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Recent increased regulatory restrictions on the use of a first-generation anticoagulant rodenticide, diphacinone, were put into place in California in January 2024 by the passage of California Assembly Bill 1322 in late 2023. Second-generation anticoagulant rodenticides were listed as California Restricted Materials in 2014, and their uses were further restricted in 2021 with the passage of California Assembly Bill 1788. As a result of the passage of AB 1322, diphacinone was added to the Restricted Materials list and prohibited for use in all areas of the state except for specific exceptional uses and sites. Specific requirements for rodenticide applicators using diphacinone are described, along with exceptions to restrictions, as well as other related regulatory requirements for rodenticide users.

The study aims to explore the intricate connections between motivations, attitudes, and purchasing behavior concerning green food. To achieve this, the Self-determination Theory (SDT) is employed as the theoretical framework. A sample of 778 green food customers is evaluated using Structural Equation Modeling (SEM), and the data analysis incorporates environmental views and conviction as moderating variables. The results of the study reveal a noteworthy relationship between integrated external regulation and intrinsic motivation in shaping attitudes and purchasing behavior. Interestingly, the study finds that attitude does not significantly impact purchase behavior. The key takeaway from the findings is that ethical considerations related to health and social values strongly motivate customers to opt for green food. Practical implications suggest that marketing practitioners should tailor advertising messages to highlight the health and well-being benefits associated with green food. By emphasizing these aspects, marketers can stimulate customer interest and encourage the purchase of green products. The study sheds light on the importance of aligning marketing strategies with ethical values and health concerns on the target audience in the context of green food consumption.

This research aimed to investigate the moral element of traffic crimes in the Palestinian legislation. It mainly identified the legal framework regulating the moral element of traffic crime in its two forms: criminal intent and unintentional error. The research defined criminal intent and its presence in traffic crimes in the legislation in force in Palestine. It also explained the idea of unintentional error and its forms in traffic crimes in the Palestinian legislation. The descriptive analytical approach was used, and the results revealed that the punishment for committing crimes is linked to the moral element. Moreover, the moral element in traffic crimes has two forms: the intentional form represented by criminal intent, and the unintentional form represented by an unintentional error. The forms of unintentional error are represented by lack of caution, negligence, and violation of laws and regulations. They are consistent with the criminal and punitive provisions contained in the Palestinian Traffic Law. [ABSTRACT FROM AUTHOR]

This article pertains to hazards and risk as well as selected security problems in unmanned aircraft vehicles operations from legal and policy perspective. It covers regulations concerning drones, statistics, safety promotion in drone sector and key risk areas. In the current world, there is a need for new legal provisions and technical solutions that will bring stability and security to public airspace. With the rapid development of artificial intelligence, more reliable hardware, and efficient software, new threats for the public domain are emerging that we have never faced before. The usage of UAVs is limited only by human imagination. It is already used in search and rescue (SAR) missions (increasing search coverage and reducing the risk of rescuers), the professional movie industry (creating breathtaking shots), or the agricultural sector (plants optimization). Hence the need to identify key safety and security concerns that might disrupt such operations. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this paper is to explore networked business models on a nascent market for a sustainable innovation. Design/methodology/approach: The study takes a qualitative approach through a comparative case study of three solar photovoltaic (PV) parks in Sweden. Data was collected from 14 interviews with multiple supply chain and network actors as well as secondary data. Industrial marketing and purchasing is applied for theoretical framing. Findings: The study demonstrates transactional, relational, environmental and social drivers for participating in the network. The study reveals the duplicity of the nascent market, which encourages supply chain actors to develop their individual business models to take a larger market share or become future competitors to current collaborators. On the nascent market with few developed regulations, the network enables actors to influence regulations on local and regional levels. Research limitations/implications: The study is limited to the nascent solar PV industry in Sweden, which is characterized by institutional turbulence, market uncertainties and few established supply networks. Practical implications: Practitioners need to consider multifarious drivers for participating in networked business models, where the economic driver may be the least motivating. Originality/value: This study provides several multiactor business models and classifies them into specific applications and general applications. The study provides unique insight into the complexity of interactions among supply chain actors in networked business models on a nascent market for sustainable innovation. Due to the scarcity of available partners on the nascent market, actors need to look beyond their on-going relationships and their network horizon, or actors' roles evolve to include activities that was not part of their individual business models. [ABSTRACT FROM AUTHOR]

Following the UK’s transition from the EU, the introduction of new or novel biocidal products must comply with the Biocidal Products Regulation (BPR). The unique characteristics of ozone, including its generation, intrinsic properties, and safety considerations, do not fully conform to the preferred methodologies for testing surface biocidal efficacy, such as BS EN 17,272:2020. The lack of standardized testing suited for ozone and resources available for efficacy and safety data may inadvertently lead to the production of inefficient disinfection equipment. The absence of a robust protocol underlies disparities in published test conditions, making comparisons and conclusions difficult to interpret, leading to delays in research, industry production, and regulatory approval. This review examines and evaluates both the intrinsic and extrinsic factors affecting gaseous ozone disinfection. This evaluation serves as a base for recommendations aimed at guiding the development of a standardized protocol, from ozone concentration to chamber parameters. These include factors applied throughout all ozone testing and factors that should be addressed per application. It is anticipated that implementing these recommendations and establishing a validated methodology will facilitate robust comparison of ozone disinfection studies, fostering standardization of microbial surface decontamination, particularly for BPR approval. [ABSTRACT FROM AUTHOR]

