Search results for: spontaneous ADR reporting

Authors: Kwaku Damoah

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This study presents a comprehensive data-driven analysis to understand the evolution of adverse events (AEs) in pharmacovigilance. Utilizing data from the FDA Adverse Event Reporting System (FAERS), we employed three analytical methods: rank-based, frequency-based, and percentage change analyses. These methods assessed temporal trends and patterns in AE reporting, focusing on various drug-active ingredients and patient demographics. Our findings reveal significant trends in AE occurrences, with both increasing and decreasing patterns from 2000 to 2023. This research highlights the importance of continuous monitoring and advanced analysis in pharmacovigilance, offering valuable insights for healthcare professionals and policymakers to enhance drug safety.

Keywords: event analysis, FDA adverse event reporting system, pharmacovigilance, temporal trend analysis

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Authors: Uyanga Jadamba

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Globalisation of the world economy has necessitated the development and implementation of a comparable and understandable reporting language suitable for use by all reporting entities. The International Accounting Standard Board (IASB) provides an international reporting language that lets all users understand the financial information of their business and potentially allows them to have access to finance at an international level. The study is based on logistic regression analysis to investigate the factors for the adoption of theInternational Financial Reporting Standard for Small and Medium sized Entities (IFRS for SMEs). The study started with a list of 217 countries from World Bank data. Due to the lack of availability of data, the final sample consisted of 136 countries, including 60 countries that have adopted the IFRS for SMEs and 76 countries that have not adopted it yet. As a result, the study included a period from 2010 to 2020 and obtained 1360 observations. The findings confirm that the adoption of the IFRS for SMEs is significantly related to the existence of national reporting standards, law enforcement quality, common law (legal system), and extent of disclosure. It means that the likelihood of adoption of the IFRS for SMEs decreases if the country already has a national reporting standard for SMEs, which suggests that implementation and transitional costs are relatively high in order to change the reporting standards. The result further suggests that the new standard adoption is easier in countries with constructive law enforcement and effective application of laws. The finding also shows that the adoption increases if countries have a common law system which suggests that efficient reportingregulations are more widespread in these countries. Countries with a high extent of disclosing their financial information are more likely to adopt the standard than others. The findings lastly show that the audit qualityand primary education levelhave no significant impact on the adoption.One possible explanation for this could be that accounting professionalsfrom in developing countries lacked complete knowledge of the international reporting standards even though there was a requirement to comply with them. The study contributes to the literature by providing factors that impact the adoption of the IFRS for SMEs. It helps policymakers to better understand and apply the standard to improve the transparency of financial statements. The benefit of adopting the IFRS for SMEs is significant due to the relaxed and tailored reporting requirements for SMEs, reduced burden on professionals to comply with the standard, and provided transparent financial information to gain access to finance.The results of the study are useful toemerging economies where SMEs are dominant in the economy in informing its evaluation of the adoption of the IFRS for SMEs.

Keywords: IFRS for SMEs, international financial reporting standard, adoption, institutional factors

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Authors: Afshan Saad, Muhammad Saad, Shah Muhammad Emaduddin

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Bug reporting systems are most important tool that guides regarding different maintenance activities in software engineering. Duplicate bug reports which describe the bugs and issues in bug reporting system repository increases processing time of bug triage that monitors all such activities and software programmers who are working and spending time on reports which were assigned by triage. These reports can reveal imperfections and degrade software quality. As there is a number of the potential duplicate bug reports increases, the number of bug reports in bug repository increases. Identifying duplicate bug reports help in decreasing development work load in fixing defects. However, it is difficult to manually identify all possible duplicates because of the huge number of already reported bug reports. In this paper, an artificial intelligence based system using Mantis is proposed to automatically detect duplicate bug reports. When new bugs are submitted to repository triages will mark it with a tag. It will investigate that whether it is a duplicate of an existing bug report by matching or not. Reports with duplicate tags will be eliminated from the repository which not only will improve the performance of the system but can also save cost and effort waste on bug triage and finding the duplicate bug.

Keywords: bug tracking, triager, tool, quality assurance

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Authors: Samuel Faboyede, Obiamaka Nwobu, Samuel Fakile, Dickson Mukoro

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In the present dynamic business environment of corporate governance and regulations, financial reporting is an inevitable and extremely significant process for every business enterprise. Several financial elements such as Annual Reports, Quarterly Reports, ad-hoc filing, and other statutory/regulatory reports provide vital information to the investors and regulators, and establish trust and rapport between the internal and external stakeholders of an organization. Investors today are very demanding, and emphasize greatly on authenticity, accuracy, and reliability of financial data. For many companies, the Internet plays a key role in communicating business information, internally to management and externally to stakeholders. Despite high prominence being attached to external reporting, it is disconnected in most companies, who generate their external financial documents manually, resulting in high degree of errors and prolonged cycle times. Chief Executive Officers and Chief Financial Officers are increasingly susceptible to endorsing error-laden reports, late filing of reports, and non-compliance with regulatory acts. There is a lack of common platform to manage the sensitive information – internally and externally – in financial reports. The Internet financial reporting language known as eXtensible Business Reporting Language (XBRL) continues to develop in the face of challenges and has now reached the point where much of its promised benefits are available. This paper looks at the emergence of this revolutionary twenty-first century language of digital reporting. It posits that today, the world is on the brink of an Internet revolution that will redefine the ‘business reporting’ paradigm. The new Internet technology, eXtensible Business Reporting Language (XBRL), is already being deployed and used across the world. It finds that XBRL is an eXtensible Markup Language (XML) based information format that places self-describing tags around discrete pieces of business information. Once tags are assigned, it is possible to extract only desired information, rather than having to download or print an entire document. XBRL is platform-independent and it will work on any current or recent-year operating system, or any computer and interface with virtually any software. The paper concludes that corporate stakeholders and the government cannot afford to ignore the XBRL. It therefore recommends that all must act locally and think globally now via the adoption of XBRL that is changing the face of worldwide business reporting.

