Search results for: regulatory changes

Authors: Rorick Daniel Tovar Galvan

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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

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Authors: Lamis Kattan, Joanne Haddad

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This paper examines the impact of gender focused labor legislation on women's labor force participation and economic empowerment. We rely on historical legislative acts passed by state legislatures and exploit whether or not states passed regulatory laws regulating overall and industry specific employment and work conditions for women, night work laws and labor laws requiring provision of seats for working women. We exploit the fact that not all states enacted these laws as well as the variation in the timing of enactment of such laws. Our results show that women in comparison to men in treated states are more likely to be in the labor force post introduction of night work laws in comparison to control states. We also document the effect of industry-specific labor policies on women's likelihood to be employed in the affected industry and in higher-wage occupations within the industry of interest. Policy implications of our findings endorse the adoption of labor laws in favor of women to advocate their empowerment through a higher involvement in the labor market and financial independence.

Keywords: female employment, labor laws, marriage, fertility

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Authors: Alexander Marx

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Measuring and mitigating market risk is essential for the stability of enterprises, especially for major banking corporations and investment bank firms. To employ these risk measurement and mitigation processes, the Value at Risk (VaR) is the most commonly used risk metric by practitioners. In the past years, we have seen significant weaknesses in the predictive performance of the VaR in times of financial market crisis. To address this issue, the purpose of this study is to investigate the value-at-risk (VaR) estimation models and their predictive performance by applying a series of backtesting methods on the stock market indices of the G7 countries (Canada, France, Germany, Italy, Japan, UK, US, Europe). The study employs parametric, non-parametric, and semi-parametric VaR estimation models and is conducted during three different periods which cover the most recent financial market crisis: the overall period (2006–2022), the global financial crisis period (2008–2009), and COVID-19 period (2020–2022). Since the regulatory authorities have introduced and mandated the Conditional Value at Risk (Expected Shortfall) as an additional regulatory risk management metric, the study will analyze and compare both risk metrics on their predictive performance.

Keywords: value at risk, financial market risk, banking, quantitative risk management

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Authors: S. Subramaniam, J. S. A. Rao, P. Ramdas, K. R. Selvaduray, N. M. Han, M. K. Kutty, A. K. Radhakrishnan

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Immune system is a complex system where the immune cells have the capability to respond against a wide range of immune challenges including cancer progression. However, in the event of cancer development, tumour cells trigger immunosuppressive environment via activation of myeloid-derived suppressor cells and T regulatory (Treg) cells. The Treg cells are subset of CD4+ T lymphocytes, known to have crucial roles in regulating immune homeostasis and promoting the establishment and maintenance of peripheral tolerance. Dysregulation of these mechanisms could lead to cancer progression and immune suppression. Recently, there are many studies reporting on the effects of natural bioactive compounds on immune responses against cancer. It was known that tocotrienol-rich-fraction consisting 70% tocotrienols and 30% α-tocopherol is able to exhibit immunomodulatory as well as anti-cancer properties. Hence, this study was designed to evaluate the effects of gamma-tocotrienol (G-T3) supplementation on T-reg cells in a syngeneic mouse model of breast cancer. In this study, female BALB/c mice were divided into two groups and fed with either soy oil (vehicle) or gamma-tocotrienol (G-T3) for two weeks followed by inoculation with tumour cells. All the mice continued to receive the same supplementation until day 49. The results showed a significant reduction in tumour volume and weight in G-T3 fed mice compared to vehicle-fed mice. Lung and liver histology showed reduced evidence of metastasis in tumour-bearing G-T3 fed mice. Besides that, flow cytometry analysis revealed T-helper cell population was increased, and T-regulatory cell population was suppressed following G-T3 supplementation. Moreover, immunohistochemistry analysis showed that there was a marked decrease in the expression of FOXP3 in the G-T3 fed tumour bearing mice. In conclusion, the G-T3 supplementation showed good prognosis towards breast cancer by enhancing the immune response in tumour-bearing mice. Therefore, gamma-T3 can be used as immunotherapy agent for the treatment of breast cancer.