Global attention is highly focused on biodiversity conservation. Various countries are actively implementing relevant conservation measures. To advance these efforts in China, it is essential to understand global conservation actions. The orchid family, one of the most diverse groups of flowering plants, has become a "flagship" group for plant conservation. In this study, we summarized 3418 policies and regulations related to orchid conservation in 45 countries. We found that orchid conservation actions in various countries have focused on in situ conservation, with 1469 policies and regulations issued for nature reserves, while ex situ conservation has been seriously neglected, with only seven relevant regulations. Most developing countries have experienced an increase in orchid conservation actions, while developed countries have plateaued. We amassed 370 non-governmental organizations (NGOs) for orchid conservation. At present, the total number of policies and regulations for orchid protection in China is approximately 84, with 67 issued since 2000. Two non-governmental organizations have been established for orchid conservation. Although the benefit of orchid conservation in China is significant, it still requires continuous improvement compared to many other countries. We recommend that the Chinese government draws on the experiences of the United States, Canada, and Australia in areas such as policy and regulation formulation, optimization of non-governmental organizations, and implementation of related conservation projects. Through learning and collaboration, challenges can be transformed into opportunities for development. [ABSTRACT FROM AUTHOR]

Occupational lung diseases result from worker exposure in occupational settings to unhealthy environments and agents, such as silica dust, antigens, coal dust, washed coal/mixed dust, asbestos, and beryllium. Most of these conditions have long latency periods, with disease manifesting years after exposure. Approximately 1 million workers in the U.S. report occupational exposure-related illnesses, including respiratory diseases. We evaluated major occupational lung diseases via an extensive literature review and present here advances in diagnosing major occupational lung diseases, preventive strategies, and regulatory considerations for maintaining a healthy workforce. We include the widely studied occupational lung diseases asbestosis, coal workers' pneumoconiosis and all other pneumoconioses, silicosis, byssinosis, malignant mesothelioma, hypersensitivity pneumonitis, and work-related asthma. The chemistry and physical properties of exposed materials play a role in the severity and pathogenesis of most occupational lung diseases. Knowledge of clinical signs and symptoms of these diseases, exposure history, and consensus diagnostic tools and criteria are crucial for accurate diagnosis, early detection, management, and improved outcomes. Further, regulatory agencies and other interested parties need to develop new and improved surveillance strategies, exposure limits, and technological and industrial safety measures, as well as implement regulations to guide industries and provide recommendations to protect all workers and reduce disease burden. [ABSTRACT FROM AUTHOR]

Redistribution is one of the key elements of contemporary social order, and research has dealt with it in various ways. Most welfare state research mixes in its analysis the regulations on redistribution and actual outcomes. However, to adequately understand redistribution, one needs to distinguish between regulations and outcomes. Measuring unequal conversion in terms of deviations between redistributions as regulated and redistributive outcomes shows how far a redistribution corresponds to what has been officially agreed upon in societies and who is actually better or worse off in the end. Empirically focusing on family-related redistribution, our analysis was based on European Union Statistics on Income and Living Conditions data and the European microsimulation tool EUROMOD. First, we assumed that differences between regulations and outcomes vary depending on the family type. Thus, we compared the actual and simulated disposable household income for various family types. Second, we assumed that differences between regulations and outcomes vary by country. Consequently, we analysed a variety of European countries. Our findings showed that there are substantial differences between regulations on redistribution and outcomes. These differences increase income inequalities between families. This held true for all of our study countries, although to a different degree. [ABSTRACT FROM AUTHOR]

Purpose of Review: Medical cannabis (MC) has entered mainstream medicine by a unique route. Regulatory acceptance as a medical product in many jurisdictions has bypassed the traditional evidence-based pathway required for therapies. Easier access to MC, especially related to recreational legalization of cannabis, has led to widespread use by patients for symptom relief of a variety of medical conditions and often without medical oversight. Musculoskeletal pain remains the most common reason for MC use. This review examines real-world issues pertaining to MC and offers some guidance for clinical care of patients with rheumatic diseases being treated with MC. Recent Findings: Controlled clinical studies of cannabis products in patients with rheumatic diseases have been small and tested a range of compounds, routes of administration, and clinical populations, limiting our ability to generate conclusions on MC's effectiveness in this population. Observational cohort studies and surveys suggest that use of MC and related products in patients with rheumatic diseases improves pain and associated symptoms but is commonly accompanied by mild to moderate side effects. Conflicting evidence contributes to practitioner and patient uncertainty regarding the use of MC for rheumatic disease-related pain. Summary: Despite promising preclinical and observational evidence that MC and cannabis-derived compounds are useful in the management of rheumatic disease-related pain, there remains limited high-quality clinical evidence to substantiate these findings. There are a significant number of clinical trials on this topic currently planned or underway, however, suggesting the next decade may yield more clarity. Nevertheless, given that many people with rheumatic diseases are using cannabis products, healthcare professionals must remain apprised of the evidence pertaining to cannabinoids, communicate such evidence to patients in a meaningful way that is free from personal bias and stigma, and maintain strong collaborative clinical care pertaining to MC. [ABSTRACT FROM AUTHOR]

Purpose: In response to multiple disruptions, the purchasing supply management (PSM) function in construction supply chain management (CSCM) has gained prominence due to stakeholder pressures, dynamic market conditions and the need to adhere to complex sustainability, safety and health regulations and standards. However, there is a noticeable absence of empirical research on measuring and mitigating PSM vulnerabilities, especially considering the distinct challenges faced by large engineer-to-order project-oriented manufacturers. To address these issues, the purpose of this study is to develop and test a novel method to assist companies in construction supply chains in assessing and managing risks associated with sustainable procuring and sourcing materials. Design/methodology/approach: Grounded in the literature gaps on construction PSM and a real case supply chain, the research uses the design science research (DSR) approach to develop an integrated method for assessing PSM strategies in this sector. The method integrates three essential purchasing dimensions: supply risks, profit impact and sustainability risks of materials, supported by nine subdimensions. Empirical validation took place within a multinational European construction company based in Denmark. Findings: Findings from the supplier–buyer relationships confirmed that the developed method allows for the identification of the key components that significantly impact supplier–buyer relationships, profitability and sustainability. The research further suggests that construction supply chain managers and purchasing practitioners can use the proposed method to evaluate PSM, thus enabling them to make more informed decisions. Practical implications: Through the utilization of the proposed artifact, construction companies can take a more proactive approach to address PSM uncertainties, thereby enhancing their competitiveness in dynamic construction supply chains. Originality/value: The research contributes to bridging the theory and practice, providing valuable assistance for construction companies assessing and managing the PSM and supply risks within global construction value chains. This paper provides original insights for the CSCM, aiding in adopting competitive PSM strategies to improve overall supply chain performance. [ABSTRACT FROM AUTHOR]

