Search results for: regulatory systems
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 9579

Search results for: regulatory systems

9579 SCANet: A Workflow for Single-Cell Co-Expression Based Analysis

Authors: Mhaned Oubounyt, Jan Baumbach

Abstract:

Differences in co-expression networks between two or multiple cells (sub)types across conditions is a pressing problem in single-cell RNA sequencing (scRNA-seq). A key challenge is to define those co-variations that differ between or among cell types and/or conditions and phenotypes to examine small regulatory networks that can explain mechanistic differences. To this end, we developed SCANet, an all-in-one Python package that uses state-of-the-art algorithms to facilitate the workflow of a combined single-cell GCN (Gene Correlation Network) and GRN (Gene Regulatory Networks) pipeline, including inference of gene co-expression modules from scRNA-seq, followed by trait and cell type associations, hub gene detection, co-regulatory networks, and drug-gene interactions. In an example case, we illustrate how SCANet can be applied to identify regulatory drivers behind a cytokine storm associated with mortality in patients with acute respiratory illness. SCANet is available as a free, open-source, and user-friendly Python package that can be easily integrated into systems biology pipelines.

Keywords: single-cell, co-expression networks, drug-gene interactions, co-regulatory networks

Procedia PDF Downloads 96
9578 ISMARA: Completely Automated Inference of Gene Regulatory Networks from High-Throughput Data

Authors: Piotr J. Balwierz, Mikhail Pachkov, Phil Arnold, Andreas J. Gruber, Mihaela Zavolan, Erik van Nimwegen

Abstract:

Understanding the key players and interactions in the regulatory networks that control gene expression and chromatin state across different cell types and tissues in metazoans remains one of the central challenges in systems biology. Our laboratory has pioneered a number of methods for automatically inferring core gene regulatory networks directly from high-throughput data by modeling gene expression (RNA-seq) and chromatin state (ChIP-seq) measurements in terms of genome-wide computational predictions of regulatory sites for hundreds of transcription factors and micro-RNAs. These methods have now been completely automated in an integrated webserver called ISMARA that allows researchers to analyze their own data by simply uploading RNA-seq or ChIP-seq data sets and provides results in an integrated web interface as well as in downloadable flat form. For any data set, ISMARA infers the key regulators in the system, their activities across the input samples, the genes and pathways they target, and the core interactions between the regulators. We believe that by empowering experimental researchers to apply cutting-edge computational systems biology tools to their data in a completely automated manner, ISMARA can play an important role in developing our understanding of regulatory networks across metazoans.

Keywords: gene expression analysis, high-throughput sequencing analysis, transcription factor activity, transcription regulation

Procedia PDF Downloads 27
9577 Relationship between Deliberate Practice of Dribbling and Self-Regulatory Behavior of Male Basketball Players

Authors: Daud Abdia, Aqsa Shamim, Farhan Tabassum

Abstract:

In order to achieve specific goals, basketball players have to use different skills to enhance their motivation, one such skill is deliberate practice. The aim of this study was to explore the relationship between deliberate practice of dribbling and self-regulatory behavior of male basketball players. For this purpose, a sample of 108 basketball players using stratified sampling was taken from public and private sector universities. Sample was divided into two groups that are experimental (n=54) and control group (n=54) using comparative experimental design. Experimental group was involved in the training of deliberate practice of dribbling for 5 weeks. Amounts of weekly practice activity and Self-Regulation of Learning Self-Report Scale (SRL-SRS) were used for self-regulatory behavior to collect data after the deliberate practice. The reliability of amounts of weekly practice activity was found to be 0.852, whereas SRL-SRS was found to be 0.890. The results of the study indicated a strong positive correlation between deliberate practice of dribbling and self-regulatory behavior (r=0.755, n=54, p=.000). Whereas, paired sample t-test; t(53)=1.37, p < 0.005 shows statistically significant improvement in the self-regulatory behavior after the training program of deliberate practice from 3.02 ± 0.64m to 3.21 ± 0.75m (p < 0.005). It was concluded that in order to enhance the self-regulatory behavior of basketball players we should work on the deliberate practice of the players.

Keywords: self-regulatory behavior, deliberate practice, dribbling, basketball

Procedia PDF Downloads 140
9576 How Manufacturing Firm Manages Information Security: Need Pull and Technology Push Perspective

Authors: Geuna Kim, Sanghyun Kim

Abstract:

This study investigates various factors that may influence the ISM process, including the organization’s internal needs and external pressure, and examines the role of regulatory pressure in ISM development and performance. The 105 sets of data collected in a survey were tested against the research model using SEM. The results indicate that NP and TP had positive effects on the ISM process, except for perceived benefits. Regulatory pressure had a positive effect on the relationship between ISM awareness and ISM development and performance.

