Search results for: regulatory system

Authors: Dalia Kubiliūtė

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Lithuania is known as a trusted location for global business institutions, and it attracts investors with it’s competitive environment for financial service providers. Along with the aspiration to offer a strong results-oriented and innovations-driven environment for financial service providers, Lithuanian regulatory authorities consistently implement the European Union's high regulatory standards for financial activities, including sustainability-related disclosures. Since European Union directed its policy towards transition to a climate-neutral, green, competitive, and inclusive economy, additional regulatory requirements for financial market participants are adopted: disclosure of sustainable activities, transparency, prevention of greenwashing, etc. The financial sector is one of the key factors influencing the implementation of sustainability objectives in European Union policies and mitigating the negative effects of climate change –public funds are not enough to make a significant impact on sustainable investments, therefore directing public and private capital to green projects may help to finance the necessary changes. The topic of the study is original and has not yet been widely analyzed in Lithuanian legal discourse. There are used quantitative and qualitative methodologies, logical, systematic, and critical analysis principles; hence the aim of this study is to reveal the problem of the implementation of the regulation on sustainability in the Lithuanian financial sector. Additional regulatory requirements could cause serious changes in financial business operations: additional funds, employees, and time have to be dedicated in order for the companies could implement these regulations. Lack of knowledge and data on how to implement new regulatory requirements towards sustainable reporting causes a lot of uncertainty for financial market participants. And for some companies, it might even be an essential point in terms of business continuity. It is considered that the supervisory authorities should find a balance between financial market needs and legal regulation.

Keywords: financial, legal, regulatory, sustainability

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Authors: Nnodi Chinweikpe Akelachi, Adebayo Oladini Kachollom Ifeoma

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Insecurity and the possession of nuclear weapons for non-peaceful purposes constitute a major threat to global peace and security, and this undermines the capacity for sustainable development. In Nigeria, the threat of terrorism is a challenge to national stability. For over a decade, Nigeria has been faced with insecurity ranging from Boko-Haram terrorist groups, kidnapping and banditry. The threat exhibited by this non-state actor poses a huge challenge to nuclear and radiological high risks facilities in Nigeria. This challenge has resulted in the regulatory authority and International stakeholders formulating policies for a good mitigation strategy. This strategy is enshrined in formulated laws, regulations and guides like the repealed Nuclear Safety and Radiation Protection Act 19 of 1995 (Nuclear safety, Physical Security and Safeguards Bill), the Nigerian Physical Protection of Nuclear Material and Nuclear Facilities, and Nigerian Nuclear Safeguards Regulations of 2021. All this will help Nigeria’s effort to meet its national nuclear security and safeguards obligations. To further enhance the implementation of nuclear security and safeguards system, Nigeria has signed the Non-Proliferation Treaty (NPT) in 1970, the Comprehensive Safeguards Agreement (INFCIRC/358) in 1988, Additional Protocol in 2007 as well as the Convention on Physical Protection of Nuclear Material and its amendment in 2005. In view of the evolving threats by non-state actors in Nigeria, physical protection security upgrades are being implemented in nuclear and all high-risk radiological facilities through the support of the United States Department of Energy (US-DOE). Also, the IAEA has helped strengthen nuclear security and safeguard systems through the provision of technical assistance and capacity development. Efforts are being made to address some of the challenges identified in the cause of implementing the measures for effective nuclear security and safeguards systems in Nigeria. However, there are eminent challenges in the implementation of the measures within the security and systems in Nigeria. These challenges need to be addressed for an effective security and safeguard regime in Nigeria. This paper seeks to address the challenges encountered in implementing the regulatory and stakeholder measures for effective security and safeguards regime in Nigeria, amongst others.

