Search results for: Regulatory Boards

Authors: Vishwesh Kulkarni, Nikhil Bellarykar

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Cellular complexity stems from the interactions among thousands of different molecular species. Thanks to the emerging fields of systems and synthetic biology, scientists are beginning to unravel these regulatory, signaling, and metabolic interactions and to understand their coordinated action. Reverse engineering of biological networks has has several benefits but a poor quality of data combined with the difficulty in reproducing it limits the applicability of these methods. A few years back, many of the commonly used predictive algorithms were tested on a network constructed in the yeast Saccharomyces cerevisiae (S. cerevisiae) to resolve this issue. The network was a synthetic network of five genes regulating each other for the so-called in vivo reverse-engineering and modeling assessment (IRMA). The network was constructed in S. cereviase since it is a simple and well characterized organism. The synthetic network included a variety of regulatory interactions, thus capturing the behaviour of larger eukaryotic gene networks on a smaller scale. We derive a new set of algorithms by solving a nonlinear optimization problem and show how these algorithms outperform other algorithms on these datasets.

Keywords: Synthetic gene network, network identification, nonlinear modeling, optimization.

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Authors: C. Chahin, M. C. Hsu, Y. H. Lin, C. Y. Huang

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Electronics Products that achieve high levels of integrated communications, computing and entertainment, multimedia features in small, stylish and robust new form factors are winning in the market place. Due to the high costs that an industry may undergo and how a high yield is directly proportional to high profits, IC (Integrated Circuit) manufacturers struggle to maximize yield, but today-s customers demand miniaturization, low costs, high performance and excellent reliability making the yield maximization a never ending research of an enhanced assembly process. With factors such as minimum tolerances, tighter parameter variations a systematic approach is needed in order to predict the assembly process. In order to evaluate the quality of upcoming circuits, yield models are used which not only predict manufacturing costs but also provide vital information in order to ease the process of correction when the yields fall below expectations. For an IC manufacturer to obtain higher assembly yields all factors such as boards, placement, components, the material from which the components are made of and processes must be taken into consideration. Effective placement yield depends heavily on machine accuracy and the vision of the system which needs the ability to recognize the features on the board and component to place the device accurately on the pads and bumps of the PCB. There are currently two methods for accurate positioning, using the edge of the package and using solder ball locations also called footprints. The only assumption that a yield model makes is that all boards and devices are completely functional. This paper will focus on the Monte Carlo method which consists in a class of computational algorithms (information processed algorithms) which depends on repeated random samplings in order to compute the results. This method utilized in order to recreate the simulation of placement and assembly processes within a production line.

Keywords: Monte Carlo simulation, placement yield, PCBcharacterization, electronics assembly

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Authors: Matteo Munaro, Stefano Michieletto, Edmond So, Daniele Alberton, Emanuele Menegatti

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In this work a dual laser triangulation system is presented for fast building of 2.5D textured models of objects within a production line. This scanner is designed to produce data suitable for 3D completeness inspection algorithms. For this purpose two laser projectors have been used in order to considerably reduce the problem of occlusions in the camera movement direction. Results of reconstruction of electronic boards are presented, together with a comparison with a commercial system.

Keywords: 3D quality inspection, 2.5D reconstruction, laser triangulation, occlusions.

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Authors: Maria E. Manioudaki, Panayiota Poirazi