Keywords: breast cancer, gamma tocotrienol, immune suppression, supplement

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Authors: Yong Chen

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To understand the detailed molecular mechanisms of memory formation in engram cells is one of the most fundamental questions in neuroscience. Recent single-cell RNA-seq (scRNA-seq) and single-nucleus RNA-seq (snRNA-seq) techniques have allowed us to explore the sparsely activated engram ensembles, enabling access to the molecular mechanisms that underlie experience-dependent memory formation and consolidation. However, the absence of specific and powerful computational methods to detect memory-related genes (modules) and their regulatory relationships in the sc/snRNA-seq datasets has strictly limited the analysis of underlying mechanisms and memory coding principles in mammalian brains. Here, we present a deep-learning method named SCENTBOX, to detect memory-related gene modules and causal regulatory relationships among themfromsc/snRNA-seq datasets. SCENTBOX first constructs codifferential expression gene network (CEGN) from case versus control sc/snRNA-seq datasets. It then detects the highly correlated modules of differential expression genes (DEGs) in CEGN. The deep network embedding and attention-based convolutional neural network strategies are employed to precisely detect regulatory relationships among DEG genes in a module. We applied them on scRNA-seq datasets of TRAP; Ai14 mouse neurons with fear memory and detected not only known memory-related genes, but also the modules and potential causal regulations. Our results provided novel regulations within an interesting module, including Arc, Bdnf, Creb, Dusp1, Rgs4, and Btg2. Overall, our methods provide a general computational tool for processing sc/snRNA-seq data from case versus control studie and a systematic investigation of fear-memory-related gene modules.

Keywords: sc/snRNA-seq, memory formation, deep learning, gene module, causal inference

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Authors: Peter Fedichev

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We studied fundamental aspects of aging to develop a mathematical model of gene regulatory network. We show that aging manifests itself as an inherent instability of gene network leading to exponential accumulation of regulatory errors with age. To validate our approach we studied age-dependent omic data such as transcriptomes, metabolomes etc. of different model organisms and humans. We build a computational platform based on our model to identify the targets and biomarkers of aging to design new drugs against aging and age-related diseases. As biomarkers of aging, we choose the rate of aging and the biological age since they completely determine the state of the organism. Since rate of aging rapidly changes in response to an external stress, this kind of biomarker can be useful as a tool for quantitative efficacy assessment of drugs, their combinations, dose optimization, chronic toxicity estimate, personalized therapies selection, clinical endpoints achievement (within clinical research), and death risk assessments. According to our model, we propose a method for targets identification for further interventions against aging and age-related diseases. Being a biotech company, we offer a complete pipeline to develop an anti-aging drug-candidate.

Keywords: aging, longevity, biomarkers, senescence

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Authors: Kelly S. Parkinson, Katherine Y. Teh-White

