Search results for: regulatory compliance.

Authors: Michael Amberg, Dipl. Kfm. Johannes C. Panitz

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Compliance requires an effective communication within an enterprise as well as towards a company-s external environment. This requirement commences with the implementation of compliance within large scale compliance projects and still persists in the compliance reporting within standard operations. On the one hand the understanding of compliance necessities within the organization is promoted. On the other hand reduction of asymmetric information with compliance stakeholders is achieved. To reach this goal, a central reporting must provide a consolidated view of different compliance efforts- statuses. A concept which could be adapted for this purpose is the balanced scorecard by Kaplan / Norton. This concept has not been analyzed in detail concerning its adequacy for a holistic compliance reporting starting in compliance projects until later usage in regularly compliance operations. At first, this paper evaluates if a holistic compliance reporting can be designed by using the balanced scorecard concept. The current status of compliance reporting clearly shows that scorecards are generally accepted as a compliance reporting tool and are already used for corporate governance reporting. Additional specialized compliance IT - solutions exist in the market. After the scorecard-s adequacy is thoroughly examined and proofed, an example strategy map as the basis to derive a compliance balanced scorecard is defined. This definition answers the question on proceeding in designing a compliance reporting tool.

Keywords: Balanced Scorecard, Compliance, ComplianceReporting, Compliance Scorecard.

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Authors: Tim Nedyalkov

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A business decision to move to the cloud brings fundamental changes in how an organization develops and delivers its Information Technology solutions. The accelerated pace of digital transformation across businesses and government agencies increases the reliance on cloud-based services. Collecting, managing, and retaining large amounts of data in cloud environments make information security and data privacy protection essential. It becomes even more important to understand what key factors drive successful cloud adoption following the commencement of the Privacy Amendment Notifiable Data Breaches (NDB) Act 2017 in Australia as the regulatory changes impact many organizations and industries. This quantitative correlational research investigated the governance, risk management, and compliance factors contributing to cloud security success. The factors influence the adoption of cloud computing within an organizational context after the commencement of the NDB scheme. The results and findings demonstrated that corporate information security policies, data storage location, management understanding of data governance responsibilities, and regular compliance assessments are the factors influencing cloud computing adoption. The research has implications for organizations, future researchers, practitioners, policymakers, and cloud computing providers to meet the rapidly changing regulatory and compliance requirements.

Keywords: Cloud compliance, cloud security, cloud security governance, data governance, privacy protection.

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Authors: Brennan Lodge

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Amidst a complex regulatory landscape, Retrieval Augmented Generation (RAG) emerges as a transformative tool for Governance Risk and Compliance (GRC) officers. This paper details the application of RAG in synthesizing Large Language Models (LLMs) with external knowledge bases, offering GRC professionals an advanced means to adapt to rapid changes in compliance requirements. While the development for standalone LLMs is exciting, such models do have their downsides. LLMs cannot easily expand or revise their memory, and they cannot straightforwardly provide insight into their predictions, and may produce “hallucinations.” Leveraging a pre-trained seq2seq transformer and a dense vector index of domain-specific data, this approach integrates real-time data retrieval into the generative process, enabling gap analysis and the dynamic generation of compliance and risk management content. We delve into the mechanics of RAG, focusing on its dual structure that pairs parametric knowledge contained within the transformer model with non-parametric data extracted from an updatable corpus. This hybrid model enhances decision-making through context-rich insights, drawing from the most current and relevant information, thereby enabling GRC officers to maintain a proactive compliance stance. Our methodology aligns with the latest advances in neural network fine-tuning, providing a granular, token-level application of retrieved information to inform and generate compliance narratives. By employing RAG, we exhibit a scalable solution that can adapt to novel regulatory challenges and cybersecurity threats, offering GRC officers a robust, predictive tool that augments their expertise. The granular application of RAG’s dual structure not only improves compliance and risk management protocols but also informs the development of compliance narratives with pinpoint accuracy. It underscores AI’s emerging role in strategic risk mitigation and proactive policy formation, positioning GRC officers to anticipate and navigate the complexities of regulatory evolution confidently.