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Yeast cells live in a constantly changing environment that requires the continuous adaptation of their genomic program in order to sustain their homeostasis, survive and proliferate. Due to the advancement of high throughput technologies, there is currently a large amount of data such as gene expression, gene deletion and protein-protein interactions for S. Cerevisiae under various environmental conditions. Mining these datasets requires efficient computational methods capable of integrating different types of data, identifying inter-relations between different components and inferring functional groups or 'modules' that shape intracellular processes. This study uses computational methods to delineate some of the mechanisms used by yeast cells to respond to environmental changes. The GRAM algorithm is first used to integrate gene expression data and ChIP-chip data in order to find modules of coexpressed and co-regulated genes as well as the transcription factors (TFs) that regulate these modules. Since transcription factors are themselves transcriptionally regulated, a three-layer regulatory cascade consisting of the TF-regulators, the TFs and the regulated modules is subsequently considered. This three-layer cascade is then modeled quantitatively using artificial neural networks (ANNs) where the input layer corresponds to the expression of the up-stream transcription factors (TF-regulators) and the output layer corresponds to the expression of genes within each module. This work shows that (a) the expression of at least 33 genes over time and for different stress conditions is well predicted by the expression of the top layer transcription factors, including cases in which the effect of up-stream regulators is shifted in time and (b) identifies at least 6 novel regulatory interactions that were not previously associated with stress-induced changes in gene expression. These findings suggest that the combination of gene expression and protein-DNA interaction data with artificial neural networks can successfully model biological pathways and capture quantitative dependencies between distant regulators and downstream genes.

Keywords: gene modules, artificial neural networks, yeast, stress

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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: 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: Suwaree Yordchim, Toby J. Gibbs

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The objective is to study the satisfaction on English with an online learning. Online learning system mainly consists of English lessons, exercises, tests, web boards, and supplementary lessons for language practice. The sample groups are 80 Thai students studying English for Business Communication, majoring in Hotel and Lodging Management. The data are analyzed by mean, standard deviation (S.D.) value from the questionnaires. The results were found that the most average of satisfaction on academic aspects are technological searching tool through E-learning system that support the students’ learning (4.51), knowledge evaluation on pre-post learning and teaching (4.45), and change for project selections according to their interest, subject contents including practice in the real situations (4.45), respectively.

Keywords: English Learning, Online System, Satisfaction.

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Authors: Mustapha Achibane, Imane Allam

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Since the nineties, all Moroccan banking institutions have to respect an arsenal of prudential ratios. The respect of these prudential measures aims to ensure the financial system stability. In order to do so, regulatory authorities tried to reduce the financial and operational risks incurred by the banking entities. Meanwhile, regulatory authorities demanded a balance sheet management work from banks. They also asked them to establish a management control system to manage operational risk, as well as an effort in terms of incurred risk-based commitments. Therefore, the prudential approach has a macroeconomic nature and it is presented as a determinant of the operational, microeconomic approach. This operational approach takes the form of a strategy that each banking entity must develop to manage the different banking risks. This study seeks to analyze the problem of risk management between the prudential and the operational approaches. It was processed through a literature review followed by an analysis of the Moroccan banking sector’s performance. At first, we will reconcile the inductive logic and then, the analytical one. The first approach consists of analyzing the phenomenon from a normative and conceptual perspective, while the second one will consist of considering the Moroccan banking system and analyzing the behavior of Moroccan banking entities in terms of risk management and performance. The results identified a favorable growth in terms of performance, despite the huge provisioning effort made to meet the international standards and the harmonization of the regulations.

Keywords: Banking performance, financial intermediation, operational approach, prudential standards, risk management.

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Authors: Yosia Mulumba, Klaus Schmidt

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Financial Inclusion is considered a key pillar for development in most countries around the world. Access to affordable financial services in a country’s economy can be a driver to overcome poverty and reduce income inequalities, and thus increase economic growth. Nevertheless, the number of financially excluded populations in developing countries continues to be very high. This paper explores the role of Financial Technology (Fintech) as a key driver for achieving financial inclusion in developing countries post the COVID-19 pandemic with an emphasis on four East African countries: Kenya, Tanzania, Uganda, and Rwanda. The research paper is inspired by the positive disruption caused by the pandemic, which has compelled societies in East Africa to adapt and embrace the use of financial technology innovations, specifically Mobile Money Services (MMS), to access financial services. MMS has been further migrated and integrated with other financial technology innovations such as Mobile Banking, Micro Savings, and Loans, and Insurance, to mention but a few. These innovations have been adopted across key sectors such as commerce, health care, or agriculture. The research paper will highlight the Mobile Network Operators (MNOs) that are behind MMS, along with numerous innovative products and services being offered to the customers. It will also highlight the regulatory framework under which these innovations are being governed to ensure the safety of the customers' funds.