Keywords: information security management, need pull, technology push, regulatory pressure

Procedia PDF Downloads 264
9575 New Advanced Medical Software Technology Challenges and Evolution of the Regulatory Framework in Expert Software, Artificial Intelligence, and Machine Learning

Authors: Umamaheswari Shanmugam, Silvia Ronchi

Abstract:

Software, artificial intelligence, and machine learning can improve healthcare through innovative and advanced technologies that can use the large amount and variety of data generated during healthcare services every day; one of the significant advantages of these new technologies is the ability to get experience and knowledge from real-world use and to improve their performance continuously. Healthcare systems and institutions can significantly benefit because the use of advanced technologies improves the efficiency and efficacy of healthcare. Software-defined as a medical device, is stand-alone software that is intended to be used for patients for one or more of these specific medical intended uses: - diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease, any other health conditions, replacing or modifying any part of a physiological or pathological process–manage the received information from in vitro specimens derived from the human samples (body) and without principal main action of its principal intended use by pharmacological, immunological or metabolic definition. Software qualified as medical devices must comply with the general safety and performance requirements applicable to medical devices. These requirements are necessary to ensure high performance and quality and protect patients' safety. The evolution and the continuous improvement of software used in healthcare must consider the increase in regulatory requirements, which are becoming more complex in each market. The gap between these advanced technologies and the new regulations is the biggest challenge for medical device manufacturers. Regulatory requirements can be considered a market barrier, as they can delay or obstacle the device's approval. Still, they are necessary to ensure performance, quality, and safety. At the same time, they can be a business opportunity if the manufacturer can define the appropriate regulatory strategy in advance. The abstract will provide an overview of the current regulatory framework, the evolution of the international requirements, and the standards applicable to medical device software in the potential market all over the world.

Keywords: artificial intelligence, machine learning, SaMD, regulatory, clinical evaluation, classification, international requirements, MDR, 510k, PMA, IMDRF, cyber security, health care systems

Procedia PDF Downloads 63
9574 Board Chairman, Share Ownership and Financial Reporting Quality of Microfinance Banks in Nigeria: Impact of Regulatory Changes

Authors: Muhammad Umar Kibiya

Abstract:

The study aims to examine whether regulatory changes have an impact on the financial reporting quality of Microfinance Banks in Nigeria. The research employed a panel data analysis technique, using data from 2018 to 2022. The sample includes 72 microfinance banks, using regression analyses to examine the relationship between variables. The findings indicate that Board Chairmanship has a positive and significant effect on financial reporting quality. It also reveals that share ownership has a negative and significant impact on financial reporting quality. The results suggest that regulatory changes have a positive and significant influence on financial reporting quality. Thus, findings have important implications for microfinance banks in Nigeria. It suggests that having a strong and competent board chairperson can enhance financial reporting quality, leading to more transparent and reliable information for stakeholders. Furthermore, the study highlights the importance of regulatory changes in improving financial reporting practices in the microfinance banking sector. The study contributes to the extant literature by providing empirical evidence on the relationship between board chairmanship, share ownership, financial reporting quality, and regulatory changes in microfinance banks. It further supports the concept that governance mechanisms and regulatory reforms play a crucial role in ensuring transparency and accountability within the microfinance banking sector. It recommends that microfinance banks should appoint experienced and qualified individuals as board chairpersons to enhance financial reporting quality. Furthermore, policymakers and regulatory authorities should continue to implement and enforce regulations that promote transparent financial reporting practices in microfinance banks.

Keywords: board chairman, share ownership, financial reporting quality, microfinance, regulatory changes

Procedia PDF Downloads 31
9573 Construction of the Large Scale Biological Networks from Microarrays

Authors: Fadhl Alakwaa

Abstract:

One of the sustainable goals of the system biology is understanding gene-gene interactions. Hence, gene regulatory networks (GRN) need to be constructed for understanding the disease ontology and to reduce the cost of drug development. To construct gene regulatory from gene expression we need to overcome many challenges such as data denoising and dimensionality. In this paper, we develop an integrated system to reduce data dimension and remove the noise. The generated network from our system was validated via available interaction databases and was compared to previous methods. The result revealed the performance of our proposed method.

Keywords: gene regulatory network, biclustering, denoising, system biology

Procedia PDF Downloads 206
9572 From Al Capone to Silk Road: Money Laundering Regulation for Cryptocurrency on the Horizon

Authors: Chinelle van der Westhuizen

Abstract:

The introduction of cryptocurrencies as an alternative payment system have placed governments in a challenging position in relation to the regulatory status of cryptocurrencies and the money laundering activities associated with it. In April 2018, the Australian government amended its Anti-Money Laundering laws to regulate digital currency exchanges in an attempt to regulate money laundering activities and the introduction of ‘know-your-customer’ policies within the digital currency sector. Part one of this paper explores the use of cryptocurrencies for money laundering purposes and its significance to money launderers. Part two studies the efficacy of the current Australian Anti-Money Laundering laws and whether more can be done on a regulatory level. This paper will, therefore, highlight recent court decisions and legislation in terms of money laundering activities within these alternative payment systems in Australia and the United Kingdom. Part three of the paper will further analyze recent case studies by the Australian Transaction Reports and Analysis Centre and the Office for Professional Body Anti-Money Laundering Supervision in the United Kingdom as the regulatory bodies for money laundering activities. The case studies and research will explore the legal disputes and future regulation concerning the use of cryptocurrencies and money laundering on a national as well as international level. This paper intends to highlight that although cryptocurrency is viewed as an innovative global phenomenon and an alternative method of payment, there are a number of legal issues associated with its use that indicate the need for regulatory reform. It is recommended in this paper that the Financial Action Task Force, International Monetary Fund as well as concerned governments have ongoing discussions on these regulatory issues and how to address it appropriately, whether through legislation or universal guidelines. Therefore, the conclusion of this paper will emphasize the benefits of a regulatory regime for money laundering activities within the cryptocurrency space and that the lack of such a regime may be detrimental to countries.

