Compliance Requirements Research Articles

Using Spectral Flow Cytometry for CAR T-Cell Clinical Trials: Game Changing Technologies Enabling Novel Therapies

Monitoring chimeric antigen redirected (CAR) T-cells post-infusion in clinical trials is a specialized application of flow cytometry. Unlike the CAR T-cell monitoring for individual patients conducted in clinical laboratories, the data generated during a clinical trial will be used not only to monitor the therapeutic response of a single patient, but determine the success of the therapy itself, or even of an entire class of therapeutic compounds. The data, typically acquired at multiple testing laboratories, will be compiled into a single database. The data may also be used for mathematical modeling of cellular kinetics or to identify predictive biomarkers. With the expanded context of use, a robust, standardized assay is mandatory in order to generate a valuable and reliable data set. Hence, the requirements for assay validation, traceable calibration, technology transfer, cross-instrument standardization and regulatory compliance are high.

Implications of cyber incident reporting obligations on multinational organizations headquartered in Switzerland

As the digital landscape evolves, states are increasingly implementing national cyber incident reporting obligations to enhance cyber resilience. This study investigates the implications of these obligations on multinational organizations, focusing on the variability of compliance requirements across jurisdictions and the challenges faced by companies in adhering to these diverse regulations. Through the methodological approach of conducting interviews with cybersecurity experts across various sectors, this study points out the growing complexity in cybersecurity incident reporting obligations. Findings reveal that companies employ multiple strategies to report to regulators, monitor regulatory changes, and educate employees responsible for reporting. However, maintaining compliance is identified as a significant challenge across all sectors, leading to calls for the standardization of regulations and the improvement of automation solutions. Given the lack of research in this area, this work lays the groundwork for future research, opening new avenues for investigation into the potential standardization and automation of cyber incident reporting processes.

Waqf and Microfinance Integration for Enabling Sustainable Financial Inclusion: Analysis of Sharīʿah Compliance

Purpose — Sustainability has remained one of the most significant challenges facing the microfinance industry, and Islamic microfinance is no exception. The need for Sharīʿah compliance poses an additional challenge for the Islamic microfinance industry. Many practitioners have argued that, in practice, social missions should be sacrificed for profitability so that microfinance institutions (MFIs) could achieve sustainability and competitiveness in the finance market. This paper investigates the potential of integrating waqf and microfinance to allay the challenge of balancing social responsibility (outreach) and financial sustainability within Islamic MFIs. Additionally, it analyses the Sharīʿah compliance requirements underpinning this integration. Design/Methodology/Approach — This study adopts a qualitative method of inquiry, utilising an inductive approach to understand the conceptual framework of waqf and financial inclusion and in discussing Sharīʿah compliance aspects of socially-oriented instruments in socio-economic development. Findings — The research finds some historical antecedents to evidence the inherent social mission of waqf which, if integrated with microfinance, ensures the sustainability of Islamic MFIs. This affirms that outreach and sustainability may not be mutually exclusive under waqf and Islamic microfinance integration. Originality/Value — This study, through historical antecedents and contemporary practices, establishes that waqf and microfinance integration can address the sustainability of the Islamic microfinance industry and preserve its social mission.

Energy commodities spillover analysis for assessing the functioning of the European Union Emissions Trading System trade network of carbon allowances

The European Union Emissions Trading System (EU ETS) is designed to promote carbon reduction in a cost-effective and economically efficient manner. To meet their compliance requirements, participants within the EU ETS can either invest in carbon abatement, thereby improving their environmental performances, or purchase carbon allowances from the market. Our analysis aims to investigate the structural features of the EU ETS trade network of allowances and assess its robustness to spillovers propagated from energy commodities. We build the EU ETS trade network of allowances on a daily basis by leveraging a granular dataset comprising over 32k accounts that performed approximately 720k trades, involving more than 127 billion of allowances from 2005 to 2020. Importantly, our analysis is able to cover entirely the first three phases of the EU ETS, thus providing an updated view on the functioning of the EU ETS. We find that the EU ETS trade network of allowances is disassortative and characterized by very active nodes belonging to the energy sector. Moreover, we detect that energy commodity transmission channels can be substantial and may shape the way nodes transfer allowances, with the configuration of the EU ETS often being a net receiver of spillovers. These findings are robust even when we analyze extreme quantiles of the distribution to account for distressed periods. Our study shows how the functioning of the EU ETS can be influenced by spillovers imported from energy commodity markets. We discuss how investors can build portfolios that either hedge or amplify the impact of such spillovers, depending on their risk appetite. Given that energy commodities are significant inputs in the production processes of energy firms—who are highly active participants in the trade network of allowances—analyzing market responses to shocks in energy commodities is crucial for the effective implementation of the policy.