Keywords: Retrieval Augmented Generation, Governance Risk and Compliance, Cybersecurity, AI-driven Compliance, Risk Management, Generative AI.

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Authors: Atul Khurana, Rajul Rastogi, Hans-Joachim Gamperl

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The pharmaceutical companies are getting more inclined towards patient support programs (PSPs) which assist patients and/or healthcare professionals (HCPs) in more desirable disease management and cost-effective treatment. The utmost objective of these programs is patient care. The PSPs may include financial assistance to patients, medicine compliance programs, access to HCPs via phone or online chat centers, etc. The PSP has a crucial role in terms of customer acquisition and retention strategies. During the conduct of these programs, Marketing Authorisation Holder (MAH) may receive information related to concerned medicinal products, which is usually reported by patients or involved HCPs. This information may include suspected adverse reaction(s) during/after administration of medicinal products. Hence, the MAH should design PSP to comply with regulatory reporting requirements and avoid non-compliance during PV inspection. The emergence of wireless health devices is lowering the burden on patients to manually incorporate safety data, and building a significant option for patients to observe major swings in reference to drug safety. Therefore, to enhance the adoption of these programs, MAH not only needs to aware patients about advantages of the program, but also recognizes the importance of time of patients and commitments made in a constructive manner. It is indispensable that strengthening the public health is considered as the topmost priority in such programs, and the MAH is compliant to Pharmacovigilance (PV) requirements along with regulatory obligations.

Keywords: Drug safety, good pharmacovigilance practice, patient support program, pharmacovigilance.

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Authors: Hiba Hasan, Khalid Raza

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Reverse engineering of genetic regulatory network involves the modeling of the given gene expression data into a form of the network. Computationally it is possible to have the relationships between genes, so called gene regulatory networks (GRNs), that can help to find the genomics and proteomics based diagnostic approach for any disease. In this paper, clustering based method has been used to reconstruct genetic regulatory network from time series gene expression data. Supercoiled data set from Escherichia coli has been taken to demonstrate the proposed method.

Keywords: Gene expression, gene regulatory networks (GRNs), clustering, data preprocessing, network visualization.

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Authors: Gary Marlin Sandquist

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Currently, a large number of license activities (Early Site Permits, Combined Operating License, reactor certifications, etc.), are pending for review before the United States Nuclear Regulatory Commission (US NRC). Much of the senior staff at the NRC is now committed to these review and licensing actions. To address this additional workload, the NRC has recruited a large number of new Regulatory Staff for dealing with these and other regulatory actions such as the US Fleet of Research and Test Reactors (RTRs). These reactors pose unusual demands on Regulatory Staff since the US Fleet of RTRs, although few (32 Licensed RTRs as of 2010), they represent a broad range of reactor types, operations, and research and training aspects that nuclear reactor power plants (such as the 104 LWRs) do not pose. The NRC must inspect and regulate all these facilities. This paper addresses selected training topics and regulatory activities providedNRC Inspectors for RTRs.

Keywords: Regulations, Research and Test Reactors, Training, US NRC

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Authors: M. Bruzza, M. Tupia, F. Rodríguez

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As part of the regulatory compliance process and the streamlining of public administration, the Peruvian government has implemented the National E-Government Plan in all state institutions with the aim of providing citizens with solid services based on the use of Information and Communications Technologies (ICT). As part of the regulations, the requisites to be met by public institutions have been submitted. However, the lack of an implementation model was detected, one that can serve as a guide to such institutions in order to materialize the organizational and technological structures needed, which allow them to provide the required digital services. This paper develops an implementation model of electronic government (e-government) for Peru’s state institutions, in compliance with current regulations based on a COBIT 5.0 framework. Furthermore, the paper introduces phase 1 of this model: business and IT goals, the goals cascade and the future model of processes.

Keywords: E-government, implementation, model, COBIT 5.0, digital services, u-government, m-government.

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Authors: Merab Khokhobaia

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Within the framework of this research, the regulatory documents, which are in force in relation to this industry, were analyzed. The main attention is turned to their modernization and necessity of their compliance with European standards. It is a current issue to direct the efforts of state policy on support of business by implementing infrastructural projects, as well as by development of human resources, which may be possible by supporting the relevant higher and vocational studying-educational programs.

