Search results for: regulatory changes

Authors: Mehrnaz Mostafavi

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Nanoliposomes, minute lipid-based vesicles at the nano-scale, show promise in the realm of photothermal therapy (PTT). This study presents an extensive overview of nanoliposomes in PTT, exploring their distinct attributes and the significant progress in this therapeutic methodology. The research delves into the fundamental traits of nanoliposomes, emphasizing their adaptability, compatibility with biological systems, and their capacity to encapsulate diverse therapeutic substances. Specifically, it examines the integration of light-absorbing materials, like gold nanoparticles or organic dyes, into nanoliposomal formulations, enabling their efficacy as proficient agents for photothermal treatment Additionally, this paper elucidates the mechanisms involved in nanoliposome-mediated PTT, highlighting their capability to convert light energy into localized heat, facilitating the precise targeting of diseased cells or tissues. This precise regulation of light absorption and heat generation by nanoliposomes presents a non-invasive and precisely focused therapeutic approach, particularly in conditions like cancer. The study explores advancements in nanoliposomal formulations aimed at optimizing PTT outcomes. These advancements include strategies for improved stability, enhanced drug loading, and the targeted delivery of therapeutic agents to specific cells or tissues. Furthermore, the paper discusses multifunctional nanoliposomal systems, integrating imaging components or targeting elements for real-time monitoring and improved accuracy in PTT. Moreover, the review highlights recent preclinical and clinical trials showcasing the effectiveness and safety of nanoliposome-based PTT across various disease models. It also addresses challenges in clinical implementation, such as scalability, regulatory considerations, and long-term safety assessments. In conclusion, this paper underscores the substantial potential of nanoliposomes in advancing PTT as a promising therapeutic approach. Their distinctive characteristics, combined with their precise ability to convert light into heat, offer a tailored and efficient method for treating targeted diseases. The encouraging outcomes from preclinical studies pave the way for further exploration and potential clinical applications of nanoliposome-based PTT.

Keywords: nanoliposomes, photothermal therapy, light absorption, heat conversion, therapeutic agents, targeted delivery, cancer therapy

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Authors: Nino Damenia

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The agricultural sector plays an important role in the development of Georgia's economy, it contributes to employment and food security. It faces various types of risks that may lead to heavy financial losses. Agricultural insurance is one of the means of combating agricultural risks. The paper discusses the agricultural insurance experience of those countries (European countries and the USA) that have successfully implemented the agricultural insurance program. Analysis of international cases shows that a well-designed and implemented agri-insurance system can bring significant benefits to farmers, insurance companies and the economy as a whole. In the background of all this, the Government of Georgia recognized the importance of agro-insurance and took important steps for its development. In 2014, in cooperation with insurance companies, an agro-insurance program was introduced, the purpose of which is to increase the availability of insurance for farmers and stimulate the agro-insurance market. Despite such a step forward, challenges remain such as awareness of farmers, insufficient infrastructure for data collection and risk assessment, involvement of insurance companies and other important factors. With the support of the government and stakeholders, it is possible to overcome the existing challenges and establish a strong and effective agro-insurance system. Objectives. The purpose of the research is to analyze the development trends of the agricultural insurance market, to identify the main factors affecting its growth, and to further develop recommendations for development prospects for Georgia. Methodologies. The research uses mixed methods, which combine qualitative and quantitative research techniques. The qualitative method includes the study of the literature of Georgian and foreign economists, which allows us to get acquainted with the challenges, opportunities, legislative and regulatory frameworks of agricultural insurance. Quantitative analysis involves collecting data from stakeholders and then analyzing it. The paper also uses the methods of synthesis, comparison and statistical analysis of the agricultural insurance market in Georgia, Europe and the USA. Conclusions. As the main results of the research, we can consider that the analysis of the insurance market has been made and its main functions have been identified; The essence, features and functions of agricultural insurance are analyzed; European and US agricultural insurance market is researched; The stages of formation and development of the agricultural insurance market of Georgia are studied, its importance for the agricultural sector of Georgia is determined; The role of the state for the development of agro-insurance is analyzed and development prospects are established based on the study of the current trends of the agro-insurance market of Georgia.

Keywords: agricultural insurance, agriculture, agricultural insurance program, risk

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Authors: O. E. Akinyemi, P. O. Alege, O. O. Ajayi, L. A. Amaghionyediwe, A. A. Ogundipe

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Nigeria as an oil-producing developing country in Africa is one of the many countries that had been subsidizing consumption of fossil fuel. Despite the numerous advantage of this policy ranging from increased energy access, fostering economic and industrial development, protecting the poor households from oil price shocks, political considerations, among others; they have been found to impose economic cost, wasteful, inefficient, create price distortions discourage investment in the energy sector and contribute to environmental pollution. These negative consequences coupled with the fact that the policy had not been very successful at achieving some of its stated objectives, led to a number of organisations and countries such as the Group of 7 (G7), World Bank, International Monetary Fund (IMF), International Energy Agency (IEA), Organisation for Economic Co-operation and Development (OECD), among others call for global effort towards reforming fossil fuel subsidies. This call became necessary in view of seeking ways to harmonise certain existing policies which may by design hamper current effort at tackling environmental concerns such as climate change. This is in addition to driving a green growth strategy and low carbon development in achieving sustainable development. The energy sector is identified to play a vital role. This study thus investigates the prospects of using fuel subsidy reform as a viable tool in driving an economy that de-emphasizes carbon growth in Nigeria. The method used is the Johansen and Engle-Granger two-step Co-integration procedure in order to investigate the existence or otherwise of a long-run equilibrium relationship for the period 1971 to 2011. Its theoretical framework is rooted in the Environmental Kuznet Curve (EKC) hypothesis. In developing three case scenarios (case of subsidy payment, no subsidy payment and effective subsidy), findings from the study supported evidence of a long run sustainable equilibrium model. Also, estimation results reflected that the first and the second scenario do not significantly influence the indicator of environmental quality. The implication of this is that in reforming fuel subsidy to drive environmental quality for an economy like Nigeria, strong and effective regulatory framework (measure that was interacted with fuel subsidy to yield effective subsidy) is essential.

Keywords: environmental quality, fuel subsidy, green growth, low carbon growth strategy

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Authors: R. Hurtado-Ortiz, D. Clermont, M. Schüngel, C. Bizet, D. Smith, E. Stackebrandt

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Microbiological resources and their derivatives are the essential raw material for the advancement of human health, agro-food, food security, biotechnology, research and development in all life sciences. Microbial resources, and their genetic and metabolic products, are utilised in many areas such as production of healthy and functional food, identification of new antimicrobials against emerging and resistant pathogens, fighting agricultural disease, identifying novel energy sources on the basis of microbial biomass and screening for new active molecules for the bio-industries. The complexity of public collections, distribution and use of living biological material (not only living but also DNA, services, training, consultation, etc.) and service offer, demands the coordination and sharing of policies, processes and procedures. The Microbial Resource Research Infrastructure (MIRRI) is an initiative within the European Strategy Forum Infrastructures (ESFRI), bring together 16 partners including 13 European public microbial culture collections and biological resource centres (BRCs), supported by several European and non-European associated partners. The objective of MIRRI is to support innovation in microbiology by provision of a one-stop shop for well-characterized microbial resources and high quality services on a not-for-profit basis for biotechnology in support of microbiological research. In addition, MIRRI contributes to the structuring of microbial resources capacity both at the national and European levels. This will facilitate access to microorganisms for biotechnology for the enhancement of the bio-economy in Europe. MIRRI will overcome the fragmentation of access to current resources and services, develop harmonised strategies for delivery of associated information, ensure bio-security and other regulatory conditions to bring access and promote the uptake of these resources into European research. Data mining of the landscape of current information is needed to discover potential and drive innovation, to ensure the uptake of high quality microbial resources into research. MIRRI is in its Preparatory Phase focusing on governance and structure including technical, legal governance and financial issues. MIRRI will help the Biological Resources Centres to work more closely with policy makers, stakeholders, funders and researchers, to deliver resources and services needed for innovation.