Keywords: cryptocurrency, know-your-customer policy, money laundering, regulation

Procedia PDF Downloads 124
9571 Process Modeling in an Aeronautics Context

Authors: Sophie Lemoussu, Jean-Charles Chaudemar, Robertus A. Vingerhoeds

Abstract:

Many innovative projects exist in the field of aeronautics, each addressing specific areas so to reduce weight, increase autonomy, reduction of CO2, etc. In many cases, such innovative developments are being carried out by very small enterprises (VSE’s) or small and medium sized-enterprises (SME’s). A good example concerns airships that are being studied as a real alternative to passenger and cargo transportation. Today, no international regulations propose a precise and sufficiently detailed framework for the development and certification of airships. The absence of such a regulatory framework requires a very close contact with regulatory instances. However, VSE’s/SME’s do not always have sufficient resources and internal knowledge to handle this complexity and to discuss these issues. This poses an additional challenge for those VSE’s/SME’s, in particular those that have system integration responsibilities and that must provide all the necessary evidence to demonstrate their ability to design, produce, and operate airships with the expected level of safety and reliability. The main objective of this research is to provide a methodological framework enabling VSE’s/SME’s with limited resources to organize the development of airships while taking into account the constraints of safety, cost, time and performance. This paper proposes to provide a contribution to this problematic by proposing a Model-Based Systems Engineering approach. Through a comprehensive process modeling approach applied to the development processes, the regulatory constraints, existing best practices, etc., a good image can be obtained as to the process landscape that may influence the development of airships. To this effect, not only the necessary regulatory information is taken on board, also other international standards and norms on systems engineering and project management are being modeled and taken into account. In a next step, the model can be used for analysis of the specific situation for given developments, derive critical paths for the development, identify eventual conflicting aspects between the norms, standards, and regulatory expectations, or also identify those areas where not enough information is available. Once critical paths are known, optimization approaches can be used and decision support techniques can be applied so to better support VSE’s/SME’s in their innovative developments. This paper reports on the adopted modeling approach, the retained modeling languages, and how they all fit together.

Keywords: aeronautics, certification, process modeling, project management, regulation, SME, systems engineering, VSE

Procedia PDF Downloads 127
9570 New Advanced Medical Software Technology Challenges and Evolution of the Regulatory Framework in Expert Software, Artificial Intelligence, and Machine Learning

Authors: Umamaheswari Shanmugam, Silvia Ronchi, Radu Vornicu

Abstract:

Software, artificial intelligence, and machine learning can improve healthcare through innovative and advanced technologies that are able to use the large amount and variety of data generated during healthcare services every day. As we read the news, over 500 machine learning or other artificial intelligence medical devices have now received FDA clearance or approval, the first ones even preceding the year 2000. One of the big advantages of these new technologies is the ability to get experience and knowledge from real-world use and to continuously improve their performance. Healthcare systems and institutions can have a great benefit because the use of advanced technologies improves the same time efficiency and efficacy of healthcare. Software-defined as a medical device, is stand-alone software that is intended to be used for patients for one or more of these specific medical intended uses: - diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease, any other health conditions, replacing or modifying any part of a physiological or pathological process–manage the received information from in vitro specimens derived from the human samples (body) and without principal main action of its principal intended use by pharmacological, immunological or metabolic definition. Software qualified as medical devices must comply with the general safety and performance requirements applicable to medical devices. These requirements are necessary to ensure high performance and quality and also to protect patients’ safety. The evolution and the continuous improvement of software used in healthcare must take into consideration the increase in regulatory requirements, which are becoming more complex in each market. The gap between these advanced technologies and the new regulations is the biggest challenge for medical device manufacturers. Regulatory requirements can be considered a market barrier, as they can delay or obstacle the device approval, but they are necessary to ensure performance, quality, and safety, and at the same time, they can be a business opportunity if the manufacturer is able to define in advance the appropriate regulatory strategy. The abstract will provide an overview of the current regulatory framework, the evolution of the international requirements, and the standards applicable to medical device software in the potential market all over the world.

Keywords: artificial intelligence, machine learning, SaMD, regulatory, clinical evaluation, classification, international requirements, MDR, 510k, PMA, IMDRF, cyber security, health care systems.

Procedia PDF Downloads 59
9569 Legal Pluralism and Efficiency in International Marriage Law: Implications of Regulatory Competition on an Analysis of Conflict of Law Rules

Authors: Rorick Daniel Tovar Galvan

Abstract:

The existence of different legal systems represents an important barrier for married couples that attempt to reside in another country. Each movement can cause important changes in the rights and obligations derived from the marriage since a different law could be used by the courts to solve legal disputes arising from their relationship. In a context in which it is increasingly common to move from one country to another, people cannot be certain about the outcomes of proceedings dealing with i.e., the dissolution of property regime, maintenance payments or time to wait to initiate divorce because a foreign – and in most cases unknown – law could apply every time they move. At first glance, the answer to this issue seems to be the harmonization of the legal systems: the greater the mobility of individuals inside a group of countries, the higher the similarities of their laws should be. Such a solution could be positive for spouses because a higher degree of legal certainty would be reached in case the same legal rules applied regardless of the place where the couple lives. However, the legal pluralism brings with it also advantages that could be appreciated when one looks closely at the economic rationale behind the legal institution of marriage. This contribution carries out an economic analysis of the existence of different legal systems in the area of marriage law and proposes another strategy to cope with the problems arising from legal pluralism. Far from eliminating the diversity of legal systems, one wishes to foster it, since significant advantages could arise from such diversity in case couples are permitted to choose the applicable law themselves. Based on the idea that the law could be seem as a product offered in the market as well as states and spouses as suppliers and consumers of this product, the paper shows the advantages of designing a legal framework that allows spouses to determine freely the law governing the legal effects of their marriage. Instead of promoting the harmonization of the substantive law, one explores the benefits of encouraging the regulatory competition at international level in the area of marriage law.

