the continuous improvement of software used in healthcare must take into consideration 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 approval, but they are necessary to ensure performance, quality, and safety, and at the same time, they can be a business opportunity if the manufacturer is able to define in advance the appropriate regulatory strategy. 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.

Procedia PDF Downloads 91

Authors: M. Macchiaroli, L. Dolores, V. Pellecchia

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With the recent Resolution n. 580/2019/R/idr, the Italian Regulatory Authority for Energy, Networks, and Environment (ARERA) for the Urban Water Management has introduced, for water managements characterized by persistent critical issues regarding the planning and organization of the service and the implementation of the necessary interventions for the improvement of infrastructures and management quality, a new mechanism for determining tariffs: the regulatory scheme of Convergence. The aim of this regulatory scheme is the overcoming of the Water Service Divided in order to improve the stability of the local institutional structures, technical quality, contractual quality, as well as in order to guarantee transparency elements for Users of the Service. Convergence scheme presupposes the identification of the cost items to be considered in the tariff in parametric terms, distinguishing three possible cases according to the type of historical data available to the Manager. The study, in particular, focuses on operations that have neither data on tariff revenues nor data on operating costs. In this case, the Manager's Constraint on Revenues (VRG) is estimated on the basis of a reference benchmark and becomes the starting point for defining the structure of the tariff classes, in compliance with the TICSI provisions (Integrated Text for tariff classes, ARERA's Resolution n. 665/2017/R/idr). The proposed model implements the recent studies on optimization models for the definition of tariff classes in compliance with the constraints dictated by TICSI in the application of the Convergence mechanism, proposing itself as a support tool for the Managers and the local water regulatory Authority in the decision-making process.

Keywords: decision-making process, economic evaluation of projects, optimizing tools, urban water management, water tariff

Procedia PDF Downloads 120

Authors: Ali Alshamrani

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This article aims to give a comprehensive and critical review of sukuk issuance in Saudi Arabia, and the extent to which the issuance of sukuk in Saudi Arabia is consistent with Shariah requirements. The article is divided into two sections. Accordingly, the first section of this article begins with an examination of sukuk in general, and includes the concept of sukuk, the basic principles of sukuk, common types of sukuk, and a critical analysis of the most important differences between sukuk and conventional bonds. The second section gives a critical analysis of how sukuk work in Saudi Arabia, offering the regulatory framework of the issuance of sukuk in the KSA, and the legal challenges from Shariah point of view, and provide recommendations to overcome these challenges.

Keywords: sukuk issuance, Shariah, Saudi Arabia, capital market authority

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Authors: Abderrahim El Maslouhi

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The paper aims to analyze an often-overlooked dimension of global constitutionalism, which is the rise of the regulatory state and its impact on parliamentary dynamics in transition regimes. In contrast to Majone’s technocratic vision of convergence towards a single regulatory system based on competence and efficiency, national transpositions of regulatory governance and, in general, the relationship to global standards primarily depend upon a number of distinctive parameters. These include policy formation process, speed of change, depth of parliamentary tradition and greater or lesser vulnerability to the normative conditionality of donors, interstate groupings and transnational regulatory bodies. Based on a comparison between three post-Arab Spring countries -Morocco, Tunisia, and Egypt, whose constitutions have undergone substantive review in the period 2011-2014- and some European Union state members, the paper intends, first, to assess the degree of permeability to global constitutionalism in different contexts. A noteworthy divide emerges from this comparison. Whereas European constitutions still seem impervious to the lexicon of global constitutionalism, the influence of the latter is obvious in the recently drafted constitutions in Morocco, Tunisia, and Egypt. This is evidenced by their reference to notions such as ‘governance’, ‘regulators’, ‘accountability’, ‘transparency’, ‘civil society’, and ‘participatory democracy’. Second, the study will provide a contextual account of internal and external rationales underlying the constitutionalization of regulatory governance in the cases examined. Unlike European constitutionalism, where parliamentarism and the tradition of representative government function as a structural mechanism that moderates the de-parliamentarization effect induced by global constitutionalism, Arab constitutional transitions have led to a paradoxical situation; contrary to the public demands for further parliamentarization, the 2011 constitution-makers have opted for a de-parliamentarization pattern. This is particularly reflected in the procedures established by constitutions and regular legislation, to handle the interaction between lawmakers and regulatory bodies. Once the ‘constitutional’ and ‘independent’ nature of these agencies is formally endorsed, the birth of these ‘fourth power’ entities, which are neither elected nor directly responsible to elected officials, will raise the question of their accountability. Third, the paper shows that, even in the three selected countries, the de-parliamentarization intensity is significantly variable. By contrast to the radical stance of the Moroccan and Egyptian constituents who have shown greater concern to shield regulatory bodies from legislatures’ scrutiny, the Tunisian case indicates a certain tendency to provide lawmakers with some essential control instruments (e. g. exclusive appointment power, adversarial discussion of regulators’ annual reports, dismissal power, later held unconstitutional). In sum, the comparison reveals that the transposition of the regulatory state model and, more generally, sensitivity to the legal implications of global conditionality essentially relies on the evolution of real-world power relations at both national and international levels.