Keywords: Regional Development, Tourism Industry, Tourism Policy, Transition.

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Authors: Jana Chvalkovska, Petr Jansky, Petr Teply

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The impact assessment in its various forms has recently become a very important part of policy-making and legislation in many different countries. Regulatory impact assessment (RIA) is yet another set of analytical methods deployed in the legislation of the European Union, of many developed countries as well as in many developing ones such as Mexico, Malaysia and Philippines. The aim of this paper is to provide a theoretical background for economic models in regulatory impact assessment and an overview of their application especially on the financial market in the Czech Republic. We found out an inadequate application of these models, what makes room for further research in this field.

Keywords: regulatory impact assessment, RIA, impact evaluation, building societies, Czech Republic

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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: Ontology, radiology, medicine, knowledge, radiation protection, audit.

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Authors: Rajoo Balaji, Omar Yaakob

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The Ballast Water Convention requires less than 5% of the world tonnage for ratification. Consequently, ships will have to comply with the requirements. Compliance evaluation and enforcement will become mandatory. Ship owners have to invest in treatment systems and shipboard personnel have to operate them and ensure compliance. The monitoring and enforcement will be the responsibilities of the Administrations. Herein, a review of the current status of the Ballast Water Management and the issues faced by these are projected. Issues range from efficacy and economics of the treatment systems to sampling and testing. Health issues of chemical systems, paucity of data for decision support etc., are other issues. It is emphasized that management of ballast water must be extended to ashore and sustainable solutions must be researched upon. An exemplar treatment system based on ship’s waste heat is also suggested.

Keywords: Ballast water management, Compliance evaluation, Compliance enforcement, Sustainability.

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Authors: J. T. Manhire

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A tax authority wants to take actions it knows will foster the greatest degree of voluntary taxpayer compliance to reduce the “tax gap.” This paper suggests that even if a tax authority could attain a state of complete knowledge, there are constraints on whether and to what extent such actions would result in reducing the macro-level tax gap. These limits are not merely a consequence of finite agency resources. They are inherent in the system itself. To show that this is one possible interpretation of the tax gap data, the paper formulates known results in a different way by analyzing tax compliance as a population with a single covariate. This leads to a standard use of the logistic map to analyze the dynamics of non-compliance growth or decay over a sequence of periods. This formulation gives the same results as the tax gap studies performed over the past fifty years in the U.S. given the published margins of error. Limitations and recommendations for future work are discussed, along with some implications for tax policy.

Keywords: Tax law, tax compliance, tax gap, income tax.

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Authors: Sevil Yildiz

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In parallel, broadcasting has changed rapidly with the changing of the world at the same area. Broadcasting is also influenced and reshaped in terms of the emergence of new communication technologies. These developments have resulted a lot of economic and social consequences. The most important consequences of these results are those of the powers of the governments to control over the means of communication and control mechanisms related to the descriptions of the new issues. For this purpose, autonomous and independent regulatory bodies have been established by the state. One of these regulatory bodies is the Radio and Television Supreme Council, which to be established in 1994, with the Code no 3984. Today’s Radio and Television Supreme Council which is responsible for the regulation of the radio and television broadcasts all across Turkey has an important and effective position as autonomous and independent regulatory body. The Radio and Television Supreme Council acts as being a remarkable organizer for a sensitive area of radio and television broadcasting on one hand, and the area of democratic, liberal and keep in mind the concept of the public interest by putting certain principles for the functioning of the Board control, in the context of media policy as one of the central organs, on the other hand. In this study, the role of the Radio and Television Supreme Council is examined in accordance with the Code no 3894 in order to control over the communication and control mechanisms as well as the examination of the changes in the duties of the Code No. 6112, dated 2011.

Keywords: Regulatory Boards, Radio and Television Supreme Council.

