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The past practice of programme accreditation in Hungary is evaluated. One of the main weaknesses was the imperfect adherence to the principle of uniformity of evaluations. Reasons for this were the uneven quality of the performance of visiting committees, and the changing of quality requirements. Another weakness was 'built in' to the system: accreditation of programmes was done in the framework of institutional accreditation, that is, all programmes of a given institution were evaluated at the same time, while the same programmes taught at various institutions were visited and evaluated by various panels at different times. Realising the drawbacks of the old system and the emerging needs of comparisons of programmes, the Hungarian Accreditation Committee plans to undertake two pilot parallel evaluations in the fields of history and psychology. The methodological framework of the new parallel evaluations is outlined.

To deal with the growing amount of e-waste propelled by introduction of new products, increasing governments are considering amending take-back regulations to impose more stringent collection targets. Motivated by this trend, this study focuses on the reuse policy for e-waste with three factors: product innovation degrees, collection targets, and reuse decisions. We first confirm the traditional wisdom that a higher innovation degree often results in a higher profitability but hurts the environment. As such, we agree with the suggestion that the environmental agencies need to impose more stringent collection targets to deal with the growing amount of e-waste propelled by new product introduction. Moreover, our analysis further indicates that the more stringent collection target results in an inverted U-shaped curve for profitability and lower environmental impact. Therefore, besides confirming the intuitive expectation, we also add a word of caution on the recast of WEEE Direct: although tightening the overall collection target for the OEM is a powerful tool, we still call for the governments and environmental agencies, rather proceeding from the entire industry, should amend take-back regulations to set detailed collection targets based on the specific products characterised by the rate of innovation. [ABSTRACT FROM AUTHOR]

Using environmentally friendly packaging (E-packaging) instead of non-environmentally friendly packaging (N-packaging) can mitigate pollution and reduce carbon emissions. However, the market penetration rate of E-packaging is low, and the packaging carbon reduction level is uneven. This study uses game theory models to examine the factors affecting packaging carbon reduction levels and fees as well as firms' package-type decisions. First, we obtain the optimal solutions for packaging manufacturers and firms when they use different types of packaging under monopoly and competition, respectively. We find that green competition reduces the carbon reduction level of E-packaging, whereas price competition can increase it under certain conditions. The unit manufacturing cost of N-packaging and cost coefficient of carbon reduction are critical considerations for package-type decisions. When the unit manufacturing cost of N-packaging is low and the cost coefficient is large, no firm uses E-packaging. We also demonstrate that firms in a competitive market may become trapped in a prisoner's dilemma after making package-type decisions. Interestingly, we show that the firms' package-type decisions can hurt consumers and welfare under certain conditions, depending on the N-packaging's unit manufacturing cost and pollution damage factor. Our findings provide insights for packaging manufacturers, firms, and environmental regulatory agencies, and can help promote E-packaging. [ABSTRACT FROM AUTHOR]

Libraries play an increasingly significant role in responding to the needs of the local economy. They have the resources to survey the business community to determine what these needs are. Libraries can also form partnerships with government agencies and nonprofits that can help to foster a thriving economy. Programming and events can be targeted to assist segments of the population that have traditionally been underserved or have only limited access to the resources needed for business creation. Richland Library in Columbia, SC, and the Baltimore County Public Library are cited for the community partnerships they have formed and for their innovative programming in support of small business. [ABSTRACT FROM AUTHOR]

The article explores the concept of crime prevention (criminal offenses) in the field of security activities, providing a characterization of the directions and measures of its prevention. Various approaches to understanding these definitions are examined, taking into account the experience of Ukrainian scholars in classifying crime prevention measures. Based on a general theoretical analysis of approaches to understanding the concept of «crime prevention» and defining its content, establishing the main crime prevention measures with their characteristics, as well as studying the system of crime prevention measures (criminal offenses) in the field of security activities and approaches to their classification, the author concludes that crime prevention is a multi-level socio-preventive activity aimed at eliminating and hindering the action of determinants or preventing the commission of acts at various stages of criminal manifestations that lead to the emergence of a certain type of crime, with the aim of ultimately ov ercoming it. The main goal and directions of crime prevention (criminal offenses) in the field of security activities in Ukraine are to create a positive, socially acceptable activity for individuals, introducing into their consciousness a correct, socially recognized understanding of criminal offenses and fostering intolerance towards their commission. General social crime prevention (criminal offenses) in the field of security activities includes a complex of measures conducted by state bodies, public organizations, and other entities aimed at reducing conflicts and stabilizing socio-economic, political, moral-psychological, and legal relations within the state and society. Special criminal crime prevention (criminal offenses) in the field of security activities includes a system of special government agencies that act to influence criminogenic factors, as well as identify the causes and conditions of committing criminal offenses in this sphere and take measures to eliminate them. Individual preventive work in the field of security activities includes early individual prevention, direct individual prevention, and post-criminal prevention. [ABSTRACT FROM AUTHOR]