Home sharing platforms have experienced a rapid growth over the last decade. Following negative publicity, many cities have started regulating the short-term rental market. Regulations often involve a cap on the number of days a property can be rented out on a short-term basis. We draw on rich data for short-term rentals on Airbnb and for the long-term rental market to examine the impact of short-term rental regulations with a day cap on various stakeholders: hosts, guests, the platform provider, and residents. Based on a difference-in-differences design, we document a sizable drop in Airbnb activity. Interestingly, not only targeted hosts (i.e., hosts with reservation days larger than the day cap), but also non-targeted hosts reduce their Airbnb activity. The reservation days of non-targeted hosts decrease between 26.27% and 51.89% depending on the treatment. Targeted hosts experience a similar decline. There is, nevertheless, significant non-compliance: more than one third of hosts do not comply with enacted short-term rental regulations. Additional analyses show that few properties are redirected from short-term rental to long-term rental use and that there is no significant drop in long-term rents. Drawing on a theoretical model, we tie the estimated effects to changes in stakeholders' welfare: Regulations significantly reduce the welfare of hosts, and the loss ranges between 46.30% and 9.02%. The welfare loss of the platform provider is proportional to the loss of the hosts. Welfare of guests decreases moderately ranging between 4.5% to 4.1%. The welfare of residents increases minimal. These results question the effectiveness and desirability of the studied short-term rental regulations. [ABSTRACT FROM AUTHOR]

In the past few years, more and more competition authorities have expanded their powers in conducting market inquiries. Some competition laws have given the competition authorities the power to impose remedies after a market inquiry and to impose fines on undertakings that resist providing information during a market inquiry. Some competition authorities are in the process of amending their laws to mirror this development. The COMESA Competition Commission is an exemplary incident of a competition authority that is amending its law to cloth it with expansive powers in the conduct of market inquiries. This article explores whether or not such expanded powers in a market inquiry are overly intrusive and whether they are consistent with the constitutional and natural justice guarantees. An interrogation on whether there are safeguards to ensure that these powers are not unfettered and do not result in abuse of the rights of those that are subject to this power will also be conducted. [ABSTRACT FROM AUTHOR]

Nowadays, agricultural practices require special attention due to their important contribution to water pollution, the more so as they are associated with environmental and health impairments. Despite legislation addressing nutrient pollution, there are still high levels of nutrients in water bodies, as evidenced by the results identified in the literature. Among nutrients of environmental concern identified in water and associated with agricultural practices are nitrogen and phosphorus. When applied in excess under fertilizer form, these nutrients accumulate in water bodies with consequences such as eutrophication or human health impairments if water is used for drinking. The purpose of this review paper is to present the current state of nutrient water pollution generated by unsustainable agricultural practices. In addition, are presented the main legislative regulations addressing water quality imposed by the European Union, are described aspects related to nitrogen and phosphorus pollution from agriculture, and levels of nutrients in water bodies from different European countries. Also, effects of agricultural pollution on the environment and humans are discussed, and possible strategies that could be employed to decrease or prevent water pollution are reviewed. [ABSTRACT FROM AUTHOR]

Government intervention, whether in the role of a regulator or a market participant, presents opportunities for corruption. A burdensome regulatory environment creates more opportunities and incentives for individuals and firms to circumvent these regulations by resorting to different forms of bribery. Glaeser and Saks find that benefits of circumventing the regulations increase as the size of the government increases. The studies collected in this special issue investigate the relationship between various forms of government interventions on corruption. [ABSTRACT FROM AUTHOR]

ABSTRACT In India, there are 626 non‐native invasive fish species (NIFS), with 16 becoming invasive in inland waters, adversely impacting native biodiversity, and fisheries by altering the abundance of NIFS in commercial catches. Scientific findings highlight that the movement of NIFS interacts with agricultural activities and the evolving environment, facilitating their spread and establishment. The scenario of NIFS invasion disrupts biological communities, ecosystem services and fisherfolk livelihoods. Despite the implementation of existed guidelines, issues related to NIFS have persisted and escalated over time scale putting increased pressure on indigenous aquatic biological resources in inland waters. This paper suggests the need of framing a new management plans, guidelines and regulatory policies to control NIFS invasions, protecting riverine fish biodiversity and ecosystem services. Proposed management strategies include functional response (FR) and adaptive response (AR)‐based approaches, which are discussed to address NIFS management in inland waters. [ABSTRACT FROM AUTHOR]

Private school choice programs are publicly-funded programs that provide families with funding to attend a private school of their choice. Since 2021, 15 states have enacted or expanded choice legislation, even making homeschoolers eligible to participate. However, homeschoolers are often reluctant to participate due to proposed regulations. We survey a national sample of hybrid school leaders, a sector that shares similarities with homeschoolers in modality, and randomly assign hypothetical regulations to them. We find that 65% are willing to encourage participation in the absence of regulations, but regulations reduce leaders' willingness to encourage participation by about 31 points. [ABSTRACT FROM AUTHOR]

his study examines the compliance of multinational companies with the Regional Minimum Wage (UMR) regulations in Indonesia and the factors contributing to violations. Although UMR is designed to protect workers' welfare, many companies still pay below the established standards. A qualitative research method was employed to collect data through in-depth interviews, field observations, and document analysis. The findings reveal that UMR violations occur across various industrial sectors, with violation rates ranging from 10% to 20%. Factors contributing to these violations include a lack of oversight, ineffective law enforcement, and legal uncertainties related to regulations that vary between regions. The research also identifies that UMR violations significantly impact workers' welfare, including difficulties in meeting basic needs and increased stress due to financial uncertainty. To enhance compliance, the study recommends improving oversight and law enforcement, harmonizing UMR standards across regions, and developing an anonymous complaint system for workers. These findings are expected to provide insights for policymakers, company management, and workers to improve the implementation of UMR regulations and enhance workers' welfare in Indonesia. [ABSTRACT FROM AUTHOR]