Keywords: XBRL, financial reporting, internet, internal and external reports

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Authors: Anam Layla, Qamar Abbas Syed, Tahir Zahoor, Muhammad Shahid

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Brassicaceae sprouts are promising candidates for functional food because of their unique phytochemistry and high nutrient density compared to their seeds and matured vegetables. Despite being admired for their health-promoting properties, white cabbage sprouts have been least explored for their nutritional significance and behavior to lactic acid fermentation. This study aimed to investigate the role of lactic acid fermentation i.e., inoculum vs. spontaneous, in reducing intrinsic toxicants load and improving nutrients delivering potential of the white cabbage sprouts. White cabbage sprouts with a 5 – 7 cm average size were processed as raw, blanched, Lactiplantibacillus plantarum inoculated fermentation and spontaneous fermentation. Plant material was dehydrated at 40˚C and evaluated for microbiological quality, macronutrients, minerals, and anti-nutrient contents. The results indicate L. plantarum inoculum fermentation of blanched cabbage sprouts (IF-BCS) to increase lactic acid bacteria count of the sprouts from 0.97 to 8.47 log CFU/g. Compared with the raw cabbage sprouts (RCS), inoculum fermented-raw cabbage sprouts (IF-RCS), and spontaneous fermented-raw cabbage sprouts (SF-RCS), the highest content of Ca (447 mg/ 100g d.w.), Mg (204 mg/100g d.w.), Fe (9.3 mg/100g d.w.), Zn (5 mg/100g d.w.) and Cu (0.5 mg/100g d.w.) were recorded in IF-BCS. L. plantarum led fermentation of BCS demonstrated a reduction in phytates, tannins, and oxalates contents at a rate of 42%, 66%, and 53%, respectively, while standalone lactic acid fermentation of the raw sprouts reduced the burden of anti-nutrients in a range between 32 to 56%. The results suggest L. plantarum led lactic acid fermentation coupled with sprouts blanching is the most promising way to improve the nutritional quality and safety of the white cabbage sprouts.

Keywords: lactic acid fermentation, anti-nutrients, mineral content, nutritional quality

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Authors: Suriyani Ariffin, Nor Aziah Alias, Khairil Iskandar Othman, Haslinda Yusoff

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An Integrated Cumulative Grade Point Average (iCGPA) is a mechanism and strategy to ensure the curriculum of an academic programme is constructively aligned to the expected learning outcomes and student performance based on the attainment of those learning outcomes that is reported objectively in a spider web. Much effort and time has been spent to develop a viable mechanism and trains academics to utilize the platform for reporting. The question is: How well do learners conceive the idea of their achievement via iCGPA and whether quality learner attributes have been nurtured through the iCGPA mechanism? This paper presents the architecture of an integrated CGPA mechanism purported to address a holistic evaluation from the evaluation of courses learning outcomes to aligned programme learning outcomes attainment. The paper then discusses the students’ understanding of the mechanism and evaluation of their achievement from the generated spider web. A set of questionnaires were distributed to a group of students with iCGPA reporting and frequency analysis was used to compare the perspectives of students on their performance. In addition, the questionnaire also explored how they conceive the idea of an integrated, holistic reporting and how it generates their motivation to improve. The iCGPA group was found to be receptive to what they have achieved throughout their study period. They agreed that the achievement level generated from their spider web allows them to develop intervention and enhance the programme learning outcomes before they graduate.

Keywords: learning outcomes attainment, iCGPA, programme learning outcomes, spider web, iCGPA reporting skills

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Authors: Timiebi Aganaba-Jeanty

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Accurate and transparent monitoring, reporting and verification of Greenhouse Gas (GHG) emissions and removals is a requirement of the United Nations Framework Convention on Climate Change (UNFCCC). Several countries are obligated to prepare and submit an annual national greenhouse gas inventory covering anthropogenic emissions by sources and removals by sinks, subject to a review conducted by an international team of experts. However, the process is not without flaws. The self-reporting varies enormously in thoroughness, frequency and accuracy including inconsistency in the way such reporting occurs. The world’s space agencies are calling for a new generation of satellites that would be precise enough to map greenhouse gas emissions from individual nations. The plan is delicate politically because the global system could verify or cast doubt on emission reports from the member states of the UNFCCC. A level playing field is required and an idea that an international system should be perceived as an instrument to facilitate fairness and equality rather than to spy on or punish. This change of perspective is required to get buy in for an international verification system. The research proposes the viability of a satellite system that provides independent access to data regarding greenhouse gas emissions and the policy and governance implications of its potential use as a monitoring and verification system for the Paris Agreement. It assesses the foundations of the reporting monitoring and verification system as proposed in Paris and analyzes this in light of a proposed satellite system. The use of remote sensing technology has been debated for verification purposes and as evidence in courts but this is not without controversy. Lessons can be learned from its use in this context.