Keywords: nuclear regulatory body, nuclear facilities and activities, international stakeholders, security and safeguards measures

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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: Guldana Zhigerbayeva, Ming Yang

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Transportation of hazardous materials (HAZMAT) is inevitable in the process industries. The statistics show a significant number of accidents has occurred during the transportation of HAZMAT. This makes risk management of HAZMAT transportation an important topic. The tree-based methods including fault-trees, event-trees and cause-consequence analysis, and Bayesian network, have been applied to risk management of HAZMAT transportation. However, there is limited work on the development of a systematic approach. The existing approaches fail to build up the linkages between the regulatory requirements and the safety measures development. The analysis of historical data from the past accidents’ report databases would limit our focus on the specific incidents and their specific causes. Thus, we may overlook some essential elements in risk management, including regulatory compliance, field expert opinions, and suggestions. A systematic approach is needed to translate the regulatory requirements of HAZMAT transportation into specified safety measures (both technical and administrative) to support the risk management process. This study aims to first adapt the House of Quality (HoQ) to House of Safety (HoS) and proposes a new approach- Safety Function Deployment (SFD). The results of SFD will be used in a multi-criteria decision-support system to develop find an optimal route for HazMats transportation. The proposed approach will be demonstrated through a hypothetical transportation case in Kazakhstan.

Keywords: hazardous materials, risk assessment, risk management, quality function deployment

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Authors: S. Subramaniam, J. S. A. Rao, P. Ramdas, K. R. Selvaduray, N. M. Han, M. K. Kutty, A. K. Radhakrishnan

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Immune system is a complex system where the immune cells have the capability to respond against a wide range of immune challenges including cancer progression. However, in the event of cancer development, tumour cells trigger immunosuppressive environment via activation of myeloid-derived suppressor cells and T regulatory (Treg) cells. The Treg cells are subset of CD4+ T lymphocytes, known to have crucial roles in regulating immune homeostasis and promoting the establishment and maintenance of peripheral tolerance. Dysregulation of these mechanisms could lead to cancer progression and immune suppression. Recently, there are many studies reporting on the effects of natural bioactive compounds on immune responses against cancer. It was known that tocotrienol-rich-fraction consisting 70% tocotrienols and 30% α-tocopherol is able to exhibit immunomodulatory as well as anti-cancer properties. Hence, this study was designed to evaluate the effects of gamma-tocotrienol (G-T3) supplementation on T-reg cells in a syngeneic mouse model of breast cancer. In this study, female BALB/c mice were divided into two groups and fed with either soy oil (vehicle) or gamma-tocotrienol (G-T3) for two weeks followed by inoculation with tumour cells. All the mice continued to receive the same supplementation until day 49. The results showed a significant reduction in tumour volume and weight in G-T3 fed mice compared to vehicle-fed mice. Lung and liver histology showed reduced evidence of metastasis in tumour-bearing G-T3 fed mice. Besides that, flow cytometry analysis revealed T-helper cell population was increased, and T-regulatory cell population was suppressed following G-T3 supplementation. Moreover, immunohistochemistry analysis showed that there was a marked decrease in the expression of FOXP3 in the G-T3 fed tumour bearing mice. In conclusion, the G-T3 supplementation showed good prognosis towards breast cancer by enhancing the immune response in tumour-bearing mice. Therefore, gamma-T3 can be used as immunotherapy agent for the treatment of breast cancer.

Keywords: breast cancer, gamma tocotrienol, immune suppression, supplement

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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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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: Chamseddine Barki, Salam Labidi, Hanen Boussi Rahmouni

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In this article, we present the principle and suitable methodology for the design of a medical ontology that highlights the radiological and dosimetric knowledge, applied in diagnostic radiology and radiation-therapy. Our ontology, which we named «Onto.Rap», is the subject of radiation protection in medical and radiology centers by providing a standardized regulatory oversight. Thanks to its added values of knowledge-sharing, reuse and the ease of maintenance, this ontology tends to solve many problems. Of which we name the confusion between radiological procedures a practitioner might face while performing a patient radiological exam. Adding to it, the difficulties they might have in interpreting applicable patient radioprotection standards. Here, the ontology, thanks to its concepts simplification and expressiveness capabilities, can ensure an efficient classification of radiological procedures. It also provides an explicit representation of the relations between the different components of the studied concept. In fact, an ontology based-radioprotection expert system, when used in radiological center, could implement systematic radioprotection best practices during patient exam and a regulatory compliance service auditing afterwards.