Potential threats to implementing instructional leadership in Western Cape township secondary schools

This empirical study examines the factors that pose challenges to the implementation of instructional leadership in township secondary schools in the Western Cape province of South Africa. The study adopts Critical Emancipatory Research (CER), which promotes peace, hope, freedom, and social justice, as its theoretical framework. Participatory action research (PAR), utilising focus group interviews, is employed to collect data. PAR is situated within a transformative paradigm, and a qualitative research approach is chosen to align with this paradigm. Data is collected through focus group discussions with the school management team (SMT), consisting of the principal, two deputy principals, and six heads of department. These discussions aim to gather information on threats to instructional leadership and strategies to mitigate these threats. The findings reveal that the local community and its dynamics, along with the prevalence of violence in the neighbourhood, are external factors that significantly impede the smooth operation of the school and negatively affect the implementation of effective instructional leadership. Conversely, factors such as limited interference from the local community, reduced workload, adherence to compliance guidelines and requirements set by the Department of Education, and an unimpeded leadership role for the management team may contribute to the successful implementation of instructional leadership. Therefore, the study recommends promoting effective and transparent communication as well as open engagement among all stakeholders within the school.

GDPR-anonymous population overlap estimation

The feasibility of many collaborative, data-driven research projects in Public Health and Social Sciences depends on the size of the overlap between the populations of contributing data partners, that is, the number of individuals for whom all parties can provide data. Where the identity of respective population members is subject to privacy protections, the overlap is traditionally estimated using de-identified cryptographic tokens to represent individuals. This does however not meet the strict standard of anonymity under GDPR and potentially runs counter to emerging privacy laws of US States, and may thus impose significant regulatory and governance burdens on research institutions, even at the early scoping stage. We present a novel method for overlap estimation, where two data partners construct a single, anonymous Bloom filter for their populations from which the overlap can be estimated. Two new techniques -- (a) the randomization of the contribution of individual population members to the Bloom filter and (b) an interactive bit-flipping protocol between data partners -- are presented which ensure that the Bloom filters are safe against dictionary attack by one party against the other party. We discuss the security aspects of this method, present the required mathematical formulas for calculating the overlap estimate, and report on the practical performance in terms of computational effort and resulting accuracy. The goal of the method is to facilitate new research by reducing the cost and complexity of initial planning and by making the overlap estimate GDPR-anonymous, and thus safer and subject to less onerous compliance requirements.

Optimizing blockchain for healthcare IoT: a practical guide to navigating scalability, privacy, and efficiency trade-offs

The adoption of blockchain technology provides significant disruptive benefits to internet-of-things (IoT) applications in healthcare in vital aspects like security, integrity, transparency, and efficiency. Nevertheless, in order to fully realize the potential of blockchain-driven solutions, healthcare organizations have to address intricate compromises between essential factors including scalability, privacy and resource utilization considering that the data sensitivity alongside strict regulatory compliance requirements characterize this sector. This research discusses the fundamental aspects of these trade-offs, including the range of consensus protocols (e.g. proof-of-work, proof-of-stake) and cryptographic techniques (e.g. zero-knowledge proofs, homomorphic encryption). A systematic choice matrix is created, which relates specific use cases of the healthcare IoT to the optimal tailored blockchain structures on such critical metrics as transaction volume, frequency, privacy level and resource restrictions. The suggested framework provides solid, actionable recommendations to healthcare organizations in order to help them benefit from the enormous promise of the blockchain for connected IoT healthcare by finding a balance between decentralization advantages and performance, security and compliance requirements.

Corruption through the Lens of Various Ethical Theories

This essay delves into the intricate dynamics of corruption in the context of businesses navigating regulatory and compliance requirements in new markets. The analysis examines how various ethical theories—relativism, consequentialism, deontology, utilitarianism, Kantianism, shareholder theory, and stakeholder theory—interpret and judge corruption. Through a detailed literature review, the paper explores the deep-rooted cultural, economic, and ethical dimensions of corruption. It also discusses potential solutions to curb corruption, emphasizing the need for stringent legal frameworks, community engagement, and transparent governance. The essay concludes by highlighting the critical role of both shareholders and stakeholders in fostering ethical business practices and ensuring sustainable growth.