Keywords: greenhouse gas emissions, reporting, monitoring and verification, satellite, UNFCCC

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Authors: Martin Surya Mulyadi, Rosinta Ria Panggabean

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The terms of intellectual capital emerge as the economic activity shift from the agricultural economy to knowledge economy and it will allow corporations to earn competitive advantage to its competitors. Considering its importance, many researches have a focus on how corporations disclose its intellectual capital. This intellectual capital research mainly focuses on developed country with only several researchers conducted this research in developing the country. While there are several intellectual capital researches in developing country, to authors’ best knowledge, there is no intellectual capital reporting research in Indonesia published internationally. This research will focus on two industries that acknowledge having a high reliance on intellectual capital: finance industry and the pharmaceutical industry. Our research found that Indonesian corporations in these industries are aware of the importance of intellectual capital, and variations of this disclosure exist within the industry.

Keywords: Developed country, Indonesia, Intellectual Capital, Intellectual Capital Reporting

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Authors: Sana Masmoudi Mardassi, Yosra Makni Fourati

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Regulators highlight the importance of the Audit Committee (AC) as a key internal corporate governance mechanism. One of the most important roles of this committee is to oversee the financial reporting process. The purpose of this paper is to examine the link between the characteristics of an audit committee and the financial reporting quality by investigating whether the characteristics of audit committees are associated with improved financial reporting quality, especially the Real Earnings Management. In the current study, a panel data from 80 nonfinancial companies listed on the Amsterdam Stock Exchange during the period between 2010 and 2017 were used. To measure audit committee characteristics, four proxies have been used, specifically, audit committee independence, financial expertise, gender diversity and AC meetings. For this research, a linear regression model was used to identify the influence of a set of board characteristics of the audit committee on real earnings management after controlling for firm audit committee size, leverage, size, loss, growth and board size. This research provides empirical evidence of the association between audit committee independence, financial expertise, gender diversity and meetings and Real Earnings Management (REM) as a proxy of financial reporting quality. The study finds that independence and AC Gender diversity are strongly related to financial reporting quality. In fact, these two characteristics constrain REM. The results also suggest that AC- financial expertise reduces to some extent, the likelihood of engaging in REM. These conclusions provide support then to the audit committee requirement under the Dutch Corporate Governance Code rules regarding gender diversity and AC meetings.

Keywords: audit committee, financial expertise, independence, real earnings management

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Authors: Wanda Luen-Wun Siu, Xiaowen Zhang

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This paper offered the primary methodical proof on how CSR reporting related to enterprise earnings in listed firms in China in light of most evidence focusing on cross-sectional data or data in a short span of time. Using full economic and business panel data on China’s publicly listed enterprise from 2006 to 2020 over two decades in the China Stock Market and Accounting Research database, we found initial evidence of significant direct relations between CSR reporting and firm corporate performance in both state-owned and privately owned firms over this period, supporting the stakeholder theory. Results also revealed that state-owned enterprises performed as well as private enterprises in the current period. But private enterprises performed better than state-owned enterprises in the subsequent years. Moreover, the release of social responsibility reports had a more significant impact on the financial performance of state-owned and private enterprises in the current period than in the subsequent periods. Specifically, CSR release was not significantly associated with the financial performance of state-owned enterprises on the lag of the first, second, and third periods. But it had an impact on the lag of the first, second, and third periods among private enterprises. Such findings suggested that CSR reporting helped improve the corporate financial performance of state-owned and private enterprises in the current period, but this kind of effect was more significant among private enterprises in the lag periods.

Keywords: China’s listed firms, CSR reporting, financial performance, panel analysis

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Authors: Seyedmohsen Mortazavi

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The purpose of this research is to investigate the personality types of internal auditors on the quality of financial reporting in companies admitted to the Tehran Stock Exchange. Personality type is one of the issues that emphasizes the field of auditors' behavior, and this field has attracted the attention of shareholders and stock companies today, because the auditors' personality can affect the type of financial reporting and its quality. The research is applied in terms of purpose and descriptive and correlational in terms of method, and a researcher-made questionnaire was used to check the research hypotheses. The statistical population of the research is all the auditors, accountants and financial managers of the companies admitted to the Tehran Stock Exchange, and due to their large number and the uncertainty of their exact number, 384 people have been considered as a statistical sample using Morgan's table. The researcher-made questionnaire was approved by experts in the field, and then its validity and reliability were obtained using software. For the validity of the questionnaire, confirmatory factor analysis was first examined, and then using divergent and convergent validity; Fornell-Larker and cross-sectional load test of the validity of the questionnaire were confirmed; Then, the reliability of the questionnaire was examined using Cronbach's alpha and composite reliability, and the results of these two tests showed the appropriate reliability of the questionnaire. After checking the validity and reliability of the research hypotheses, PLS software was used to check the hypotheses. The results of the research showed that the personalities of internal auditors can affect the quality of financial reporting; The personalities investigated in this research include neuroticism, extroversion, flexibility, agreeableness and conscientiousness, all of these personality types can affect the quality of financial reporting.

Keywords: flexibility, quality of financial reporting, agreeableness, conscientiousness

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Authors: Joanna Kufel-Orlowska