Ketamine is a restricted and regulated medication in Australia and New Zealand, which has implications when considering treatment for patients with treatment-resistant depression and a history of illicit drug use, abuse or dependence. Regulations governing prescription of ketamine for treatment-resistant depression vary between jurisdictions in Australia and New Zealand, though most restrict use in those with drug dependence. There is substantial variation in definitions of drug dependence used in each jurisdiction, and between the legal and clinical definitions, with the latter specified in the current International Classification of Diseases, Eleventh Revision and Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. This paper reviews the literature assessing the risk of ketamine misuse and dependence in patients with a history of illicit drug use, abuse or dependence and presents recommendations for psychiatrists who prescribe ketamine in such patients with treatment-resistant depression. [ABSTRACT FROM AUTHOR]

Abstract and ARP Position Statement: Based on the available body of scientific evidence and with the goals of promoting safety of combat sports athletes and striving for the advancement of clean sport, the Association of Ringside Physicians recommends the following regarding cannabis: • Use of marijuana or synthetic cannabinoids by combat sports athletes is discouraged due to unproven benefits and many known adverse effects. Acute use can impair cognition and complex motor function, which likely leads to reduced performance in combat sports. Chronic use can increase risk for heart and lung disease, several cancers, schizophrenia, and can reduce testosterone in men and impair fertility. Benefits from cannabis in most contexts, including athletic performance, have not been proven. • Use of topical purified CBD is neither encouraged nor discouraged. • Since acute cannabis intoxication can impair complex cognitive and motor function, any athlete suspected of acute intoxication at the time of competition – based on clinical judgment – should be banned from that competition. • Wide-scale regulation of cannabis based on quantitative testing has limited usefulness in combat sports, for the following reasons: ∘ Cannabis is not ergogenic and is likely ergolytic. ∘ Concentrations in body fluids correlate poorly with clinical effects and timing of use. ∘ Access to testing resources varies widely across sporting organizations. [ABSTRACT FROM AUTHOR]

Main conclusion: The review offers insights into the current state of research on insect pest-resistant GM crops and the regulations governing the cultivation of GM crops in India. India has a rich crop diversity of more than 160 major and minor crops through its diverse agroclimatic conditions. Insect pests alone cause around USD 36 billion in crop loss annually in India. The last two decades witnessed considerable progress in managing insect pests by adopting innovative techniques including transgenics. In research, significant advancement has been brought in insect pest-resistant transgenics in India since its inception in 2002. However, any events have not been endorsed owing to biosafety impediments, except Bt cotton reaching the commercial release stage. A landmark decision to exempt certain types of gene-edited plants from genetically modified organism (GMO) regulations offers great promise for developing novel insect-resistant crops in India. The article reviews the current research on insect pest-resistant transgenics and its regulations in India. [ABSTRACT FROM AUTHOR]

Copyright of Environmental & Social Management Journal / Revista de Gestão Social e Ambiental is the property of Environmental & Social Management Journal and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Journal of Contemporary Educational Studies / Sodobna Pedagogika is the property of Association of Slovenian Educationalists and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Geographical indications are beginning to make an important place in the agri-food products market, as they ensure the recognition of products on the world market, therefore the issues of ensuring their protection and effective use are relevant. The main goal of the study was to conduct a comparative statistical analysis of legal and economic issues of geographical indications of food products in the agricultural sector of Poland and Ukraine. The research used the methods of descriptive statistics, the method of comparative analysis, the graphic method, the monographic approach, and the abstract-logical method. The structure of agricultural market output of European Union countries, Poland, and Ukraine was investigated. It was established that Ukraine is dominated by the export of plant products, while Poland and the European Union countries focus on goods with added value. An analysis of geographical indications in force by product category and geographical indications in force by legal means was carried out. Geographical indications registered in Poland and Ukraine for specific types of products were examined. It was established that fresh fruits, vegetables, and cereals predominate among the categories of registered geographical indications in Poland, while wine and mineral water are the most common groups of geographical indications registered in Ukraine. The approaches to the interpretation of the category of geographical indication in the European Union, Poland and Ukraine in accordance with the norms of the current legal acts have been analysed, and the main differences have been established. An analysis of the main common and different approaches to the regulation of geographical indications in the European Union, Poland and Ukraine in accordance with the regulatory framework was carried out. It has been established that in Poland there are different registration procedures and authorities for goods of industrial property and separately for agricultural goods. In the European Union, there is a separate regulation on geographical indications of alcohol. In Ukraine, there is a separate procedure for the registration of only alcoholic beverages, and there is no separate procedure for agricultural products. The results of the study are of practical importance for regulatory bodies of Ukraine in the direction of innovation development and expansion of intellectual property protection procedures in the agricultural sector

Abstract Background The COVID-19 pandemic significantly increased the demand for remote healthcare services delivery, including remote access to medications. This study explored the practices and challenges associated with remote provision of pharmaceutical products and services in Kampala, Uganda. Methods A cross-sectional study was conducted from July to September 2022, enrolling 174 out of 198 sampled retail pharmacies. Data was collected using a pre-tested questionnaire on remote service provision, platforms used, products offered, delivery methods, and challenges faced. Results Over 58% of pharmacies provided remote services, primarily through social media (especially WhatsApp) and phone calls. OTCs and POMs were the most commonly dispensed products remotely. Key challenges identified included high internet costs, labor shortages, poor internet quality, and a lack of specific regulations for remote provision of pharmaceutical products and services. Conclusion The proportion of retail pharmacies providing pharmaceutical products and services remotely is significant in Kampala, but they face challenges that need to be addressed. Regulations are crucial to ensure responsible dispensing practices and rational medicine use. Addressing internet affordability and quality, staffing issues, and delivery logistics is essential for sustainable and effective remote pharmaceutical products and services.