Keywords: knowledge, ontology, radiation protection, radiology

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Authors: Nino Grigolaia

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Introduction: The article discusses the experience of the EU in the social field, analyzes the peculiarities of the functioning of the social system in Georgia, and reveals the priority and importance of social policy. Methodology: Different research methods are applied in the presented paper. There are used induction, deduction, analysis, synthesis, analogy, correlation, and statistical observation methodologies in the work. Main Findings: Based on the analysis of social security reforms in Georgia, the main systematic problems are detected, the recommendations on social security system components, integration of the social security field in the unified insurance system, the formation of the national social system, perfection of the legislative, regulatory framework of social protection, adoption of foreign experience are developed in the article. Conclusion: The article concludes that the social protection system in Georgia is at an early stage of development, with the significant impact of factors such as high level of unemployment, low pensions, a large number of families living under the poverty line, and other ones. Accordingly, it is well-established that the study of the social security problem in Georgia is still actual. Based on the analysis, appropriate suggestions in the field of social security are made, and relevant recommendations are proposed.

Keywords: social security, social system, social policy, social security models

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Authors: Javier Sanchez Vidal, Ciarán Mac An Bhaird, Brian Lucey

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This study examines the decision by firm owners not to apply for intermediated debt due to a perception that their application will be rejected. Based on a sample of SMEs in 9 European countries over the period 2009-2011, we examine potential explanatory factors for borrower discouragement, including firm, macroeconomic, regulatory and banking industry variables. Compared with firms that applied for bank loans, discouraged borrowers are smaller, younger, have declining turnover and an increasing debt/assets ratio. Perceived willingness of banks to lend rather than the company’s own credit history is more important to encourage applications. Perceptions of refusal are procyclical and may be self-perpetuating. Increased concentration in the banking sector reduces discouragement, indicating the importance of relationship banking. Transmission of macro effects through the banking system and economic environment may also lead to higher levels of discouragement. A good regulatory scheme is also advisable, either for the lenders or the borrowers (overall the good ones).

Keywords: entrepreneurial finance, discouraged borrowers, banking, financial crisis, eurozone

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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: 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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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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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: 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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Authors: Mohamed Aljarallah, Mohamed Nurullah, George Saridakis

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This paper aims and objectives are to investigate how the structural change of the financial regulatory bodies affect the financial supervision and how the regulators can design such a structure with taking into account; the Central Bank, the conduct of business and the prudential regulators, it will also consider looking at the structure of the international regulatory bodies and what barriers are found. There will be five questions to be answered; should conduct of business and prudential regulation be separated? Should the financial supervision and financial stability be separated? Should the financial supervision be under the Central Bank? To what extent the politician should intervene in changing the regulatory and supervisory structure? What should be the regulatory and supervisory structure when there is financial conglomerate? Semi structure interview design will be applied. This research sample selection contains a collective of financial regulators and supervisors from the emerged and emerging countries. Moreover, financial regulators and supervisors must be at a senior level at their organisations. Additionally, senior financial regulators and supervisors would come from different authorities and from around the world. For instance, one of the participants comes from the International Bank Settlements, others come from European Central Bank, and an additional one will come from Hong Kong Monetary Authority and others. Such a variety aims to fulfil the aims and objectives of the research and cover the research questions. The analysis process starts with transcription of the interview, using Nvivo software for coding, applying thematic interview to generate the main themes. The major findings of the study are as follow. First, organisational structure changes quite frequently if the mandates are not clear. Second, measuring structural change is difficult, which makes the whole process unclear. Third, effective coordination and communication are what regulators looking for when they change the structure and that requires; openness, trust, and incentive. In addition to that, issues appear during the event of crisis tend to be the reason why the structure change. Also, the development of the market sometime causes a change in the regulatory structure. And, some structural change occurs simply because of the international trend, fashion, or other countries' experiences. Furthermore, when the top management change the structure tends to change. Moreover, the structure change due to the political change, or politicians try to show they are doing something. Finally, fear of being blamed can be a driver of structural change. In conclusion, this research aims to provide an insight from the senior regulators and supervisors from fifty different countries to have a clear understanding of why the regulatory structure keeps changing from time to time through a qualitative approach, namely, semi-structure interview.