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Domestic violence is a social threat to public safety and order. It poses a threat not only to the family members of the perpetrator but also disturbs the functioning of society and even the state. In a situation of danger, an individual either defends himself or/and calls for help by contacting an appropriate institution whose aim is to ensure civil security. Most often, such contact takes place through a telephone conversation, which is aimed at diagnosing the problem and prompt intervention. People in different situations and in different ways, despite the general reporting standards, try to inform about the need for help. The article aims to present the results of research on non-standard forms of reporting domestic violence in the opinion of the Polish society and operators of the Polish emergency number 112 (911). The research was conducted in the form of a survey technique on a sample of 160 operators (purposeful selection) and 300 people living in Poland (random selection). The research was conducted in the form of online surveys. The study found that in Poland: 1. emergency number operators often receive reports of domestic violence although they are not always able to diagnose whether the case is strictly about violence; 2. non-standard reports of domestic violence are received by about 30% of emergency number operators. Non-standard should be understood as reports of violence that deviate from the norm, are unusual, or are reported by a non-victim. 3. The most common forms of reporting violence not directly are: pretending to talk to a friend, calling a cab, making an appointment with a dentist/doctor, calling a store and helping with the selection of goods, asking about the bank's hotline, not speaking (in order for the emergency number operator to hear what is going on). 4. Emergency number operators in Poland are properly trained and are able to recognize the threatening situation of the reporting party and conduct the conversation in a safe manner for the reporting party. On the other hand, Polish people support the ability to report violence in a non-standard way and would do so themselves in the event of a threat to their own life, health, or property, thus expecting the emergency number operator to recognize a report and help us.

Keywords: domestic violence, operator of the emergency number 112 (911), emergency call center, reporting domestic violence

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Authors: Sheena Christabel Pravin, M. Palanivelan

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Speech disfluencies are common in spontaneous speech. The primary purpose of this study was to distinguish linguistic disfluencies from stuttering disfluencies in bilingual Tamil–English (TE) speaking children. The secondary purpose was to determine whether their disfluencies are mediated by native language dominance and/or on an early onset of developmental stuttering at childhood. A detailed study was carried out to identify the prosodic and acoustic features that uniquely represent the disfluent regions of speech. This paper focuses on statistical modeling of repetitions, prolongations, pauses and interjections in the speech corpus encompassing bilingual spontaneous utterances from school going children – English and Tamil. Two classifiers including Hidden Markov Models (HMM) and the Multilayer Perceptron (MLP), which is a class of feed-forward artificial neural network, were compared in the classification of disfluencies. The results of the classifiers document the patterns of disfluency in spontaneous speech samples of school-aged children to distinguish between Children Who Stutter (CWS) and Children with Language Impairment CLI). The ability of the models in classifying the disfluencies was measured in terms of F-measure, Recall, and Precision.

Keywords: bi-lingual, children who stutter, children with language impairment, hidden markov models, multi-layer perceptron, linguistic disfluencies, stuttering disfluencies

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Authors: Edward Chamisa, Colin C. Smith, Hamutyinei H. Pamburai, Abdul C. Abdulla

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South Africa (SA) adopted International Financial Reporting Standards (IFRS) for listed firms effective 1 January 2005. However, it was not until 2011 that substantial financial reporting enforcement changes were introduced, which were meant to ensure compliance with IFRS. This innovative setting allows us to examine the value relevance of accounting amounts during the (1) pre-IFRS adoption period (2002-2004); (2) post-IFRS adoption, but pre-enforcement changes period (2006-2010); and (3) post-enforcement changes period (2011-2012). The results show that accounting amounts were most value relevant in the post-enforcement changes period (R2, 75.5%) compared to both the pre-IFRS adoption period (adjusted R2 is 24.3%) and the period after IFRS adoption but before enforcement changes (adjusted R2 is 37.5%). Also, during the 2008 financial crisis, the equity book value per share was significantly value relevant (at 1%) but not earnings per share, whereas before the crisis, the opposite was true. We make two important contributions to the literature. First, we identify SA as an innovative setting that allows researchers to examine separately the effects of IFRS adoption and enforcement changes on capital markets and accounting quality. This is a departure from prior studies that are dominated by the European Union setting, where IFRS adoption occurred contemporaneously with enforcement and other regulatory changes. Second, we provide preliminary findings which suggest that while the adoption of IFRS seems to have improved the financial reporting quality of accounting amounts of SA listed firms, its impact appears to be limited unless combined with effective enforcement.

Keywords: international financial reporting standards (ifrs), ifrs adoption, financial reporting enforcement, value relevance, price model, equity book value, earnings per share

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Authors: Namhyun An, Byungho Lee, Hwauk Lee, Youngmin Lee, Deuk Young Kim, Sejoon Lee

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In this study, the Cr-doped ZnO thin films have been deposited by reactive magnetron sputtering method with different Cr-contents (1.0at.%, 2.5at.% and 12.5at.%) and their ferromagnetic properties have been characterized. All films revealed clear ferromagnetism above room temperature. However, the spontaneous magnetization of the films was observed to depend on the Cr contents in the films. Namely, the magnitude of effective magnetic moment (per each Cr ion) was exponentially decreased with increasing the Cr contents. We attributed the decreased spontaneous magnetization to the degraded crystal magnetic anisotropy. In other words, we found out that the high concentration of magnetic ions causes the lattice distortion in the magnetic ion-doped thin film, and it consequently degrades ferromagnetic channeling in the solid-state material system.

Keywords: Cr-doped ZnO, ferromagnetic properties, magnetization, sputtering, thin film

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Authors: Haouam Djemaa

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This study aimed to identify the possibility for applying fair value accounting by Algerian enterprises coted in capital maket (Algiers stock exchange). To achieve the objectives of this study, we made an interview with preparers of accounting information. The results document that enterprises are aware of fair value accounting in financial reporting because of its ability to provide useful accounting, but it depends on the availability of favorable circumstances for its application and this is what is missing in the Algerian environment.