Keywords: culture collections, microbiology, infrastructure, microbial resources, biotechnology

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Authors: Najeh Lakhoua

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Introduction: Scientific developments and techniques for the systemic approach generate several names to the systemic approach: systems analysis, systems analysis, structural analysis. The main purpose of these reflections is to find a multi-disciplinary approach which organizes knowledge, creates universal language design and controls complex sets. In fact, system analysis is structured sequentially by steps: the observation of the system by various observers in various aspects, the analysis of interactions and regulatory chains, the modeling that takes into account the evolution of the system, the simulation and the real tests in order to obtain the consensus. Thus the system approach allows two types of analysis according to the structure and the function of the system. The purpose of this paper is to present an application of system analysis of Unmanned Aerial Vehicle (UAV) components in order to represent the architecture of this system. Method: There are various analysis methods which are proposed, in the literature, in to carry out actions of global analysis and different points of view as SADT method (Structured Analysis and Design Technique), Petri Network. The methodology adopted in order to contribute to the system analysis of an Unmanned Aerial Vehicle has been proposed in this paper and it is based on the use of SADT. In fact, we present a functional analysis based on the SADT method of UAV components Body, power supply and platform, computing, sensors, actuators, software, loop principles, flight controls and communications). Results: In this part, we present the application of SADT method for the functional analysis of the UAV components. This SADT model will be composed exclusively of actigrams. It starts with the main function ‘To analysis of the UAV components’. Then, this function is broken into sub-functions and this process is developed until the last decomposition level has been reached (levels A1, A2, A3 and A4). Recall that SADT techniques are semi-formal; however, for the same subject, different correct models can be built without having to know with certitude which model is the good or, at least, the best. In fact, this kind of model allows users a sufficient freedom in its construction and so the subjective factor introduces a supplementary dimension for its validation. That is why the validation step on the whole necessitates the confrontation of different points of views. Conclusion: In this paper, we presented an application of system analysis of Unmanned Aerial Vehicle components. In fact, this application of system analysis is based on SADT method (Structured Analysis Design Technique). This functional analysis proved the useful use of SADT method and its ability of describing complex dynamic systems.

Keywords: system analysis, unmanned aerial vehicle, functional analysis, architecture

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Authors: Eusèbe Gnonlonfoun, Xavier Framboisier, Michel Fick, Emmanuel Rondags

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Pathogenic fungi represent a generic problem for cereals, including barley, as they can produce a number of thermostable toxic metabolites such as mycotoxins that contaminate plants and food products, leading to serious health issues for humans and animals and causing significant losses in global food production. In addition, mycotoxins represent a significant technological concern for the malting and brewing industries, as they may affect the quality and safety of raw materials (barley and malt) and final products (beer). Moreover, this situation is worsening due to the highly variable climatic conditions that favor microbial development and the societal desire to reduce the use of phytosanitary products, including fungicides. In this complex environmental, regulatory and economic context for the French barley-malt-beer industry, this project aims to develop an innovative biocontrol process by using technological bacteria, isolated from infection-resistant barley cultures, that are able to reduce the development of spoilage fungi and the associated mycotoxin production. The experimental approach consists of i) coculturing bacterial and pathogenic fungal strains in solid and liquid media to access the growth kinetics of these microorganisms and to evaluate the impact of these bacteria on fungal growth and mycotoxin production; then ii) the results will be used to carry out a micro-malting process in order to develop the aforementioned process, and iii) the technological and sanitary properties of the generated barley malts will finally be evaluated in order to validate the biocontrol process developed. The process is expected to make it possible to guarantee, with controlled costs, an irreproachable hygienic and technological quality of the malt, despite the increasingly complex and variable conditions for barley production. Thus, the results will not only make it possible to maintain the dominant world position of the French barley-malt chain but will also allow it to conquer emerging markets, mainly in Africa and Asia. The use of this process will also contribute to the reduction of the use of phytosanitary products in the field for barley production while reducing the level of contamination of malting plant effluents. Its environmental impact would therefore be significant, especially considering that barley is the fourth most-produced cereal in the world.

Keywords: barley, pathogenic fungi, mycotoxins, malting, bacterial biocontrol

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Authors: Nan Wu, Peng Liu

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As a morphological element reflecting the land property rights structure, the plot pattern plays a crucial role in shaping the form and quality of the built environment. Therefore, it is one of the core control elements of urban regeneration. As China's urban development mode is shifting from growth-based development to urban regeneration, it is urgent to explore a more refined way for the planning control of the plot pattern, which further promotes the optimization of urban form and land property structure. European and American countries such as Germany and the United States began to deal with the planning control of plot patterns in urban regeneration earlier and established relatively mature methods and mechanisms. Therefore, this paper summarizes two typical scenarios of plot pattern regeneration in old cities in China: the first one is "limited scale plot pattern rezoning", which mainly deals with the regeneration scenario of tearing down the old and building the new, and the focus of its control is to establish an adaptive plot pattern rezoning methodology and mechanism; The second is "localized parcel regeneration under the existing property rights," which mainly deals with the renewal scenario of alteration and addition, and its control focuses on the establishment of control rules for individual plot regeneration. For the two typical plot pattern regeneration scenarios, Germany (Berlin) and the United States (New York) are selected as two international cases with reference significance, and the framework of plot pattern form and property rights control elements of urban regeneration is established from four latitudes, namely, the overall operation mode, form control methods, property rights control methods, and effective implementation prerequisites, so as to compare and analyze the plot pattern control methods of the two countries under different land systems and regeneration backgrounds. Among them, the German construction planning system has formed a more complete technical methodology for block-scale rezoning, and together with the overall urban design, it has created a practical example in the critical redevelopment of the inner city of Berlin. In the United States (New York), the zoning method establishes fine zoning regulations and rules for adjusting development rights based on the morphological indicators plots so as to realize effective control over the regeneration of local plots under the existing property rights pattern. On the basis of summarizing the international experience, we put forward the proposal of plot pattern and property rights control for the organic regeneration of old cities in China.

Keywords: plot pattern, urban regeneration, urban morphology, property rights, regulatory planning

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Authors: Mirka Januszkiewicz

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The Regional Municipality of Durham is the upper level of a two-tier municipal and regional structure comprised of eight lower-tier municipalities. With a population of 655,000 in both urban and rural settings, the Region is approximately 2,537 square kilometers neighboring the City of Toronto, Ontario Canada to the east. The Region has been focused on diverting waste from disposal since the development of its Long Term Waste Management Strategy Plan for 2000-2020. With a 54 percent solid waste diversion rate, the focus now is on achieving 70 percent diversion on the path to zero waste using local waste management options whenever feasible. The Region has an Integrated Waste Management System that consists of a weekly curbside collection of recyclable printed paper and packaging and source separated organics; a seasonal collection of leaf and yard waste; a bi-weekly collection of residual garbage; and twice annual collection of intact, sealed household batteries. The Region also maintains three Waste Management Facilities for residential drop-off of household hazardous waste, polystyrene, construction and demolition debris and electronics. Special collection events are scheduled in the spring, summer and fall months for reusable items, household hazardous waste, and electronics. The Region is in the final commissioning stages of an energy from the waste facility for residual waste disposal that will recover energy from non-recyclable wastes. This facility is state of the art and is equipped for installation of carbon capture technology in the future. Despite all of these diversion programs and efforts, there is still room for improvement. Recent residential waste studies revealed that over 50% of the residual waste placed at the curb that is destined for incineration could be recycled. To move towards a zero waste community, the Region is looking to more advanced technologies for extracting the maximum recycling value from residential waste. Plans are underway to develop a pre-sort facility to remove organics and recyclables from the residual waste stream, including the growing multi-residential sector. Organics would then be treated anaerobically to generate biogas and fertilizer products for beneficial use within the Region. This project could increase the Region’s diversion rate beyond 70 percent and enhance the Region’s climate change mitigation goals. Zero waste is an ambitious goal in a changing regulatory and economic environment. Decision makers must be willing to consider new and emerging technologies and embrace change to succeed.

