Search results for: regulatory systems

Authors: Muna Mohamed Omer Mirghani

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This paper responds to one of the key national development strategies and a typical challenge in the Gash Basin as well as in different parts of Sudan, namely managing water scarcity in view of climate change impacts in minor water systems sustaining over 50% of the Sudan population. While now focusing on the Gash river basin, the ultimate aim is to replicate the same approach in similar water systems in central and west Sudan. The key objective of the paper is the identification of outcome-based water governance interventions in Gash Basin, guided by the global Sustainable Development Goal six (SDG 6 on water and sanitation) and the Sudan water resource policy framework. The paper concluded that improved water resources management of the Gash Basin is a prerequisite for ensuring desired policy outcomes of groundwater use and flood risk management purposes. Analysis of various water governance dimensions in the Gash indicated that the operationalization of a Basin-level institutional reform is critically focused on informed actors and adapted practices through knowledge and technologies along with the technical data and capacity needed to make that. Adapting the devolved Institutional structure at state level is recommended to strengthen the Gash basin regulatory function and improve compliance of groundwater users.

Keywords: water governance, Gash Basin, integrated groundwater management, Sudan

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Authors: Dermot O'Brien, Vasileios Christaras, Georgios Fontaras, Igor Nai Fovino, Ioannis Kounelis

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With the rise of the Internet of Things (IoT), 5G, and blockchain (BC) technologies, vehicles are becoming ever increasingly connected and are already transmitting substantial amounts of data to the original equipment manufacturers (OEMs) servers. This data could be used to help detect mileage fraud and enable more accurate vehicle emissions monitoring. This would not only help regulators but could enable applications such as permitting efficient drivers to pay less tax, geofencing for air quality improvement, as well as pollution tolling and trading platforms for transport-related businesses and EU citizens. Other applications could include traffic management and shared mobility systems. BC enables the transmission of data with additional security and removes single points of failure while maintaining data provenance, identity ownership, and the possibility to retain varying levels of privacy depending on the requirements of the applied use case. This research performs simulations of vehicles interacting with European member state authorities and European Commission BC nodes that are running hyperleger fabric and explores whether the technology is currently feasible for transport applications such as the emission monitoring use-case.

Keywords: future transportation systems, technological innovations, policy approaches for transportation future, economic and regulatory trends, blockchain

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Authors: Dinesh Sivaguru, Kamal Thilakasiri

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Preventing money laundering and terrorist financing is a major national and international problem today. Several attempts have been made to prevent money laundering by national and international dimension. These are often counteracted by the multi dynamic nature of the crimes. However, launders are often to use remittance systems to clean their ill-gotten money. This study presents the role of domestic financial institutions and the effective practices and actions should implement within domestic financial institutions to control and prevent financial crimes. This thesis highlights the progress that is required to prevent money laundering and terrorist financing, further it is an original contribution to the knowledge in an under researched field in Sri Lanka.

Keywords: money laundering, terrorists financing, financial institutions, regulatory bodies

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Authors: Winfred Okoe Addy, Jean Jacques Dominique Beraud

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Access control systems (ACs) are some of the most important components in safety areas. Inaccuracies of regulatory frameworks make personal policies and remedies more appropriate than standard models or protocols. This problem is exacerbated by the increasing complexity of software, such as integrated Big Data (BD) software for controlling large volumes of encrypted data and resources embedded in a dedicated BD production system. This paper proposes a general access control strategy system for the diffusion of Big Data domains since it is crucial to secure the data provided to data consumers (DC). We presented a general access control circulation strategy for the Big Data domain by describing the benefit of using designated access control for BD units and performance and taking into consideration the need for BD and AC system. We then presented a generic of Big Data access control system to improve the dissemination of Big Data.

Keywords: access control, security, Big Data, domain

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Authors: George Kyriakopoulos, Photini Pazartzis, Anthi Koskina, Crystalie Bourcha