Keywords: financial regulation bodies, financial regulatory structure, global financial regulation, financial crisis

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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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Authors: Maulana Ayoub Ali, Pradeep Kulshrestha

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Laws of any given secular state have a huge contribution in the growth of the Islamic banking system because the system uses conventional laws to govern its activities. Therefore, the former should be ready to accommodate the latter in order to make the Islamic banking system work properly without affecting the current conventional banking system and therefore without affecting its system. Islamic financial rules have been practiced since the birth of Islam. Following the recent world economic challenges in the financial sector, a quick rebirth of the contemporary Islamic ethical banking system took place. The coming of the Islamic banking system is due to various reasons including but not limited to the failure of the interest based economy in solving financial problems around the globe. Therefore, the Islamic banking system has been adopted as an alternative banking system in order to recover the highly damaged global financial sector. But the Islamic banking system has been facing a number of challenges which hinder its smooth operation in different parts of the world. It has not been the aim of this paper to discuss other challenges rather than the legal ones, but the same was partly discussed when it was justified that it was proper to do so. Generally, there are so many things which have been discovered in the course of writing this paper. The most important part is the issue of the regulatory and supervisory framework for the Islamic banking system in Tanzania and in other nations is considered to be a crucial part for the development of the Islamic banking industry. This paper analyses what has been observed in the study on that area and recommends for necessary actions to be taken on board in a bid to make Islamic banking system reach its climax of serving the larger community by providing ethical, equitable, affordable, interest-free and society cantered banking system around the globe.

Keywords: Islamic banking, interest free banking, ethical banking, legal framework

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Authors: Zidane Abderrezzaq

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In contrast to recent successful developments in macro monetary policies, the modelling, measurement and management of systemic financial stability has remained problematical. Indeed, the focus of most effort has been on improving individual, rather than systemic, bank risk management; the Basel II objective has been to bring regulatory bank capital into line with the (sophisticated) banks’ assessment of their own economic capital. Even at the individual bank level there are concerns over appropriate diversification allowances, differing objectives of banks and regulators, the need for a buffer over regulatory minima, and the distinction between expected and unexpected losses (EL and UL). At the systemic level the quite complex and prescriptive content of Basel II raises dangers of ‘endogenous risk’ and procyclicality. Simulations suggest that this latter could be a serious problem. In an extension to the main analysis we study how liquidity effects interact with banking structure to produce a greater chance of systemic breakdown. We finally consider how the risk of contagion might depend on the degree of asymmetry (tiering) inherent in the structure of the banking system. A number of our results have important implications for public policy, which this paper also draws out.

Keywords: systemic stability, financial regulation, credit risk, systemic risk

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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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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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Authors: Hadiza Kabir Bako, Munir Abba Dandago

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The fright of food-borne diseases as a result of animal health across the globe is creating the need for origin confirmation, safety of food and method of identification of food produce within the supply chain. In this paper, we investigated two commercial and one backyard poultry farm; live poultry, poultry meat and egg. We propose various implementation options for the poultry traceability system with respect to trace and track, and food recall and withdrawal requirements. With the intention that farmers, Investors or Regulatory agencies would find it useful for the Nigerian poultry sector and we highlight the future needs and challenges that lie ahead in the two most significant system of poultry production in Nigeria: the commercial poultry and backyard breeding.