Keywords: fair value, financial reporting, accounting information, valuation method

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Authors: Ruel A. Welch

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Since the introduction of ServiceNow, the UK’s Science Museum Group’s (SMG) ICT service desk portal. There has not been an analysis of the tools available to SMG staff for just-in-time knowledge acquisition (knowledge management systems) and reporting ICT incidents with a focus on an aspect of professional identity, namely, gender. This study is conducted in the milieu of UK museums, galleries, arts, academic, charitable, and cultural heritage sectors. Numerous authors suggest that males and females experience ICT usage differently. Therefore, it is important for SMG to investigate the apparent disparities so that solutions can be derived to minimize this digital divide if one exists. It is acknowledged at SMG that there are challenges with keeping up with an ever-changing digital landscape. Subsequently, this entails the rapid upskilling of staff and developing an infrastructure that supports just-in-time technological knowledge acquisition and reporting technology-related issues. This problem was addressed by analyzing ServiceNow ICT incident reports and reports from knowledge articles from a six-month period from February to July. This study found a statistically significant relationship between gender and reporting an ICT incident. There is also a significant relationship between gender and the priority level of ICT incidents. Interestingly, there is no statistically significant relationship between gender and reading knowledge articles. Additionally, there is no statistically significant relationship between gender and reporting an ICT incident related to the knowledge article that was read by staff. The knowledge acquired from this study is useful to service desk management practice as it will help to inform the creation of future knowledge articles and ICT incident reporting processes.

Keywords: digital divide, ICT service desk practice, knowledge management systems, workplace learning

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Authors: Eko Budi Santoso

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There is a growing interest in Corporate Social Responsibility (CSR) issues in developing countries such as Indonesia. Firms disclose their CSR activities, and some provide assurance to gain recognition as socially responsible firms. However, several of those socially responsible firms involve in tax scandals and raise a question of whether CSR disclosure is used to disguise firm misconduct or as a reflection of socially responsible firms. Specifically, whether firms engage in CSR disclosure and its assurance also responsible for their tax matters. This study examines the association between CSR disclosure and tax aggressiveness and the role of sustainability reporting assurance to the association. This research develops a modified index according to global reporting initiatives to measure CSR disclosure and various measurement for tax aggressiveness. Using a sample of Indonesian go public companies issued CSR disclosure, the empirical result shows that there is an association between CSR disclosure and tax aggressiveness. In addition, results also indicate sustainability reporting assurance moderate those association. The findings suggest that stakeholder in developing countries should examine carefully firms with active CSR disclosure before label it as socially responsible firms. JEL Classification: M14

Keywords: CSR disclosure, tax aggressiveness, assurance, business ethics

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Authors: Peter Yamoah, Frasia Oosthuizen

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Introduction: Reporting of Adverse Events Following Immunization continues to be a challenge. Pharmacovigilance centers throughout the world are mandated by the WHO to submit AEFI reports from various countries to a large pool of adverse drug reaction electronic database called Vigibase. Despite the relevant information of AEFI in Vigibase, it is unavailable to the general public. However, the WHO has an alternative website called VigiAccess which is an open access website serving as a repository of reported adverse drug reactions and AEFIs. The aim of the study was to ascertain the reporting pattern of a number of commonly used vaccines in VigiAccess. Methods: VigiAccess was thoroughly searched on the 5th of February 2018 for AEFI reports of measles vaccine, oral polio vaccine (OPV), yellow fever vaccine, pneumococcal vaccine, rotavirus vaccine, meningococcal vaccine, tetanus vaccine and tuberculosis (BCG) vaccine. These were reports from all pharmacovigilance centers in the world from the time they joined the WHO drug monitoring program. Results: After a thorough search in VigiAccess, there were 9,062 measles vaccine AEFIs, 185,829 OPV AEFIs, 24,577 yellow fever vaccine AEFIs, 317,208 pneumococcal vaccine AEFIs, 73,513 rotavirus vaccine AEFIs, 145,447 meningococcal vaccine AEFIs, 22,781 tetanus vaccine AEFIs and 35,556 BCG vaccine AEFIs. Conclusion: The study revealed that out of the eight vaccines studied, pneumococcal vaccines are associated with the highest number of AEFIs whilst measles vaccines were associated with the least AEFIs.

Keywords: vaccines, adverse reactions, VigiAccess, adverse event reporting

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Authors: Katarzyna Drela, Miroslaw Wielgos, Mikolaj Wrobel, Barbara Lukomska

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Mesenchymal stem cells (MSCs) have a great potential in regenerative medicine. Since the initial number of isolated MSCs is limited, in vitro propagation is often required to reach sufficient numbers of cells for therapeutic applications. During long-term culture MSCs may undergo genetic or epigenetic alterations that subsequently increase the probability of spontaneous malignant transformation. Thus, factors that influence genomic stability of MSCs following long-term expansions need to be clarified before cultured MSCs are employed for clinical application. The aim of our study was to investigate the potential for spontaneous transformation of human neonatal cord blood (HUCB-MSCs) and adult bone marrow (BM-MSCs) derived MSCs. Materials and Methods: HUCB-MSCs and BM-MSCs were isolated by standard Ficoll gradient centrifugations method. Isolated cells were initially plated in high density 106 cells per cm2. After 48 h medium were changed and non-adherent cells were removed. The malignant transformation of MSCs in vitro was evaluated by morphological changes, proliferation rate, ability to enter cell senescence, the telomerase expression and chromosomal abnormality. Proliferation of MSCs was analyzed with WST-1 reduction method and population doubling time (PDT) was calculated at different culture stages. Then the expression pattern of genes characteristic for mesenchymal or epithelial cells, as well as transcriptions factors were examined by RT-PCR. Concomitantly, immunocytochemical analysis of gene-related proteins was employed. Results: Our studies showed that MSCs from all bone marrow isolations ultimately entered senescence and did not undergo spontaneous malignant transformation. However, HUCB-MSCs from one of the 15 donors displayed an increased proliferation rate, failed to enter senescence, and exhibited an altered cell morphology. In this sample we observed two different cell phenotypes: one mesenchymal-like exhibited spindle shaped morphology and express specific mesenchymal surface markers (CD73, CD90, CD105, CD166) with low proliferation rate, and the second one with round, densely package epithelial-like cells with significantly increased proliferation rate. The PDT of epithelial-like populations was around 1day and 100% of cells were positive for proliferation marker Ki-67. Moreover, HUCB-MSCs showed a positive expression of human telomerase reverse transcriptase (hTERT), cMYC and exhibit increased number of CFU during the long-term culture in vitro. Furthermore, karyotype analysis revealed chromosomal abnormalities including duplications. Conclusions: Our studies demonstrate that HUCB-MSCs are susceptible to spontaneous malignant transformation during long-term culture. Spontaneous malignant transformation process following in vitro culture has enormous effect on the biosafety issues of future cell-based therapies and regenerative medicine regimens.