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Authors: Ines Hamdi, Mohamed Ben Ahmed

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The understanding of the system level of biological behavior and phenomenon variously needs some elements such as gene sequence, protein structure, gene functions and metabolic pathways. Challenging problems are representing, learning and reasoning about these biochemical reactions, gene and protein structure, genotype and relation between the phenotype, and expression system on those interactions. The goal of our work is to understand the behaviors of the interactions networks and to model their evolution in time and in space. We propose in this study an ontological meta-model for the knowledge representation of the genetic regulatory networks. Ontology in artificial intelligence means the fundamental categories and relations that provide a framework for knowledge models. Domain ontology's are now commonly used to enable heterogeneous information resources, such as knowledge-based systems, to communicate with each other. The interest of our model is to represent the spatial, temporal and spatio-temporal knowledge. We validated our propositions in the genetic regulatory network of the Aarbidosis thaliana flower

Keywords: Ontological model, spatio-temporal modeling, Genetic Regulatory Networks (GRNs), knowledge representation.

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Authors: Darby Tien-Hao Chang, Guan-Yu Shiu, You-Jie Sun

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Various cis-regulatory module (CRM) predictors have been proposed in the last decade. Several well-established CRM predictors adopted different categories of prediction strategies, including window clustering, probabilistic modeling and phylogenetic footprinting. Appropriate integration of them has a potential to achieve high quality CRM prediction. This study analyzed four existing CRM predictors (ClusterBuster, MSCAN, CisModule and MultiModule) to seek a predictor combination that delivers a higher accuracy than individual CRM predictors. 465 CRMs across 140 Drosophila melanogaster genes from the RED fly database were used to evaluate the integrated CRM predictor proposed in this study. The results show that four predictor combinations achieved superior performance than the best individual CRM predictor.

Keywords: Cis-regulatory module, transcription factor binding site.

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Authors: Shinji Oouchi, Hajime Nomura, Kung-Da Wu, Yong-Run Chen, Jui-Pin Hung

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This paper presents the variation of the dynamic characteristics of a spindle with the change of bearing preload. The correlations between the variation of bearing preload and fundamental modal parameters were first examined by conducting vibration tests on physical spindle units. Experimental measurements show that the dynamic compliance and damping ratio associated with the dominating modes were affected to vary with variation of the bearing preload. When the bearing preload was slightly deviated from a standard value, the modal frequency and damping ability also vary to different extent, which further enable the spindle to perform with different compliance. For the spindle used in this study, a standard preload value set on bearings would enable the spindle to behave a higher stiffness as compared with others with a preload variation. This characteristic can be served as a reference to examine the variation of bearing preload of spindle in assemblage or operation.

Keywords: Dynamic compliance, Bearing preload, Modal damping.

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Authors: Wenqin Wang, Shouming Zhong

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This paper presents the robust stability criteria for uncertain genetic regulatory networks with time-varying delays. One key point of the criterion is that the decomposition of the matrix ˜D into ˜D = ˜D1 + ˜D2. This decomposition corresponds to a decomposition of the delayed terms into two groups: the stabilizing ones and the destabilizing ones. This technique enables one to take the stabilizing effect of part of the delayed terms into account. Meanwhile, by choosing an appropriate new Lyapunov functional, a new delay-dependent stability criteria is obtained and formulated in terms of linear matrix inequalities (LMIs). Finally, numerical examples are presented to illustrate the effectiveness of the theoretical results.

Keywords: Genetic regulatory network, Time-varying delay, Uncertain system, Lyapunov-Krasovskii functional

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Authors: Achim Washington, Reece Clothier, Jose Silva

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System Safety Regulations (SSR) are a central component to the airworthiness certification of Unmanned Aircraft Systems (UAS). There is significant debate on the setting of appropriate SSR for UAS. Putting this debate aside, the challenge lies in how to apply the system safety process to UAS, which lacks the data and operational heritage of conventionally piloted aircraft. The limited knowledge and lack of operational data result in uncertainty in the system safety assessment of UAS. This uncertainty can lead to incorrect compliance findings and the potential certification and operation of UAS that do not meet minimum safety performance requirements. The existing system safety assessment and compliance processes, as used for conventional piloted aviation, do not adequately account for the uncertainty, limiting the suitability of its application to UAS. This paper discusses the challenges of undertaking system safety assessments for UAS and presents current and envisaged research towards addressing these challenges. It aims to highlight the main advantages associated with adopting a risk based framework to the System Safety Performance Requirement (SSPR) compliance process that is capable of taking the uncertainty associated with each of the outputs of the system safety assessment process into consideration. Based on this study, it is made clear that developing a framework tailored to UAS, would allow for a more rational, transparent and systematic approach to decision making. This would reduce the need for conservative assumptions and take the risk posed by each UAS into consideration while determining its state of compliance to the SSR.