Assessing the Impact of Effective Internal Controls in Fraud Prevention in Zambian Beverage Companies, a Case of Falls Beverages Zambia Limited

Internal controls encompass policies, procedures, and organizational structures designed to provide reasonable assurance that a company achieves its business objectives and prevents or detects undesired risk events, whether initiated by management concerns or compliance requirements. The study aimed to evaluate how effective internal controls impact fraud prevention, using a survey to collect data from 109 employees, including an internal auditor. Findings revealed that existing internal controls significantly aided in preventing major fraudulent activities and ensuring measures were in place to detect and deter fraud. Over 50% of respondents confirmed effective monitoring and implementation of internal controls capable of uncovering fraudulent behaviors within the company. The study emphasized that fraudulent activities adversely affected company operations and recommended measures such as fostering better management-staff relations, strengthening the audit department, offering incentives for fraud reporting, and implementing stringent controls. In conclusion, improving internal controls was identified as crucial for preventing fraud and safeguarding Falls Beverages from financial losses and resource mismanagement. Keywords: Internal Controls, Fraud Prevention

Harmonizing innovation and regulation: The EU Artificial Intelligence Act in the international trade context

The European Union's Artificial Intelligence Act focuses on establishing harmonized rules across EU Member States so that AI systems are safe, transparent, and respectful of existing laws and fundamental rights. It introduces a risk-based regulatory approach, classifying AI applications by risk levels and imposing stringent compliance requirements on high-risk applications. The paper critically examines the Act's provisions, including its prohibitions on certain AI practices, requirements for high-risk AI systems, and mandates for transparency and human oversight. The paper examines the implications of the Act for international trade and technological regulation, particularly in the context of the World Trade Organization's Technical Barriers to Trade (TBT) Agreement. It addresses the Act's potential impact on developing countries, highlighting concerns that the Act's uniform standards could potentially exacerbate the digital divide and create barriers in global AI innovation and trade. The paper suggests incorporating flexibility and differential standards in the Act, enhancing technical assistance for developing countries, and advocating the EU's active participation in global standard-setting.

Study on the Legal Adaptation of Digital Asset Trading and Securities Laws

This thesis discusses the connection between digital asset trading and securities law, and analyzes the role and importance of securities law in digital asset trading. As an emerging market, digital asset trading involves the issues of investor protection, information disclosure, and compliance of trading platforms. Securities law provides legal protection and regulatory framework for digital asset trading by regulating market behavior, protecting investors' rights and interests and maintaining market order. Investors should be aware of local securities laws and comply with compliance requirements to ensure the legality and safety of transactions. Regulators should actively follow up the market development and continuously improve the regulatory mechanism of digital asset trading to promote the healthy development of the market.

THE USE OF PERSONAL PROTECTIVE EQUIPMENT BY PHARMACISTS AND RADIOGRAPHERS DURING THE COVID-19 PANDEMIC IN KENDAL DISTRICT

In order to control the transmission of covid-19 which entered Indonesia in early 2020, the government implemented health protocol regulations. Apart from health protocols, one of the steps that health workers can implement to control the transmission of covid-19 when providing services during the pandemic is to use personal protective equipment while working. This is the background for the author to study further in research that aims to determine the use of personal protective equipment used by pharmacists and radiographers during the covid-19 pandemic while in service in Kendal District. The research method used was descriptive qualitative by giving questionnaires electronically using google form to research respondents. The research results obtained include, the majority of respondents were female with a percentage of 62%, the health workers who participated as research respondents consisted of 38% pharmacists and 62% radiographers. The use of personal protective equipment used by pharmacists during the covid-19 pandemic includes masks and gloves which are adjusted to the risks of the work activities carried out. The use of personal protective equipment used by radiographers during the covid-19 pandemic includes wearing work clothes according to hospital regulations, surgical isolation gowns, N95 respirators, eye protection, medical gloves, closed shoes, face shields when carrying out medical interventions and tools additional personal protection according to the risks of the work activities carried out. So, it can be concluded that the personal protective equipment used by pharmacists and radiographers in Kendal District while on duty during the covid-19 pandemic has met the elements of compliance requirements in efforts to control the transmission of covid-19, such as the use of personal protective equipment based on indications for their use by considering the risk of exposure and possible transmission dynamics. By implementing appropriate personal protective equipment when working, it is hoped that pharmacists and radiographers in Kendal District can be protected from transmission of covid-19.