Keywords: Arab legislatures, de-parliamentarization, global constitutionalism, normative conditionality, regulatory state

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Authors: Khaled Alkadamani

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Using the simultaneous equations model, this paper examines the impact of capital requirements on bank risk-taking during the recent financial crisis. It also explores the relationship between capital and risk decisions and the impact of economic instability on this relationship. By analyzing the data of 20 Islamic commercial banks between 2004 and 2014 from four Middle East countries, the study concludes a positive effect of regulatory pressure on bank capital in Saudi Arabia and UAE and a negative effect in Jordan and Kuwait. Moreover, the results show a negative impact of regulatory pressure on bank risk taking in Saudi Arabia, Jordan and UAE. The findings reveal also that banks close to the minimum regulatory capital requirements improve their capital adequacy by increasing their capital and decreasing their risk taking. Furthermore, the results show that economic crisis negatively affects bank risk changes, suggesting that banks react to the impact of uncertainty by reducing their risk taking. Finally, the estimations show a negative correlation between banks profitability and capital adequacy ratio (CAR), implying that as more capital is set aside as a buffer for banks safety; it affects the performance of Islamic banks.

Keywords: bank capital, bank regulation, crisis, Islamic banks, risk taking

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Authors: Cai Qianyi

Abstract:

In the midst of global digital revolution, the flow of data poses security threats that call China's existing legislative framework for protecting personal information into question. As a preliminary procedure for risk analysis and prevention, the risk assessment of personal data transmission lacks detailed guidelines for support. Existing provisions reveal unclear responsibilities for network operators and weakened rights for data subjects. Furthermore, the regulatory system's weak operability and a lack of industry self-regulation heighten data transmission hazards. This paper aims to compare the regulatory pathways for data information transmission risks between China and Europe from a legal framework and content perspective. It draws on the “Data Protection Impact Assessment Guidelines” to empower multiple stakeholders, including data processors, controllers, and subjects, while also defining obligations. In conclusion, this paper intends to solve China's digital security shortcomings by developing a more mature regulatory framework and industry self-regulation mechanisms, resulting in a win-win situation for personal data protection and the development of the digital economy.

Keywords: personal information data transmission, risk assessment, DPIA, internet service provider, personal information data transimission, risk assessment

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Authors: Pedro Paulino

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The majority of the world’s population is already living in urban areas and the urban population is expected to keep increasing in the next decades. This exponential increase in urban population carries with it obvious mobility problems. Not only a new paradigm in the transport sector is needed in order to address these problems; effective regulatory policies to ensure the quality of services, passenger rights, competition between operators and consistency of the entire mobile ecosystem are needed as well. The purpose of this paper is to present the problems the world faces in this sector and contribute to their solution. Indeed, our study concludes that only through the active supervision of the markets and the activity of monitoring the various operators will it be possible to develop a sustainable and efficient transport system which meets the needs of a changing world.