Keywords: Part 1309 regulations, unmanned aircraft systems, system safety, uncertainty.

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Authors: C. V. Pietreanu, S. E. Zaharia, C. Dinu

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Hazard assessment and risks quantification are key components for estimating the impact of existing regulations. But since regulatory compliance cannot cover all risks in aviation, the authors point out that by studying causal factors and eliminating uncertainty, an accurate analysis can be outlined. The research debuts by making delimitations on notions, as confusion on the terms over time has reflected in less rigorous analysis. Throughout this paper, it will be emphasized the fact that the variation in human performance and organizational factors represent the biggest threat from an operational perspective. Therefore, advanced risk assessment methods analyzed by the authors aim to understand vulnerabilities of the system given by a nonlinear behavior. Ultimately, the mathematical modeling of existing hazards and risks by eliminating uncertainty implies establishing an optimal solution (i.e. risk minimization).

Keywords: Control, human factor, optimization, risk management, uncertainty.

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Authors: S. K. Balashanmugam, Padmavati Manchikanti, S. R. Subramanian

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The question of legal liability over injury arising out of the import and the introduction of GM food emerges as a crucial issue confronting to promote GM food and its derivatives. There is a greater possibility of commercialized GM food from the exporting country to enter importing country where status of approval shall not be same. This necessitates the importance of fixing a liability mechanism to discuss the damage, if any, occurs at the level of transboundary movement or at the market. There was a widespread consensus to develop the Cartagena Protocol on Biosafety and to give for a dedicated regime on liability and redress in the form of Nagoya Kuala Lumpur Supplementary Protocol on the Liability and Redress (‘N-KL Protocol’) at the international context. The national legal frameworks based on this protocol are not adequately established in the prevailing food legislations of the developing countries. The developing economy like India is willing to import GM food and its derivatives after the successful commercialization of Bt Cotton in 2002. As a party to the N-KL Protocol, it is indispensable for India to formulate a legal framework and to discuss safety, liability, and regulatory issues surrounding GM foods in conformity to the provisions of the Protocol. The liability mechanism is also important in the case where the risk assessment and risk management is still in implementing stage. Moreover, the country is facing GM infiltration issues with its neighbors Bangladesh. As a precautionary approach, there is a need to formulate rules and procedure of legal liability to discuss any kind of damage occurs at transboundary trade. In this context, the proposed work will attempt to analyze the liability regime in the existing Food Safety and Standards Act, 2006 from the applicability and domestic compliance and to suggest legal and policy options for regulatory authorities.

Keywords: Commercialisation, food safety, FSSAI, genetically modified foods, India, liability.

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Authors: M. McHugh, D. Lillis

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Mobile applications are being used to perform a wide variety of tasks in day-to-day life, ranging from checking email to controlling your home heating. Application developers have recognized the potential to transform a smart device into a medical device, by using a mobile medical application i.e. a mobile phone or a tablet. When initially conceived these mobile medical applications performed basic functions e.g. BMI calculator, accessing reference material etc.; however, increasing complexity offers clinicians and patients a range of functionality. As this complexity and functionality increases, so too does the potential risk associated with using such an application. Examples include any applications that provide the ability to inflate and deflate blood pressure cuffs, as well as applications that use patient-specific parameters and calculate dosage or create a dosage plan for radiation therapy. If an unapproved mobile medical application is marketed by a medical device organization, then they face significant penalties such as receiving an FDA warning letter to cease the prohibited activity, fines and possibility of facing a criminal conviction. Regulatory bodies have finalized guidance intended for mobile application developers to establish if their applications are subject to regulatory scrutiny. However, regulatory controls appear contradictory with the approaches taken by mobile application developers who generally work with short development cycles and very little documentation and as such, there is the potential to stifle further improvements due to these regulations. The research presented as part of this paper details how by adopting development techniques, such as agile software development, mobile medical application developers can meet regulatory requirements whilst still fostering innovation.