Keywords: mesenchymal stem cells, spontaneous, transformation, long-term culture

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Authors: Sarita Puri, Tapan K. Chaudhuri

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Chaperonin GroEL is a tetradecameric Escherichia coli protein having identical subunits of 57 kDa. The elucidation of thermodynamic parameters related to stability for the native GroEL is not feasible as it undergoes irreversible unfolding because of its large size (800kDa) and multimeric nature. Nevertheless, it is important to determine the thermodynamic stability parameters for the highly stable GroEL protein as it helps in folding and holding of many substrate proteins during many cellular stresses. Properly folded monomers work as building-block for the formation of native tetradecameric GroEL. Spontaneous refolding behavior of monomeric GroEL makes it suitable for protein-denaturant interactions and thermodynamic stability based studies. The urea mediated unfolding is a three state process which means there is the formation of one intermediate state along with native and unfolded states. The heat mediated denaturation is a two-state process. The unfolding process is reversible as observed by the spontaneous refolding of denatured protein in both urea and head mediated refolding processes. Analysis of folding/unfolding data provides a measure of various thermodynamic stability parameters for the monomeric GroEL. The proposed mechanism of unfolding of monomeric GroEL is a three state process which involves formation of one stable intermediate having folded apical domain and unfolded equatorial, intermediate domains. Research in progress is to demonstrate the importance of specific residues in stability and oligomerization of GroEL protein. Several mutant versions of GroEL are under investigation to resolve the above mentioned issue.

Keywords: equilibrium unfolding, monomeric GroEl, spontaneous refolding, thermodynamic stability

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Authors: Pradip Kumar Das

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India is a developing country and is also one of the most industrialized developing countries of the world. In post-independence period, industry has grown rapidly in India and with industrialization corporate sector in the country has been growing day after day. Nowadays, the investment is not limited to be shareholders alone, apart from the shareholders the common people of the society have also started investing in shares of the corporate sectors. Thus, the responsibilities of the corporate sectors have increased much. Corporate financial reporting refers to a system which provides valuable information to different types of users in the society for taking resourceful decisions with regards to investment policy, organization credit worthiness, profitability, liquidity, provision of taxation etc. The quality of information available to different users fosters the efficient allocation of resources which are very urgent for economic development of a country like India. It is the responsibility of the management of the corporate sector to convey reliable and authentic information with the help of generally accepted accounting principles. Corporate sectors which disclose information through annual reports should be sufficient enough for the purpose of bringing out the salient features relating to business performances and other activities. However, the disclosures practices of the corporate sectors though annual reports have undergone several major changes from time to time. Many a time, these vital changes are in the fashion of presenting information in the annual reports and addition of so many non-statutory disclosures of the company. Very often managements of the corporate sectors are blamed for concealing true picture which is not desirable at all. The corporate financial reporting practice which in the current period has gained a place of prime importance suffers from certain limitations and invites question from the public about its reliability. Thus, the wide gap created by management between the exhibited picture and the real picture sometimes attains to such extent that the purpose of the reporting practice loses its importance. The requirement of full and adequate disclosure of information including information relating to human resources in the annual report in free trade economy of India helps the prospective investors to select the best portfolio of their investments. This paper is a reflection of a modest attempt of the author to highlight the corporate reporting practices followed in India. A cursory glance of the conceptual study shows limitations along with reliability of the reporting practices and suggests measures to overcome the shortcomings of the financial reporting practices.

Keywords: corporate enterprise, cursory glance, portfolio, yawning gap

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Authors: Alison Ryan, Himani Chhabra, Mohammed Dungarwalla, Judith Jones

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Background: Impacted and ectopic teeth present in 1-2% of orthodontic patients and often require joint surgical and orthodontic management. The authors present two patients undergoing orthodontic treatment, where the impacted teeth, in a hopeless position, spontaneously erupted during the period of cessation of general anaesthetic lists during the COVID-19 pandemic. Patient information: A healthy 11-year-old boy was referred to the Department of Oral and Maxillofacial Surgery for the management of a mesioangular impacted LR7. The patient was seen by the joint oral surgery/orthodontic team, who planned for the removal of the LR7 under general anaesthetic. A healthy 13-year-old boy was referred to the same Department and team for surgical extraction of unerupted and buccally impacted UL3 and UR3 under general anaesthetic. Management and outcome: The majority of elective dental-alveolar work ceased as a result of the global pandemic. On resumption of activity, the first patient was reviewed in July 2021. The LR7 had spontaneously erupted in a favourable position, and following MDT review, a decision was made to forgo any further surgical intervention. The second patient was reviewed in July 2021. The UL3 had clinically erupted, and there was radiographic evidence of favourable movement of UR3. Due to the nature of the patient’s malocclusion, the decision was made to proceed with the extractions as previously planned. Key Learning Points: Severely impacted teeth do have a prospect of spontaneous eruption or alignment without clinical intervention, and current literature states the initial location, axial inclination, degree of root formation, and relation of the impacted tooth to adjacent teeth roots may influence spontaneous eruption. There is potential to introduce a period of observation to account for this possibility in the developing dentition, with the aim of reducing the unnecessary need for surgical intervention. This could help prevent episodes of general anaesthetic and allocate theatre space more appropriately.