Abstract Background Cell and gene therapy products (CGTPs) often receive accelerated approvals, lacking comprehensive long-term safety and efficacy data, which can raise significant safety concerns. This research aims to study the post-marketing surveillance (PMS) of CGTPs in the European Union (EU), the United States (US), Japan, South Korea, and China, to offer insights for the development of a secure and standardized post-marketing regulatory framework for CGTPs. Methods Related regulations and the implementation effect of PMS for approved CGTPs were studied searching PubMed, CNKI, and the official websites of the European Medicines Agency, the US Food and Drug Administration, Japan’s Pharmaceuticals and Medical Device Agency, South Korea’s Ministry of Food and Drug Safety, and the National Medical Products Administration of China. Results Compared to those in China, the guidelines of PMS for CGTPs in the EU, the US, Japan, and South Korea was more comprehensive. Notably, the EU had dedicated regulations and supporting guidelines of PMS. Of the 26 CGTPs approved in the EU, 88% were under additional monitoring, 38% received conditional marketing authorization, and 12% were authorized under exceptional circumstances, with 77% designated as orphan drugs. The US had released 34 guidelines specifically for CGTPs which, forming the foundation of post-marketing risk management. Among the 27 CGTPs approved in the US, 22% were required to perform risk evaluation and mitigation strategies, 37% added black box warnings in the package inserts, 63% mandated to post-marketing requirements, and 15% subject to post-marketing commitments. In Japan, stringent supervision measures encompassing all-case surveillance (79%) and re-examination (53%) were applied to the 19 approved CGTPs, with 21% approved through conditional and time-limited approval. The PMS for CGTPs in South Korea, mainly included PSUR, re-examination, and re-evaluation. China had introduced several relevant regulations, which consisted of general statements and lacked detailed guidance. Conclusions This study demonstrates that the regulatory policies of PMS for CGTPs in the EU, the US, Japan, and South Korea were comprehensive. The implementation of PMS for CGTPs in the EU, the US, and Japan was well developed. This knowledge holds valuable insights for China’s future learning and development in this field.

The subject of the article is a model of correlation between anti-corruption institutions of international and national law. The research methodology involved the use of formal and dialectical logic, historical and legal, comparative legal, anthropological and legal, economic and legal, hermeneutical, synergetic, systemic, and statistical methods. The purpose of the article is to reveal the model of correlation between anti-corruption institutions of international and national law. It is determined that anti-corruption policy becomes a value when it is implemented on an institutional basis. Such a basis means its independence from the acquisition of public power by any person. The sustainability and completeness of the manifestation of virtues in legal relations are ontologically determined by the processes of nation-building, which, in turn, are based on the values of law inherent in human nature. The anti-corruption model is influenced by historical, spiritual, cultural, external conditions, climatic, geographical and other living conditions. Such a model becomes effective when all these factors and their conditions form the best basis for the development of the nation, compared to others, through the full use of the energy potential of the virtues of all its members. Any delay, irresponsibility and/or unjustified loss of vigilance regarding the components of this model leads to decline. It is emphasised that the national anti-corruption model is ternary, since it is based on three main elements, namely, anthropospatial legislation, the practice of its application within the framework of administrative and jurisdictional procedures. The configuration of both elements of the model and their parts is determined by its uniqueness. The most superficial classification of these models is based on the system of criminal justice components. The fundamental classifications of national anti-corruption models are based on the anthropological dimension of legislation and practices of its application outside the criminal process. This is the strategy of anti-corruption work. The role of a person in the strategy process is not to remain in office as long as possible, but to remain in office as useful and effective as possible. Corruption distortions in legal relations disappear where the individual nourishes the institutions of law and power rather than replaces them. The author establishes that the correlation between national and international anti-corruption models is conditional, since the international model has not yet been formed and largely reflects the worldview of the Western legal tradition. It is also precocious to discuss an international anti-corruption model because the international community has not reached a sincere agreement on a universal set of human rights and freedoms and their scope. However, such a substantive understanding is the essence of anti-corruption policy, where its rules and practices reveal the nature of human virtues in legal relations. Currently, there is no complete description of the counterbalance to this tradition of law. Eastern, Muslim, Hindu and other non-Western cultures have adopted legal institutions for the declaration of assets and interests of public officials, conflicts of interest, financial audits of public procurement and anti-corruption criminal justice systems. The Republics of Singapore, Japan and Hong Kong have been the most successful in this anti-corruption legislative reception. The implementation of these institutions by other nations requires their adaptation to unique existential conditions, so that the potential for the liberation of human virtues by the force of legislative requirements is organically strengthened by the conditions of the nation's development. This will manifest the features of both innovation and anthropo-dimensionality of law.

Indian biotech startup sector – a rapidly growing business segment focused on the development of innovative products has the potential to make significant contributions to the country’s economy. Indian bio-entrepreneurs’ optimistic expectation of rapidly moving product development from bench to bedside faces tremendous challenges of the complex Indian regulatory system, which is shaped by a diversity of regulatory authorities, rules, guidelines, and processes. This brief review discusses specific regulatory issues faced by bio-entrepreneurs investing in a variety of innovative products – new drugs, vaccines, medical devices, cell, and gene therapy and suggests approaches which can ease Indian entrepreneur’s endeavors.