Keywords: Financial inclusion, financial technology, regulatory framework, mobile money services.

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Authors: Ingrid Göpfert, Michael Stephan, Wanja Wellbrock, Malte Ackermann

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Empirical insights into the implementation of logistics competencies at the top management level are scarce. This paper addresses this issue with an explorative approach which is based on a dataset of 872 observations in the years 2000, 2004 and 2008 using quantitative content analysis from annual reports of the 500 publicly listed firms with the highest global research and development expenditures according to the British Department for Business Innovation and Skills. We find that logistics competencies are more pronounced in Asian companies than in their European or American counterparts. On an industrial level the results are quite mixed. Using partial point-biserial correlations we show that logistics competencies are positively related to financial performance.

Keywords: Logistics, supply chain management, content analysis, executive boards, multinational corporations.

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Authors: Kolis Karel, Kubicek Ales

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The purpose of this paper is to explore the relationship between the customers- issues in company corporate governance and the financial performance. At the beginning theoretical background consisting stakeholder theory and corporate governance is presented. On this theoretical background, the empirical research is built, collecting data of 60 Czech joint stock companies- boards considering their relationships with customers. Correlation analysis and multivariate regression analysis were employed to test the sample on two hypotheses. The weak positive correlation between stakeholder approach and the company size was identified. But both hypotheses were not supported, because there was no significant relation of independent variables to financial performance.

Keywords: customers, stakeholder theory, corporate governance, financial performance

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Authors: Pedro M. A. Vitoriano, Tito. G. Amaral

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Automated Optical Inspection (AOI) Systems are commonly used on Printed Circuit Boards (PCB) manufacturing. The use of this technology has been proven as highly efficient for process improvements and quality achievements. The correct extraction of the component for posterior analysis is a critical step of the AOI process. Nowadays, the Pattern Matching Algorithm is commonly used, although this algorithm requires extensive calculations and is time consuming. This paper will present an improved algorithm for the component localization process, with the capability of implementation in a parallel execution system.

Keywords: AOI, automated optical inspection, SMD, surface mounting devices, pattern matching, parallel execution.

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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: B. Noruziaan, A. Shvarzman, R. Leahy

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An innovative flooring underlayment was produced and tested. The composite system is made of common OSB boards and a layer of eco-friendly non-cement gypsum based material (GeoGypTM). It was found that the shear bond between the two materials is sufficient to secure the composite interaction between the two. The very high compressive strength and relatively high tensile strength of the non-cement based component together with its high modulus of elasticity provides enough strength and stiffness for the composite product to cover wider spacing between the joists. The initial findings of this study indicate that with joist spacing as wide as 800 mm, the flooring system provides enough strength without compromising the serviceability requirements of the building codes.

Keywords: Composite, floor deck, gypsum based, lumber joist, non-cement, oriented strandboard, shear bond.

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Authors: Jihyun Song, Kyeongjoo Kim, Minsoo Lee

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Due to the development of information technology and wireless Internet technology, various data are being generated in various fields. These data are advantageous in that they provide real-time information to the users themselves. However, when the data are accumulated and analyzed, more various information can be extracted. In addition, development and dissemination of boards such as Arduino and Raspberry Pie have made it possible to easily test various sensors, and it is possible to collect sensor data directly by using database application tools such as MySQL. These directly collected data can be used for various research and can be useful as data for data mining. However, there are many difficulties in using the board to collect data, and there are many difficulties in using it when the user is not a computer programmer, or when using it for the first time. Even if data are collected, lack of expert knowledge or experience may cause difficulties in data analysis and visualization. In this paper, we aim to construct a library for sensor data collection and analysis to overcome these problems.

Keywords: Clustering, data mining, DBSCAN, k-means, k-medoids, sensor data.