Keywords: farm, food safety, food traceability, poultry

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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: 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

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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: David Sarpong, Waleed Khursheed, Ernest Danquah, Erin Murphy

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Shigella is a pathogenic bacterium responsible for shigellosis, a severe diarrheal disease that claims the lives of immunocompromised individuals worldwide. To develop therapeutics against this disease, an understanding of the molecular mechanisms underlying the pathogen’s physiology is crucial. Small non-coding RNAs (sRNAs) have emerged as important regulators of bacterial physiology, including as components of toxin-antitoxin systems. In this study, we investigated the role of RyfA in S. flexneri physiology and virulence. RyfA, originally identified as an sRNA in Escherichia coli, is conserved within the Enterobacteriaceae family, including Shigella. Whereas two copies of ryfA are present in S. dysenteriae, all other Shigella species contain only one copy of the gene. Additionally, we identified a putative open reading frame within the RyfA transcript, suggesting that it may be a dual-functioning gene encoding a small protein in addition to its sRNA function. To study ryfA in vitro, we cloned the gene into an inducible plasmid and observed the effect on bacterial growth. Here, we report that RyfA production inhibits the growth of S. flexneri, and this inhibition is dependent on the contained open reading frame. In-silico analyses have revealed the presence of two divergently transcribed sRNAs, RyfB1 and RyfB2, which share nucleotide complementarity with RyfA and thus are predicted to function as anti-toxins. Our data demonstrate that RyfB2 has a stronger antitoxin effect than RyfB1. This regulatory pattern suggests a novel form of a toxin-antitoxin system in which the activity of a single toxin is inhibited to varying degrees by two sRNA antitoxins. Studies are ongoing to investigate the regulatory mechanism(s) of the antitoxin genes, as well as the downstream targets and mechanism of growth inhibition by the RyfA toxin. This study offers distinct insights into the regulatory mechanisms underlying Shigella physiology and may inform the development of new anti-Shigella therapeutics.

Keywords: sRNA, shigella, toxin-antitoxin, Type 1 toxin antitoxin

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Authors: Calvince Okome Odeny

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There is a current action to increase radiotherapy services in Kenya. The National government of Kenya, in collaboration with the county governments, has embarked on building radiotherapy centers in all 47 regions of the country. As these new centers are established in Kenya, it has to be ensured that minimum radiation safety standards are in place prior to operation. For full implementation of this, it is imperative that more Research and training for regulators are done on radiation protection, and safety and national regulatory infrastructure is geared towards ensuring radiation protection and safety in all aspects of the use of external radiotherapy practices. The present work aims at reviewing the level of protection and safety for patients and staff during external beam radiotherapy using Linac in Kenya and provides relevant guidance to improve protection and safety. A retrospective evaluation was done to verify whether those occupationally exposed workers and patients are adequately protected from the harmful effect of radiation exposure during the treatment procedures using Linac. The project was experimental Research, also including an analysis of resource documents obtained from the literature and international organizations. The critical findings of the work revealed that the key elements of protection of occupationally exposed workers and patients include a comprehensive quality Management system governing all planned activities from siting, safety, and design of the Facility, construction, acceptance testing, commissioning, operation, and decommissioning of the Facility; Government empowering the Regulatory Authority to license Medical Linear facilities and to enforce the applicable regulations to ensure adequate protection; A comprehensive Radiation Protection and Safety program must be established to ensure adequate safety and protection of workers and patients during treatment planning and treatment delivery of patients and categories of staff associated with the Facility must be well educated and trained to perform professionally with a commitment to sound safety culture. Relevant recommendations from the findings are shared with the Medical Linear Accelerator facilities and the regulatory authority to provide guidance and continuous improvement of protection and safety to improve regulatory oversight.

Keywords: oncology, radiotherapy, protection, staff

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Authors: Muneeb Ahmad, Ali Raza

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A computational method inspired by the immune system (IS) is presented, leveraging its shared characteristics of robustness, fault tolerance, scalability, and adaptability with swarm intelligence. This method aims to showcase flocking behaviors in a swarm of robots (SR). The innate part of the IS offers a variety of reactive and probabilistic cell functions alongside its self-regulation mechanism which have been translated to enable swarming behaviors. Although, the research is specially focused on flocking behaviors in a variety of simulated environments using e-puck robots in a physics-based simulator (CoppeliaSim); the artificial innate immune system (AIIS) can exhibit other swarm behaviors as well. The effectiveness of the immuno-inspired approach has been established with extensive experimentations, for scalability and adaptability, using standard swarm benchmarks as well as the immunological regulatory functions (i.e., Dendritic Cells’ Maturity and Inflammation). The AIIS-based approach has proved to be a scalable and adaptive solution for emulating the flocking behavior of SR.