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The need for securing safe access to and return from outer space, as well as ensuring the viability of outer space operations, maintains vivid the debate over the promotion of organization of space traffic through a Space Traffic Management System (STM). The proliferation of outer space activities in recent years as well as the dynamic emergence of the private sector has gradually resulted in a diverse universe of actors operating in outer space. The said developments created an increased adverse impact on outer space sustainability as the case of the growing number of space debris clearly demonstrates. The above landscape sustains considerable threats to outer space environment and its operators that need to be addressed by a combination of scientific-technological measures and regulatory interventions. In this context, recourse to recent technological advancements and, in particular, to Artificial Intelligence (AI) and machine learning systems, could achieve exponential results in promoting space traffic management with respect to collision avoidance as well as launch and re-entry procedures/phases. New technologies can support the prospects of a successful space traffic management system at an international scale by enabling, inter alia, timely, accurate and analytical processing of large data sets and rapid decision-making, more precise space debris identification and tracking and overall minimization of collision risks and reduction of operational costs. What is more, a significant part of space activities (i.e. launch and/or re-entry phase) takes place in airspace rather than in outer space, hence the overall discussion also involves the highly developed, both technically and legally, international (and national) Air Traffic Management System (ATM). Nonetheless, from a regulatory perspective, the use of AI for the purposes of space traffic management puts forward implications that merit particular attention. Key issues in this regard include the delimitation of AI-based activities as space activities, the designation of the applicable legal regime (international space or air law, national law), the assessment of the nature and extent of international legal obligations regarding space traffic coordination, as well as the appropriate liability regime applicable to AI-based technologies when operating for space traffic coordination, taking into particular consideration the dense regulatory developments at EU level. In addition, the prospects of institutionalizing international cooperation and promoting an international governance system, together with the challenges of establishment of a comprehensive international STM regime are revisited in the light of intervention of AI technologies. This paper aims at examining regulatory implications advanced by the use of AI technology in the context of space traffic management operations and its key correlating concepts (SSA, space debris mitigation) drawing in particular on international and regional considerations in the field of STM (e.g. UNCOPUOS, International Academy of Astronautics, European Space Agency, among other actors), the promising advancements of the EU approach to AI regulation and, last but not least, national approaches regarding the use of AI in the context of space traffic management, in toto. Acknowledgment: The present work was co-funded by the European Union and Greek national funds through the Operational Program "Human Resources Development, Education and Lifelong Learning " (NSRF 2014-2020), under the call "Supporting Researchers with an Emphasis on Young Researchers – Cycle B" (MIS: 5048145).

Keywords: artificial intelligence, space traffic management, space situational awareness, space debris

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Authors: Lala Rukh, Muhammad Abbas Choudhary, Saddam Akber Abbasi

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In Pakistan, the privatization of major sector of the national economy i.e. power, telecom, and gas is very strongly advocated since 80s. With varying degree of progress made in these sectors, it has been the government’s approach that the privatization accelerates the sectorial growth, increases operational efficiency and attracts the foreign investment and is of special significance for developing economies. The gas sector was not an exception and the privatization in this sector has moved through various stages during this time within the realms of socio-political agenda. This paper presents the overview of the gas sector in the country. The Oil and Gas Regulatory Authority (OGRA) Ordinance and privatization commission policy position as depicted in the press briefings provides philosophical foundations to the privatization and sectorial restructuring in this paper. The role of the major players from privatization perspective is discussed with special reference to the importance of natural gas sector. The case study further discusses the economic regulations that are being adopted by utility regulators in Pakistan and elsewhere in the world and some issues that the Regulatory Authority will be concerned are outlined. Major operators in the gas sector including Oil & Gas Development Corporation (OGDC), Sui Northern Gas Pipelines Limited (SNGPL), Sui Southern Gas Pipelines Limited (SSGPL) is also presented.

Keywords: privatization, economic regulation, OGDCL, SSGCL, SNGPL

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Authors: Charintorn Suwannawong, Tananpon Yavilas, Sopida Boonaneksap, Chotika Viriyarattanasak, Chairath Tangduangdee

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With increasing aging population and health conscious consumers, the demand for health promoting products such as functional foods, dietary supplements, and nutraceutical products has continuously increased in Thailand. Nevertheless, the strategic framework for regulatory functional food developments in Thailand is still unclear. The objective of this study was to survey stakeholders’ perspectives on three scopes, consisting of 1) the current status 2) obstacles, and 3) future trend for the development and production of functional foods in Thailand. A survey was conducted by interviewing ten experts from governmental organization, industrial sector and academic institute. The obtained results show that there is no established definition for functional foods in Thailand. There is a variety of raw materials that are capable to be potential ingredients for functional food production in Thailand and exported to global market. However, the scaling up technology into a commercial production is limited. Moreover, there is a need to establish the infrastructures, such as testing laboratory, and regulatory standards for quality control and ensuring product safety. This information is useful for government in the development of the strategic framework and policy statement on improvement of functional food industry in Thailand.

Keywords: functional foods, interview, perspective, Thailand

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Authors: Libo Jiang, Huan Li, Rongling Wu

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Ordinary differentiation equations (ODE) have proven to be powerful for reconstructing precise and informative gene regulatory networks (GRNs) from dynamic gene expression data. However, joint modeling and analysis of all genes, essential for the systematical characterization of genetic interactions, are challenging due to high dimensionality and a complex pattern of genetic regulation including activation, repression, and antitermination. Here, we address these challenges by unifying variable selection and game theory through ODE. Each gene within a GRN is co-expressed with its partner genes in a way like a game of multiple players, each of which tends to choose an optimal strategy to maximize its “fitness” across the whole network. Based on this unifying theory, we designed and conducted a real experiment to infer salt tolerance-related GRNs for Euphrates poplar, a hero tree that can grow in the saline desert. The pattern and magnitude of interactions between several hub genes within these GRNs were found to determine the capacity of Euphrates poplar to resist to saline stress.