Keywords: conflict of laws, harmonization, international marriage law, law and economics, regulatory competition

Procedia PDF Downloads 161
9568 The Legal and Regulatory Gaps of Blockchain-Enabled Energy Prosumerism

Authors: Karisma Karisma, Pardis Moslemzadeh Tehrani

Abstract:

This study aims to conduct a high-level strategic dialogue on the lack of consensus, consistency, and legal certainty regarding blockchain-based energy prosumerism so that appropriate institutional and governance structures can be put in place to address the inadequacies and gaps in the legal and regulatory framework. The drive to achieve national and global decarbonization targets is a driving force behind climate goals and policies under the Paris Agreement. In recent years, efforts to ‘demonopolize’ and ‘decentralize’ energy generation and distribution have driven the energy transition toward decentralized systems, invoking concepts such as ownership, sovereignty, and autonomy of RE sources. The emergence of individual and collective forms of prosumerism and the rapid diffusion of blockchain is expected to play a critical role in the decarbonization and democratization of energy systems. However, there is a ‘regulatory void’ relating to individual and collective forms of prosumerism that could prevent the rapid deployment of blockchain systems and potentially stagnate the operationalization of blockchain-enabled energy sharing and trading activities. The application of broad and facile regulatory fixes may be insufficient to address the major regulatory gaps. First, to the authors’ best knowledge, the concepts and elements circumjacent to individual and collective forms of prosumerism have not been adequately described in the legal frameworks of many countries. Second, there is a lack of legal certainty regarding the creation and adaptation of business models in a highly regulated and centralized energy system, which inhibits the emergence of prosumer-driven niche markets. There are also current and prospective challenges relating to the legal status of blockchain-based platforms for facilitating energy transactions, anticipated with the diffusion of blockchain technology. With the rise of prosumerism in the energy sector, the areas of (a) network charges, (b) energy market access, (c) incentive schemes, (d) taxes and levies, and (e) licensing requirements are still uncharted territories in many countries. The uncertainties emanating from this area pose a significant hurdle to the widespread adoption of blockchain technology, a complementary technology that offers added value and competitive advantages for energy systems. The authors undertake a conceptual and theoretical investigation to elucidate the lack of consensus, consistency, and legal certainty in the study of blockchain-based prosumerism. In addition, the authors set an exploratory tone to the discussion by taking an analytically eclectic approach that builds on multiple sources and theories to delve deeper into this topic. As an interdisciplinary study, this research accounts for the convergence of regulation, technology, and the energy sector. The study primarily adopts desk research, which examines regulatory frameworks and conceptual models for crucial policies at the international level to foster an all-inclusive discussion. With their reflections and insights into the interaction of blockchain and prosumerism in the energy sector, the authors do not aim to develop definitive regulatory models or instrument designs, but to contribute to the theoretical dialogue to navigate seminal issues and explore different nuances and pathways. Given the emergence of blockchain-based energy prosumerism, identifying the challenges, gaps and fragmentation of governance regimes is key to facilitating global regulatory transitions.

Keywords: blockchain technology, energy sector, prosumer, legal and regulatory.

Procedia PDF Downloads 152
9567 A Resource-Based Understanding of Health and Social Care Regulation

Authors: David P. Horton, Gary Lynch-Wood

Abstract:

Western populations are aging, prone to various lifestyle health problems, and increasing their demand for health and social care services. This demand has created enormous fiscal and regulatory challenges. In response, government institutions have deployed strategies of behavior modification to encourage people to exercise greater personal responsibility over their health and care needs (i.e., welfare responsibilisation). Policy strategies are underpinned by the assumption that people if properly supported, will make better health and lifestyle selections. Not only does this absolve governments of the responsibility for meeting all health and care needs, but it also enables government institutions to assert fiscal control over welfare spending. Looking at the regulation of health and social care in the UK, the authors identify and outline a suite of regulatory tools that are designed to extract and manage the resources of health and social care services users and to encourage them to make (‘better’) use of these resources. This is important for our understanding of how health and social care regulation is responding to ongoing social and economic challenges. It is also important because there has been a failure to systematically examine the relevance of resources for regulation, which is surprising given that resources are crucial to how and whether regulation succeeds or fails. In particular, drawing from the regulatory welfare state concept, the authors analyse the key legal and regulatory changes and mechanisms that have been introduced since the 2008 financial crisis, focusing on critical measures such as the Health and Social Care Act and regulations introduced under the National Health Service Act. The authors show how three types of user resources (i.e., tangible, labor, and data) are being used to assert fiscal control and increase welfare responsibilisation. Amongst other things, the paper concludes that service users have become more than rule followers and targets of behavioral modification; rather, they are producers of resources that regulatory systems have come to rely on.

Keywords: health care, regulation, resources, social care

Procedia PDF Downloads 62
9566 The Effects of Governmental Regulation on Technological Innovation in Korean Firms

Authors: SeungKu Ahn, Sewon Lee

Abstract:

This study examines the effects of regulatory policies on corporate R&D activities and innovation and suggests regulatory directions for the enhancement of corporate performance. This study employs a regression model with R&D activities as dependent variables and the regulatory index as an independent variable. The results of this study are as follows: The regulation is negatively associated with the input and output of R&D activities. The regulation encourages small and medium-sized firms to invest in R&D. The regulation has a positive effect on patent applications for small and medium-sized firms.