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Authors: M. Pieńko, A. Robak, E. Błazik-Borowa, J. Szer

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This paper presents the results of analysis of 100 full-scale scaffolding structures in terms of compliance with legal acts and safety of use. In 2016 and 2017, authors examined scaffolds in Poland located at buildings which were at construction or renovation stage. The basic elements affecting the safety of scaffolding use such as anchors, supports, platforms, guardrails and toe-boards have been taken into account. All of these elements were checked in each of considered scaffolding. Based on the analyzed scaffoldings, the most common errors concerning assembly process and use of scaffolding were collected. Legal acts on the scaffoldings are not always clear, and this causes many issues. In practice, people realize how dangerous the use of incomplete scaffolds is only when the accident occurs. Despite the fact that the scaffolding should ensure the safety of its users, most accidents on construction sites are caused by fall from a height.

Keywords: Façade scaffolds, load capacity, practice, safety of people.

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Authors: Danielle Morin, Jennifer D.E.Thomas, Raafat G. Saade

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While computers are known to facilitate lower levels of learning, such as rote memorization of facts, measurable through electronically administered and graded multiple-choice questions, yes/no, and true/false answers, the imparting and measurement of higher-level cognitive skills is more vexing. These require more open-ended delivery and answers, and may be more problematic in an entirely virtual environment, notwithstanding the advances in technologies such as wikis, blogs, discussion boards, etc. As with the integration of all technology, merit is based more on the instructional design of the course than on the technology employed in, and of, itself. With this in mind, this study examined the perceptions of online students in an introductory Computer Information Systems course regarding the fostering of various higher-order thinking and team-building skills as a result of the activities, resources and technologies (ART) used in the course.

Keywords: Critical thinking, deep learning, distance learning, elearning, online learning, virtual environments.

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Authors: Sanghun Lee

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Since the advent of the information era, the Internet has brought various positive effects in everyday life. Nevertheless, recently, problems and side-effects have been noted. Internet witch-trials and spread of pornography are only a few of these problems.In this study, problems and causes of malicious replies on internet boards were analyzed, using the key ideas of game theory. The study provides a mathematical model for the internet reply game to devise three possible plans that could efficiently counteract malicious replies. Furthermore, seven specific measures that comply with one of the three plans were proposed and evaluated according to the importance and utility of each measure using the orthogonal array survey and SPSS conjoint analysis.The conclusion was that the most effective measure would be forbidding unsigned user access to malicious replies. Also notable was that some analytically proposed measures, when implemented, could backfire and encourage malicious replies.

Keywords: Conjoint Analysis, Game Theory, Internet, MaliciousReplies, Prisoner's Dilemma

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Authors: Vanchai Laemlaksakul

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This research was to evaluate a technical feasibility of making single-layer experimental particleboard panels from bamboo waste (Dendrocalamus asper Backer) by converting bamboo into strips, which are used to make laminated bamboo furniture. Variable factors were density (600, 700 and 800 kg/m3) and temperature of condition (25, 40 and 55 °C). The experimental panels were tested for their physical and mechanical properties including modulus of elasticity (MOE), modulus of rupture (MOR), internal bonding strength (IB), screw holding strength (SH) and thickness swelling values according to the procedures defined by Japanese Industrial Standard (JIS). The test result of mechanical properties showed that the MOR, MOE and IB values were not in the set criteria, except the MOR values at the density of 700 kg/m3 at 25 °C and at the density of 800 kg/m3 at 25 and 40 °C, the IB values at the density of 600 kg/m3, at 40 °C, and at the density of 800 kg/m3 at 55 °C. The SH values had the test result according to the set standard, except with the density of 600 kg/m3, at 40 and 55 °C. Conclusively, a valuable renewable biomass, bamboo waste could be used to manufacture boards.

Keywords: Particleboard, Urea Formaldehyde Resin, BambooWaste

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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: Rui Antunes

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This article presents a simple way to perform programmed voice commands for the interface with commercial Digital and Analogue Input/Output PCI cards, used in Robotics and Automation applications. Robots and Automation equipment can "listen" to voice commands and perform several different tasks, approaching to the human behavior, and improving the human- machine interfaces for the Automation Industry. Since most PCI Digital and Analogue Input/Output cards are sold with several DLLs included (for use with different programming languages), it is possible to add speech recognition capability, using a standard speech recognition engine, compatible with the programming languages used. It was created in this work a Visual Basic 6 (the world's most popular language) application, that listens to several voice commands, and is capable to communicate directly with several standard 128 Digital I/O PCI Cards, used to control complete Automation Systems, with up to (number of boards used) x 128 Sensors and/or Actuators.