Keywords: gene regulatory network, ordinary differential equation, game theory, LASSO, saline resistance

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Authors: Pavel Borodkin, Nikolay Khrennikov, Azamat Gazetdinov

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The problem of ensuring of VVER type reactor equipment integrity is now most actual in connection with justification of safety of the NPP Units and extension of their service life to 60 years and more. First of all, it concerns old units with VVER-440 and VVER-1000. The justification of the VVER equipment integrity depends on the reliability of estimation of the degree of the equipment damage. One of the mandatory requirements, providing the reliability of such estimation, and also evaluation of VVER equipment lifetime, is the monitoring of equipment radiation loading parameters. In this connection, there is a problem of justification of such normative parameters, used for an estimation of the pressure vessel metal embrittlement, as the fluence and fluence rate (FR) of fast neutrons above 0.5 MeV. From the point of view of regulatory practice, a comparison of displacement per atom (DPA) and fast neutron fluence (FNF) above 0.5 MeV has a practical concern. In accordance with the Russian regulatory rules, neutron fluence F(E > 0.5 MeV) is a radiation exposure parameter used in steel embrittlement prediction under neutron irradiation. However, the DPA parameter is a more physically legitimate quantity of neutron damage of Fe based materials. If DPA distribution in reactor structures is more conservative as neutron fluence, this case should attract the attention of the regulatory authority. The purpose of this work was to show what radiation load parameters (fluence, DPA) on all VVER equipment should be under control, and give the reasonable estimations of such parameters in the volume of all equipment. The second task is to give the conservative estimation of each parameter including its uncertainty. Results of recently received investigations allow to test the conservatism of calculational predictions, and, as it has been shown in the paper, combination of ex-vessel measured data with calculated ones allows to assess unpredicted uncertainties which are results of specific unique features of individual equipment for VVER reactor. Some results of calculational-experimental investigations are presented in this paper.

Keywords: equipment integrity, fluence, displacement per atom, nuclear power plant, neutron activation measurements, neutron transport calculations

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Authors: Hazem Abd El Megeed, Mohamed El-Refaay, Norhan Magdi Osman

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Spectrum scarcity is a challenging obstacle in wireless communications systems. It hinders the introduction of innovative wireless services and technologies that require larger bandwidth comparing to legacy technologies. In addition, the current worldwide allocation of radio spectrum bands is already congested and can not afford additional squeezing or optimization to accommodate new wireless technologies. This challenge is a result of accumulative contributions from different factors that will be discussed later in this paper. One of these factors is the radio spectrum allocation policy governed by national regulatory authorities nowadays. The framework for this policy allocates specified portion of radio spectrum to a particular wireless service provider on exclusive utilization basis. This allocation is executed according to technical specification determined by the standard bodies of each Radio Access Technology (RAT). Dynamic access of spectrum is a framework for flexible utilization of radio spectrum resources. In this framework there is no exclusive allocation of radio spectrum and even the public safety agencies can share their spectrum bands according to a governing policy and service level agreements. In this paper, we explore different methods for accessing the spectrum dynamically and its associated implementation challenges.

Keywords: licensed shared access, cognitive radio, spectrum sharing, spectrum congestion, dynamic spectrum access, spectrum database, spectrum trading, reconfigurable radio systems, opportunistic spectrum allocation (OSA)

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Authors: Isil Gazioglu, Abdulselam Ertas

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Aflatoxins (AFs) are secondary toxic metabolites of Aspergillus flavus and A. parasiticus. AFs can be absorbed through the skin. Potent carcinogens like AFs should be completely absent from cosmetics, this can be achieved by careful quality control of the raw plant materials. Regulatory limits for aflatoxins have been established in many countries, and reliable testing methodology is needed to implement and enforce the regulatory limits. In this study, ten medicinal plant samples (Bundelia tournefortti, Capsella bursa-pastoris, Carduus tenuiflorus, Cardaria draba, Malva neglecta, Malvella sharardiana, Melissa officinalis, Sideritis libanotica, Stakys thirkei, Thymus nummularius) were investigated for aflatoxin (AF) contaminations by employing an HPLC assay for the determination of AFB1, B2, G1 and G2. The samples were extracted with 70% (v/v) methanol in water before further cleaned up with an immunoaffinity column and followed by the detection of AFs by using an electrochemically post-column derivatization with Kobra-Cell and fluorescence detector. The extraction procedure was optimized in order to obtain the best recovery. The method was successfully carried out with all medicinal plant samples. The results revealed that five (50%) of samples were contaminated with AFs. The association between particular samples and the AF contaminated could not be determined due to the low frequency of positive samples.

Keywords: aflatoxin B1, HPLC-FLD, KOBRA-Cell, mycotoxin

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Authors: Jyothi Nagraj, Sudeshna Mukherjee, Rajdeep Chowdhury

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Autophagy has recently been linked with cancer cell survival post drug insult contributing to acquisition of resistance. However, the molecular signaling governing autophagic survival response is poorly explored. In our study, in osteosarcoma (OS) cells cisplatin shock was found to activate both MAPK and autophagy signaling. An activation of JNK and autophagy acted as pro-survival strategy, while ERK1/2 triggered apoptotic signals upon cisplatin stress. An increased sensitivity of the cells to cisplatin was obtained with simultaneous inhibition of both autophagy and JNK pathway. Furthermore, we observed that the autophagic stimulation upon drug stress regulates other developmentally active signaling pathways like the Hippo pathway in OS cells. Cisplatin resistant cells were thereafter developed by repetitive drug exposure followed by clonal selection. Basal levels of autophagy were found to be high in resistant cells to. However, the signaling mechanism leading to autophagic up-regulation and its regulatory effect differed in OS cells upon attaining drug resistance. Our results provide valuable clues to regulatory dynamics of autophagy that can be considered for development of improved therapeutic strategy against resistant type cancers.