Keywords: municipal waste, residential, waste diversion, zero waste

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Authors: Andre Sanches Siqueira Campos

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Central banks can play a significant role in promoting regional economic and monetary integration by strengthening the payment and settlement systems. However, close coordination and cooperation require facilitating the implementation of reforms at domestic and cross-border levels in order to benchmark with international standards and commitments to the liberal order. This situation reflects the normative power of the regulatory globalization dimension of strong states, which may drive or constrain regional integration. In the MERCOSUR and SAARC regions, central banks have set financial initiatives that could facilitate South America and South Asia regions to move towards convergence integration and facilitate trade and investments connectivities. This is qualitative method research based on a combination of the Process-Tracing method with Qualitative Comparative Analysis (QCA). This research approaches multiple forms of data based on central banks, regional organisations, national governments, and financial institutions supported by existing literature. The aim of this research is to analyze the decision-making process of the Central Bank of Brazil (BCB) and the Reserve Bank of India (RBI) towards regional financial cooperation by identifying connectivity instruments that foster, gridlock, or redefine cooperation. The BCB and The RBI manage the monetary policy of the largest economies of those regions, which makes regional cooperation a relevant framework to understand how they provide an effective institutional arrangement for regional organisations to achieve some of their key policies and economic objectives. The preliminary conclusion is that both BCB and RBI demonstrate a reluctance to deepen regional cooperation because of the existing economic, political, and institutional asymmetries. Deepening regional cooperation is constrained by the interests of central banks in protecting their economies from risks of instability due to different degrees of development between countries in their regions and international financial crises that have impacted the international system in the 21st century. Reluctant regional integration also provides autonomy for national development and political ground for the contestation of Global Financial Governance by Brazil and India.

Keywords: Brazil, central banks, decision-making process, global financial governance, India, MERCOSUR, connectivity, payment system, regional cooperation, SAARC

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Authors: Luan Vardari, Dena Arapi Vardari

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The Balkan countries, known for their diverse landscapes and cultural heritage, face the dual challenge of promoting economic growth while addressing pressing environmental concerns. In recent years, the concept of green finance has emerged as a powerful tool to achieve sustainable development and mitigate the environmental impact of various sectors, including architecture. This extended abstract explores the untapped potential of green finance in architecture within the Balkan region and highlights its role in driving sustainable construction practices and fostering a greener future. The abstract begins by defining green finance and emphasizing its relevance in the context of the architectural sector in Balkan countries. It underlines the benefits of green finance, such as economic growth, environmental conservation, and social well-being. Integrating green finance into architectural projects is important as a means to achieve sustainable development goals while promoting financial viability. Also, delves into the current state of green building practices in the Balkan countries and identifies the need for financial support to further drive adoption. It explores the existing regulatory frameworks and policies that promote sustainable architecture and discusses how green finance can complement these initiatives. Unique challenges faced by Balkan countries are highlighted, along with the potential opportunities that green finance presents in overcoming these challenges. We highlight successful sustainable architectural projects in the region to showcase the practical application of green finance in the Balkans. These projects exemplify the effective utilization of green finance mechanisms, resulting in tangible economic and environmental impacts, including job creation, energy efficiency, and reduced carbon emissions. The abstract concludes by identifying replicable models and lessons learned from these projects that can serve as a blueprint for future sustainable architecture initiatives in the Balkans. The importance of collaboration and knowledge sharing among stakeholders is emphasized. Engaging architects, financial institutions, governments, and local communities is crucial to promoting green finance in architecture. The abstract suggests the establishment of knowledge exchange platforms and regional/international networks to foster collaboration and facilitate the sharing of expertise among Balkan countries.

Keywords: sustainable finance, renewable energy, Balkan region, investment opportunities, green infrastructure, ESG criteria, architecture

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Authors: Ava Zarif Sanayei, Sedigheh Sina

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Radiological protection for plants and animals is an area of regulatory importance. Acute doses of 0.1 Gy/d (10 rad/d) or below are highly unlikely to produce permanent, measurable negative effects on populations or communities of plants or animals. The advancement of radio diagnostics for domestic animals, particularly dogs and cats, has gained popularity in veterinary medicine. As pets are considered to be members of the family worldwide, they are entitled to the same care and protection. It is important to have a system of radiological protection for nonhuman organisms that complies with the focus on human health as outlined in ICRP publication 19. The present study attempts to assess surface-skin entrance doses in small pets undergoing abdominal radio diagnostic procedures utilizing a direct measurements technique with a thermoluminescent dosimeter. These measurements allow the determination of the entrance skin dose (ESD) by calculating the amount of radiation absorbed by the skin during exposure. A group of Thirty TLD-100 dosimeters produced by Harshaw Company, each with a repeatability greater than 95% and calibration using ¹³⁷Cs gamma source, were utilized to measure doses to ten small pets, including cats and dogs in the radiological department in a veterinary clinic in Shiraz, Iran. Radiological procedures were performed using a portable imaging unit (Philips Super M100, Philips Medical System, Germany) to acquire images of the abdomen; ten exams of abdomen images of different pets were monitored, measuring the thicknesses of the two projections (lateral and ventrodorsal) and the distance of the X-ray source from the surface of each pet during the exams. A group of two dosimeters was used for each pet which has been stacked on their skin on the abdomen region. The outcome of this study involved medical procedures with the same kVp, mAs, and nearly identical positions for different diagnostic X-ray procedures executed over a period of two months. The result showed the mean ESD value was 260.34±50.06 µGy due to the approximate size of pets. Based on the results, the ESD value is associated with animal size, and larger animals have higher values. If a procedure doesn't require repetition, the dose can be optimized. For smaller animals, the main challenge in veterinary radiology is the dose increase caused by repetitions, which is most noticeable in the ventro-dorsal position due to the difficulty in immobilizing the animal.

Keywords: direct dose measuring, dosimetry, radiation protection, veterinary medicine

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Authors: Elizabeth Owusu Asiamah

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The Ghanaian news media play a crucial role in shaping people's thinking patterns through the nature of the coverage they give to issues, events and personalities. Since the media do not work in a vacuum but within a broader spectrum, which is society, whatever stories they cover and the nature of frames used to narrate such stories go a long way to influence how citizens perceive issues in the country. Consequently, the National Media Commission and the National Communications Authority were instituted to monitor and direct the activities of the media to ensure professionalism that prioritizes society's interest over commercial interest. As the two media regulators go about their routine task of monitoring the operations of the media, they receive coverage from various media outlets (newspapers, radio, television and online). Some people believe that the kind of approach the regulators adopt depends on the nature of coverage the media give them in their reportage. This situation demands an investigation into how the media, regulated by these regulatory bodies, are representing the regulators in the public's eye and the issues arising from such coverage. Extant literature indicates that studies on media framing have centered on politics, environmental issues, public health issues, conflict and wars, etc. However, there appear to be no studies on media framing of media regulators, especially in the Ghanaian context. Since online newspapers have assumed more mainstream positions in the Ghanaian media and have attracted more audiences in recent times, this study investigates the nature of coverage given to media regulators by four purposively sampled online newspapers in Ghana. 96 news articles are extracted from the websites of the Daily Graphic, Ghanaian Times, Daily Guide and Chronicle newspapers within a five-year period to identify the prominence given to stories about the two media regulators and the frames used to narrate stories about them. Data collected are thematically analyzed through the lens of agenda-setting and media-framing theories. The findings of the study revealed that the two regulators were not given much coverage by way of frequency; however, much prominence was given to them in terms of enhancements such as images. The study further disclosed that most of the news articles framed the regulators as weak and incompetent, which is likely to affect how the public also views the regulators. The study concludes that since frames around the supportive nature of the regulators to issues of the media were not hammered by the online newspapers, the public will not perceive the regulators as playing their roles effectively. Thus, a need for more positive frames to be used to narrate stories about the National Media Commission and the National Communication Authority to promote a cordial relationship between the two institutions and a good image to the public.