Keywords: spontaneous eruption, impaction, observation, hopeless position, surgical, orthodontic, change in treatment plan

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Authors: T. Miková

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This paper analyzes the effect of a single uniform accounting rule on reporting quality by investigating the influence of IFRS on earnings management. This paper examines whether earnings management is reduced after IFRS adoption through the use of “loss avoidance thresholds”, a method that has been verified in earlier studies. This paper concentrates on two European countries: one that represents the continental code law tradition with weak protection of investors (France) and one that represents the Anglo-American common law tradition, which typically implies a strong enforcement system (the United Kingdom). The research investigates a sample of 526 companies (6822 firm-year observations) during the years 2000 – 2013. The results are different for the two jurisdictions. This study demonstrates that a single set of accounting standards contributes to better reporting quality and reduces the pervasiveness of earnings management in France. In contrast, there is no evidence that a reduction in earnings management followed the implementation of IFRS in the United Kingdom. Due to the fact that IFRS benefit France but not the United Kingdom, other political and economic factors, such legal system or capital market strength, must play a significant role in influencing the comparability and transparency cross-border companies’ financial statements. Overall, the result suggests that IFRS moderately contribute to the accounting quality of reported financial statements and bring benefit for stakeholders, though the role played by other economic factors cannot be discounted.

Keywords: accounting standards, earnings management, international financial reporting standards, loss avoidance, reporting quality

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Authors: Giulia Bonaldo, Alberto Vaccheri, Ottavio D'Annibali, Domenico Motola

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The Human Papilloma Virus (HPV) was shown to be the cause of different types of carcinomas, first of all of the cervical intraepithelial neoplasia. Since the early 80s to today, thanks first to the preventive screening campaigns (pap-test) and following to the introduction of HPV vaccines on the market; the number of new cases of cervical cancer has decreased significantly. The HPV vaccines currently approved are three: Cervarix® (HPV2 - virus type: 16 and 18), Gardasil® (HPV4 - 6, 11, 16, 18) and Gardasil 9® (HPV9 - 6, 11, 16, 18, 31, 33, 45, 52, 58), which all protect against the two high-risk HPVs (6, 11) that are mainly involved in cervical cancers. Despite the remarkable effectiveness of these vaccines has been demonstrated, in the recent years, there have been many complaints about their risk-benefit profile due to Adverse Events Following Immunization (AEFI). The purpose of this study is to provide a support about the ongoing discussion on the safety profile of HPV vaccines based on real life data deriving from spontaneous reports of suspected AEFIs collected in the Vaccine Adverse Events Reporting System (VAERS). VAERS is a freely-available national vaccine safety surveillance database of AEFI, co-administered by the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA). We collected all the reports between January 2007 to December 2017 related to the HPV vaccines with a brand name (HPV2, HPV4, HPV9) or without (HPVX). A disproportionality analysis using Reporting Odds Ratio (ROR) with 95% confidence interval and p value ≤ 0.05 was performed. Over the 10-year period, 54889 reports of AEFI related to HPV vaccines reported in VAERS, corresponding to 224863 vaccine-event pairs, were retrieved. The highest number of reports was related to Gardasil (n = 42244), followed by Gardasil 9 (7212) and Cervarix (3904). The brand name of the HPV vaccine was not reported in 1529 cases. The two events more frequently reported and statistically significant for each vaccine were: dizziness (n = 5053) ROR = 1.28 (CI95% 1.24 – 1.31) and syncope (4808) ROR = 1.21 (1.17 – 1.25) for Gardasil. For Gardasil 9, injection site pain (305) ROR = 1.40 (1.25 – 1.57) and injection site erythema (297) ROR = 1.88 (1.67 – 2.10) and for Cervarix, headache (672) ROR = 1.14 (1.06 – 1.23) and loss of consciousness (528) ROR = 1.71 (1.57 – 1.87). In total, we collected 406 reports of death and 2461 cases of permanent disability in the ten-year period. The events consisting of incorrect vaccine storage or incorrect administration were not considered. The AEFI analysis showed that the most frequently reported events are non-serious and listed in the corresponding SmPCs. In addition to these, potential safety signals arose regarding less frequent and severe AEFIs that would deserve further investigation. This already happened with the referral of the European Medicines Agency (EMA) for the adverse events POTS (Postural Orthostatic Tachycardia Syndrome) and CRPS (Complex Regional Pain Syndrome) associated with anti-papillomavirus vaccines.