Keywords: JNK, autophagy, drug resistance, cancer

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Authors: Jonathan Palatz Cedeño

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The paper will seek to examine the scope and limitations of the process of construction of ordinary and extraordinary migration regulatory tools of the countries of Latin America, due to the Venezuelan diaspora in Ibero-America (2015-2018). The analysis methodology will be based on a systematic presentation of the existing advances in the subject under a qualitative approach, in which the results are detailed. We hold that an important part of the Latin American countries that used to be the emitters of migrants have had to generate, with greater or lesser success both nationally and regionally, ordinary and extraordinary migration regulatory tools to respond to the rapid intensification of the current Venezuelan migratory flows. This fact beyond implementing policies for the reception and integration of this population marks a new moment that represents a huge challenge both for the receiving States and for the young Ibero-American institutional migration system. Therefore, we can say that measures to adopt reception and solidarity policies, despite being supported by organs of the multilateral system such as UNHCR and IOM, are not found as guidelines for national and regional action, at the expense of the reactions of the respective public opinions and the influence of what to do of the neighboring countries in the face of the problem.

Keywords: Venezuela, migration, migration policies and governance, Venezuelan diaspora

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Authors: L. Calcagni, A. Battisti, M. Hensel, D. S. Hensel

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Since the beginning of the 21st century, we have seen a dynamic growth of water-based (WB) architecture, mainly due to the increasing threat of floods caused by sea level rise and heavy rains, all correlated with climate change. At the same time, the shortage of land available for urban development also led architects, engineers, and policymakers to reclaim the seabed or to build floating structures. Furthermore, the drive to produce energy from renewable resources has expanded the sector of offshore research, mining, and energy industry which seeks new types of WB structures. In light of these considerations, the time is ripe to consider floating architecture as a full-fledged building typology. Currently, there is no universally recognized academic definition of a floating building. Research on floating architecture lacks a proper, commonly shared vocabulary and typology distinction. Moreover, there is no global international legal framework for urban development on water, and there is no structured performance based building design (PBBD) approach for floating architecture in most countries, let alone national regulatory systems. Thus, first of all, the research intends to overcome the semantic and typological issues through the conceptualization of floating architecture, laying the proto-ontological conditions for floating development, and secondly to identify the parameters to be considered in the definition of a specific PBBD framework, setting the scene for national planning strategies. The theoretical overview and re-semanticization process involve the attribution of a new meaning to the term floating architecture. This terminological work of semantic redetermination is carried out through a systematic literature review and involves quantitative and historical research as well as logical argumentation methods. As it is expected that floating urban development is most likely to take place as an extension of coastal areas, the needs and design criteria are definitely more similar to those of the urban environment than to those of the offshore industry. Therefore, the identification and categorization of parameters –looking towards the potential formation of a PBBD framework for floating development– takes the urban and architectural guidelines and regulations as the starting point, taking the missing aspects, such as hydrodynamics (i.e. stability and buoyancy) from the offshore and shipping regulatory frameworks. This study is carried out through an evidence-based assessment of regulatory systems that are effective in different countries around the world, addressing on-land and on-water architecture as well as offshore and shipping industries. It involves evidence-based research and logical argumentation methods. Overall, inhabiting water is proposed not only as a viable response to the problem of rising sea levels, thus as a resilient frontier for urban development, but also as a response to energy insecurity, clean water, and food shortages, environmental concerns, and urbanization, in line with Blue Economy principles and the Agenda 2030. This review shows how floating architecture is to all intents and purposes, an urban adaptation measure and a solution towards self-sufficiency and energy-saving objectives. Moreover, the adopted methodology is, to all extents, open to further improvements and integrations, thus not rigid and already completely determined. Along with new designs and functions that will come into play in the practice field, eventually, life on water will seem no more unusual than life on land, especially by virtue of the multiple advantages it provides not only to users but also to the environment.

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

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Authors: Nur Fareza Mustapha

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Solutions to policy problems need to be curated to the local context, taking into account the trajectory of the local development path to ensure its efficacy. For Kuala Lumpur, rapid urbanization and migration into the city for the past few decades have increased the demand for housing to accommodate a growing urban population. As a critical factor affecting housing affordability, land supply constraints have been attributed to intensifying market pressures, which grew in tandem with the demands of urban development, along with existing institutional constraints in the governance of land. While demand-side pressures are inevitable given the fixed supply of land, supply-side constraints in regulations distort markets and if addressed inappropriately, may lead to mistargeted policy interventions. Given Malaysia’s historical development, regulatory barriers for land may originate from the British colonial period, when many aspects of the current laws governing tenure were introduced and formalized, and henceforth, became engrained in the system. This research undertakes a postcolonial institutional analysis approach to uncover the causal mechanism driving the evolution of land tenure systems in post-colonial Kuala Lumpur. It seeks to determine the sources of these shifts, focusing on the incentives and bargaining positions of actors during periods of institutional flux/change. It aims to construct a conceptual framework to further this understanding and to elucidate how this historical trajectory affects current access to urban land markets for housing. Archival analysis is used to outline and analyse the evolution of land tenure systems in Kuala Lumpur while stakeholder interviews are used to analyse its impact on the current urban land market, with a particular focus on the provision of and access to affordable housing in the city. Preliminary findings indicate that many aspects of the laws governing tenure that were introduced and formalized during the British colonial period have endured until the present day. Customary rules of tenure were displaced by rules following a European tradition, which found legitimacy through a misguided interpretation of local laws regarding the ownership of land. Colonial notions of race and its binary view of native vs. non-natives have also persisted in the construction and implementation of current legislation regarding land tenure. More concrete findings from this study will generate a more nuanced understanding of the regulatory land supply constraints in Kuala Lumpur, taking into account both the long and short term spatial and temporal processes that affect how these rules are created, implemented and enforced.