Considerations for extending sound studies beyond typical regulatory compliance requirements for data centers in suburban and rural environments.

The escalating presence of data centers in suburban and rural environments has emerged as a potential new source of noise in areas often lacking comprehensive noise regulations. Where noise regulations do exist, many do not provide spectral limitations or other methods of assessing and regulating the frequently cited community concerns such as low-frequency noise (LFN) and tonality of the sounds. This may lead to public dissatisfaction of the data center sounds despite compliance with the applicable noise limits. This paper provides an overview of representative codes and standards to help illustrate the deficiencies in some codes to identify community concerns. In addition, the paper conducts an initial examination of sound spectra associated with a variety of mechanical equipment types used for cooling data halls in these facilities, focusing on identifying outliers or common characteristics that may cause community annoyance. This review emphasizes the need for heightened scrutiny during the due diligence or design phase of data center projects.

Підвищення ефективності забезпечення працездатності транспортних засобів

Accidental failures, leading to unplanned repairs, significantly increase the cost of their elimination compared to planned measures. A significant part of such failures are not sudden in nature. Gradual failure is preceded by a gradual change in some parameters. The impact of gradual failures on the efficient operation of road freight transport is increasing. Despite the fact that the failure of the engine, clutch or automatic transmission is not dangerous to the life and health of people, their impact on the economic condition of the enterprise is significant. There is a trend of decreasing the size of the rolling stock fleet for most of the country's motor transport enterprises. Therefore, the importance of keeping each car in working condition increases. To increase the accuracy of the prevention of gradual and sudden-gradual failures, a forecasting method based on the diagnosis of trucks with a specialized diagnostic car scanner TEXA Navigator MULTIHUB is proposed. The selection of diagnostic parameters was carried out in accordance with the requirements for compliance with the accuracy, efficiency, and informativeness of the diagnostic parameters. The research was carried out on MAN TG-X, MAN TGA, VOLVO FH 12, DAF 105 XF, and DAF 106 cars. A sequential cylinder shutdown test was conducted to determine the compression and efficiency of all cylinders. A gradual change in the operating parameter is determined based on the obtained decrease in revolutions. In the next test, the correction of the injectors for the amount of fuel injected into the cylinders is checked. The reference value is taken as 0. The correction tolerance for increasing or decreasing the fuel supply time should be within +1 or –1. Based on the received data, the nozzle is determined, in the correction gradually increases, which signals a problem with the nozzle's operation. For the clutch, a test of the position of the start of switching on and off was carried out. By reducing the percentage of idling, you can determine the gradual engagement of the clutch. All the conducted tests make it possible to graphically display a change in a parameter or property and, using extrapolation, to predict the moment of failure. All cars carry out freight transportation in international traffic. Control parameters and data extrapolation made it possible to predict engine, clutch, and automatic transmission failures. Selected diagnostic parameters can be used to predict and prevent failures.

An Overview of Cloud Computing Systems

Cloud computing has revolutionized IT resource management, providing scalable and flexible internet services that significantly differ from traditional on-premises infrastructure. This paper presents a comprehensive overview of cloud computing systems, examining their architecture, service models, deployment models, and the advantages and challenges they pose. The architecture of cloud computing is foundational, comprising client-side devices, cloud infrastructure backend, and networking components. Service models are categorized into Infrastructure as a Service (IaaS), Platform as a Service (PaaS), and Software as a Service (SaaS), each offering different levels of abstraction and control. Deployment models include public, private, hybrid, and community clouds, each tailored to specific organizational needs. The advantages of cloud computing, such as cost efficiency, scalability, accessibility, disaster recovery, and innovation, are significant. However, challenges like security and privacy concerns, downtime and reliability issues, compliance requirements, and vendor lock-in necessitate careful planning and management. Understanding these facets is crucial for organizations to effectively leverage cloud computing and navigate its complex landscape.