The article approaches regulation of the wholesale energy market as a part of coordinated effort to establish single EU-27 energy market. We analyze the forms of the cooperation among the national regulators responsible for competition in the wholesale energy markets; such responsibility is split - between two, three or more regulators. The principle of cooperation dominates in the oversight of the wholesale energy market [over concurrency] and has been institutionalized in the form the memo, statute or code; it had also evolved in the EU acquis. Domestic legal system of a state remains a fundamental framework in the traditional nation-state world order as the domestic regulators (NCA, NRA or SMA), along with domestic authority, get also to vote in the EU authorities. Previous research concentrated on delegation of the sovereign powers to the EU level and, to a lesser extent, on coordination between national and state level in the federal EU Member States. This article, instead, looks at horizontal cooperation on the national level only using the comparative legal method. The national level appears to generate the ideas for the EU level and not vice versa, at least, in the analyzed settings of Belgium, France, Germany, the Netherlands, Spain and the United Kingdom. The working arrangements on the information exchange, pooling of resources in the form of task force, investigation crew, joint unit as well as consultations and mutual comments on the policy proposals are common cooperation formats in each of the countries analyzed, often as a formal legislative rule. At the same time, the EU level inter-agency cooperation for the wholesale energy market can boast only memoranda of understanding, quite short. The research also lay prospectives of how Ukrainian government could fit in with its oversight mandate split among the competition authority, financial market authority and energy regulating authority given decision by the European Council on 14-15 December 2023 to open accession negotiations with Ukraine. This publication is third in the planned series of four comparative legal research papers on the inter-action between the regulatory agencies, the first two papers deal with the characterization of the wholesale energy product and wholesale energy market, undertake a content-analysis of the EU-level agencies interactions; the closing fourth part will systematize regulatory policy proposals for the domestic inter-agency cooperation in Ukraine. [ABSTRACT FROM AUTHOR]

With the rise of digital technologies, a political‐economic configuration recognised as “platform capitalism” has raised concerns over monopolistic tendencies, lack of accountability, expanded rentiership, workers’ precarity, and more. Existing analyses, however, show a distinctly urban bias—centring on housing, transportation, retail, and gig labour—and have yet to engage with the agrarian dimensions of this phenomenon despite considerable potential impacts on the future of farming. Here we begin the process of theorising agrarian platform capitalism, offering a typology of platforms in the agri‐food sector, and bringing together critiques of platform capitalism with the distinctive features of agrarian political economy. Our analysis identifies four prominent characteristics of agrarian platform capitalism which largely corroborate existing critiques albeit with some distinctive contours. As in other sectors, platforms intensify rentiership regarding both real estate and digital assets. Agricultural platforms also display a familiar tendency to thrive in spaces of regulatory retreat and are in some cases even endorsed by regulatory agencies, highlighting the potential for public–private platformisation. Some agricultural platform companies deploy populist rhetoric beyond established tropes of consumer welfare, latching onto farmers’ deep frustrations with the highly concentrated agribusiness sector. Efforts to reign in agrarian platform power may be further constrained by legitimising discourses of hunger relief and sustainability. [ABSTRACT FROM AUTHOR]

This perspective reflects on conservation efforts to increase the coverage of marine protected areas in Solomon Islands. We demonstrate that the current model in which international conservation NGOs provide technical and financial support to pilot projects, from which community‐based resource management will spontaneously spread, is misguided. These site‐based projects typically require substantial financial resources, ignore external threats to coastal ecosystems, and tend to bypass existing governance structures, which makes replication in other areas highly problematic. We argue that to effectively support indigenous peoples and local communities in the management of marine resources and, thereby, achieve biodiversity conservation outcomes at scale, it is necessary to move away from site‐based conservation projects and focus instead on strengthening the capability of government agencies. [ABSTRACT FROM AUTHOR]

ABSTRACT Background Methods Results Discussion Immigrants and newcomers are identified by many provincial midwifery associations as “priority populations.” Recently, newcomer populations have shifted considerably, with more people coming to Canada with precarious immigration status who are increasingly ineligible for public healthcare insurance and facing barriers to accessing care. Our aims were to: (1) gain an understanding of the policies related to equitable access to midwifery care and how they may apply to migrant groups without public healthcare insurance and (2) identify existing policy themes, gaps, and regulatory barriers that limit access for this vulnerable population in Canada.We conducted a high‐level document content analysis using a health equity framework. We aimed to identify language related to equitable access in midwifery services, with particular emphasis on uninsured populations. A total of 64 documents were analyzed, including legislation and publicly available statements from midwifery regulatory bodies and associations.Midwifery regulatory authorities and associations across Canada are consistent in establishing an expectation that midwives will provide accessible care to diverse clientele. However, how these commitments are put into practice varies considerably between jurisdictions. We compared the cases of Manitoba and Ontario to illustrate the disconnect between commitments to priority populations and implementation.While there is a clearly demonstrated intention to provide equitable access to midwifery care to all people, including “priority populations” like migrants and newcomers, in practice, these commitments have not been fully realized. Equity is encumbered by broader structural issues, such as the growth in the number of newcomers without access to public health insurance. Moves toward equity within midwifery and healthcare more broadly need to meaningfully engage with other policy sectors, such as immigration, to be able to adapt to emerging issues affecting reproductive care, such as the growing precarity of newcomer populations in Canada. [ABSTRACT FROM AUTHOR]