Keywords: colonial discourse, historical institutionalism, housing, land policy, post-colonial city

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Authors: Laura Mion

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Concepts of quality assurance and management are now part of the organizational culture of the Universities. Quality Assurance (QA) systems are, in large part, provided for by national regulatory dictates or supranational indications (such as, for example, at European level are, the ESG Guidelines "European Standard Guidelines"), but their specific definition, in terms of guiding principles, requirements and methodologies, are often delegated to the national evaluation agencies or to the autonomy of individual universities. For this reason, the experiences of implementation of QA systems in different countries and in different universities is an interesting source of information to understand how quality in universities is understood, pursued and verified. The literature often deals with the treatment of the experiences of implementation of QA systems in the individual areas in which the University's activity is carried out - teaching, research, third mission - but only rarely considers quality systems with a systemic and integrated approach, which allows to correlate subjects, actions, and performance in a virtuous circuit of continuous improvement. In particular, it is interesting to understand how to relate the results and uses of the QA in the triple distinction of university activities, identifying how one can cause the performance of the other as a function of an integrated whole and not as an exploit of specific activities or processes conceived in an abstractly atomistic way. The aim of the research is, therefore, to investigate which experiences of "integrated" QA systems are present on the international scene: starting from the experience of European countries that have long shared the Bologna Process for the creation of a European space for Higher Education (EHEA), but also considering experiences from emerging countries that use QA processes to develop their higher education systems to keep them up to date with international levels. The concept of "integration", in this research, is understood in a double meaning: i) between the different areas of activity, in particular between the didactic and research areas, and possibly with the so-called "third mission" "ii) the functional integration between those involved in quality assessment and management and the governance of the University. The paper will present the results of a systematic review conducted according with a method of an integrative review aimed at identifying best practices of quality assurance systems, in individual countries or individual universities, with a high level of integration. The analysis of the material thus obtained has made it possible to grasp common and transversal elements of QA system integration practices or particularly interesting elements and strengths of these experiences that can, therefore, be considered as winning aspects in a QA practice. The paper will present the method of analysis carried out, and the characteristics of the experiences identified, of which the structural elements will be highlighted (level of integration, areas considered, organizational levels included, etc.) and the elements for which these experiences can be considered as best practices.

Keywords: quality assurance, university, integration, country

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Authors: Mark E. Lokanan, Liz Lee

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This paper aims to examine the role of accountants as gatekeepers in anti-money laundering compliance in real estate transactions. The paper seeks to answer questions on ways in which accountants are involved in real estate transactions and mandatory compliance with regulatory authorities in Canada. The data for the study came from semi-structured interviews with accountants, lawyers, and government officials. Preliminary results reveal that there is a conflict between accountants’ obligation to disclose and loyalty to their clients. Accountants often do not see why they are obligated to disclose their clients' information to government agencies. The importance of the client in terms of the amount of revenue contributed to the accounting firm also plays a significant role in accountants' reporting decision-making process. Although the involvement of accountants in real estate purchase and sale transactions is limited to lawyers or notaries, they are often involved in designing financing schemes, which may involve money laundering activities. The paper is of wider public policy interests to both accountants and regulators. It is hard not to see Chartered Professional Accountant (CPA) Canada and government regulators using the findings to better understand the decision-making processes of accountants in their reporting practices to regulatory authorities.

Keywords: money laundering, real estate, disclosure, legislation, compliance

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Authors: Alaa Abdellatif, Gabrièle Breda