Keywords: mobility, regulation policies, sanctioning powers, sustainable transport

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Authors: Surajit Bhattacharya, Daniel Veltri, Atit A. Patel, Daniel N. Cox

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miRNAs have emerged as key post-transcriptional regulators of gene expression, however identification of biologically-relevant target genes for this epigenetic regulatory mechanism remains a significant challenge. To address this knowledge gap, we have developed a novel tool in R, Intra-miR-ExploreR, that facilitates integrated discovery of miRNA targets by incorporating target databases and novel target prediction algorithms, using statistical methods including Pearson and Distance Correlation on microarray data, to arrive at high confidence intragenic miRNA target predictions. We have explored the efficacy of this tool using Drosophila melanogaster as a model organism for bioinformatics analyses and functional validation. A number of putative targets were obtained which were also validated using qRT-PCR analysis. Additional features of the tool include downloadable text files containing GO analysis from DAVID and Pubmed links of literature related to gene sets. Moreover, we are constructing interaction maps of intragenic miRNAs, using both micro array and RNA-seq data, focusing on neural tissues to uncover regulatory codes via which these molecules regulate gene expression to direct cellular development.

Keywords: miRNA, miRNA:mRNA target prediction, statistical methods, miRNA:mRNA interaction network

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Authors: I. Diaz Sanchez, I. M. Martinez-Conesa, M. Illueca

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Accounting conservatism is a desirable quality of earnings that is positively associated with the stridency of regulatory and supervisory regimen and high market discipline. But how these three pillars interact each other is the main research question that is not empirically solved. We analyze how regulatory and supervisory regimes interact with the market discipline measures, such as listing status, ownership and market concentration using a sample of 14,651 bank-year observations covering 54 countries over the period 1997-2009. We evidence that regulation a supervision and extend on which they are enforcement is a strong mechanism to achieved accounting conservatism in those countries or situations where the market discipline fails. Generally, the supervisory power reinforces the effect of listing status, ownership and concentration on conservatism, while capital regulatory mitigates the effect of market discipline on conservatism. This paper may contribute to debate about the mechanism introduced by Basel III that strongly increases the regulation, his enforcement, and the supervisory power after long deregulation period. Although Market discipline is relevant to achieve the financial stability, strong Pillar I and II can ensure the quality of the accounting earnings to prevent bank failures.

Keywords: accounting conservatism, bank regulation, bank supervision, loan loss recognition, market discipline

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Authors: Wafula Simon Peter, Kimuli Nabayego Ibtihal, Nabaggala Kimuli Nashua

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The worldwide use of information and communications technology (ICT) equipment and other electronic equipment is growing and consequently, there is a growing amount of equipment that becomes waste after its time in use. This growth is expected to accelerate since equipment lifetime decreases with time and growing consumption. As a result, e-waste is one of the fastest-growing waste streams globally. The United Nations University (UNU) calculates in its second Global E-waste Monitor 44.7 million metric tonnes (Mt) of e-waste were generated globally in 2016. The study population was 80 respondents, from which a sample of 69 respondents was selected using simple and purposive sampling techniques. This research was carried out to investigate the problem of e-waste and come up with a framework to improve e-waste management. The objective of the study was to develop a framework for improving e-waste management at the College of Engineering, Design, Art and Technology (CEDAT). This was achieved by breaking it down into specific objectives, and these included the establishment of the policy and other Regulatory frameworks being used in e-waste management at CEDAT, the determination of the effectiveness of the e-waste management practices at CEDAT, the establishment of the critical challenges constraining e-waste management at the College, development of a framework for e-waste management. The study reviewed the e-waste regulatory framework used at the college and then collected data which was used to come up with a framework. The study also established that weak policy and regulatory framework, lack of proper infrastructure, improper disposal of e-waste and a general lack of awareness of the e-waste and the magnitude of the problem are the critical challenges of e-waste management. In conclusion, the policy and regulatory framework should be revised, localized and strengthened to contextually address the problem. Awareness campaigns, the development of proper infrastructure and extensive research to establish the volumes and magnitude of the problems will come in handy. The study recommends a framework for the improvement of e-waste.