Keywords: governmental regulation, research and development performance, small and medium-sized firms, technological innovation

Procedia PDF Downloads 234
9565 Regulatory Measures on Effective Nuclear Security and Safeguards System in Nigeria

Authors: Nnodi Chinweikpe Akelachi, Adebayo Oladini Kachollom Ifeoma

Abstract:

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

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

Procedia PDF Downloads 87
9564 Law, Regulatory Transformations and Evolving Paradigm: The Case of Corporate Social Responsibility in India

Authors: Shuchi Bharti

Abstract:

This article intends to analyse the transforming nature of state and corporate sector relationship in the light of evolving regulatory and institutional aspects pertaining to Corporate Social Responsibility (CSR) in India. The focus is on evaluating the accounts of law and decentred discourses, relevant within the changing regulatory and institutional paradigm that substantially goes ahead of formal legal control of state towards corporate actors. At this vantage point, it is important to understand the state’s posture towards a changing scenario particularly as the tone is set by regulatory parameters pertaining to CSR to drive process of engagement with the stakeholders. The tripartite framework of the article intends to focus on finding on the vital interconnected aspects of the CSR provisions (Section 135) of The Companies Act 2013 (The Act), rise of new institutions and the emergence of the decentred regulatory space. Thus is earmarked in a neo-liberal paradigm; state is witnessed to perform a responsive function in engendering enhanced public role for the corporate sector. In this overarching framework the aim is to undertake a causal, exploratory and relational analysis of aspects pertaining law, regulation and institutional transformations. Firstly, focus is drawn on to investigate the relational facets of the advent of law and regulatory framework of CSR. Secondly, in the light of the historical evolution, a causal connection is attempted between globalization, emergence of international soft law framework and the Indian case of CSR. Finally, I look into how the new Companies Act mandates CSR expenditure vis- a -vis multiple parameters and guidelines.

Keywords: corporate social responsibility, stakeholders, soft law, decentred regulation

Procedia PDF Downloads 267
9563 Regulatory Guidelines to Support the Design of Nanosatellite Projects in Mexican Academic Contexts

Authors: Alvaro Armenta-Ramade, Arturo Serrano-Santoyo, Veronica Rojas-Mendizabal, Roberto Conte-Galvan

Abstract:

The availability and affordability of commercial off-the-shell products have brought a major impetus in the development of university projects related to the design, construction and launching of small satellites on a global scale. Universities in emerging economies as well as in least developed countries have been able to develop prototypes of small satellites (cubesats and cansats) with limited budgets. The experience gained in the development of small satellites gives rise to capacity building for designing more complex aerospace systems. This trend has significantly increased the pace and number of aerospace university projects around the world. In the case of Mexico, projects funded by different agencies have been very effective in accelerating the capacity building and technology transfer initiatives in the aerospace ecosystem. However, many of this initiatives have centered their efforts in technology development matters with minimum or no considerations of key regulatory issues related to frequency assignment, management and licensing, as well as launching requirements and measures of mitigation of space debris. These regulatory concerns are fundamental to accomplish successful missions that take into account the complete value chain of an aerospace project. The purpose of this paper is to develop a regulatory framework to support the efforts of educational institutions working on the development of small satellites in Mexico. We base our framework on recommendations from the International Telecommunications Union (ITU), the United Nations Office for Outer Space Affairs (UNOOSA) and other major actors of the Mexican regulatory ecosystem. In order to develop an integrated and cohesive framework, we draw on complexity science to identify the agents, their role and interactions. Our goal is to create a guiding instrument available both in print and online that can also be used in other regions of the world

Keywords: capacity building, complexity science, cubesats, space regulations, small satellites

Procedia PDF Downloads 219
9562 Common Regulatory Mechanisms Reveals Links between Aberrant Glycosylation and Biological Hallmarks in Cancer

Authors: Jahanshah Ashkani, Kevin J. Naidoo

Abstract:

Glycosylation is the major posttranslational modification (PTM) process in cellular development. In tumour development, it is marked by structural alteration of carbohydrates (glycans) that is the result of aberrant glycosylation. Altered glycan structures affect cell surface ligand-receptor interactions that interfere with the regulation of cell adhesion, migration, and proliferation. The resulting changes in glycan biosynthesis pathways originate from altered expression of glycosyltransferases and glycosidases. While the alteration in glycosylation patterns is a recognized “hallmark of cancer”, the influential overview of the biology of cancer proposes eight hallmarks with no explicit suggestion to connectivity with glycosylation. Recently, we have discovered a connection between the glycosyltransferase gene expression and cancer type and subtype. Here we present an association between aberrant glycosylation and the biological hallmarks of breast cancer by exploring the common regulatory mechanisms at the genomic scale. The result of this study bridges the glycobiological and biological pathways that are accepted hallmarks of cancer by connecting their common regulatory pathways. This is an impetus for further investigation as target therapies of breast cancer are very likely to be uncovered from this.