Keywords: artificial innate immune system, flocking swarm, immune system, swarm intelligence

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Authors: Abhimanyu Behera

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Over the past few years, energy security and sustainable development have moved rapidly into the global agenda. There are two main reasons: first, the impact of high and often volatile energy prices; second, concerns over environmental sustainability particularly about the global climate. Both issues are critically important in which impressive economic growth has boosted the demand for energy and put corresponding strains on the environment. Energy security is a broad concept that focuses on energy availability and pricing. Specifically, it refers to the ability of the energy supply system i.e. suppliers, transporters, distributors and regulatory, financial and R&D institutions to deliver the amount of competitively priced energy that customers demand, within accepted standards of reliability, timeliness, quality, safety. Traditionally, energy security has been defined in the context of the geopolitical risks to external oil supplies but today it is encompassing all energy forms, all the external and internal links bringing the energy to the final consumer, and all the many ways energy supplies can be disrupted including equipment malfunctions, system design flaws, operator errors, malicious computer activities, deficient market and regulatory frameworks, corporate financial problems, labour actions, severe weather and natural events, aggressive acts (e.g. war, terrorism and sabotage), and geopolitical disruptions. In practice, the most challenging disruptions are those linked to: 1) extreme weather events; 2) mismatched electricity supply and demand; 3) regulatory failures; and 4) concentration of oil and gas resources in certain regions of the world. However, insecure energy supplies inhibit development by raising energy costs and imposing expensive cuts in services when disruptions actually occur. The energy supply sector can best advance sustainable development by producing and delivering secure and environmentally-friendly sources of energy and by increasing the efficiency of energy use. With this objective, this paper seeks to highlight the significance of energy security and sustainable development in today’s world. Moreover, it critically overhauls the major challenges towards sustainability of energy security and what are the major policies are taken to overcome these challenges by Government is lucidly explicated in this paper.

Keywords: energy, policies, security, sustainability

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Authors: Anjuri Srivastava, Akhouri Nishant Bhanu

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Soil is a natural material with a distinctive form. It is regarded to be a natural source of nutrients and minerals for plants. It meets many of our needs through the crops, trees, and inhabited places that have grown on or underneath it. Productive and rich soil plays a crucial role in both its wealth and well-being. If any external substance changes the soil's composition, it directly impacts the plant that was grown in that soil. If the soil is deficient in one or more essential components, fly ash can be utilized as fertilizer by incorporating it into the soil. This can also increase the porosity of the soil. Fly ash has a sufficient concentration of essential components to promote the growth of plants. The high concentration of elements in fly ash, including C, Na, K, Fe, and Zn, increases crop yields. Hazardous compounds harm plant life as soon as they get into the soil. The US Environmental Protection Agency and other regulatory agencies have found it as non-hazardous. By employing fly ash as a potential fertilizer supplement for degraded soils, the problem of disposing of solid waste can be partially handled. Fly ash's rapid growth can slow down mineralization because it contains a higher proportion of harmful heavy metals. The chemical characteristics, inclusion ratio, and composting process of fly ash have a significant impact on the fly ash compost’s potential to improve soil nutrition. Research institutions and regulatory agencies have been thoroughly investigating fly ash for a long time. Guard cells on plant leaves that accumulate fly ash trigger the regulatory system. Fly ash increases both chemical and physical damage at certain humidity levels. The lengthy sowing period is caused by the high levels of fly ash in the soil, which also slows down seedling germination and growth. For the sake of human health, it is crucial to consider the bioaccumulation of dangerous heavy metals and their necessary concentrations in plant tissues and soil.

Keywords: soil, fly ash, plant, fertilizer, composts

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