Keywords: Speech Recognition, Automation, Robotics.

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Authors: Mustafa Kavraz

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This study investigated the differences in the objective parameters of sound depending on the changes in the lengths of the lateral surfaces of a space and on the replacement of the sound absorbers that are placed on these surfaces. To this end, three models of room were chosen. The widths and heights of these rooms were the same but the lengths of the rooms were changed. The smallest room was 8 m. wide and 10 m. long. The lengths of the other two rooms were 15 m. and 20 m. For each model, the differences in the objective parameters of sound were determined by keeping all the material in the space intact and by changing only the positions of the sound absorbers that were placed on the walls. The sound absorbers that were used on the walls were of two different sizes. The sound absorbers that were placed on the walls were 4 m and 8 m. long and story-height (3 m.). In all model room types, the sound absorbers were placed on the long walls in three different ways: at the end of the long walls where the long walls meet the front wall; at the end of the long walls where the long walls meet the back wall; and in the middle part of the long walls. Except for the specially placed sound absorbers, the ground, wall and ceiling surfaces were covered with three different materials. There were no constructional elements such as doors and windows on the walls. On the surfaces, the materials specified in the Odeon 10 material library were used as coating material. Linoleum was used as flooring material, painted plaster as wall coating material and gypsum boards as ceiling covering (2 layers with a total of 32 mm. thickness). These were preferred due to the fact that they are the commonly used materials for these purposes. This study investigated the differences in the objective parameters of sound depending on the changes in the lengths of the lateral surfaces of a space and on the replacement of the sound absorbers that are placed on these surfaces. To this end, three models of room were chosen. The widths and heights of these rooms were the same but the lengths of the rooms were changed. The smallest room was 8 m. wide and 10 m. long. The lengths of the other two rooms were 15 m. and 20 m. For each model, the differences in the objective parameters of sound were determined by keeping all the material in the space intact and by changing only the positions of the sound absorbers that were placed on the walls. The sound absorbers that were used on the walls were of two different sizes. The sound absorbers that were placed on the walls were 4 m and 8 m. long and story-height (3 m.). In all model room types, the sound absorbers were placed on the long walls in three different ways: at the end of the long walls where the long walls meet the front wall; at the end of the long walls where the long walls meet the back wall; and in the middle part of the long walls. Except for the specially placed sound absorbers, the ground, wall and ceiling surfaces were covered with three different materials. There were no constructional elements such as doors and windows on the walls. On the surfaces, the materials specified in the Odeon 10 material library were used as coating material. Linoleum was used as flooring material, painted plaster as wall coating material and gypsum boards as ceiling covering (2 layers with a total of 32 mm. thickness). These were preferred due to the fact that they are the commonly used materials for these purposes.

Keywords: Jnd, objective parameters of sound, room model, sound absorber.

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Authors: Jörg Linde, Ekaterina Buyko, Robert Altwasser, Udo Hahn, Reinhard Guthke

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Reverse engineering of full-genomic interaction networks based on compendia of expression data has been successfully applied for a number of model organisms. This study adapts these approaches for an important non-model organism: The major human fungal pathogen Candida albicans. During the infection process, the pathogen can adapt to a wide range of environmental niches and reversibly changes its growth form. Given the importance of these processes, it is important to know how they are regulated. This study presents a reverse engineering strategy able to infer fullgenomic interaction networks for C. albicans based on a linear regression, utilizing the sparseness criterion (LASSO). To overcome the limited amount of expression data and small number of known interactions, we utilize different prior-knowledge sources guiding the network inference to a knowledge driven solution. Since, no database of known interactions for C. albicans exists, we use a textmining system which utilizes full-text research papers to identify known regulatory interactions. By comparing with these known regulatory interactions, we find an optimal value for global modelling parameters weighting the influence of the sparseness criterion and the prior-knowledge. Furthermore, we show that soft integration of prior-knowledge additionally improves the performance. Finally, we compare the performance of our approach to state of the art network inference approaches.