A qualitative exploration of transitions, compliance, and onboarding challenges for international students in health professional education degrees

Background: Australia provides education services to international students which includes international students completing a health professional education (HPE) degree. Studying for a HPE degree can be challenging for most students. There are specific challenges for international students when completing a degree with clinical placements. The challenges international students can face include receiving adequate and timely information, understanding health service access, and receiving the correct information from education providers and agents. Objectives: To gain an in-depth understanding of the challenges for international health professional education students in accessing healthcare, understanding the requirements of compliance to attend clinical placements and the difficulties with attending clinical placements. Design: A semi-structured interview schedule based on findings from a survey (N = 318 participants) was used to explore international student perspectives in one-on-one interviews. Methods: Data were collected from international HPE students from a single Australian metropolitan multi-campus university using a questionnaire, which included qualitative open-ended questions, in addition to semi-structured follow-on interviews. Data collection took place between March and October 2021 and qualitative data were inductively thematically analysed. Results: Challenges reported in interviews by six international students were focused on understanding the navigation of new administrative systems and compliance processes. Students noted gaps in the communication of understanding legislative compliance requirements to attend clinical placements, difficulties accessing healthcare and making use of overseas student health cover, organisational issues, and transport issues when attending clinical placements. Conclusions: Higher education providers and international education agents must address communication deficits in course requirements linked to clinical placement prerequisites. This study highlights gaps in commencing international students’ understanding, and higher education providers' communication of clear, timely detailed information.

Digital Assistant for Video KYC Framework in India

The Know Your Customer (KYC) operations in India need to be done securely and efficiently due to the financial services industry's fast digitalization. The creation of a digital assistant that is customized for the Video KYC framework and prioritizes user experience over compliance requirements is suggested in this abstract. The digital assistant uses artificial intelligence and natural language processing to automate the KYC process and guarantee accuracy, dependability, and compliance with rules like those issued by the Reserve Bank of India (RBI). The assistant improves security protocols by utilizing advanced facial recognition, document verification, and biometric authentication, hence reducing the potential for identity fraud and data breaches.

The Impact of Political Risks on Foreign Companies’ Market Entry Strategies in China

This study explores the challenges faced by multinational companies operating in China, focusing on political risks and entry challenges. The analysis is based on five established companies: IBM (China) Co., Maersk Logistics (China) Co., Ltd., Schneider Electric (China) Co., Ltd., 3M China Limited, and Marriott International (Greater China) Limited. The findings reveal high risks associated with government regulations, cultural differences, intellectual property protection, trade barriers, compliance requirements, and technology/cybersecurity. Political challenges during market entry include concerns about intellectual property theft, piracy, and cyber espionage. In response, a strategic plan is proposed to mitigate these challenges, emphasizing financial cooperation, cultural adaptation, intellectual property management, trade compliance, and cybersecurity readiness. The goals include enhancing corporate image, reducing disputes, increasing market share, and achieving leadership in compliance and cybersecurity. Conclusions highlight the strategic approaches adopted by the analyzed companies and the necessity for careful consideration of regulatory environments. Recommendations include building local partnerships, investing in research and development, implementing sustainability initiatives, and developing comprehensive compliance systems. The proposed strategies aim to help foreign companies navigate the complex Chinese market successfully.

A COMPARATIVE STUDY OF AUDIT EXPENDITURE IN PRIVATE SECTOR AND PUBLIC SECTOR BANKS

The paper embarks on a thorough examination, comparing the audit expenditures incurred by private sector banks and public sector banks. It's not merely a financial analysis; rather, it aims to uncover whether there's a discernible variance in how these two categories of banks allocate resources to auditing. However, the focus extends beyond financial figures; it seeks to unravel the underlying attitudes and perceptions towards auditing within the banking landscape. The study endeavors to unravel the intricate fabric of the banking industry, by scrutinizing these divergent perspectives, where perceptions often shape practices and policies. The core inquiry revolves around whether private sector banks and public sector banks view auditing through the same lens of importance. The paper intends to settle query whether they both equally invested in ensuring robust audit mechanisms, or does one category regard it as a perfunctory exercise? This line of questioning opens a window into the broader ethos of banking governance and risk management. Is auditing perceived merely as a regulatory obligation, a box to be checked to fulfill compliance requirements? Or is it recognized as a fundamental pillar of organizational resilience and financial health?

Speaking of games: AI-based content moderation of real-time voice interactions in video games under the DSA

AI-based content moderation in real-time voice interactions within multiplayer video games confronts both technological limitations and complex ethical issues, especially under the stringent compliance requirements of regulatory frameworks like the Digital Services Act. The deployment of AI-driven tools must navigate the transient nature of voice communication, balancing the need for quick, effective moderation with the imperatives of transparency and freedom of expression protection. By exploring the practicalities and pitfalls of these technologies in this specific context, this article advocates for a ‘freedom of expression by design’ paradigm. This approach integrates robust user protections into content moderation systems, aiming to significantly reduce rather than eliminate harmful interactions. The findings underscore a nuanced strategy that respects user rights while addressing the dynamic challenges of voice communication in multiplayer video games.