Keywords: e-waste, treatment, disposal, computers, model, management policy and guidelines

Procedia PDF Downloads 79

Authors: Mohammaad Afzal Khan, Ghazi Abdulmalik Ashoor , Fatimah Alanazi, Talal Shamma, Abdullah Altuhami, Hala Abdalrahman Ahmed, Abdullah Mohammed Assiri, Dieter Clemens Broering

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Microvascular injuries during inflammation are key causes of transplant malfunctioning and permanent failure, which play a major role in the development of chronic rejection of the transplanted organ. Inflammation-induced microvascular loss is a promising area to investigate the decisive roles of regulatory and effector responses. The present study was designed to investigate the impact of IL-10 on immunotolerance, in particular, the microenvironment of the allograft during rejection. Here, we investigated the effects of IL-10 blockade/ reconstitution and serially monitored regulatory T cells (Tregs), graft microvasculature, and airway epithelium in rejecting airway transplants. We demonstrated that the blocking/reconstitution of IL-10 significantly modulates CD4+FOXP3+ Tregs, microvasculature, and airway epithelium during rejection. Our findings further highlighted that blockade of IL-10 upregulated proinflammatory cytokines, IL-2, IL-1β, IFN-γ, IL-15, and IL-23, but suppressed IL-5 secretion during rejection; however, reconstitution of IL-10 significantly upregulated CD4+FOXP3+ Tregs, tissue oxygenation/blood flow and airway repair. Collectively, these findings demonstrate a potential reparative modulation of IL-10 during microvascular and epithelial repair, which could provide a vital therapeutic window to rejecting transplants in clinical practice.

Keywords: interleukin -10, regulatory T cells, allograft rejection, immunotolerance

Procedia PDF Downloads 176

Authors: P. Asiabi, M. Shahhoseini, R. Favaedi, F. Hassani, N. Nassiri, B. Movaghar, L. Karimian, P. Eftekhariyazdi

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Introduction: Polycystic Ovary Syndrome is a common gynecologic disorder. Many factors including environment, metabolism, hormones and genetics are involved in etiopathogenesis of PCOS. Of genes that have altered expression in human reproductive system disorders are HOX family genes which act as transcription factors in regulation of cell proliferation, differentiation, adhesion and migration. Since recent evidences consider epigenetic factors as causative mechanisms of PCOS, evaluation of association between known epigenetic marks of acetylation/methylation of histone 3 (H3K9ac/me) with regulatory regions of these genes can represent better insight about PCOS. In the current study, cumulus cells (CCs) which have critical roles during folliculogenesis, oocyte maturation, ovulation and fertilization were aimed to monitor epigenetic alterations of HOX genes. Material and methods: CCs were collected from 20 PCOS patients and 20 fertile women (18-36 year) with male infertility problems referred to the Royan Institute to have ICSI under GnRH antagonist protocol. Informed consents were obtained from the participants. Thirty six hours after hCG injection, ovaries were punctured and cumulus oocyte complexes were dissected. Soluble chromatin were extracted from CCs and Chromatin Immune precipitation (ChIP) coupled with Real Time PCR was performed to quantify the epigenetic marks of histone H3K9 acetylation/methylation (H3K9ac/me) on regulatory regions of 15 members of HOX genes from A-D subfamily. Results: Obtained data showed significant increase of H3K9ac epigenetic mark on regulatory regions of HOXA1, HOXB2, HOXC4, HOXD1, HOXD3 and HOXD4 (P < 0.01) and HOXC5 (P < 0.05) and also significant decrease of H3K9ac into regulatory regions of HOXA2, HOXA4, HOXA5, HOXB1 and HOXB5 (P < 0.01) and HOXB3 (P<0.05) in PCOS patients vs. control group. On the other side, there was a significant decrease in incorporation of H3K9me level on regulatory region of HOXA2, HOXA3, HOXA4, HOXA5, HOXB3 and HOXC4 (P≤0.01) and HOXB5 (P < 0.05) in PCOS patients vs. control group. This epigenetic mark (H3K9me2) has significant increase on regulatory region of HOXB1, HOXB2, HOXC5, HOXD1, HOXD3 and HOXD4 (P ≤ 0.01) and HOXB4 (P < 0.05) in patients vs. control group. There were no significant changes in acetylation/methylation levels of H3K9 on regulatory regions of the other studied genes. Conclusion: Current study suggests that epigenetic alterations of HOX genes can be correlated with PCOS and consequently female infertility. This finding might offer additional definitions of PCOS, and eventually provides insight for novel treatments with epidrugs for this disease.