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Futureye has a bespoke social licence to operate methodology which has successfully secured community approval and commercial return for fisheries which have faced regulatory and financial risk. This unique approach to fisheries management focuses on delivering improved social and environmental outcomes to support the fishing industry make steps towards achieving the United Nations SDGs. An SLO is the community’s implicit consent for a business or project to exist. An SLO must be earned and maintained alongside regulatory licences. In current and new operations, it helps you to anticipate and measure community concerns around your operations – leading to more predictable and sensible policy outcomes that will not jeopardise your commercial returns. Rising societal expectations and increasing activist sophistication mean the international fishing industry needs to resolve community concerns at each stage their supply chain. Futureye applied our tested social licence to operate (SLO) methodology to help Austral Fisheries who was being attacked by activists concerned about the sustainability of Patagonian Toothfish. Austral was Marine Stewardship Council certified, but pirates were making the overall catch unsustainable. Austral wanted to be carbon neutral. SLO provides a lens on the risk that helps industries and companies act before regulatory and political risk escalates. To do this assessment, we have a methodology that assesses the risk that we can then translate into a process to create a strategy. 1) Audience: we understand the drivers of change and the transmission of those drivers across all audience segments. 2) Expectation: we understand the level of social norming of changing expectations. 3) Outrage: we understand the technical and perceptual aspects of risk and the opportunities to mitigate these. 4) Inter-relationships: we understand the political, regulatory, and reputation system so that we can understand the levers of change. 5) Strategy: we understand whether the strategy will achieve a social licence through bringing the internal and external stakeholders on the journey. Futureye’s SLO methodologies helped Austral to understand risks and opportunities to enhance its resilience. Futureye reviewed the issues, assessed outrage and materiality and mapped SLO threats to the company. Austral was introduced to a new way that it could manage activism, climate action, and responsible consumption. As a result of Futureye’s work, Austral worked closely with Sea Shepherd who was campaigning against pirates illegally fishing Patagonian Toothfish as well as international governments. In 2016 Austral launched the world’s first carbon neutral fish which won Austral a thirteen percent premium for tender on the open market. In 2017, Austral received the prestigious Banksia Foundation Sustainability Leadership Award for seafood that is sustainable, healthy and carbon neutral. Austral’s position as a leader in sustainable development has opened doors for retailers all over the world. Futureye’s SLO methodology can identify the societal, political and regulatory risks facing fisheries and position them to proactively address the issues and become an industry leader in sustainability.

Keywords: carbon neutral, fisheries management, risk communication, social licence to operate, sustainable development

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

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

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

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

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

Keywords: functional foods, interview, perspective, Thailand

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Authors: Libo Jiang, Huan Li, Rongling Wu

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

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

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Authors: Pavel Borodkin, Nikolay Khrennikov, Azamat Gazetdinov

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

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

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Authors: Isil Gazioglu, Abdulselam Ertas

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

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

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Authors: Jyothi Nagraj, Sudeshna Mukherjee, Rajdeep Chowdhury

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

Keywords: JNK, autophagy, drug resistance, cancer

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Authors: Patcharaporn Sudchada, Nuntika Prommee

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Background: Herbal medicines constitute a vital component of Thailand's healthcare system and possess significant potential for international recognition. However, the absence of standardized clinical research guidelines aligned with international standards, coupled with unique local challenges, has hindered the development and registration of Thai herbal medicines in the global market. Objective: To establish comprehensive research and development guidelines for herbal medicine formulations that comply with international standards, with particular emphasis on enhancing research quality, scientific credibility, and facilitating both domestic registration and international market acceptance. Methods: The research methodology comprised eight sequential phases: (1) systematic collection and review of relevant documentation and regulatory frameworks; (2) development of preliminary content structure and template designs; (3) systematic analysis and synthesis of scientific evidence and regulatory data; (4) creation of detailed research guidelines and accompanying templates; (5) execution of domestic and international consultation meetings and study visits involving nine stakeholder groups; (6) systematic expert review of the draft guidelines; (7) incorporation of feedback from relevant regulatory and research agencies; and (8) finalization and validation of the comprehensive guidelines. Results: The study produced comprehensive research and development guidelines for herbal medicines that meet international standards, encompassing the complete development pathway from initial concept through pre-clinical studies, product development, preparation protocols, clinical trial conduct, and product registration procedures. The guidelines include standardized templates and forms specifically designed for clinical research documentation. Conclusion: The established guidelines represent a significant advancement in standardizing clinical research for Thai herbal medicines, enhancing their scientific credibility and potential for international acceptance. Nevertheless, Thailand continues to face specific challenges, including insufficient specialized personnel in herbal research (particularly in clinical trials), challenges in integrating traditional Thai medicine principles with modern scientific methodology, limited research infrastructure, inadequate funding mechanisms, complex registration procedures, and public skepticism toward herbal products. The policy recommendations outlined in this research provide a strategic framework for addressing these challenges and promoting sustainable development of Thai herbal medicines within the national context.