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Background. Advanced therapy medicinal products (ATMPs) are innovative therapies that mainly target orphan diseases and high unmet medical needs. ATMP includes gene therapy medicinal products (GTMP), somatic cell therapy medicinal products (CTMP), and tissue-engineered therapies (TEP). Since legislation opened the way in 2007, 25 ATMPs have been approved in the EU, which is about the same amount as the U.S. Food and Drug Administration. However, not all of the ATMPs that have been approved have successfully reached the market and retained their approval. Objectives. We aim to understand all the factors limiting the market access to very promising therapies in a systemic approach, to be able to overcome these problems, in the future, with scientific, regulatory and commercial innovations. Further to recent reviews that focus either on specific countries, products, or dimensions, we will address all the challenges faced by ATMP development today. Methodology. We used mixed methods and a multi-level approach for data collection. First, we performed an updated academic literature review on ATMP development and their scientific and market access challenges (papers published between 2018 and April 2023). Second, we analyzed industry feedback from cell and gene therapy webinars and white papers published by providers and pharmaceutical industries. Finally, we established a comparative analysis of the regulatory guidelines published by EMA and the FDA for ATMP approval. Results: The main challenges in bringing these therapies to market are the high development costs. Developing ATMPs is expensive due to the need for specialized manufacturing processes. Furthermore, the regulatory pathways for ATMPs are often complex and can vary between countries, making it challenging to obtain approval and ensure compliance with different regulations. As a result of the high costs associated with ATMPs, challenges in obtaining reimbursement from healthcare payers lead to limited patient access to these treatments. ATMPs are often developed for orphan diseases, which means that the patient population is limited for clinical trials which can make it challenging to demonstrate their safety and efficacy. In addition, the complex manufacturing processes required for ATMPs can make it challenging to scale up production to meet demand, which can limit their availability and increase costs. Finally, ATMPs face safety and efficacy challenges: dangerous adverse events of these therapies like toxicity related to the use of viral vectors or cell therapy, starting material and donor-related aspects. Conclusion. As a result of our mixed method analysis, we found that ATMPs face a number of challenges in their development, regulatory approval, and commercialization and that addressing these challenges requires collaboration between industry, regulators, healthcare providers, and patient groups. This first analysis will help us to address, for each challenge, proper and innovative solution(s) in order to increase the number of ATMPs approved and reach the patients

Keywords: advanced therapy medicinal products (ATMPs), product development, market access, innovation

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Authors: Hien T. T. Ho, Tsunemi Watanabe

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The regulatory and market pressures on the restriction of nonylphenol and its ethoxylates in textile articles have confronted the textile manufacturers, particularly those in developing countries. This study aimed to examine the tentative behavior of the textile manufacturers in Vietnam from the perspectives of attitude and the perceptions of technical and organizational adaptabilities, risks, benefits, and barriers. Personal interviews were conducted with five technical specialists from four textile firms and one chemical supplier. The environmental regulatory and market situations regarding the chemical use in Vietnam were also described. The findings revealed two main opposing trends of chemical substitution depending on the market orientation of firms that governed the patterns of risk and benefit perception. The indirect influence of perceived adaptabilities on firm tentative behavior through perceived risks was elucidated, which initiated a conceptual model of firm’s behavior combining the organizational-based and the rational-based relationships. The intermediary role of non-governmental textile and garment industrial/ trade associations is highlighted to strengthen private firm’s informative capacity.

Keywords: firm behavior, institutional analysis, organizational adaptation, technical adaptation

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Authors: Mario M. J. Musonda

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Access to health care is a human right, which includes having timely access to affordable and quality essential medicines at the right place and in sufficient quantity. However, inefficient public sector supply chain management contributes to constant shortages of essential medicines at health facilities. Literature review involved a desktop study of published research studies and reports on risk management, supply chain management of essential medicines and their integration to increase the efficiency of the latter. The research was conducted on a sample population of offices under Ministry of Health Headquarters, Lusaka Provincial and District Offices, selected health facilities in Lusaka, Medical Stores Limited, Zambia Medicines Regulatory Authority and Cooperating Partners. Individuals involved in study were selected judgmentally by their functions under selection and quantification, regulation, procurement, storage, distribution, quality assurance, and dispensing of essential medicines. Structured interviews and discussions were held with selected experts and self-administered questionnaires were distributed. Collected and analysed data of 35 returned and usable questionnaires from the 50 distributed. The highest prioritised risks were; inadequate and inconsistent fund disbursements, weak information management systems, weak quality management systems and insufficient resources (HR and infrastructure) among others. The results for this research can be used to increase the efficiency of the public sector supply chain of essential medicines and other pharmaceuticals. The results of the study showed that there is need to implement effective risk management systems by participating institutions and organisations to increase the efficiency of the entire supply chain in order to avoid and/or reduce shortages of essential medicines at health facilities.

Keywords: essential medicine, risk assessment, risk management, supply chain, supply chain risk management

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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. They are collecting, managing, and retaining large amounts of data in cloud environments makes 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, data governance, privacy protection

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Authors: Chengwei Wang, Shuqing Xu, Philipp M. Schlüter

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The genus Ophrys is remarkable for its mimicry, flower-lip closely resembling pollinator females in a species-specific manner. Therefore, floral traits associated with pollinator attraction, especially scent, are suitable models for investigating the molecular basis of adaption, speciation, and evolution. Within the two Ophrys species groups: O. sphegodes (S) and O. fusca (F), pollinator shifts among the same insect species have taken place. Preliminary data suggest that they involve a comparable hydrocarbon profile in their scent, which is mainly composed of alkanes and alkenes. Genes encoding stearoyl-acyl carrier protein desaturases (SAD) involved in alkene biosynthesis have been identified in the S group. This study aims to investigate the control and parallel evolution of ecologically significant alkene production in Ophrys. Owing to the central role those SAD genes play in determining positioning of the alkene double-bonds, a detailed understanding of their functional mechanism and of regulatory aspects is of utmost importance. We have identified 5 transcription factors potentially related to SAD expression in O. sphegodes which belong to the MYB, GTE, WRKY, and MADS families. Ultimately, our results will contribute to understanding genes important in the regulatory control of floral scent synthesis.