Keywords: Pathogen, network inference, text-mining, Candida albicans, LASSO, mutual information, reverse engineering, linear regression, modelling.

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Authors: Ponshano Kaselekela, Simooya O. Oscar, Lunshano Boyd

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The Copperbelt University Health Services (CBUHS) was designated by the Zambia Medicines Regulatory Authority (ZAMRA), formally the Pharmaceutical Regulatory Authority (PRA) as a regional pharmacovigilance centre to carryout activities of drug safety monitoring in four provinces in Zambia. CBUHS’s mandate included stimulating the reporting of adverse drug reactions (ADRs), as well as collecting and collating ADR reports from health institutions in the four provinces. This report covers the researchers’ experiences from May 2008 to September, 2016. The main objectives are 1) to monitor ADRs in the Zambian population, 2) to disseminate information to all health professionals in the region advising that the CBU health was a centre for reporting ADRs in the region, 3) to monitor polypharmacy as well as the benefit-risk profile of medicines, 4) to generate independent, evidence based recommendations on the safety of medicines, 5) to support ZAMRA in formulating safety related regulatory decisions for medicines, and 6) to communicate findings with all key stakeholders. The methodology involved monthly visits, beginning in early May 2008 to September, 2016, by the CBUHS to health institutions in the programme areas. Activities included holding discussions with health workers, distribution of ADR forms and collection of ADRs reports. These reports, once collected, were documented and assessed at the CBUHS. A report was then prepared for ZAMRA on quarterly basis. At ZAMRA, serious ADRs were noted and recommendations made to the Ministry of Health of the Republic of Zambia. The results show that 2,600 ADRs reports were received at the pharmacovigilance regional centre. Most of the ADRs reports that received were due to antiretroviral drugs, as well as a few from anti-malarial drugs like Artemether/Lumefantrine – Coartem®. Three hundred and twelve ADRs were entered in the Uppsala Monitoring Centre WHO Vigiflow for further analysis. It was concluded that in general, 2008-16 were exciting years for the pharmacovigilance group at CBUHS. From a very tentative beginning, a lot of strides were made and contacts established with healthcare facilities in the region. The researchers were encouraged by the support received from the Copperbelt University management, the motivation provided by ZAMRA and most importantly the enthusiasm of health workers in all the health care facilities visited. As a centre for drug safety in Zambia, the results show it achieves its objectives for monitoring ADRs, Pharmacovigilance (drug safety monitoring), and activities of monitoring ADRs as well as preventing them. However, the centre faces critical challenges caused by erratic funding that prevents the smooth running of the programme.

Keywords: Assessments, evaluation, monitoring, pharmacovigilance.

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Authors: S. Shakibaei, P. Alpkokin

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The railway network is one of the major components of a transportation system in a country which may be an indicator of the country’s level of economic improvement. Since 2000s on, revival of national railways and development of High Speed Rail (HSR) lines are one of the most remarkable policies of Turkish government in railway sector. Within this trend, the railway age is to be revived and coming decades will be a golden opportunity. Indubitably, major infrastructures such as road and railway networks require sizeable investment capital, precise maintenance and reparation. Traditionally, governments are held responsible for funding, operating and maintaining these infrastructures. However, lack or shortage of financial resources, risk responsibilities (particularly cost and time overrun), and in some cases inefficacy in constructional, operational and management phases persuade governments to find alternative options. Financial power, efficient experiences and background of private sector are the factors convincing the governments to make a collaboration with private parties to develop infrastructures. Public-Private Partnerships (PPP or 3P or P3) and related regulatory issues are born considering these collaborations. In Turkey, PPP approaches have attracted attention particularly during last decade and these types of investments have been accelerated by government to overcome budget limitations and cope with inefficacy of public sector in improving transportation network and its operation. This study mainly tends to present a comprehensive overview of PPP concept, evaluate the regulatory procedure in Europe and propose a general framework for Turkish State Railways (TCDD) as an outlook on privatization, liberalization and deregulation of railway network.