Keywords: epigenetic, HOX genes, PCOS, female infertility

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Authors: Sophie Lemoussu, Jean-Charles Chaudemar, Robertus A. Vingerhoeds

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Many innovative projects exist in the field of aeronautics, each addressing specific areas so to reduce weight, increase autonomy, reduction of CO2, etc. In many cases, such innovative developments are being carried out by very small enterprises (VSE’s) or small and medium sized-enterprises (SME’s). A good example concerns airships that are being studied as a real alternative to passenger and cargo transportation. Today, no international regulations propose a precise and sufficiently detailed framework for the development and certification of airships. The absence of such a regulatory framework requires a very close contact with regulatory instances. However, VSE’s/SME’s do not always have sufficient resources and internal knowledge to handle this complexity and to discuss these issues. This poses an additional challenge for those VSE’s/SME’s, in particular those that have system integration responsibilities and that must provide all the necessary evidence to demonstrate their ability to design, produce, and operate airships with the expected level of safety and reliability. The main objective of this research is to provide a methodological framework enabling VSE’s/SME’s with limited resources to organize the development of airships while taking into account the constraints of safety, cost, time and performance. This paper proposes to provide a contribution to this problematic by proposing a Model-Based Systems Engineering approach. Through a comprehensive process modeling approach applied to the development processes, the regulatory constraints, existing best practices, etc., a good image can be obtained as to the process landscape that may influence the development of airships. To this effect, not only the necessary regulatory information is taken on board, also other international standards and norms on systems engineering and project management are being modeled and taken into account. In a next step, the model can be used for analysis of the specific situation for given developments, derive critical paths for the development, identify eventual conflicting aspects between the norms, standards, and regulatory expectations, or also identify those areas where not enough information is available. Once critical paths are known, optimization approaches can be used and decision support techniques can be applied so to better support VSE’s/SME’s in their innovative developments. This paper reports on the adopted modeling approach, the retained modeling languages, and how they all fit together.

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

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Authors: Ivan Poza Martínez

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The international energy landscape has been significantly affected by the Covid-19 pandemic and te conflict in Ukraine. The Vaca Muerta sedimentary formation in Argentina´s Neuquén province has become a crucial area for energy production, specifically in the shale gas ad shale oil sectors. The massive investment required for theexploitation of this reserve make it essential to understand te determinants of the investment in the upstream sector at both local ad international levels. The aim of this study is to identify the qualitative and quantitative determinants of investment in Vaca Muerta. The research methodolody employs both quantiative ( econometrics ) and qualitative approaches. A linear regression model is used to analyze the impact in non-conventional hydrocarbons. The study highlights that, in addition to quantitative factors, qualitative variables, particularly the design of a regulatory framework, significantly influence the level of the investment in Vaca Muerta. The analysis reveals the importance of attracting both domestic and foreign capital investment. This research contributes to understanding the factors influencing investment inthe Vaca Muerta regioncomapred to other published studies. It emphasizes to role of qualitative varibles, such as regulatory frameworks, in the development of the shale gas and oil sectors. The study uses a combination ofquantitative data , such a investment figures, and qualitative data, such a regulatory frameworks. The data is collected from various rpeorts and industry publications. The linear regression model is used to analyze the relationship between the variables and the investment in Vaca Muerta. The research addresses the question of what factors drive investment in the Vaca Muerta region, both from a quantitative and qualitative perspective. The study concludes that a combination of quantitative and qualitative factors, including the design of a regulatory framework, plays a significant role in attracting investment in Vaca Muerta. It highlights the importance of these determinants in the developmentof the local energy sector and the potential economic benefits for Argentina and the Southern Cone region.

Keywords: vaca muerta, FDI, shale gas, shale oil, YPF

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Authors: Ramazan I. Kadiev, Arcady Ponosov

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Mathematical models of gene regulatory networks can in many cases be described by ordinary differential equations with switching nonlinearities, where the initial value problem is ill-posed. Several regularization methods are known in the case of deterministic networks, but the presence of stochastic noise leads to several technical difficulties. In the presentation, it is proposed to apply the methods of the stochastic singular perturbation theory going back to Yu. Kabanov and Yu. Pergamentshchikov. This approach is used to regularize the above ill-posed problem, which, e.g., makes it possible to design stable numerical schemes. Several examples are provided in the presentation, which support the efficiency of the suggested analysis. The method can also be of interest in other fields of biomathematics, where differential equations contain switchings, e.g., in neural field models.