Keywords: floral traits, transcription factors, biosynthesis, parallel evolution

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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: Salisu Ibrahim

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The paper studies the commutativity associated with fractional order linear time-varying systems (LTVSs), which is an important area of study in control systems engineering. In this paper, we explore the properties of these systems and their ability to commute. We proposed the necessary and sufficient condition for commutativity for fractional order LTVSs. Through a simulation and mathematical analysis, we demonstrate that these systems exhibit commutativity under certain conditions. Our findings have implications for the design and control of fractional order systems in practical applications, science, and engineering. An example is given to show the effectiveness of the proposed method which is been computed by Mathematica and validated by the use of MATLAB (Simulink).

Keywords: fractional differential equation, physical systems, equivalent circuit, analog control

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Authors: Wassamon Kun-Amornpong

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When a financial crisis occurs, there will be a law and regulatory reform in order to manage the turmoil and prevent a future crisis. One of the most important regulatory efforts to help cope with systemic risk and a financial crisis is the third version of the Basel Accord. Basel III has introduced some measures and tools (e.g., systemic risk buffer, countercyclical buffer, capital conservation buffer and liquidity risk) in order to mitigate systemic risk. Nevertheless, the effectiveness of these measures in Basel III in adequately addressing the problem of contagious runs that can quickly spread throughout the financial system is questionable. This paper seeks to contribute to the knowledge regarding the role of the Basel Accords in mitigating systemic risk. The research question is to what extent the Basel Accords can help control systemic risk in the financial markets? The paper tackles this question by analysing the concept of systemic risk. It will then examine the weaknesses of the Basel Accords before and after the Global financial crisis in 2008. Finally, it will suggest some possible solutions in order to improve the Basel Accord. The rationale of the study is the fact that academic works on systemic risk and financial crises are largely studied from economic or financial perspective. There is comparatively little research from the legal and regulatory perspective. The finding of the paper is that there are some problems in all of the three pillars of the Basel Accords. With regards to Pillar I, the risk model is excessively complex while the benefits of its complexity are doubtful. Concerning Pillar II, the effectiveness of the risk-based supervision in preventing systemic risk still depends largely upon its design and implementation. Factors such as organizational culture of the regulator and the political context within which the risk-based supervision operates might be a barrier against the success of Pillar II. Meanwhile, Pillar III could not provide adequate market discipline as market participants do not always act in a rational way. In addition, the too-big-to-fail perception reduced the incentives of the market participants to monitor risks. There has been some development in resolution measure (e.g. TLAC and MREL) which might potentially help strengthen the incentive of the market participants to monitor risks. However, those measures have some weaknesses. The paper argues that if the weaknesses in the three pillars are resolved, it can be expected that the Basel Accord could contribute to the mitigation of systemic risk in a more significant way in the future.

Keywords: Basel accords, financial regulation, risk-based supervision, systemic risk

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Authors: Ryspek Usubamatov, Tan San Chin, Sarken Kapaeva

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Productivity of the manufacturing systems depends on technological processes, a technical data of machines and a structure of systems. Technology is presented by the machining mode and data, a technical data presents reliability parameters and auxiliary time for discrete production processes. The term structure of manufacturing systems includes the number of serial and parallel production machines and links between them. Structures of manufacturing systems depend on the complexity of technological processes. Mathematical models of productivity rate for manufacturing systems are important attributes that enable to define best structure by criterion of a productivity rate. These models are important tool in evaluation of the economical efficiency for production systems.

Keywords: productivity, structure, manufacturing systems, structural design

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Authors: Wanjiku Karanja

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Facebook has monopoly power in the social networking market. It has grown and entrenched its monopoly power through the capture of its users’ data value chains. However, antitrust law’s consumer welfare roots have prevented it from effectively addressing the role of data capture in Facebook’s market dominance. These regulatory blind spots are augmented in Facebook’s proposed Diem cryptocurrency project and its Novi Digital wallet. Novi, which is Diem’s digital identity component, shall enable Facebook to collect an unprecedented volume of consumer data. Consequently, Novi has seismic implications on internet identity as the network effects of Facebook’s large user base could establish it as the de facto internet identity layer. Moreover, the large tracts of data Facebook shall collect through Novi shall further entrench Facebook's market power. As such, the attendant lock-in effects of this project shall be very difficult to reverse. Urgent regulatory action is therefore required to prevent this expansion of Facebook’s data resources and monopoly power. This research thus highlights the importance of data capture to competition and market health in the social networking industry. It utilizes interviews with key experts to empirically interrogate the impact of Facebook’s data capture and control of its users’ data value chains on its market power. This inquiry is contextualized against Novi’s expansive effect on Facebook’s data value chains. It thus addresses the novel antitrust issues arising at the nexus of Facebook’s monopoly power and the privacy of its users’ data. It also explores the impact of platform design principles, specifically data portability and data portability, in mitigating Facebook’s anti-competitive practices. As such, this study finds that Facebook is a powerful monopoly that dominates the social media industry to the detriment of potential competitors. Facebook derives its power from its size, annexure of the consumer data value chain, and control of its users’ social graphs. Additionally, the platform design principles of data interoperability and data portability are not a panacea to restoring competition in the social networking market. Their success depends on the establishment of robust technical standards and regulatory frameworks.