Keywords: Deregulation, high-speed rail, liberalization, privatization, public-private partnership.

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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: Pradeep Kulshrestha, Maulana Ayoub Ali

Abstract:

The concept of financial inclusion has been tabled in the whole world where practitioners, academicians, policy makers and economists are working hard to look for the best possible opportunities in order to enable the whole society to be in the banking cycle. The Islamic banking system is considered to be one of the said opportunities. Countries like the United Kingdom, United States of America, Malaysia, Saudi Arabia, the whole of the United Arab Emirates and many African countries have accommodated the aspect of Islamic banking in the conventional banking system as one of the financial inclusion strategies. This paper tries to analyse the current state of affairs of the Islamic Banking system in Tanzania in order to understand the improvement of the provision of Islamic banking products and services in the said country. The paper discusses the historical background of the banking system in Tanzania, the level of penetration of banking products and services and the coming of the Islamic banking system in the country. Furthermore, the paper discusses banking regulatory bodies, legal instruments governing banking operations as well as number of legal challenges facing Islamic banking operations in the country. Following a critical literature review, the paper discovered that there is no legal instrument which talks about the introduction and provision of Islamic banking system in Tanzania. Furthermore, the Islamic banking system was considered as a banking product which is absolutely incorrect because Islamic banking is considered to be as a banking system of its own. In addition to that, it has been discovered that lack of a proper regulatory system and legal instruments to harmonize the conventional and Islamic banking systems has resulted in the closure of one Islamic window in the country, which in the end affects the credibility of the newly introduced banking system. In its conclusive remarks, the paper suggests that Tanzania should work on all legal challenges affecting the smooth operations of the Islamic banking system. This can be in a way of adopting various Islamic banking legal models which are used in countries like Malaysia and others, or a borrowing legal harmonization process which has been adopted by the UK, Uganda, Nigeria and Kenya.

Keywords: Islamic banking, Islamic Windows, regulations, banks.

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

Abstract:

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: Kari Huhtala, Iiro Jussila

Abstract:

The supervisory board is assumed to use power in the governance of a firm, but the actual use of power has been scantly investigated. The research question of the paper is “How does the supervisory board use power in the selection of the board of directors”. The data stem from 11 large Finnish agricultural cooperatives. The research approach was qualitative including semi-structured interviews of the board of directors and supervisory board chairpersons. The results were analyzed and interpreted against theories of social power. As a result, the use of power is approached from two perspectives: (1) formal position-based authority and (2) informal power. Central elements of power were the mandate of the supervisory board, the role of the supervisory board, the supervisory board chair, the nomination committee, collaboration between the supervisory board and the board of directors, the role of regions and the role of the board of directors. The study contributes to the academic discussion on corporate governance in cooperatives and on the supervisory board in the context of the two-tier model. Additional research of the model in other countries and of other types of cooperatives would further academic understanding of supervisory boards.

Keywords: Board, cooperative, supervisory board, selection, director, power.

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Authors: Azmi Hamid, Rozainun Aziz

Abstract:

The study aims to investigate the impact on board and audit committee characteristics and firm performance before and after the revision of MCCG (2007) on GLCs over the period 2005-2010. We used Return on Assets (ROA) as a proxy for firm performance. The data consists of two groups; data collected before and after the amendments of MCCG (2007). Findings show that boards of directors with accounting / finance qualifications (BEXP) are statistically significant with performance for period before the amendments. As for audit committee members with accounting or finance qualifications (ACEXP), correlation results indicate a negative association and non-significant results for the years before amendments. However, the years after the amendments show positive relationship with highly significant correlations (1%) to ROA. This indicates that the amendments of MCCG 2007 on the audit committee members- literacy in accounting have impacted the governance structures and performance of GLCs.

Keywords: BOD and Audit Committees, firm performance, GLCs.

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