La legislación es el eje vertebrador de la política educativa. En función de lo que estipule la normativa educativa se aplicarán unos principios u otros. Este trabajo de investigación emplea un diseño cualitativo, basado en el análisis de contenido de la normativa vigente en España, en materia educativa. Para ello se han seleccionado todas las leyes orgánicas, ordinarias, decretos legislativos, decretos-ley y órdenes ministeriales que afecten total o parcialmente al sistema educativo español. Los principales hallazgos de esta investigación ponen de relieve, por un lado, que el sistema de evaluación educativa ha evolucionado de una evaluación centrada en los conocimientos teóricos a una evaluación centrada en las competencias que el alumnado ha de adquirir en cada etapa educativa; y, por otro lado, que existe una excesiva producción normativa en el campo educativo español, lo que provoca alteraciones en los diferentes subsistemas que conforman el sistema educativo Abstract Legislation is the backbone of education policy. Depending on what the educational regulations stipulate, certain principles will be applied. This research work uses a qualitative design, based on a content analysis of the current legislation in force in Spain in the field of education. For this purpose, all the organic and ordinary laws, legislative decrees, decree-laws and ministerial orders that totally or partially affect the Spanish education system have been selected. The main findings of this research highlight, on the one hand, that the educational assessment system has evolved from an assessment centred on theoretical knowledge to an assessment centred on the competences that students must acquire at each educational stage; and, on the other hand, that there is an excessive production of regulations in the Spanish educational field, which causes alterations in the different subsystems that make up the educational system

Legislation refers to a law or a set of laws, but also to a process of making or enacting laws. Foundation of administration in today's social order, legislation has a significant impact on people's lives and the functioning of organizations. Legislation is expressed in different forms. Every country in the world has its own legislation. The Romanian legal framework includes the following sources of law: the Constitution of Romania, legislation adopted by Parliament, decrees of the President of Romania, legislative acts of the Government, legislative acts issued by central government, acts of the autonomous administrative authorities, legislative acts issued by local government authorities. This article highlights the legal and regulatory framework of accounting in Romania. The current Romanian accounting system is dualist, comprising financial accounting or external accounting, and management accounting or internal accounting. Accounting Law no. 82 of 1991, republished in 2008, with subsequent amendments and additions, is the main legislative instrument for all entities obliged to keep accounts. For the organization and management of the accounting of public sector entities, as well as for the organization and management of the accounting of private sector entities, the Ministry of Public Finance has developed accounting regulations, approved by orders of the Minister of Public Finance. For each type of entity there are specific regulations. The results consist in providing the main legal accounting regulations for both public and private sector entities, with the aim of assisting accounting economists and all those interested in the field of accounting. It is important not only to know the legislation in force for the accounting field, but also to have that legislation updated.

Villages are stated to be the smallest government structure in Indonesia. A village is an area that has certain boundaries, as a legal community unit that has the right to regulate and manage the affairs of local communities based on their origins. Apart from that, the village government also has the authority to determine legislative products mentioned in village regulations. However, this form of legal regulation is not included in the hierarchy of legal regulations in Indonesia, and in practice it is rarely known by the public. Therefore, this research will focus on identifying the legality of the position of regulations in villages as part of the national legal and regulatory framework. The research method used is a normative legal research method which discusses the position and legality of regulations in the village based on applicable laws and regulations as primary legal material. Apart from that, the discussion is also complemented by secondary legal materials in the form of books and articles published in journals based on theories, concepts, as well as legal principles and adages. The research results show that the village government is the smallest unit in the government system in Indonesia. The village government, like other governments in the region, has the authority to regulate and manage its government affairs autonomously based on the division of affairs and rights according to the origins of the village. Regarding this authority, the village government has the authority to form village regulations and village head regulations. The status and legitimacy of village regulations and village head regulations are recognized as statutory regulations and have binding legal force as long as they are formed based on higher statutory regulations or based on their authority over the village's original rights.

Villages have actually been existing before the Republic of Indonesia was established, but in the journey of this Republic of Indonesia, they are often intentionally designed by the law-forming state elite. One of the main causes for the presence of the various portraits of the marginalization is the absence of respect, protection and the fulfillment of village community autonomy in our Constitution that has been amended 4 (four) times. This directly implies on the obscurity of the existence and position of village regulation and legal products in executing village authority and autonomy. The present research is aimed at (1) explaining the existence and position of village regulation in various legal products arranging the hierarchy of regulations; (2) finding a design of the setting of existence and position of village regulation in the hierarchy of the regulations based on the recognition and subsidiary principles in the village community autonomy. A normative juridical with an analytic descriptive specification based on the legal history and statutory approach. The result shows that the existence of village regulations will be recognized and they will possess a binding power if they are formed on the basis of the instruction of the higher regulation or authority. The village regulations, however, are made to reinforce and guard the subsidiarity and recognition principles-based village autonomy. In order to arrange the existence and the position of village regulations in the system of regulation, further changes of the Constitution have to accommodate the arrangement of village community autonomy. The existence and position of village regulatios should be strengthened in the statutory system in order to guard and reinforce village autonomy so that villages become autonomous and may maintain their local wisdom, economic and ecological sustainability, and their local wisdom-based economic growth.

Aquaporins (AQPs) are transmembrane channels initially discovered for their role in water flux facilitation through biological membranes. Over the years, a much more complex and subtle picture of these channels appeared, highlighting many other solutes accommodated by AQPs and a dense regulatory network finely tuning cell membranes’ water permeability. At the intersection between several transduction pathways (e.g., cell volume regulation, calcium signaling, potassium cycling, etc.), this wide and ancient protein family is considered an important therapeutic target for cancer treatment and many other pathophysiologies. However, a precise and isoform-specific modulation of these channels function is still challenging. Among the modulators of AQPs functions, cations have been shown to play a significant contribution, starting with mercury being historically associated with the inhibition of AQPs since their discovery. While the comprehension of AQPs modulation by cations has improved, a unifying molecular mechanism integrating all current knowledge is still lacking. In an effort to extract general trends, we reviewed all known modulations of AQPs by cations to capture a first glimpse of this regulatory network. We paid particular attention to the associated molecular mechanisms and pinpointed the residues involved in cation binding and in conformational changes tied up to the modulation of the channel function.