Keywords: herbal medicine, clinical research, international standards, research guidelines, drug development, traditional thai medicine, regulatory compliance

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Authors: Jonathan Palatz Cedeño

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

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

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Authors: Mark E. Lokanan, Liz Lee

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

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

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Authors: Alaa Abdellatif, Gabrièle Breda

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

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

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Authors: Hien T. T. Ho, Tsunemi Watanabe

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

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

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Authors: Ibrahim Danjuma, Dahiru Dauda Hammawa

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Economic growth and development can be driven by entrepreneurial innovation. The Nigerian economy has faced numerous obstacles over the past few years, including the energy crisis, the death and winding up of many small and medium enterprises, high unemployment rates, and escalating inflation, amongst others. Entrepreneurial innovation has emerged as a potential catalyst for revitalizing the troubled economy and driving sustainable growth. Entrepreneurial innovation can revitalize key industries and foster job creation. This paper proposes significant options as key drivers to entrepreneurial innovation that can take the troubled Nigerian economy out of the woods. It also discusses the significance of government assistance and regulatory actions in fostering entrepreneurial creativity. It argues that initiatives such as funding support, infrastructure development, and regulatory reforms are necessary for fostering a vibrant entrepreneurial ecosystem in Nigeria in order to unlock the full potential of innovative entrepreneurs. Finally, the paper emphasizes the transformative power of entrepreneurial innovation in revamping the troubled Nigerian economy and calls for concerted efforts by all stakeholders to harness its potential for sustainable growth and development. By fostering a culture of innovation, fostering entrepreneurship, and supporting emerging ventures, Nigeria can overcome its economic challenges and pave the way for a prosperous future.

Keywords: entrepreneurial innovation, entrepreneurial ecosystem, troubled economy, Nigeria

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Authors: David Sarpong, Waleed Khursheed, Ernest Danquah, Erin Murphy

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Shigella is a pathogenic bacterium responsible for shigellosis, a severe diarrheal disease that claims the lives of immunocompromised individuals worldwide. To develop therapeutics against this disease, an understanding of the molecular mechanisms underlying the pathogen’s physiology is crucial. Small non-coding RNAs (sRNAs) have emerged as important regulators of bacterial physiology, including as components of toxin-antitoxin systems. In this study, we investigated the role of RyfA in S. flexneri physiology and virulence. RyfA, originally identified as an sRNA in Escherichia coli, is conserved within the Enterobacteriaceae family, including Shigella. Whereas two copies of ryfA are present in S. dysenteriae, all other Shigella species contain only one copy of the gene. Additionally, we identified a putative open reading frame within the RyfA transcript, suggesting that it may be a dual-functioning gene encoding a small protein in addition to its sRNA function. To study ryfA in vitro, we cloned the gene into an inducible plasmid and observed the effect on bacterial growth. Here, we report that RyfA production inhibits the growth of S. flexneri, and this inhibition is dependent on the contained open reading frame. In-silico analyses have revealed the presence of two divergently transcribed sRNAs, RyfB1 and RyfB2, which share nucleotide complementarity with RyfA and thus are predicted to function as anti-toxins. Our data demonstrate that RyfB2 has a stronger antitoxin effect than RyfB1. This regulatory pattern suggests a novel form of a toxin-antitoxin system in which the activity of a single toxin is inhibited to varying degrees by two sRNA antitoxins. Studies are ongoing to investigate the regulatory mechanism(s) of the antitoxin genes, as well as the downstream targets and mechanism of growth inhibition by the RyfA toxin. This study offers distinct insights into the regulatory mechanisms underlying Shigella physiology and may inform the development of new anti-Shigella therapeutics.