Keywords: aberrant glycosylation, biological hallmarks, breast cancer, regulatory mechanism

Procedia PDF Downloads 219
9561 Towards Competence-Based Regulatory Sciences Education in Sub-Saharan Africa: Identification of Competencies

Authors: Abigail Ekeigwe, Bethany McGowan, Loran C. Parker, Stephen Byrn, Kari L. Clase

Abstract:

There are growing calls in the literature to develop and implement competency-based regulatory sciences education (CBRSE) in sub-Saharan Africa to expand and create a pipeline of a competent workforce of regulatory scientists. A defined competence framework is an essential component in developing competency-based education. However, such a competence framework is not available for regulatory scientists in sub-Saharan Africa. The purpose of this research is to identify entry-level competencies for inclusion in a competency framework for regulatory scientists in sub-Saharan Africa as a first step in developing CBRSE. The team systematically reviewed the literature following the PRISMA guidelines for systematic reviews and based on a pre-registered protocol on Open Science Framework (OSF). The protocol has the search strategy and the inclusion and exclusion criteria for publications. All included publications were coded to identify entry-level competencies for regulatory scientists. The team deductively coded the publications included in the study using the 'framework synthesis' model for systematic literature review. The World Health Organization’s conceptualization of competence guided the review and thematic synthesis. Topic and thematic codings were done using NVivo 12™ software. Based on the search strategy in the protocol, 2345 publications were retrieved. Twenty-two (n=22) of the retrieved publications met all the inclusion criteria for the research. Topic and thematic coding of the publications yielded three main domains of competence: knowledge, skills, and enabling behaviors. The knowledge domain has three sub-domains: administrative, regulatory governance/framework, and scientific knowledge. The skills domain has two sub-domains: functional and technical skills. Identification of competencies is the primal step that serves as a bedrock for curriculum development and competency-based education. The competencies identified in this research will help policymakers, educators, institutions, and international development partners design and implement competence-based regulatory science education in sub-Saharan Africa, ultimately leading to access to safe, quality, and effective medical products.

Keywords: competence-based regulatory science education, competencies, systematic review, sub-Saharan Africa

Procedia PDF Downloads 164
9560 Persuading ICT Consumers to Disconnect from Work: An Experimental Study on the Influence of Message Frame, Regulatory Focus, Ad Believability and Attitude toward the Ad on Message Effectiveness

Authors: Katharina Ninaus, Ralf Terlutter, Sandra Diehl

Abstract:

Information and communication technologies (ICT) have become pervasive in all areas of modern life, both in work and leisure. Technological developments and particularly the ubiquity of smartphones have made it possible for ICT consumers to be constantly connected to work, fostering an always-on mentality and increasing the pressure to be accessible at all times. However, performing work tasks outside of working hours using ICT results in a lack of mental detachment and recovery from work. It is, therefore, necessary to develop effective behavioral interventions to increase risk awareness of a constant connection to the workplace in the employed population. Drawing on regulatory focus theory, this study aims to investigate the persuasiveness of tailoring messages to individuals’ chronic regulatory focus in order to encourage ICT consumers to set boundaries by defining fixed times for professional accessibility outside of working hours in order to contribute to the well-being of ICT consumers with high ICT involvement in their work life. The experimental study examines the interaction effect between consumers’ chronic regulatory focus (i.e. promotion focus versus prevention focus) and positive or negative message framing (i.e. gain frame versus loss frame) on consumers’ intention to perform the advocated behavior. Based on the assumption that congruent messages create regulatory fit and increase message effectiveness, it is hypothesized that behavioral intention will be higher in the condition of regulatory fit compared to regulatory non-fit. It is further hypothesized that ad believability and attitude toward the ad will mediate the effect of regulatory fit on behavioral intention given that ad believability and ad attitude both determine consumer behavioral responses. Results confirm that the interaction between regulatory focus and message frame emerged as a predictor of behavioral intention such as that consumers’ intentions to set boundaries by defining fixed times for professional accessibility outside of working hours increased as congruency with their regulatory focus increased. The loss-framed ad was more effective for consumers with a predominant prevention focus, while the gain-framed ad was more effective for consumers with a predominant promotion focus. Ad believability and attitude toward the ad both emerged as predictors of behavioral intention. Mediation analysis revealed that the direct effect of the interaction between regulatory focus and message frame on behavioral intention was no longer significant when including ad believability and ad attitude as mediators in the model, indicating full mediation. However, while the indirect effect through ad believability was significant, the indirect effect through attitude toward the ad was not significant. Hence, regulatory fit increased ad believability, which then increased behavioral intention. Ad believability appears to have a superior effect indicating that behavioral intention does not depend on attitude toward the ad, but it depends on whether or not the ad is perceived as believable. The study shows that the principle of regulatory fit holds true in the context of ICT consumption and responds to calls for more research on mediators of health message framing effects.

Keywords: always-on mentality, Information and communication technologies (ICT) consumption, message framing, regulatory focus

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9559 Honor Endorsement from the Perspective of System Justification and Regulatory Focus Orientation

Authors: Gülçin Akbas Uslu

Abstract:

Honor cultures put importance on the sexual purity of women. Women are expected to avoid acts that may spoil their honor. The emphasis on honor leads to the subordination of women and the dominance of men. In order to protect and clean honor, women are exposed to physical and psychological violence. Therefore, understanding the motivations driving people to endorse honor bears importance. For this purpose, this study aims to explore honor endorsement from the joint perspective of System Justification Theory (SJT) and Regulatory Focus Theory (RFT). SJT asserts that people have a tendency to support and rationalize the system. The motivation to maintain the system may be a factor in the endorsement of honor. RFT proposes two distinct regulatory processes, namely promotion and prevention focus. Having a dominant prevention focus, such as a deep concern for responsibilities, risk avoidance, and minimizing negative outcomes, may have a role in honor. Data were collected conveniently from 366 participants (216 women; 150 men). Participants filled out Honor Endorsement Index, Honor Based System Justification Scale and Regulatory Focus Orientation Scale Results revealed that both regulatory focus and system justification play a role in understanding honor. One-way ANOVA findings showed that individuals with a dominant prevention focus endorse honor beliefs more than individuals with a dominant promotion focus. Besides, regression analysis revealed that prevention focus and system justification significantly and positively predict honor. Results provide clarifications for why honor has an important meaning in individuals’ life and why honor-based violence is approved. These findings bear great importance in Turkey, where emphasis on honor is high and can be used in reducing people’s adherence to honor, which is based on women’s sexuality and men’s power over women.