Keywords: ill-posed problems, singular perturbation analysis, stochastic differential equations, switching nonlinearities

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Authors: Thelma Maria Melo Pinheiro, Guilherme Raposo Diniz Vieira, Sidney Matos da Silva, Leonardo Mendonça de Oliveira Queiroz, Mateus Sousa Pinheiro, Danyllo Wenceslau de Oliveira Lopes

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The present article has the objective to describe the regulatory impact analysis (RIA) of the contracting efficiency of the Brazilian transmission system usage. This contracting is made by users connected to the main transmission network and is used to guide necessary investments to supply the electrical energy demand. Therefore, an inefficient contracting of this energy amount distorts the real need for grid capacity, affecting the sector planning accuracy and resources optimization. In order to provide this efficiency, the Brazilian Electricity Regulatory Agency (ANEEL) homologated the Normative Resolution (NR) No. 666, from July 23th of 2015, which consolidated the procedures for the contracting of transmission system usage and the contracting efficiency verification. Aiming for a more efficient and rational transmission system contracting, the resolution established economic incentives denominated as Inefficiency installment for excess (IIE) and inefficiency installment for over-contracting (IIOC). The first one, IIE, is verified when the contracted demand exceeds the established regulatory limit; it is applied to consumer units, generators, and distribution companies. The second one, IIOC, is verified when the distributors over-contract their demand. Thus, the establishment of the inefficiency installments IIE and IIOC intends to avoid the agent contract less energy than necessary or more than it is needed. Knowing that RIA evaluates a regulatory intervention to verify if its goals were achieved, the results from the application of the above-mentioned normative resolution to the Brazilian transmission sector were analyzed through indicators that were created for this RIA to evaluate the contracting efficiency transmission system usage, using real data from before and after the homologation of the normative resolution in 2015. For this, indicators were used as the efficiency contracting indicator (ECI), excess of demand indicator (EDI), and over-contracting of demand indicator (ODI). The results demonstrated, through the ECI analysis, a decrease of the contracting efficiency, a behaviour that was happening even before the normative resolution of 2015. On the other side, the EDI showed a considerable decrease in the amount of excess for the distributors and a small reduction for the generators; moreover, the ODI notable decreased, which optimizes the usage of the transmission installations. Hence, with the complete evaluation from the data and indicators, it was possible to conclude that IIE is a relevant incentive for a more efficient contracting, indicating to the agents that their contracting values are not adequate to keep their service provisions for their users. The IIOC also has its relevance, to the point that it shows to the distributors that their contracting values are overestimated.

Keywords: contracting, electricity regulation, evaluation, regulatory impact analysis, transmission power system

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Authors: Jian-Jun Shu

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The statistical properties of CRMs are explored by estimating similar-word set occurrence distribution. It is observed that CRMs tend to have a fat-tail distribution for similar-word set occurrence. Thus, the fat-tail test with two fatness coefficients is proposed to distinguish CRMs from non-CRMs, especially from exons. For the first fatness coefficient, the separation accuracy between CRMs and exons is increased as compared with the existing content-based CRM prediction method – fluffy-tail test. For the second fatness coefficient, the computing time is reduced as compared with fluffy-tail test, making it very suitable for long sequences and large data-base analysis in the post-genome time. Moreover, these indexes may be used to predict the CRMs which have not yet been observed experimentally. This can serve as a valuable filtering process for experiment.