Keywords: agenda setting, media framing, media regulators, online newspapers

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Authors: Ana Carolina Kogawa, Selma Gutierrez Antonio, Hérida Regina Nunes Salgado

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Rifaximin is an oral antimicrobial, gut - selective and not systemic with adverse effects compared to placebo. It is used for the treatment of hepatic encephalopathy, travelers diarrhea, irritable bowel syndrome, Clostridium difficile, ulcerative colitis and acute diarrhea. The crystalline form present in the rifaximin with minimal systemic absorption is α, being the amorphous form significantly different. Regulators are increasingly attention to polymorphisms. Polymorphs can change the form by altering the drug characteristics compromising the effectiveness and safety of the finished product. International Conference on Harmonization issued the ICH Guidance Q6A, which aim to improve the control of polymorphism in new and existing pharmaceuticals. The objective of this study was to obtain polymorphic forms of rifaximin employing recrystallization processes and characterize them by thermal analysis (thermogravimetry - TG and differential scanning calorimetry - DSC), X-ray diffraction, scanning electron microscopy and solubility test. Six polymorphic forms of rifaximin, designated I to VI were obtained by the crystallization process by evaporation of the solvent. The profiles of the TG curves obtained from polymorphic forms of rifaximin are similar to rifaximin and each other, however, the DTG are different, indicating different thermal behaviors. Melting temperature values of all the polymorphic forms were greater to that shown by the rifaximin, indicating the higher thermal stability of the obtained forms. The comparison of the diffractograms of the polymorphic forms of rifaximin with rifaximin α, β and γ constant in patent indicate that forms III, V and VI are formed by mixing polymorph β and α and form III is formed by polymorph β. The polymorphic form I is formed by polymorph β, but with a significant amount of amorphous material. Already, the polymorphic form II consists of polymorph γ, amorphous. In scanning electron microscope is possible to observe the heterogeneity of morphological characteristics of crystals of polymorphic forms among themselves and with rifaximin. The solubility of forms I and II was greater than the solubility of rifaximin, already, forms III, IV and V presented lower solubility than of rifaximin. Similarly, the bioavailability of the amorphous form of rifaximin is considered significantly higher than the form α, the polymorphic forms obtained in this work can not guarantee the excellent tolerability of the reference medicine. Therefore, studies like these are extremely important and they point to the need for greater requirements by the regulatory agencies competent about polymorphs analysis of the raw materials used in the manufacture of medicines marketed globally. These analyzes are not required in the majority of official compendia. Partnerships between industries, research centers and universities would be a viable way to consolidate researches in this area and contribute to improving the quality of solid drugs.

Keywords: electronic microscopy, polymorphism, rifaximin, solubility, X-ray diffraction

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Authors: Priya Sepaha

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Commercial Surrogacy refers to a contract in which a woman carries a pregnancy for intended parents. There are two types of surrogacy; first, Traditional Surrogacy, in which, sperm of the donor or father is artificially inseminated in the women and carries the fetus till birth. Second, Gestational Surrogacy, in which the egg and sperm of the intended parent are collected for artificial fertilization through In Vitro Fertilization (IVF) technique and after the embryo formation, it is transferred into the womb of a surrogate mother with the help of Assisted Reproductive Technique. Surrogacy has become so widespread in India that it has now been nicknamed the "rent-a-womb" capital of the world due to relatively low cost and lack of stringent regulatory legalisation. The legal aspects surrounding surrogacy are complex, diverse and mostly unsettled. Although this appears to be beneficial for the parties concerned, there are certain sensitive issues which need to be addressed to ensure ample protection to all stakeholders. Commercial surrogacy is an emerging business and a new means of human trafficking particularly in India. Poor and illiterate women are often lured in such deals by their spouse or broker for earning easy money. Traffickers also use force, fraud, or coercion at times to intimidate the probable surrogate mothers. A major chunk of money received from covert surrogacy agreement is taken away by the brokers. The Law Commission of India has specifically reviewed the issue as India is emerging as a major global surrogacy destination. The Supreme Court of India held in the Manji's case in 2008, that commercial surrogacy can be permitted with certain restrictions but had directed the Legislature to pass an appropriate Law for governing Surrogacy in India. The draft Assisted Reproductive Technique (ART) Bill, 2010 is still pending for approval. At present, the Surrogacy Contract between the parties and the ART Clinics Guidelines are perhaps the only guiding force. The Immoral Trafficking Prevention Act (ITPA), 1956 and Sections 366(A) and 372 of the Indian Penal Code, 1860 are perhaps the only existing laws, which deal with human trafficking. Yet, none of these provisions specifically deal with the serious issue of trafficking for the purpose of Commercial Surrogacy. India remains one of the few countries that still allow commercial surrogacy. International Surrogacy involves bilateral issues, where the laws of both the nations have to be at par in order to ensure that the concerns and interests of parties involved get amicably resolved. There is urgent need to pass a comprehensive law by incorporating the latest developments in this field in order to make it ethical on the one hand and to curb disguised human trafficking on the other.

Keywords: business, human trafficking, legal, surrogacy

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Authors: Jacolien Barnard, Corlia Van Heerden

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Effective and accessible consensual dispute resolution and in particular alternative dispute resolution, are central to consumer protection legislation. In this regard, the Consumer Protection Act 68 of 2008 (CPA) of South Africa is no exception. Due to the nature of consumer disputes, alternative dispute resolution (in theory) is an effective vehicle for the adjudication of disputes in a timely manner avoiding overburdening of the courts. The CPA sets down as one of its core purposes the provision of ‘an accessible, consistent, harmonized, effective and efficient system of redress for consumers’ (section 3(1)(h) of the CPA). Section 69 of the Act provides for the enforcement of consumer rights and provides for the National Consumer Commission to be the Central Authority which streamlines, adjudicates and channels disputes to the appropriate forums which include Alternative Dispute Resolution Agents (ADR-agents). The purpose of this paper is to analyze the regulation of these enforcement and redress mechanisms with particular focus on the Central Authority as well as the ADR-agents and their crucial role in successful and efficient adjudication of disputes in South Africa. The South African position will be discussed comparatively with the European Union (EU) position. In this regard, the European Union (EU) Directive on Alternative Dispute Resolution for Consumer Disputes (2013/11/EU) will be discussed (The ADR Directive). The aim of the ADR Directive is to solve contractual disputes between consumers and traders (suppliers or businesses) regardless of whether the agreement was concluded offline or online or whether or not the trader is situated in another member state (Recitals 4-6). The ADR Directive provides for a set of quality requirements that an ADR body or entity tasked with resolving consumer disputes should adhere to in member states which include regulatory mechanisms for control. Transparency, effectiveness, fairness, liberty and legality are all requirements for a successful ADR body and discussed within this chapter III of the Directive. Chapters III and IV govern the importance of information and co-operation. This includes information between ADR bodies and the European Commission (EC) but also between ADR bodies or entities and national authorities enforcing legal acts on consumer protection and traders. (In South Africa the National Consumer Tribunal, Provincial Consumer Protectors and Industry ombuds come to mind). All of which have a responsibility to keep consumers informed. Ultimately the papers aims to provide recommendations as to the successfulness of the current South African position in light of the comparative position in Europe and the highlight the importance of proper regulation of these redress and enforcement institutions.