This study aims to determine and analyze the determinants of the complexity of tax regulations and the principles of justice regarding taxpayer compliance in Indonesia. The study surveyed 148 individual taxpayers who are entrepreneurs of micro, small, and medium enterprises (MSMEs) using a Google Form. The results show that the complexity of tax regulations has a significant negative effect (–0.253) on taxpayer compliance, and the principles of justice (0.501) have a significant positive effect on taxpayer compliance. An R square shows that independent variables have a 45.5% influence on increasing taxpayer compliance. The degree of the correlation relationship between all independent variables is around 0.674. The results confirm the relationship between the complexity of tax regulations and the principle of justice and their effect on taxpayer compliance. Therefore, to increase taxpayer compliance, the government should put efforts into simplifying and explaining tax regulations. This can help reduce inadvertent errors, increase taxpayer confidence, and reduce the overall cost of complying with regulations. It is important to consider aspects of justice when designing and implementing the tax system. Efforts to increase transparency, reduce injustice, and make taxes applied proportionally can help strengthen taxpayer compliance and support the sustainability of state revenues.

Background: Cell and gene therapy products (CGTPs) often receive accelerated approvals, lacking comprehensive long-term safety and efficacy data, which can raise significant safety concerns. This research aims to study the post-marketing surveillance (PMS) of CGTPs in the European Union (EU), the United States (US), Japan, South Korea, and China, to offer insights for the development of a secure and standardized post-marketing regulatory framework for CGTPs. Methods: Related regulations and the implementation effect of PMS for approved CGTPs were studied searching PubMed, CNKI, and the official websites of the European Medicines Agency, the US Food and Drug Administration, Japan's Pharmaceuticals and Medical Device Agency, South Korea's Ministry of Food and Drug Safety, and the National Medical Products Administration of China. Results: Compared to those in China, the guidelines of PMS for CGTPs in the EU, the US, Japan, and South Korea was more comprehensive. Notably, the EU had dedicated regulations and supporting guidelines of PMS. Of the 26 CGTPs approved in the EU, 88% were under additional monitoring, 38% received conditional marketing authorization, and 12% were authorized under exceptional circumstances, with 77% designated as orphan drugs. The US had released 34 guidelines specifically for CGTPs which, forming the foundation of post-marketing risk management. Among the 27 CGTPs approved in the US, 22% were required to perform risk evaluation and mitigation strategies, 37% added black box warnings in the package inserts, 63% mandated to post-marketing requirements, and 15% subject to post-marketing commitments. In Japan, stringent supervision measures encompassing all-case surveillance (79%) and re-examination (53%) were applied to the 19 approved CGTPs, with 21% approved through conditional and time-limited approval. The PMS for CGTPs in South Korea, mainly included PSUR, re-examination, and re-evaluation. China had introduced several relevant regulations, which consisted of general statements and lacked detailed guidance. Conclusions: This study demonstrates that the regulatory policies of PMS for CGTPs in the EU, the US, Japan, and South Korea were comprehensive. The implementation of PMS for CGTPs in the EU, the US, and Japan was well developed. This knowledge holds valuable insights for China's future learning and development in this field. [ABSTRACT FROM AUTHOR]

The aquaculture industry will be crucial in helping the world's food supply and keep up with the demand. Aquaculture, like agriculture, must expand and develop sustainably in all the countries to keep up with the rising demand for food. To this end, the aquaculture industry has forged new scientific and technological frontiers in pursuit of long‐term food security. Among these is organic aquaculture, whose distinctive protocol has great potential to advance aquaculture. Organic aquaculture is being explored for multiple reasons, encompassing the aim to minimize environmental footprints, fulfill escalating consumer appetites for seafood, and contend within the industry this paper endeavors to address the gaps in current literature by offering an exhaustive overview of various aspects of organic aquaculture. This encompasses its regulation, production methods, food quality, environmental impact, economic viability, as well as socioeconomic and marketing aspects. It is necessary to acquire more knowledge about organic farming techniques before switching over to organic aquaculture on a large scale. Organic regulation, production, food quality, economic performance, and social and marketing issues are at the top. This review found that consumers lack understanding of organic principles, and regulations are inconsistently applied. However, organic aquaculture promotes social equality by protecting producers' rights to work without discrimination based on gender, race, or sexual orientation factors that ultimately boost the industry's popularity. Organic aquaculture viability varies depending on factors like feed costs, fixed expenses, and the premium pricing sensitivity, making it unfeasible for certain species. However, from both societal and economic standpoints, organic aquaculture appears most suitable for implementation in developing nations. [ABSTRACT FROM AUTHOR]

The maritime industry is exploring ammonia as an alternative fuel to reduce greenhouse gas emissions. However, the high toxicity of ammonia poses significant safety challenges for onboard handling and storage. This study investigates ammonia dispersion and toxicity levels from vent mast releases on ships, aiming to enhance safety measures for future ammonia-fueled vessels. Using CFD analysis on a 31,000-dwt general cargo ship model, the research examines various release scenarios, considering regulatory requirements, vent mast design, and environmental conditions. Results show that direct ammonia release from the vent mast poses fatal risks to the crew in the accommodation area and on adjacent ships, regardless of current regulatory stipulations. The study recommends installing an ammonia-catching system to reduce concentrations to safe levels of 30 ppm before release. These findings offer crucial insights for improving the safety of using ammonia as marine fuel through risk assessment and management. [Display omitted] • Provides key safety recommendations for the toxic release of ammonia from the ships. • Critically examines existing regulatory gaps related to ammonia release via vent mast. • Investigates dispersion scenarios considering different environmental conditions, vent mast designs, and release rates. • Regardless of vent mast location and height, direct ammonia release poses a fatal threat to humans onboard the ship. • Recommends the installation of an ammonia catch system before releasing ammonia into the atmosphere. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic significantly increased the demand for remote healthcare services delivery, including remote access to medications. This study explored the practices and challenges associated with remote provision of pharmaceutical products and services in Kampala, Uganda. Methods: A cross-sectional study was conducted from July to September 2022, enrolling 174 out of 198 sampled retail pharmacies. Data was collected using a pre-tested questionnaire on remote service provision, platforms used, products offered, delivery methods, and challenges faced. Results: Over 58% of pharmacies provided remote services, primarily through social media (especially WhatsApp) and phone calls. OTCs and POMs were the most commonly dispensed products remotely. Key challenges identified included high internet costs, labor shortages, poor internet quality, and a lack of specific regulations for remote provision of pharmaceutical products and services. Conclusion: The proportion of retail pharmacies providing pharmaceutical products and services remotely is significant in Kampala, but they face challenges that need to be addressed. Regulations are crucial to ensure responsible dispensing practices and rational medicine use. Addressing internet affordability and quality, staffing issues, and delivery logistics is essential for sustainable and effective remote pharmaceutical products and services. [ABSTRACT FROM AUTHOR]