Keywords: statistical approach, transcription factor binding sites, cis-regulatory modules, DNA sequences

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Authors: Jill Round

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In the economic system, the financial sector plays a crucial role as an intermediary between market participants, other financial institutions, and customers. Financial institutions such as banks have to make decisions to satisfy the demands of all the participants by keeping abreast of regulatory change. In recent years, progress has been made regarding frameworks, development of rules, standards, and processes to manage risks in the banking sector. The increasing focus of regulators and policymakers placed on risk management, corporate governance, and the organization’s culture is of special interest as it requires a well-resourced risk controlling function, compliance function, and internal audit function. In the past years, the relevance of these functions that make up the so-called Three Lines of Defense has moved from the backroom to the boardroom. The approach of the model can vary based on the various organizational characteristics. Due to the intense regulatory requirements, organizations operating in the financial sector have more mature models. In less regulated industries there is more cloudiness about what tasks are allocated where. All parties strive to achieve their objectives through the effective management of risks and serve the identical stakeholders. Today, the Three Lines of Defense model is used throughout the world. The research looks at trends and emerging issues in the professions of the Three Lines of Defense within the banking sector. The answers are believed to helping to explain the increasing regulatory requirements for the banking sector. While the number of supervisory practices increases the risk management requirements intensify and demand more regulatory compliance at the same time. The Structural Equation Modeling (SEM) is applied by making use of conducted surveys in the research field. It aims to describe (i) the theoretical model regarding the applicable linearity relationships, (ii) the causal relationship between multiple predictors (exogenous) and multiple dependent variables (endogenous), (iii) taking into consideration the unobservable variables and (iv) the measurement errors. The surveys conducted on the research field suggest that the observable variables are caused by various latent variables. The SEM consists of the 1) measurement model and the 2) structural model. There is a detectable correlation regarding the cause-effect relationship among the performed supervisory practices and the increasing scope of regulation. Supervisory practices reinforce the regulatory density. In the past, controls were placed after supervisory practices were conducted or incidents occurred. In further research, it is of interest to examine, whether risk management is proactive, reactive to incidents and supervisory practices or can be both at the same time.

Keywords: risk management, structural equation model, supervisory practice, three lines of defense

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Authors: Kalbende Krunal Ramesh

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The Carbon Capture and Storage Technology (CCS) provides a veritable platform to bridge the gap between the seemingly irreconcilable twin global challenges of ensuring a secure, reliable and diversified energy supply and mitigating climate change by reducing atmospheric emissions of carbon dioxide. Making its proper regulatory policy and making it flexible for the government and private company by law to regulate, also exploring the opportunity in this sector is the main aim of this paper. India's total annual emissions was 1725 Mt CO2 in 2011, which comprises of 6% of total global emission. It is very important to control the greenhouse gas emission for the environment protection. This paper discusses the various regulatory policy and technology adopted by some of the countries for successful using CCS technology. The brief geology of sedimentary basins in India is studied, ranging from the category I to category IV and deep water and potential for mature technology in CCS is reviewed. Areas not suitable for CO2 storage using presently mature technologies were over viewed. CSS and Clean development mechanism was developed for India, considering the various aspects from research and development, project appraisal, approval and validation, implementation, monitoring and verification, carbon credit issued, cap and trade system and its storage potential. The opportunities in oil and gas operations, power sector, transport sector is discussed briefly.

Keywords: carbon credit issued, cap and trade system, carbon capture and storage technology, greenhouse gas

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Authors: Karisma Karisma, Pardis Moslemzadeh Tehrani