Keywords: alternative dispute resolution, consumer protection law, enforcement, redress

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Authors: Renata Hrecska

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This research seeks to fully examine the internal employment law of international organizations by comparing it with the characteristics of the national civil service. The aim of the research is to compare the legal system that has developed over many centuries and the relatively new internal staffing regulations to find out what solution schemes can help each other through mutual legal development in order to respond effectively to the social challenges of everyday life. Generally, the rules of civil service of any country or international entity have in common that they have, in their pragmatics inherently, the characteristic that makes them serving public interests. Though behind the common base there are many differences: there is the clear fragmentation of state regulation and the unity of organizational regulation. On the other hand, however, this difference disappears to some extent: the public service regulation of international organizations can be considered uniform until we examine it within, but not outside an organization. As soon as we compare the different organizations we may find many different solutions for staffing regulations. It is clear that the national civil service is a strong model for international organizations, but the question may be whether the staffing policy of international organizations can serve the national civil service as an example, too. In this respect, the easiest way to imagine a legislative environment would be to have a single comprehensive code, the general part of which is the Civil Service Act itself, and the specific part containing specific, necessarily differentiating rules for each layer of the civil service. Would it be advantageous to follow the footsteps of the leading international organizations, or is there any speciality in national level civil service that we cannot avoid during regulating processes? In addition to the above, the personal competencies of officials working in international organizations and public administrations also show a high degree of similarity, regardless of the type of employment. Thus, the whole public service system is characterized by the fundamental and special values that a person capable of holding a public office must be able to demonstrate, in some cases, even without special qualifications. It is also interesting how we can compare the two spheres of employment in light of the theory of Lawyer Louis Brandeis, a judge at the US Supreme Court, who formulated a complex theory of profession as distinguished from other occupations. From this point of view we can examine the continuous development of research and specialized knowledge at work; the community recognition and social status; that to what extent we can see a close-knit professional organization of altruistic philosophy; that how stability grows in the working conditions due to the stability of the profession; and that how the autonomy of the profession can prevail.

Keywords: civil service, comparative law, international organizations, regulatory systems

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Authors: Keigo Ide, Toru Maruyama, Michihiro Ito, Hiroyuki Fujimura, Yoshikatu Nakano, Shoichiro Suda, Sachiyo Aburatani, Haruko Takeyama

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Understanding environmental system is one of the important tasks. In recent years, conservation of coral environments has been focused for biodiversity issues. The damage of coral reef under environmental impacts has been observed worldwide. However, the casual relationship between damage of coral and environmental impacts has not been clearly understood. On the other hand, structure/diversity of marine bacterial community may be relatively robust under the certain strength of environmental impact. To evaluate the coral environment conditions, it is necessary to investigate relationship between marine bacterial composition in coral reef and environmental factors. In this study, the Time Scale Network Analysis was developed and applied to analyze the marine environmental data for investigating the relationship among coral, bacterial community compositions and environmental factors. Seawater samples were collected fifteen times from November 2014 to May 2016 at two locations, Ishikawabaru and South of Sesoko in Sesoko Island, Okinawa. The physicochemical factors such as temperature, photosynthetic active radiation, dissolved oxygen, turbidity, pH, salinity, chlorophyll, dissolved organic matter and depth were measured at the coral reef area. Metagenome and metatranscriptome in seawater of coral reef were analyzed as the biological factors. Metagenome data was used to clarify marine bacterial community composition. In addition, functional gene composition was estimated from metatranscriptome. For speculating the relationships between physicochemical and biological factors, cross-correlation analysis was applied to time scale data. Even though cross-correlation coefficients usually include the time precedence information, it also included indirect interactions between the variables. To elucidate the direct regulations between both factors, partial correlation coefficients were combined with cross correlation. This analysis was performed against all parameters such as the bacterial composition, the functional gene composition and the physicochemical factors. As the results, time scale network analysis revealed the direct regulation of seawater temperature by photosynthetic active radiation. In addition, concentration of dissolved oxygen regulated the value of chlorophyll. Some reasonable regulatory relationships between environmental factors indicate some part of mechanisms in coral reef area.

Keywords: coral environment, marine microbiology, network analysis, omics data analysis

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Authors: Philippe Gugler

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The aim of this study is to investigate how home country patterns may influence the competitiveness of EMNEs in international markets and more specifically their ability to invest abroad. The study examines the dynamic relationship between home country specific advantage and firms’ competitiveness. Are EMNEs still driven by strong country specific advantages or are EMNEs increasingly relying on their own firm specific competitiveness? EMNEs are not commonly recognized as a ‘homogeneous group’. Therefore, the approaches to these questions need to be specific while still attempting to extract some common evidence. The aim of the study is to elaborate a framework to investigate this issue in a dynamic context of international business’s strategies. The study focuses on two major research questions. The first one relates to the role of the home-base context in the internationalization process of EMNEs and more specifically the home-base assets’ influence on EMNEs competitiveness. Another question is to investigate the interactions among home-base context, recipient country context and EMNEs competitiveness. The evolution of EMNEs’ competitiveness is shaped by the evolution of the home country’s business environment. The nature of the home-based components in EMNEs’ specific advantages has changed over time due to the increased integration of emerging countries in the world market and the inherent changes related to their institutional, structural and regulatory patterns. The home country offers not only inherited assets but also a productive business environment, allowing firms to innovate, be more productive, create unique value for customers and finally, to face international competition successfully. The more sophisticated the home business environment is, the more opportunities there are for firms to developed exclusive and unique competitive assets. The international expansion of EMNEs is a fascinating but challenging issue. Among the numerous questions raised by the involvement of EMNEs in international competition is the evolving role of the home market. The purpose of this study is to examine some of the theoretical ideas and empirical evidence to allow us to deepen our understanding of the role of emerging home countries in the internationalization process of their domestic firms and more specifically in their ability to compete successfully abroad. How much do home specific assets still influence EMNEs’ foreign investment? Which home country assets provide the main competitive drivers to invest and compete abroad? How do EMNEs combine home country assets and host country assets to strengthen their competitive advantages? These questions as well as various others deserve further examination by the scientific community.

Keywords: competitiveness, emerging countries' multinational enterprises, foreign direct investments, international business

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Authors: Giselly Barros Rodrigues, Carlos Leite de Souza

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In recent years, there has been a great discussion about urbanism, the right to the city, the search for the public space and the occupation and appropriation of people in the spaces of the city. This movement happens all over the world and also in the great Brazilian metropolises. The more human-friendly city - the desirable construction of urbanity - as well as the encouragement of walking or bicycling to the detriment of cars is one of the major issues addressed by urban planners and challenges in the process of reviewing regulatory frameworks. The fact is that even if there are public spaces or space for public use in private areas - it is essential that there be, besides a project focused on the people and the use of space, a good management not to generate excess of control and consequently the segregation between different ethnicities, classes or creed. With the insertion of the Strategic Master Plan of Sao Paulo (2014), there is great incentive for them to implement - in the private spaces - of mixed uses and active facades (Services and commerce in the basement of buildings), these incentives will generate a city for people in the medium and long term. This research seeks to discuss the extent to which these spaces are democratic, what their perceptions are in relation to the space of public use in private areas and why this perception may be the one that was originally idealized. For this study, we carried out bibliographic reviews where applied research were carried out in three case studies listed in Sao Paulo. Questionnaires were also applied to the actors who gave answers regarding their perceptions and how they were approached in the places analyzed. After analyzing the material, it was verified that in the three case studies analyzed, sitting on the floor is prohibited. In the two places in Paulista Avenue (Cetenco Plaza and Square of Mall Cidade Sao Paulo) there was no problem whatsoever in relation to the clothes or attitudes of the actors in the streets of Paulista Avenue in Sao Paulo city. Different from what happened in the Itaim neighborhood (Brascan Century Plaza), with more conservative characteristics, where the actors were heavily watched by security and observed by others due to their clothes and attitudes in that area. The city of Sao Paulo is slowly changing, people are increasingly looking for places of quality in public use in their daily lives. The Strategic Master Plan of Sao Paulo (2014) and the Legislation approved in 2016 envision a city more humane and people-oriented in the future. It is up to the private sector, the public, and society to work together so that this glimpse becomes an abundant reality in every city, generating quality of life and urbanity for all.