Keywords: sRNA, shigella, toxin-antitoxin, Type 1 toxin antitoxin

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Authors: Buhari Samaila, Buhari Maidamma

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Background: The use of ionizing radiation in medical diagnostics and treatment is indispensable for accurate imaging and effective cancer therapies. However, radiation exposure carries inherent risks, necessitating strict protection measures to safeguard both patients and healthcare workers. This review critically examines the existing radiation protection measures in diagnostic radiology and radiotherapy, highlighting technological advancements, regulatory frameworks, and challenges. Objective: The objective of this review is to critically evaluate the effectiveness of current radiation protection measures in diagnostic and therapeutic radiology, focusing on minimizing patient and staff exposure to ionizing radiation while ensuring optimal clinical outcomes and propose future directions for improvement. Method: A comprehensive literature review was conducted, covering scientific studies, regulatory guidelines, and international standards on radiation protection in both diagnostic radiology and radiotherapy. Emphasis was placed on ALARA principles, dose optimization techniques, and protective measures for both patients and healthcare workers. Results: Radiation protection measures in diagnostic radiology include the use of shielding devices, minimizing exposure times, and employing advanced imaging technologies to reduce dose. In radiotherapy, accurate treatment planning and image-guided techniques enhance patient safety, while shielding and dose monitoring safeguard healthcare personnel. Challenges such as limited infrastructure in low-income settings and gaps in healthcare worker training persist, impacting the overall efficacy of protection strategies. Conclusion: While significant advancements have been made in radiation protection, challenges remain in optimizing safety, especially in resource-limited settings. Future efforts should focus on enhancing training, investing in advanced technologies, and strengthening regulatory compliance to ensure continuous improvement in radiation safety practices.

Keywords: radiation protection, diagnostic radiology, radiotherapy, ALARA, patient safety, healthcare worker safety

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Authors: Tim Nedyalkov

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

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

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

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

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

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Authors: Abhimanyu Behera

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Over the past few years, energy security and sustainable development have moved rapidly into the global agenda. There are two main reasons: first, the impact of high and often volatile energy prices; second, concerns over environmental sustainability particularly about the global climate. Both issues are critically important in which impressive economic growth has boosted the demand for energy and put corresponding strains on the environment. Energy security is a broad concept that focuses on energy availability and pricing. Specifically, it refers to the ability of the energy supply system i.e. suppliers, transporters, distributors and regulatory, financial and R&D institutions to deliver the amount of competitively priced energy that customers demand, within accepted standards of reliability, timeliness, quality, safety. Traditionally, energy security has been defined in the context of the geopolitical risks to external oil supplies but today it is encompassing all energy forms, all the external and internal links bringing the energy to the final consumer, and all the many ways energy supplies can be disrupted including equipment malfunctions, system design flaws, operator errors, malicious computer activities, deficient market and regulatory frameworks, corporate financial problems, labour actions, severe weather and natural events, aggressive acts (e.g. war, terrorism and sabotage), and geopolitical disruptions. In practice, the most challenging disruptions are those linked to: 1) extreme weather events; 2) mismatched electricity supply and demand; 3) regulatory failures; and 4) concentration of oil and gas resources in certain regions of the world. However, insecure energy supplies inhibit development by raising energy costs and imposing expensive cuts in services when disruptions actually occur. The energy supply sector can best advance sustainable development by producing and delivering secure and environmentally-friendly sources of energy and by increasing the efficiency of energy use. With this objective, this paper seeks to highlight the significance of energy security and sustainable development in today’s world. Moreover, it critically overhauls the major challenges towards sustainability of energy security and what are the major policies are taken to overcome these challenges by Government is lucidly explicated in this paper.

Keywords: energy, policies, security, sustainability

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Authors: Wassamon Kun-Amornpong

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

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

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Authors: 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

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Authors: Wanjiku Karanja

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

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

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Authors: Baskar Kotte

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

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

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Authors: Cesar Julio Recalde

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

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

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Authors: Brennan Lodge

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

Keywords: cybersecurity, gen AI, retrieval augmented generation, cybersecurity defense strategies

Procedia PDF Downloads 96