The paper analyses the implications of the emergence of artificial intelligence (AI), especially generative AI, on current research information systems (CRIS). It reviews the recent European regulations for high-risk AI systems, the Spanish AI strategy, and the IntelComp project as use cases. The study found that the maturity of CRIS systems, coupled with the increasing complexity due to data aggregation, sets the stage for innovative AI applications. The paper proposes key domains where AI can impact and be applied in CRIS, including data management, research assessment, and advanced analytics. It also provides examples of how generative AI can be leveraged to enhance scientific information management within CRIS. The findings highlight the need to ensure the responsible and ethical development of AI technologies in the research domain. [ABSTRACT FROM AUTHOR]

Import and export controls ensure plant pests and diseases harmful to food production, the plants across our landscape, and ecosystem services, are not moved during trade. The 'International Plant Protection Convention' (IPPC) provides the framework for applying preventive measures where they are technically justified, and stipulates controls are not to be used as arbitrary restrictions on international trade. This article examines the aims of the Brexit trade agreements and reviews their alignment with the IPPC and other World Trade Organisation agreements. It argues that unjustified controls have been applied under the guise of protective requirements (contributing to EU-GB trade disruption) and identifies a divergence at the point of regulatory implementation of these laws and treaties by official bodies on both sides. The article reviews the position of Northern Ireland, which, to avoid a 'hard border' on the island of Ireland, remains under the European Union (EU)'s plant health (phytosanitary) regime. Reflecting on legislative options available to bring the application of plant health regulations into alignment with the IPPC (such as dispute resolution), these options remain unused. However, the possibility of utilising 'import authorisations' would leave neither Great Britain nor EU Member States exposed to any greater environmental risk than that under the single market. [ABSTRACT FROM AUTHOR]

Nonclinical safety studies are typically conducted to establish a toxicity profile of a new pharmaceutical in clinical development. Such a profile may encompass multiple differing types of animal studies, or not! Some types of animal studies may not be warranted for a specific program or may only require a limited evaluation if scientifically justified. The goal of this course was to provide a practical perspective on regulatory writing of a dossier(s) using the weight of evidence (WOE) approach for carcinogenicity, drug abuse liability and pediatric safety assessments. These assessments are typically done after some clinical data are available and are highly bespoke to the pharmaceutical being developed. This manuscript will discuss key data elements to consider and strategy options with some case studies and examples. Additionally, US FDA experience with dossier(s) including WOE arguments is discussed. [ABSTRACT FROM AUTHOR]

Does the adoption of restrictive regulations shape numbers of non-governmental organizations? Since the late 1990s, governments around the world have been enacting new legal measures designed to suppress civil society's functions and organizational space to carry out advocacy and politically oriented work. Scholars have investigated the impact of these new regulations on foreign aid flows, voting behavior, and on organizations, but to date, we lack a systematic analysis about the cross-national global effects of these legal restrictions on numbers of international non-governmental organizations (INGOs) in particular, since it is these organizations (and their funders) that have been heavily targeted. In this research note, we fill this gap through an empirical analysis of the effects of various types of restrictive laws on INGO numbers in 96 countries between 1992 and 2018 and find that advocacy restrictions result in a reduction of transnational human rights organizations but not numbers of INGOs. [ABSTRACT FROM AUTHOR]

This study investigates the impact of legal and regulatory frameworks on whistleblowing intention (WI) in the context of the United Arab Emirates multicultural setting and legal environment. Applying the ethical decision-making model and using data collected via an online survey, it examines factors leading to employees' decisions to blow a whistle. The results support the premise of a model promulgating the interdependency of WI upon ethical awareness and ethical judgement; however, while respondents showed willingness to report major fraud and behaviors resulting in "harm to others," they preferred to ignore and not report minor fraud. This contention is also supported by the effects of work tenure and fear of retaliation on WI. To explain the findings, the study scrutinizes the effect of the country's legal environment on employees' intent to blow a whistle. It argues in favor of the implementation of a stand-alone comprehensive whistleblowing law. [ABSTRACT FROM AUTHOR]

Integrating pharmacists into interdisciplinary care models is essential for achieving the Quintuple Aim in health care, which emphasizes improving patient outcomes, enhancing patient and provider experiences, reducing costs, and advancing health equity. Despite expanded scopes of practice that facilitate collaborative models, pharmacists often face significant barriers due to inconsistent and insufficient reimbursement for their clinical services. This review seeks to address these challenges by focusing on state‐based legislation and regulations that establish payment parity or create pathways for reimbursing pharmacist clinical services. Through a narrative review, this article systematically compares different states' approaches to pharmacist reimbursement by examining affected payers, billable services, and other pertinent details. The ultimate goal is to propose model characteristics for states considering the enhancement or development of legislation and regulations to ensure equitable payment mechanisms for pharmacist services. By providing a comprehensive overview of existing models and identifying effective legislative characteristics, this review aims to inform and empower pharmacists and their advocates with a better understanding of reimbursement regulations and to inspire community‐driven advocacy for equitable compensation, thus supporting the integration of pharmacists as essential health care providers. [ABSTRACT FROM AUTHOR]