Keywords: urbanity, space for public use, appropriation of space, segregation

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Authors: Chua Si Wen Alicia, Marcus Goh Tian Xi, Eunice Gan Ghee Wu, Helen Bound, Lee Liang Ying, Albert Lee

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In a world full of rapid changes, people often need a set of skills to help them navigate an ever-changing workscape. These skills, often known as “future-oriented skills,” include learning to learn, critical thinking, understanding multiple perspectives, and knowledge creation. Future-oriented skills are typically assumed to be domain-general, applicable to multiple domains, and can be cultivated through a learning approach called Dialogical Inquiry. Dialogical Inquiry is known for its benefits of making sense of multiple perspectives, encouraging critical thinking, and developing learner’s capability to learn. However, it currently exists as a quantitative tool, which makes it hard to track and compare learning processes over time. With these concerns, the present research aimed to develop and validate a quantitative tool for the Map of Dialogical Inquiry, focusing Imagining aspect of learning. The Imagining aspect four dimensions: 1) speculative/ look for alternatives, 2) risk taking/ break rules, 3) create/ design, and 4) vision/ imagine. To do so, an exploratory literature review was conducted to better understand the dimensions of Imagining. This included deep-diving into the history of the creation of the Map of Dialogical Inquiry and a review on how “Imagining” has been conceptually defined in the field of social psychology, education, and beyond. Then, we synthesised and validated scales. These scales measured the dimension of Imagination and related concepts like creativity, divergent thinking regulatory focus, and instrumental risk. Thereafter, items were adapted from the aforementioned procured scales to form items that would contribute to the preliminary version of the Imagining Scale. For scale validation, 250 participants were recruited. A Confirmatory Factor Analysis (CFA) sought to establish dimensionality of the Imagining Scale with an iterative procedure in item removal. Reliability and validity of the scale’s dimensions were sought through measurements of Cronbach’s alpha, convergent validity, and discriminant validity. While CFA found that the distinction of Imagining’s four dimensions could not be validated, the scale was able to establish high reliability with a Cronbach alpha of .96. In addition, the convergent validity of the Imagining scale was established. A lack of strong discriminant validity may point to overlaps with other components of the Dialogical Map as a measure of learning. Thus, a holistic approach to forming the tool – encompassing all eight different components may be preferable.

Keywords: learning, education, imagining, pedagogy, dialogical teaching

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Authors: Rajkumar Ghosh, Bhabani Prasad Mukhopadhyay

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The increasing demand for environmentally friendly energy solutions highlights the need to optimize solar energy systems. This study compares two types of solar energy systems: ground-mounted solar panels for drought-prone locations and rooftop solar PV installations measuring 300 sq. ft. (approx. 28 sq. m.). The electricity output of 4730 kWh/year saves ₹ 14191/year. As a clean and sustainable energy source, solar power is pivotal in reducing greenhouse gas CO2 emissions reduction by 85 tonnes in 25 years and combating climate change. This effort, "PM Suryadaya Ghar-Muft Bijli Yojana," seeks to empower Indian homes by giving free access to solar energy. The initiative is part of the Indian government's larger attempt to encourage clean and renewable energy sources while reducing reliance on traditional fossil fuels. This report reviews various installations and government reports to analyse the performance and impact of both ground-mounted and rooftop solar systems. Besides, effectiveness of government subsidy programs for residential on-grid solar systems, including the ₹78,000 incentive for systems above 3 kW. The study also looks into the subsidy schemes available for domestic agricultural grid use. Systems up to 3 kW receive ₹43,764, while systems over 10 kW receive a fixed subsidy of ₹94,822. Households can save a substantial amount of energy and minimize their reliance on grid electricity by installing the proper solar plant capacity. In terms of monthly consumption at home, the acceptable Rooftop Solar Plant capacity for households is 0-150 units (1-2 kW), 150-300 units (2-3 kW), and >300 units (above 3 kW). Ground-mounted panels, particularly in arid regions, offer benefits such as scalability and optimal orientation but face challenges like land use conflicts and environmental impact, particularly in drought-prone regions. By evaluating the distinct advantages and challenges of each system, this study aims to provide insights into their optimal applications, guiding stakeholders in making informed decisions to enhance solar energy efficiency and sustainability within regulatory constraints. This research also explores the implications of regulations, such as Italy's ban on ground-mounted solar panels on productive agricultural land, on solar energy strategies.

Keywords: sustainability, solar energy, subsidy, rooftop solar energy, renewable energy

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Authors: Golnush Masghati-Amoli, Paul Chin

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Over the past recent years, with the rapid increases in data availability and computing power, Machine Learning (ML) techniques have been called on in a range of different industries for their strong predictive capability. However, the use of Machine Learning in commercial banking has been limited due to a special challenge imposed by numerous regulations that require lenders to be able to explain their analytic models, not only to regulators but often to consumers. In other words, although Machine Leaning techniques enable better prediction with a higher level of accuracy, in comparison with other industries, they are adopted less frequently in commercial banking especially for scoring purposes. This is due to the fact that Machine Learning techniques are often considered as a black box and fail to provide information on why a certain risk score is given to a customer. In order to bridge this gap between the explain-ability and performance of Machine Learning techniques, a Hybrid Model is developed at Dun and Bradstreet that is focused on blending Machine Learning algorithms with traditional approaches such as scorecards. The Hybrid Model maximizes efficiency of traditional scorecards by merging its practical benefits, such as explain-ability and the ability to input domain knowledge, with the deep insights of Machine Learning techniques which can uncover patterns scorecard approaches cannot. First, through development of Machine Learning models, engineered features and latent variables and feature interactions that demonstrate high information value in the prediction of customer risk are identified. Then, these features are employed to introduce observed non-linear relationships between the explanatory and dependent variables into traditional scorecards. Moreover, instead of directly computing the Weight of Evidence (WoE) from good and bad data points, the Hybrid Model tries to match the score distribution generated by a Machine Learning algorithm, which ends up providing an estimate of the WoE for each bin. This capability helps to build powerful scorecards with sparse cases that cannot be achieved with traditional approaches. The proposed Hybrid Model is tested on different portfolios where a significant gap is observed between the performance of traditional scorecards and Machine Learning models. The result of analysis shows that Hybrid Model can improve the performance of traditional scorecards by introducing non-linear relationships between explanatory and target variables from Machine Learning models into traditional scorecards. Also, it is observed that in some scenarios the Hybrid Model can be almost as predictive as the Machine Learning techniques while being as transparent as traditional scorecards. Therefore, it is concluded that, with the use of Hybrid Model, Machine Learning algorithms can be used in the commercial banking industry without being concerned with difficulties in explaining the models for regulatory purposes.

Keywords: machine learning algorithms, scorecard, commercial banking, consumer risk, feature engineering

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Authors: Kaddour Fellague Mohammed

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The world has seen in recent years, significant developments affected various aspects of life and influenced the different types of institutions, thus was born a new world is a world of globalization, which dominated the scientific revolution and the tremendous technological developments, and that contributed to the re-formation of human resources in contemporary organizations, and made patterns new regulatory and at the same time raised and strongly values and new ideas, the organizations have become more flexible, and faster response to consumer and environmental conditions, and exceeded the problem of time and place in the framework of communication and human interaction and use of advanced information technology and adoption mainly mechanism in running its operations , focused on performance and based strategic thinking and approach in order to achieve its strategic goals high degrees of superiority and excellence, this new reality created an increasing need for a new type of human resources, quality aims to renew and aspire to be a strategic player in managing the organization and drafting of various strategies, think globally and act locally, to accommodate local variables in the international markets, which began organizations tend to strongly as well as the ability to work under different cultures. Human resources management of the most important management functions to focus on the human element, which is considered the most valuable resource of the Department and the most influential in productivity at all, that the management and development of human resources Tattabra a cornerstone in the majority of organizations which aims to strengthen the organizational capacity, and enable companies to attract and rehabilitation of the necessary competencies and are able to keep up with current and future challenges, human resources can contribute to and strongly in achieving the objectives and profit organization, and even expand more than contribute to the creation of new jobs to alleviate unemployment and achieve full operation, administration and human resources mean short optimal use of the human element is available and expected, where he was the efficiency and capabilities, and experience of this human element, and his enthusiasm for the work stop the efficiency and success in reaching their goals, so interested administration scientists developed the principles and foundations that help to make the most of each individual benefit in the organization through human resources management, these foundations start of the planning and selection, training and incentives and evaluation, which is not separate from each other, but are integrated with each other as a system systemic order to reach the efficient functioning of the human resources management and has been the organization as a whole in the context of development sustainable.