Keywords: Medical, mobile, applications, software Engineering, FDA, standards, regulations, agile.

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Authors: Benjamin Osei-Tutu

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Food contaminated with biological, chemical and physical hazards usually leads to foodborne illnesses which in turn increase the disease burden of developing and developed economies. Restaurants play a key role in the food service industry and violations in application of standardized food safety management systems in these establishments have been associated with foodborne disease outbreaks. This study was undertaken to assess the level of compliance to the Code of practice that was developed and implemented after conducting needs assessment of the food safety management systems employed by the Food Service Establishments in Ghana. Data on pre-licence inspections were reviewed to assess the compliance of the Food Service Establishments. During the period under review (2012-2016), 74.52% of the food service facilities in the hospitality industry were in compliance with the FDA’s code of practice. Main violations observed during the study bordered on facility layout and fabrication (61.8%) and this is because these facilities may not have been built for use as a food service establishment. Another fact that came to the fore was that the redesigning of the facilities to bring them into compliance required capital intensive investments, which some establishments are not prepared for. Other challenges faced by the industry regarded issues on records and documentations, personnel facilities and hygiene, raw materials acquisition, storage and control, and cold storage.

Keywords: Assessment, Accra, food safety management systems, restaurants, hotel.

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

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

Keywords: Aeronautics, certification, process modeling, project management, SME, systems engineering.

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Authors: Ananya Das, Arun Kumar, Gazala Habib, Vivekanandan Perumal

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Regulatory bodies has proposed limits on Particulate Matter (PM) concentration in air; however, it does not explicitly indicate the incorporation of effects of toxicities of constituents of PM in developing regulatory limits. This study aimed to provide a structured approach to incorporate toxic effects of components in developing regulatory limits on PM. A four-step human health risk assessment framework consists of - (1) hazard identification (parameters: PM and its constituents and their associated toxic effects on health), (2) exposure assessment (parameters: concentrations of PM and constituents, information on size and shape of PM; fate and transport of PM and constituents in respiratory system), (3) dose-response assessment (parameters: reference dose or target toxicity dose of PM and its constituents), and (4) risk estimation (metric: hazard quotient and/or lifetime incremental risk of cancer as applicable). Then parameters required at every step were obtained from literature. Using this information, an attempt has been made to determine limits on PM using component-specific information. An example calculation was conducted for exposures of PM_2.5 and its metal constituents from Indian ambient environment to determine limit on PM values. Identified data gaps were: (1) concentrations of PM and its constituents and their relationship with sampling regions, (2) relationship of toxicity of PM with its components.

Keywords: Air, component-specific toxicity, human health risks, particulate matter.

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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-β, FoxP3, Graves’ disease.

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Authors: Mădălina Maria Gîrbină, Cătălin Nicolae Albu, Nadia Albu

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The IFRS for Small and Medium-sized Entities (SMEs) was issued in July 2009 and currently regulators are considering various implementation strategies of this standard. Romania is a member of the European Union since 2007, thus accounting regulations were issued in order to ensure compliance with the European Accounting Directives. As the European Commission rejected recently the mandatory use of IFRS for SMEs, regulatory bodies from the Member States have to decide if the standard will affect or not the accounting practices of SMEs from their countries. Recently IASB invited stakeholders to discuss the revision of IFRS for SMEs. Empirical studies on the differences and similarities between national standards and IFRS for SMEs could inform decision makers on the actual level of convergence in different countries. The purpose of this paper is to provide empirical evidences on the convergence of the Romanian regulations with IFRS for SMEs analyzing the results in the context of the last revisions proposed to the EU Accounting Directives.