Keywords: antitrust law, data protection law, data portability, data interoperability, digital identity, Facebook

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Authors: Baskar Kotte

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Many organizations are constantly striving to implement numerous techniques for long-term sustainability, for food related organizations it is imperative to conceptualize the critical concepts which constitute food safety sustainability. This presentation provides three critical pillars to develop a sustainable organization. Financial sustainability, regulatory sustainability and excellence standards sustainability are the three components which practiced and implemented effectively with process performance metrics defined objectives and targets lead to sustainable and safe food organizations. The participants take away a well-developed concept diagram with all elements impacting sustainability. Proven disciplined path which worked to achieve desired results is presented for effective implementation. Effective implementation of this proven disciplined path positions organizations to achieve world class status with bottomline improvement. Additionally, this presentation highlights critical terms, principles and implementation difficulties related to using the proven disciplined path. This presentation is beneficial for business leaders, food safety compliance managers, food safety practitioners, financial managers, Lean & Six sigma continual improvement managers, BRC/SQF/ IFS / FSSC 22000 practitioners and food manufacturing personnel.

Keywords: food safety, sustainability, regulatory, lean, six sigma, bottom-line improvement disciplined path

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Authors: Cesar Julio Recalde

Abstract:

Background: The role of intangible assets in today´s society is undeniable and continuously growing. More than 80% of corporate market is related to intellectual capital(IC). However, corporate governance principles and practices seem strongly based and oriented towards tangible assets. The impact of intangible assets on corporate governance might require prevention and adaptative actions. Adherence to voluntary mechanisms of intellectual capital reporting (ICR) seems to be a gateway towards adapting corporate governance to intangible assets influence and a conceptual cornerstone. The impact of adherence to intellectual capital reporting on corporate governance and performance needs to be evaluated. Purposes: This work has a sequential two folded purpose: (1) exploring the influences exerted by IC on corporate governance theory and practice, and within that context (2) analyzing the impact of adherence to voluntary mechanisms of ICR on corporate governance. Design and summary: This work employs the theory of the firm and agency theory in order to conceptually explore the effects of each dimension of IC on key corporate governance issues, namely property rights and control by shareholders and residual claims by stakeholders, fiduciary duties of management and the board, opportunistic behavior and transparency. A comprehensive IC taxonomy and map is presented. Within the resulting context, internal and external impact of ICR on corporate governance and performance is conceptually analyzed. IRC constraint and barriers are identified. Intellectual liabilities are presented within the context of IRC. Finally, IRC regulatory framework is surveyed. Findings: Relevant conclusions were rendered on the influence of intellectual capital on corporate governance. Sufficient evidence of a positive impact of IRC on corporate governance and performance was found. Additionally, it was found that IRC exerts a leveraging effect on IC itself. Intellectual liabilities are insufficiently researched and seem to have a relevant importance on IC measuring. IRC regulatory framework was found to be insufficiently developed to capture the essence of intangible assets and to meet corporate governance challenges facing IC. Originality: This work develops a progressive approach to conceptually analyze the mutual influences between IC and corporate governance. An epistemic ideogram represents the intersection of analyzed theories. An IC map is presented. The relatively new topic of intellectual liabilities is conceptually analyzed in the context of IRC. Social liabilities and client liabilities are presented.

Keywords: corporate governance, intellectual capital, intellectual capital reporting, intellectual assets, intellectual liabilities, voluntary mechanisms, regulatory framework

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Authors: Kakha Nadiardze, Nana Phirosmanashvili

Abstract:

The goal of this paper is to present the problems of lack of information among farmers in food safety. Global food supply chains are becoming more and more diverse, making traceability systems much harder to implement across different food markets. In this abstract, we will present our work for analyzing the key developments in Georgian food market from regulatory controls to administrative procedures to traceability technologies. Food safety and quality assurance are most problematic issues in Georgia as food trade networks become more and more complex, food businesses are under more and more pressure to ensure that their products are safe and authentic. The theme follow-up principles from farm to table must be top-of-mind for all food manufacturers, farmers and retailers. Following the E. coli breakout last year, as well as more recent cases of food mislabeling, developments in food traceability systems is essential to food businesses if they are to present a credible brand image. Alongside this are the ever-developing technologies in food traceability networks, technologies that manufacturers and retailers need to be aware of if they are to keep up with food safety regulations and avoid recall. How to examine best practice in food management is the main question in order to protect company brand through safe and authenticated food. We are working with our farmers to work with our food safety experts and technology developers throughout the food supply chain. We provide time by time food analyses on heavy metals, pesticide residues and different pollutants. We are disseminating information among farmers how the latest food safety regulations will impact the methods to use to identify risks within their products.

Keywords: food safety, GMO, LMO, E. coli, quality

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