Keywords: configuration, training, development, human resources, operating

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Authors: Rodrigo Fernandes da Silva, Daniela Maira Cardozo, Paulo Cesar Martins Alves, Sophie Françoise Derchain, Fernando Guimarães

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T-reg lymphocytes are important for the control of peripheral tolerance. They control the adaptive immune system and prevent autoimmunity through its suppressive action on CD4+ and CD8+ lymphocytes. The suppressive action also includes B lymphocytes, dendritic cells, monocytes/macrophages and recently, studies have shown that T-reg are also able to inhibit NK cells, therefore they exert their control of the immune response from innate to adaptive response. Most tumors express self-ligands, therefore it is believed that T-reg cells induce tolerance of the immune system, hindering the development of successful immunotherapies. T-reg cells have been linked to the suppression mechanisms of the immune response against tumors, including ovarian cancer. The goal of this study was to disclose the sub-population of the expanded CD3+ lymphocytes reported by previous studies, using the long-term culture model designed by Carlens et al 2001, to generate effector cell suspensions enriched with cytotoxic CD3-CD56+ NK cells, from PBMC of ovarian neoplasia patients. Methods and Results: Blood was collected from 12 patients with ovarian neoplasia after signed consent: 7 benign (Bng) and 5 malignant (Mlg). Mononuclear cells were separated by Ficoll-Paque gradient. Long-term culture was conducted by a 21 day culturing process with SCGM CellGro medium supplemented with anti-CD3 (10ng/ml, first 5 days), IL-2 (1000UI/ml) and FBS (10%). After 21 days of expansion, there was an increase in the population of CD3+ lymphocytes in the benign and malignant group. Within CD3+ population, there was a significant decrease in the population of CD4+ lymphocytes in the benign (median Bgn D-0=73.68%, D-21=21.05%) (p<0.05) and malignant (median Mlg D-0=64.00%, D-21=11.97%) (p < 0.01) group. Inversely, after 21 days of expansion, there was an increase in the population of CD8+ lymphocytes within the CD3+ population in the benign (median Bgn D-0=16.80%, D-21=38.56%) and malignant (median Mlg D-0=27.12%, D-21=72.58%) group. However, this increase was only significant on the malignant group (p<0.01). Within the CD3+CD4+ population, there was a significant increase (p < 0.05) in the population of T-reg lymphocytes in the benign (median Bgn D-0=9.84%, D-21=39.47%) and malignant (median Mlg D-0=3.56%, D-21=16.18%) group. Statistical analysis inter groups was performed by Kruskal-Wallis test and intra groups by Mann Whitney test. Conclusion: The CD4+ and CD8+ sub-population of CD3+ lymphocytes shifts with the culturing process. This might be due to the process of the immune system to produce a cytotoxic response. At the same time, T-reg lymphocytes increased within the CD4+ population, suggesting a modulation of the immune response towards cells of the immune system. The expansion of the T-reg population can hinder an immune response against cancer. Therefore, an immunotherapy using this expansion procedure should aim to halt the expansion of T-reg or its immunosuppresion capability.

Keywords: regulatory T cells, CD8+ T cells, CD4+ T cells, NK cell expansion

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Authors: Ratneev Kaur, Tajinder Kaur, Anupam Kaur

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Introduction: Polycystic Ovary Syndrome (PCOS) is a heterogenous disorder of endocrine system among women of reproductive age. PCOS is characterized by hyperandrogenism, anovulation, polycystic ovaries, hirsutism, obesity, and hyperinsulinemia. Several pathways are implicated in its etiology including the metabolic pathway of steroid hormone synthesis regulatory pathways. PCOS is an androgen excess disorder, genes operating in steroidogenesis may alter pathogenesis of PCOS. The cytochrome P450scc is a cholesterol side chain cleavage enzyme coded by CYP11A1 gene and catalyzes conversion of cholesterol to pregnenolone, the initial and rate-limiting step in steroid hormone synthesis. It is postulated that polymorphisms in this gene may play an important role in the regulation of CYP11A1 expression and leading to increased or decreased androgen production. The present study will be the first study from north India to best of our knowledge, to analyse the association of CYP11A1 (rs11632698) polymorphism in women suffering from PCOS. Methodology: The present study was approved by ethical committee of Guru Nanak Dev University in consistent with declaration of Helsinki. A total of 300 samples (150 PCOS cases and 150 controls) were recruited from Hartej hospital, for the present study. Venous blood sample (3ml) was withdrawn from women diagnosed with PCOS by doctor, according to Rotterdam 2003 criteria and from healthy age matched controls only after informed consent and detailed filled proforma. For molecular genetics analysis, blood was stored in EDTA vials. After DNA isolation by organic method, PCR-RFLP approach was used for genotyping and association analysis of rs11632698 polymorphism. Statistical analysis was done to check for significance of selected polymorphism with PCOS. Results: In 150 PCOS cases, the frequency of AA, AG and GG genotype was found to be 48%, 35%, and 13% compared to 62%, 27% and 8% in 150 controls. The major allele (A) and minor allele (G) frequency was 68% and 32% in cases and 78% and 22% in controls. Minor allele frequency was higher in cases as compared to controls, as well as the distribution of genotype was observed to be statistically significant (ᵡ²=6.525, p=0.038). Odds ratio in dominant, co-dominant and recessive models observed was 1.81 (p=0.013), 1.54 (p=0.012) and 1.77 (p=0.132) respectively. Conclusion: The present study showed statistically significant association of rs11632698 with PCOS (p=0.038) in North Indian women.

Keywords: polycystic ovary syndrome, CYP11A1, rs11632698, hyperandrogenism

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Authors: Lacheheb Dhia Eddine Zakaria, Ballout Amor

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Today, it is necessary to be thrifty for its planet, on one hand the space being a rare, nonrenewable resource, and on the other hand the ecological, economic and social cost of the urban sprawl. It is commonly asserted that the promotion of a more compact and dense city has a positive effect in terms of public costs of investment, functioning and costs for the citizens and the users of the city. It is clear that the modes urban development management have to evolve profoundly, in particular towards a densification favourable to the raising of the urban quality through an ideal urban density on the scale of the individual housing estate. The lot as an individual housing estate was adopted as an alternative development model to the collective housing, thought in an anthropocentric perspective to emerge as a quality model where the density plays an important role, by being included in operations of a global coherence, in an optimal organization without forgetting the main importance of the deadlines of construction and the finalization of the works. The image of eternal construction site inflicted to our cities explains the renewed interest for the application of the regulatory framework and the completion of these limited operations without global coherence, which are summed up in our case to a ground cut in plots of land, sold then built independently without being finished, and support the relevance of the essential question of the improvement of the outside aspect bound to the appearance which can be revealed as a so important factor for a better use and a better acceptance of its housing environment, that the ratio of a number of houses on a plot of land or the number of square meters by house. To demonstrate the impact of the completion degree of the subdivision dwellings, roads system and urban public utilities on the density or the densification and therefore on the urban quality, we studied two residential subdivisions, the private subdivision Sellam and the subdivision El Imane with a common situation, and a different land surface, density and cutting, being occupied by various social classes, with different needs and different household average size. The approach of this work is based on the typo morphological analysis to reveal the differences in the degrees of completions of the subdivision’s built environment and on the investigation, by a household’s survey, to demonstrate importance of the degree of completion and to reveal the conditions of qualitative densification favourable and convenient to a better subdivision’s appropriation.

Keywords: subdivision, degree of completion, densification, urban quality

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Authors: Jignasha Derasari, Patel Krishna M, Modi Jignasa G.