Keywords: honor, system justification theory, regulatory focus theory, prevention focus

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9558 Building and Development of the Stock Market Institutional Infrastructure in Russia

Authors: Irina Bondarenko, Olga Vandina

Abstract:

The theory of evolutionary economics is the basis for preparation and application of methods forming the stock market infrastructure development concept. The authors believe that the basis for the process of formation and development of the stock market model infrastructure in Russia is the theory of large systems. This theory considers the financial market infrastructure as a whole on the basis of macroeconomic approach with the further definition of its aims and objectives. Evaluation of the prospects for interaction of securities market institutions will enable identifying the problems associated with the development of this system. The interaction of elements of the stock market infrastructure allows to reduce the costs and time of transactions, thereby freeing up resources of market participants for more efficient operation. Thus, methodology of the transaction analysis allows to determine the financial infrastructure as a set of specialized institutions that form a modern quasi-stable system. The financial infrastructure, based on international standards, should include trading systems, regulatory and supervisory bodies, rating agencies, settlement, clearing and depository organizations. Distribution of financial assets, reducing the magnitude of transaction costs, increased transparency of the market are promising tasks in the solution for questions of services level and quality increase provided by institutions of the securities market financial infrastructure. In order to improve the efficiency of the regulatory system, it is necessary to provide "standards" for all market participants. The development of a clear regulation for the barrier to the stock market entry and exit, provision of conditions for the development and implementation of new laws regulating the activities of participants in the securities market, as well as formulation of proposals aimed at minimizing risks and costs, will enable the achievement of positive results. The latter will be manifested in increasing the level of market participant security and, accordingly, the attractiveness of this market for investors and issuers.

Keywords: institutional infrastructure, financial assets, regulatory system, stock market, transparency of the market

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9557 Systems Engineering and Project Management Process Modeling in the Aeronautics Context: Case Study of SMEs

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

Procedia PDF Downloads 140
9556 Regulatory Frameworks and Bank Failure Prevention in South Africa: Assessing Effectiveness and Enhancing Resilience

Authors: Princess Ncube

Abstract:

In the context of South Africa's banking sector, the prevention of bank failures is of paramount importance to ensure financial stability and economic growth. This paper focuses on the role of regulatory frameworks in safeguarding the resilience of South African banks and mitigating the risks of failures. It aims to assess the effectiveness of existing regulatory measures and proposes strategies to enhance the resilience of financial institutions in the country. The paper begins by examining the specific regulatory frameworks in place in South Africa, including capital adequacy requirements, stress testing methodologies, risk management guidelines, and supervisory practices. It delves into the evolution of these measures in response to lessons learned from past financial crises and their relevance in the unique South African banking landscape. Drawing on empirical evidence and case studies specific to South Africa, this paper evaluates the effectiveness of regulatory frameworks in preventing bank failures within the country. It analyses the impact of these frameworks on crucial aspects such as early detection of distress signals, improvements in risk management practices, and advancements in corporate governance within South African financial institutions. Additionally, it explores the interplay between regulatory frameworks and the specific economic environment of South Africa, including the role of macroprudential policies in preventing systemic risks. Based on the assessment, this paper proposes recommendations to strengthen regulatory frameworks and enhance their effectiveness in bank failure prevention in South Africa. It explores avenues for refining existing regulations to align capital requirements with the risk profiles of South African banks, enhancing stress testing methodologies to capture specific vulnerabilities, and fostering better coordination among regulatory authorities within the country. Furthermore, it examines the potential benefits of adopting innovative approaches, such as leveraging technology and data analytics, to improve risk assessment and supervision in the South African banking sector.

Keywords: banks, resolution, liquidity, regulation

Procedia PDF Downloads 52
9555 Evaluation and Assessment of Bioinformatics Methods and Their Applications

Authors: Fatemeh Nokhodchi Bonab

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Bioinformatics, in its broad sense, involves application of computer processes to solve biological problems. A wide range of computational tools are needed to effectively and efficiently process large amounts of data being generated as a result of recent technological innovations in biology and medicine. A number of computational tools have been developed or adapted to deal with the experimental riches of complex and multivariate data and transition from data collection to information or knowledge. These bioinformatics tools are being evaluated and applied in various medical areas including early detection, risk assessment, classification, and prognosis of cancer. The goal of these efforts is to develop and identify bioinformatics methods with optimal sensitivity, specificity, and predictive capabilities. The recent flood of data from genome sequences and functional genomics has given rise to new field, bioinformatics, which combines elements of biology and computer science. Bioinformatics is conceptualizing biology in terms of macromolecules (in the sense of physical-chemistry) and then applying "informatics" techniques (derived from disciplines such as applied maths, computer science, and statistics) to understand and organize the information associated with these molecules, on a large-scale. Here we propose a definition for this new field and review some of the research that is being pursued, particularly in relation to transcriptional regulatory systems.