Keywords: EU Accounting Directives, IFRS for SMEs, national regulations

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Authors: Wafa Ghonaim

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Though quite fast on growth, Islamic financing at large, and its diverse instruments, is a controversial matter among scholars. This is evident from the ongoing debates on its Shariah compliance. Arguments, however, are inciting doubts and concerns among clients about its credibility, which is harming this lucrative sector. The work here investigates, particularly, some issues related to the Tawarruq instrument. The work examines the issues of linking Murabaha and Wakala contracts, the reselling of commodities to same traders, and the transfer of ownerships. The work affirms that a multi-agent smart electronic market design would facilitate Shariah compliance. The smart market exploits the rational decision-making capabilities of autonomous proxy agents that enable the clients, traders, brokers, and the bank buy and sell commodities, and manage transactions and cash flow. The smart electronic market design delivers desirable qualities that terminate the need for Wakala contracts and the reselling of commodities to the same traders. It also resolves the ownership transfer issues by allowing stakeholders to trade independently. The bank administers the smart electronic market and assures reliability of trades, transactions and cash flow. A multi-agent simulation is presented to validate the concept and processes. We anticipate that the multi-agent smart electronic market design would deliver Shariah compliance of personal financing to the aspiration of scholars, banks, traders and potential clients.

Keywords: Islamic finance, Shariah compliance, smart electronic markets design, multi-agent systems.

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Authors: D. Kubiliute

Abstract:

The Republic of Lithuania is known as a trusted location for global business institutions and it attracts investors with its 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 the 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, and other. The financial sector is one of the key factors influencing the implementation of sustainability objectives in the 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 problematic of the implementation of 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 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, market participant, legal, regulation, sustainability.

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Authors: Petr Teply

Abstract:

Liquidity risk management ranks to key concepts applied in finance. Liquidity is defined as a capacity to obtain funding when needed, while liquidity risk means as a threat to this capacity to generate cash at fair costs. In the paper we present challenges of liquidity risk management resulting from the 2007- 2009 global financial upheaval. We see five main regulatory liquidity risk management issues requiring revision in coming years: liquidity measurement, intra-day and intra-group liquidity management, contingency planning and liquidity buffers, liquidity systems, controls and governance, and finally models testing the viability of business liquidity models.

Keywords: liquidity, risk management, regulation, global crisis

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Authors: Md. Omar Bin Harun Khan

Abstract:

The collapse of the infamous Rana Plaza, a multi-storeyed commercial building in Savar, near Dhaka, Bangladesh has brought with it a plethora of positive and negative consequences. Bangladesh being a key player in the export of clothing, found itself amidst a wave of economic upheaval following this tragic incident that resulted in numerous Bangladeshis, most of whom were factory workers. This paper compares the consequences that the country’s Ready Made Garments (RMG) sector is facing now, two years into the incident. The paper presents a comparison of statistical data from study reports and brings forward perspectives from all dimensions of Labour, Employment and Industrial Relations in Bangladesh following the event. The paper brings across the viewpoint of donor organizations and donor countries, the impacts of several initiatives taken by foreign organizations like the International Labour Organization, and local entities like the Bangladesh Garment Manufacturers and Exporters Association (BGMEA) in order to reinforce compliance and stabilize the shaky foundation that the RMG sector had found itself following the collapse. Focus of the paper remains on the stance taken by the suppliers in Bangladesh, with inputs from buying houses and factories, and also on the reaction of foreign brands. The paper also focuses on the horrific physical, mental and financial implications sustained by the victims and their families, and the consequent uproar from workers in general regarding compliance with work safety and workers’ welfare conditions. The purpose is to get across both sides of the scenario: the economic impact that suppliers / factories/ sellers/ buying houses/exporters have faced in Bangladesh as a result of complete loss of reliability on them regarding working standards; and also to cover the aftershock felt on the other end of the spectrum by the importers/ buyers, particularly the foreign entities, in terms of the sudden accountability of being affiliated with non- compliant factories. The collapse of Rana Plaza has received vast international attention and strong criticism. Nevertheless, the almost immediate strengthening of labourrights and the wholesale reform undertaken on all sides of the supply chain, evidence a move of all local and foreign stakeholders towards greater compliance and taking of precautionary steps for prevention of further disasters. The tragedy that Rana Plaza embodies served as a much-needed epiphany for the soaring RMG Sector of Bangladesh. Prompt co-operation on the part of all stakeholders and regulatory bodies now show a move towards sustainable development, which further ensures safeguarding against any future irregularities and pave the way for steady economic growth.

Keywords: Economy, employment standards, Ranaplaza, RMG.

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