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Chemical stability of pharmaceutical molecules is a matter of great concern as it affects the safety and efficacy of the drug product.Stability testing data provides the basis to understand how the quality of a drug substance and drug product changes with time under the influence of various environmental factors. Besides this, it also helps in selecting proper formulation and package as well as providing proper storage conditions and shelf life, which is essential for regulatory documentation. The ICH guideline states that stress testing is intended to identify the likely degradation products which further help in determination of the intrinsic stability of the molecule and establishing degradation pathways, and to validate the stability indicating procedures. A simple, accurate and precise stability indicating RP- HPLC method was developed and validated for simultaneous estimation of Amiloride Hydrochloride and Furosemide in tablet dosage form. Separation was achieved on an Phenomenexluna ODS C18 (250 mm × 4.6 mm i.d., 5 µm particle size) by using a mobile phase consisting of Ortho phosphoric acid: Acetonitrile (50:50 %v/v) at a flow rate of 1.0 ml/min (pH 3.5 adjusted with 0.1 % TEA in Water) isocratic pump mode, Injection volume 20 µl and wavelength of detection was kept at 283 nm. Retention time for Amiloride Hydrochloride and Furosemide was 1.810 min and 4.269 min respectively. Linearity of the proposed method was obtained in the range of 40-60 µg/ml and 320-480 µg/ml and Correlation coefficient was 0.999 and 0.998 for Amiloride hydrochloride and Furosemide, respectively. Forced degradation study was carried out on combined dosage form with various stress conditions like hydrolysis (acid and base hydrolysis), oxidative and thermal conditions as per ICH guideline Q2 (R1). The RP- HPLC method has shown an adequate separation for Amiloride hydrochloride and Furosemide from its degradation products. Proposed method was validated as per ICH guidelines for specificity, linearity, accuracy; precision and robustness for estimation of Amiloride hydrochloride and Furosemide in commercially available tablet dosage form and results were found to be satisfactory and significant. The developed and validated stability indicating RP-HPLC method can be used successfully for marketed formulations. Forced degradation studies help in generating degradants in much shorter span of time, mostly a few weeks can be used to develop the stability indicating method which can be applied later for the analysis of samples generated from accelerated and long term stability studies. Further, kinetic study was also performed for different forced degradation parameters of the same combination, which help in determining order of reaction.

Keywords: amiloride hydrochloride, furosemide, kinetic study, stability indicating RP-HPLC method validation

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Authors: Teodorica G. Ani

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Economic activity requires an encouraging regulatory environment and effective rules that are transparent and accessible to all. The World Bank has been publishing the annual Doing Business reports since 2004 to investigate the scope and manner of regulations that enhance business activity and those that constrain it. A streamlined business environment supporting the development of competitive small and medium enterprises (SMEs) may expand employment opportunities and improve the living conditions of low income households. Asia has emerged as one of the most attractive markets in the world. Economies in East Asia and the Pacific were among the most active in making it easier for local firms to do business. The study aimed to describe the ease of doing business and its effect to economic growth among selected economies in Asia for the year 2014. The study covered 29 economies in East Asia, Southeast Asia, South Asia and Middle Asia. Ease of doing business is measured by the Doing Business indicators (DBI) of the World Bank. The indicators cover ten aspects of the ease of doing business such as starting a business, dealing with construction permits, getting electricity, registering property, getting credit, protecting investors, paying taxes, trading across borders, enforcing contracts and resolving insolvency. In the study, Gross Domestic Product (GDP) was used as the proxy variable for economic growth. Descriptive research was the research design used. Graphical analysis was used to describe the income and doing business among selected economies. In addition, multiple regression was used to determine the effect of doing business to economic growth. The study presented the income among selected economies. The graph showed China has the highest income while Maldives produces the lowest and that observation were supported by gathered literatures. The study also presented the status of the ten indicators of doing business among selected economies. The graphs showed varying trends on how easy to start a business, deal with construction permits and to register property. Starting a business is easiest in Singapore followed by Hong Kong. The study found out that the variations in ease of doing business is explained by starting a business, dealing with construction permits and registering property. Moreover, an explanation of the regression result implies that a day increase in the average number of days it takes to complete a procedure will decrease the value of GDP in general. The research proposed inputs to policy which may increase the awareness of local government units of different economies on the simplification of the policies of the different components used in measuring doing business.

Keywords: doing business, economic growth, gross domestic product, Asia

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Authors: Nayoma Ranawaka

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The demand for the high quality internationally comparable financial information has been increased than ever with the expansion of economic activities beyond its national boundaries. Thus, the necessity of converging accounting practices across the world is now continuously discussed with greater emphasis. The global convergence to International Financial Reporting Standards has been one of the main objectives of the International Accounting Standards Setting Board (IASB) since its establishment in 2001. Accordingly, Sri Lanka has adopted IFRSs in 2012. Among the other standards as a newly introduced standard by the IASB, IFRS 13 plays a pivotal role as it deals with the Fair Value Accounting (FVA). Therefore, it is valuable to obtain knowledge about the consequences of implementing IFRS 13 in Sri Lanka and compare results across nations. According to the IFRS Jurisdictional provision of Sri Lanka, Institute of Chartered Accountants of Sri Lanka has taken official steps to adopt IFRS 13 by introducing SLFRS 13 with de jure convergence. Then this study was identified the de facto convergence of the SLFRS 13 in measuring the Fair Value of Financial Instruments in the Sri Lankan context. Accordingly, the objective of this study is to explore the consequences to financial reporting by implementing SLFRS 13 on measuring the financial instruments. In order to achieve the objective of the study expert interview and in-depth interviews with the interviewees from the selected three case studies and their independent auditor were carried out using customized three different interview guides. These three cases were selected from three different industries; Banking, Manufacturing and Finance. NVivo version 10 was used to analyze the data collected through in-depth interviews. Then the content analysis was carried out and conclusions were derived based on the findings. Contribution to the knowledge by this study can be identified in different aspects. Findings of this study facilitate accounting practitioners to get an overall picture of application of fair value standard in measuring the financial instruments and to identify the challenges and barriers to the adoption process. Further, assist auditors in carrying out their audit procedures to check the level of compliance to the fair value standard in measuring the financial instruments. Moreover, this would enable foreign investors in assessing the reliability of the financial statements of their target investments as a result of SLFRS 13 in measuring the FVs of the FIs. The findings of the study could be used to open new avenues of thinking for policy formulators to provide the necessary infrastructure to eliminate disparities exists among different regulatory bodies to facilitate full convergence and thereby growth of the economy. Further, this provides insights to the dynamics of FVA implementation that are also relevant for other developing countries.

Keywords: convergence, fair value, financial instruments, IFRS 13

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Authors: Radu Deju, Carmen Mustata

Abstract:

The VVR-S nuclear research reactor owned by Horia Hubulei National Institute of Physics and Nuclear Engineering (IFIN-HH) was designed for research and radioisotope production, being permanently shut-down in 2002, after 40 years of operation. All amount of the nuclear spent fuel S-36 and EK-10 type was returned to Russian Federation (first in 2009 and last in 2012), and the radioactive waste resulted from the reprocessing of it will remain permanently in the Russian Federation. The decommissioning strategy chosen is immediate dismantling. At this moment, the radionuclides with half-life shorter than 1 year have a minor contribution to the contamination of materials and equipment used in reactor department. The decommissioning of the reactor has started in 2010 and is planned to be finalized in 2020, being the first nuclear research reactor that has started the decommissioning project from the South-East of Europe. The management system applied in the decommissioning of the VVR-S research reactor integrates all common elements of management: nuclear safety, occupational health and safety, environment, quality- compliance with the requirements for decommissioning activities, physical protection and economic elements. This paper presents the application of integrated management system in decommissioning of systems, structures, equipment and components (SSEC) from pumps room, including the management of the resulted radioactive waste. The primary cooling system of this type of reactor includes circulation pumps, heat exchangers, degasser, filter ion exchangers, piping connection, drainage system and radioactive leaks. All the decommissioning activities of primary circuit were performed in stage 2 (year 2014), and they were developed and recorded according to the applicable documents, within the requirements of the Regulatory Body Licenses. In the presentation there will be emphasized how the integrated management system provisions are applied in the dismantling of the primary cooling system, for elaboration, approval, application of necessary documentation, records keeping before, during and after the dismantling activities. Radiation protection and economics are the key factors for the selection of the proper technology. Dedicated and advanced technologies were chosen to perform specific tasks. Safety aspects have been taken into consideration. Resource constraints have also been an important issue considered in defining the decommissioning strategy. Important aspects like radiological monitoring of the personnel and areas, decontamination, waste management and final characterization of the released site are demonstrated and documented.

Keywords: decommissioning, integrated management system, nuclear reactor, waste management

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