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This study aims to conduct a high-level strategic dialogue on the lack of consensus, consistency, and legal certainty regarding blockchain-based energy prosumerism so that appropriate institutional and governance structures can be put in place to address the inadequacies and gaps in the legal and regulatory framework. The drive to achieve national and global decarbonization targets is a driving force behind climate goals and policies under the Paris Agreement. In recent years, efforts to ‘demonopolize’ and ‘decentralize’ energy generation and distribution have driven the energy transition toward decentralized systems, invoking concepts such as ownership, sovereignty, and autonomy of RE sources. The emergence of individual and collective forms of prosumerism and the rapid diffusion of blockchain is expected to play a critical role in the decarbonization and democratization of energy systems. However, there is a ‘regulatory void’ relating to individual and collective forms of prosumerism that could prevent the rapid deployment of blockchain systems and potentially stagnate the operationalization of blockchain-enabled energy sharing and trading activities. The application of broad and facile regulatory fixes may be insufficient to address the major regulatory gaps. First, to the authors’ best knowledge, the concepts and elements circumjacent to individual and collective forms of prosumerism have not been adequately described in the legal frameworks of many countries. Second, there is a lack of legal certainty regarding the creation and adaptation of business models in a highly regulated and centralized energy system, which inhibits the emergence of prosumer-driven niche markets. There are also current and prospective challenges relating to the legal status of blockchain-based platforms for facilitating energy transactions, anticipated with the diffusion of blockchain technology. With the rise of prosumerism in the energy sector, the areas of (a) network charges, (b) energy market access, (c) incentive schemes, (d) taxes and levies, and (e) licensing requirements are still uncharted territories in many countries. The uncertainties emanating from this area pose a significant hurdle to the widespread adoption of blockchain technology, a complementary technology that offers added value and competitive advantages for energy systems. The authors undertake a conceptual and theoretical investigation to elucidate the lack of consensus, consistency, and legal certainty in the study of blockchain-based prosumerism. In addition, the authors set an exploratory tone to the discussion by taking an analytically eclectic approach that builds on multiple sources and theories to delve deeper into this topic. As an interdisciplinary study, this research accounts for the convergence of regulation, technology, and the energy sector. The study primarily adopts desk research, which examines regulatory frameworks and conceptual models for crucial policies at the international level to foster an all-inclusive discussion. With their reflections and insights into the interaction of blockchain and prosumerism in the energy sector, the authors do not aim to develop definitive regulatory models or instrument designs, but to contribute to the theoretical dialogue to navigate seminal issues and explore different nuances and pathways. Given the emergence of blockchain-based energy prosumerism, identifying the challenges, gaps and fragmentation of governance regimes is key to facilitating global regulatory transitions.

Keywords: blockchain technology, energy sector, prosumer, legal and regulatory.

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Authors: Ilya B. Tsyrlov, Dmitry Y. Oshchepkov

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A computational search for dioxin response elements (DREs) in genes of proteins comprising the Ah receptor (AhR) cytosolic core complex was performed by highly efficient tool SITECON. Eventually, the following number of new DREs in 5’flanking region was detected by SITECON: one in AHR gene, five in XAP2, eight in HSP90AA1, and three in HSP90AB1 genes. Numerous DREs found in genes of AhR and AhR cytosolic complex members would shed a light on potential mechanisms of expression, the stoichiometry of unliganded AhR core complex, and its degradation vs biosynthesis dynamics resulted from treatment of target cells with the AhR most potent ligand, 2,3,7,8-TCDD. With human viruses, reduced susceptibility to TCDD of geneencoding HIV-1 P247 was justified by the only potential DRE determined in gag gene encoding HIV-1 P24 protein, whereas the regulatory region of CMV genes encoding IE gp/UL37 has five potent DRE, 1.65 kb/UL36 – six DRE, pp65 and pp71 – each has seven DRE, and pp150 – ten DRE. Also, from six to eight DRE were determined with SITECON in the regulatory region of HSV-1 IE genes encoding tegument proteins, UL36 and UL37, and of UL19 gene encoding bindingglycoprotein C (gC). So, TCDD in the low picomolar range may activate in human cells AhR: Arnt transcription pathway that triggers CMV and HSV-1 reactivation by binding to numerous promoter DRE within immediate-early (IE) genes UL37 and UL36, thus committing virus to the lytic cycle.

Keywords: dioxin response elements, Ah receptor, AhR: Arnt transcription pathway, human and viral genes

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Authors: Paulina Pietrzak

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The understanding of the role of the contemporary translator is fraught with contradictions and idealistic visions of individuals who, by definition, should be fully competent and versatile. In spite of the fact that lots of translation researchers have probed into the identification and exploration of the concept of translator competence, little study has been devoted to its metacognitive aspects. Due to the dynamic nature of the translator’s occupation, it is difficult to predict what specific skills will prove useful for novice translators in their professional career. Thus, it is crucial that the translator is self-regulated enough to adapt to changing job demands and effectively function in the contemporary, highly dynamic, translation market. The objective of the presentation is to investigate the role and nature of the translator’s self-regulation. It will also demonstrate the results of a pilot study into translation trainees’ self-regulatory skills and explore implications of these findings for translator training in relation to theories of student empowerment.

Keywords: cognitive translation research, translator competence, self-regulatory skills, translator training

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