Keywords: adverse drug reactions, pharmacovigilance, safety, vaccines

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Authors: M. Asgari, N. Heydari, N. Shojai Kaveh, S. N. Ashrafizadeh

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Chemical flooding methods are having importance in enhanced oil recovery to recover the trapped oil after conventional recovery, as conventional oil resources become scarce. The surfactant/alkaline process consists of injecting alkali and synthetic surfactant. The addition of surfactant to injected water reduces oil/water IFT and/or alters wettability. The alkali generates soap in situ by reaction between the alkali and naphthenic acids in the crude oil. Oil recovery in fractured reservoirs mostly depends on spontaneous imbibition (SI) of brine into matrix blocks. Thus far, few efforts have been made toward understanding the relative influence of capillary and gravity forces on the fluid flow. This paper studies the controlling mechanisms of spontaneous imbibition process in chalk formations by consideration of type and concentration of surfactants, CMC, pH and alkaline reagent concentration. Wetting properties of carbonate rock have been investigated by means of contact-angle measurements. Interfacial-tension measurements were conducted using spinning drop method. Ten imbibition experiments were conducted in atmospheric pressure and various temperatures from 30°C to 50°C. All experiments were conducted above the CMC of each surfactant. The experimental results were evaluated in terms of ultimate oil recovery and reveal that wettability alteration achieved by nonionic surfactant, which led to imbibition of brine sample containing the nonionic surfactant, while IFT value was not in range of ultra low. The displacement of oil was initially dominated by capillary forces. However, for cationic surfactant, gravity forces was the dominant force for oil production by surfactant solution to overcome the negative capillary pressure.

Keywords: alkaline, capillary, gravity, imbibition, surfactant, wettability

Procedia PDF Downloads 187

Authors: Norhayati Mat Wajid, Abdul Murad Zainal Abidin, Faiz Fadzil, Mohd Yusof Aizad Mukhtar

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One of the areas that present an opportunity to reduce the national carbon emission is the energy management of public buildings. To our present knowledge, there is no easy-to-use and centralized mechanism that enables the government to monitor the overall energy performance, as well as the carbon footprint, of Malaysia’s public buildings. Therefore, the Public Works Department Malaysia, or PWD, has developed a web-based energy performance reporting tool called JENOSYS (JKR Energy Online System), which incorporates a database of utility account numbers acquired from the utility service provider for analysis and reporting. For test case purposes, 23 buildings under PWD were selected and monitored for their monthly energy performance (in kWh), carbon emission reduction (in tCO₂eq) and utility cost (in MYR), against the baseline. This paper demonstrates the simplicity with which buildings without energy metering can be monitored centrally and the benefits that can be accrued by the government in terms of building energy disclosure and concludes with the recommendation of expanding the system to all the public buildings in Malaysia.

Keywords: energy-efficient buildings, energy management systems, government buildings, JENOSYS

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Authors: Arne Fagerstrom, Gary Cunningham, Fredrik Hartwig

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In this paper, a theory of sustainable enterprises, sustainable enterprise theory (SET), is developed. The sustainable enterprise theory can only be a valid theory if knowledge about life and nature is complete. Knowledge limitations should not stop enterprises from doing business with a goal of better long-term life on earth. Life demands stewardship of the resources used during one’s lifetime. This paper develops a model influenced by (the classical) enterprise theory and resource theory that includes more than money in the business activities of an enterprise. The sustainable enterprise theory is then used in an analysis of accountability and in discussions about sustainable businesses.

Keywords: sustainable business, sustainability reporting, sustainable values, theory of the firm

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Authors: Thapthep Paprach, Benya Lertsuwan

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Investment fraud is not a new criminal, but there are still more victims during the Internet of Things era. This kind of criminal has been classified as a national and transnational financial crime problem all over the world. In Thailand, the country has also been attacked by this kind of crime. This research concerns whether the mass media that is supposed to cover news about online investment scams realized and warned Thais about this crime. Thus, this study explores the value of news about investment fraud in terms of frequency. The methodology uses web crawling from the top 5 news agency websites that have the most access. We pull out all information reporting about investment fraud. The findings revealed that the ‘Khaosod’ news agency was the first rank in reporting on investment crime. On the other hand, ‘Matichon’ was the least reported. Thairat news agencies frequently reported such criminals from midnight to very early in the morning, while other news agencies reported during the daytime. The results between the frequency of news reporting about investment fraud and the monthly number of victim reports are not correlated. Although the most cases reported to Thai police were in February 2023, but the most news reported was in January 2023. In conclusion, there might be a negative correlation between the amount of investment fraud news reported and the number of victims.

Keywords: investment fraud, news value, online news report, Ponzi schemes, Romance scam

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Authors: Garba Iliyasu, Lamaran Dattijo

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Introduction: Ebola virus disease (EVD) is a disease of humans and other primates caused by Ebola viruses. The most widespread epidemic of EVD in history occurred recently in several West African countries. The burden and outcome of EVD in pregnant women remains uncertain. There are very few studies to date reporting on maternal and fetal outcomes among pregnant women with EVD, hence the justification for this comprehensive review of these published studies. Methods: Published studies in English that reported on maternal and or fetal outcome among pregnant women with EVD up to May 2016 were searched in electronic databases (Google Scholar, Medline, Embase, PubMed, AJOL, and Scopus). Studies that did not satisfy the inclusion criteria were excluded. We extracted the following variables from each study: geographical location, year of the study, settings of the study, participants, maternal and fetal outcome.Result: There were 12 studies that reported on 108 pregnant women and 110 fetal outcomes. Six of the studies were case reports, 3 retrospective studies, 2 cross-sectional studies and 1 was a technical report. There were 91(84.3%) deaths out of the 108 pregnant women, while only 1(0.9%) fetal survival was reported out of 110. Survival rate among the 15 patients that had spontaneous abortion/stillbirth or induced delivery was 100%. Conclusion: There was a poor maternal and fetal outcome among pregnant women with EVD, and fetal evacuation significantly improves maternal survival.

Keywords: Africa, ebola, maternofetal, outcome

Procedia PDF Downloads 236