Keywords: methods, applications, transcriptional regulatory systems, techniques

Procedia PDF Downloads 89
9554 Systematic Identification of Noncoding Cancer Driver Somatic Mutations

Authors: Zohar Manber, Ran Elkon

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Accumulation of somatic mutations (SMs) in the genome is a major driving force of cancer development. Most SMs in the tumor's genome are functionally neutral; however, some cause damage to critical processes and provide the tumor with a selective growth advantage (termed cancer driver mutations). Current research on functional significance of SMs is mainly focused on finding alterations in protein coding sequences. However, the exome comprises only 3% of the human genome, and thus, SMs in the noncoding genome significantly outnumber those that map to protein-coding regions. Although our understanding of noncoding driver SMs is very rudimentary, it is likely that disruption of regulatory elements in the genome is an important, yet largely underexplored mechanism by which somatic mutations contribute to cancer development. The expression of most human genes is controlled by multiple enhancers, and therefore, it is conceivable that regulatory SMs are distributed across different enhancers of the same target gene. Yet, to date, most statistical searches for regulatory SMs have considered each regulatory element individually, which may reduce statistical power. The first challenge in considering the cumulative activity of all the enhancers of a gene as a single unit is to map enhancers to their target promoters. Such mapping defines for each gene its set of regulating enhancers (termed "set of regulatory elements" (SRE)). Considering multiple enhancers of each gene as one unit holds great promise for enhancing the identification of driver regulatory SMs. However, the success of this approach is greatly dependent on the availability of comprehensive and accurate enhancer-promoter (E-P) maps. To date, the discovery of driver regulatory SMs has been hindered by insufficient sample sizes and statistical analyses that often considered each regulatory element separately. In this study, we analyzed more than 2,500 whole-genome sequence (WGS) samples provided by The Cancer Genome Atlas (TCGA) and The International Cancer Genome Consortium (ICGC) in order to identify such driver regulatory SMs. Our analyses took into account the combinatorial aspect of gene regulation by considering all the enhancers that control the same target gene as one unit, based on E-P maps from three genomics resources. The identification of candidate driver noncoding SMs is based on their recurrence. We searched for SREs of genes that are "hotspots" for SMs (that is, they accumulate SMs at a significantly elevated rate). To test the statistical significance of recurrence of SMs within a gene's SRE, we used both global and local background mutation rates. Using this approach, we detected - in seven different cancer types - numerous "hotspots" for SMs. To support the functional significance of these recurrent noncoding SMs, we further examined their association with the expression level of their target gene (using gene expression data provided by the ICGC and TCGA for samples that were also analyzed by WGS).

Keywords: cancer genomics, enhancers, noncoding genome, regulatory elements

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9553 The Impact of Regulatory Changes on the Development of Mobile Medical Apps

Authors: M. McHugh, D. Lillis

Abstract:

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

Keywords: agile, applications, FDA, medical, mobile, regulations, software engineering, standards

Procedia PDF Downloads 333
9552 The Analysis of Regulation on Sustainability in the Financial Sector in Lithuania

Authors: Dalia Kubiliūtė

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

Keywords: financial, legal, regulatory, sustainability

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9551 The Novelty of Mobile Money Solution to Ghana’S Cashless Future: Opportunities, Challenges and Way Forward

Authors: Julius Y Asamoah

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Mobile money has seen faster adoption in the decade. Its emergence serves as an essential driver of financial inclusion and an innovative financial service delivery channel, especially to the unbanked population. The rising importance of mobile money services has caught policymakers and regulators' attention, seeking to understand the many issues emerging from this context. At the same time, it is unlocking the potential of knowledge of this new technology. Regulatory responses and support are essential, requiring significant changes to current regulatory practices in Ghana. The article aims to answer the following research questions: "What risk does an unregulated mobile money service pose to consumers and the financial system? "What factors stimulate and hinder the introduction of mobile payments in developing countries? The sample size used was 250 respondents selected from the study area. The study has adopted an analytical approach comprising a combination of qualitative and quantitative data collection methods. Actor-network theory (ANT) is used as an interpretive lens to analyse this process. ANT helps analyse how actors form alliances and enrol other actors, including non-human actors (i.e. technology), to secure their interests. The study revealed that government regulatory policies impact mobile money as critical to mobile money services in developing countries. Regulatory environment should balance the needs of advancing access to finance with the financial system's stability and draw extensively from Kenya's work as the best strategies for the system's players. Thus, regulators need to address issues related to the enhancement of supportive regulatory frameworks. It recommended that the government involve various stakeholders, such as mobile phone operators. Moreover, the national regulatory authority creates a regulatory environment that promotes fair practices and competition to raise revenues to support a business-enabling environment's key pillars as infrastructure.

Keywords: actor-network theory (ANT), cashless future, Developing countries, Ghana, Mobile Money

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9550 Contested Space for Regulation in Higher Education

Authors: Sulila Anar

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Institutions of any kind are regulated by laws which could be formal or informal, visible or invisible that influences the very structure of the institutions itself. Here in this paper the attempt will be to see how institutions of higher education are regulated by the regulatory institutions by taking the case of India, the third largest education system in the world. The attempt is to try to see how regulation of higher education creates a space for contestation among regulatory institutions based on secondary resources and how this affects the governance of university to achieve the goals and visions.

Keywords: higher education, regulation, autonomy, space

Procedia PDF Downloads 361