Objective Methods Results Conclusions To assess dental utilization of resettled adult refugees in Washington (WA) state and the demographic factors associated with dental utilization.Data were collected between January 1, 2015, and December 31, 2015 for newly arrived adult refugees (>21 years) enrolled in Washington State dental Medicaid program. Three state agencies provided enrollment and claims data that included demographic information as well as number and types of dental claims, and time to first dental claim for the newly resettled adult refugee population.A total of 1294 adult refugees resettled in WA State in 2015. Approximately, 67% were aged 21–39 years and 32.4% White race and 93.9% without any disability. Over half (57%) of adult refugees had at least one dental claim within 12 months, and the median time to first dental utilization was 4.1 months [IQR:2.4–6.8]. Black refugees had a 74% greater chance of a first dental claim within 12 months of resettlement compared to White refugees (p < .001), and people from countries with high volume of refugees also had a 31% greater chance than those from countries with low volume of refugees (p = .005).Over half of all the adult refugees resettled in WA utilized dental services within 12 months of arrival. Understanding the mosaic of demographic backgrounds of newly resettled refugees in any given state will improve early utilization of dental care needs and therefore improve their oral health. [ABSTRACT FROM AUTHOR]

Sensitivity analyses are important components of physiologically based pharmacokinetic (PBPK) model development and are required by regulatory agencies for PBPK submissions. They assess the impact of parametric uncertainty and variability on model estimates, aid model optimization by identifying parameters requiring calibration, and enable the testing of assumptions within PBPK models. One‐at‐a‐time (OAT) sensitivity analyses quantify the impact on a model output in response to changes in a single parameter while holding others fixed. Global sensitivity analysis (GSA) methods provide more comprehensive assessments by accounting for changes in all uncertain or variable parameters, though at a higher computational cost. This tutorial article presents a software package for conducting both OAT and GSA of PBPK models built in the Open Systems Pharmacology (OSP) Suite. The tool is accessible through either an R script or a graphical user interface, and the outputs consist of sensitivity metrics of pharmacokinetic (PK) parameters, such as Cmax and AUC, evaluated with respect to model input parameters. Results are formatted according to regulatory standards. The OAT analysis methods comprise two‐way local sensitivity analyses and probabilistic uncertainty analyses, whereas the GSA methods include the Morris, Sobol, and EFAST methods. These analyses can be conducted on single PBPK models or pairs of models for the evaluation of the sensitivity of PK parameter ratios in drug–drug interaction studies. The practical application of the package is demonstrated through three illustrative case studies. [ABSTRACT FROM AUTHOR]

This article discusses the provision of mental health support to the victims of the 2023 earthquake in Syria and Turkey by social workers. The recommendations are applicable to countries in which professional social work lacks recognition and have global implications for both policy and practice. [ABSTRACT FROM AUTHOR]

The European Commission (EC) has tasked the European Medicines Agency (EMA) to provide a recommendation towards the acceptability of titanium dioxide (TiO 2) in pharmaceutical products by early 2024 to inform on final decision in early 2025[1]. Unlike the already implemented ban of TiO 2 in foods, removing this excipient from pharmaceutical products will likely have significant impact on the pharmaceutical industry, regulatory agencies, and patients. This commentary explores the challenges facing the pharmaceutical industry tasked with supporting the development and registration of TiO 2 free (TF) drug products. Specifically, justification of formulation changes and potential impact to in vitro and in vivo performance, as well as differences in global regulatory comparative dissolution requirements to justify changing to TF drug product are discussed. Particularly, the uncertainties around how a formulation change such as removal of TiO 2 from immediate release solid oral dosage forms will be viewed in Europe compared to other regions is discussed. To respond to these challenges and avoid disruption to the medicines supply chain in case in vitro data such as dissolution is either too challenging or insufficient to justify changing to TF product, pharmaceutical companies may have to decide if the level of risk is worth the effort needed to reformulate, develop, and register a new TF product. [ABSTRACT FROM AUTHOR]

OBJECTIVES: To characterize the spectrum of legal options considered in cases of treatment refusal, nonadherence, and abandonment (TRNA); clinicians' thought processes regarding legal intervention; and perceived consequences of legal involvement. METHODS: We conducted in-depth, semistructured interviews with 30 pediatric oncologists between May and September of 2019 regarding experiences with TRNA. The interview guide covered types of conflicts encountered; factors and strategies considered in response; effects of TRNA cases, personally and professionally; the role of ethical frameworks and legal requirements; and resources needed to manage TRNA cases. Interviews were transcribed and coded iteratively using thematic analysis. RESULTS: Participants represented a range of institutional sizes, geographic locations, and years in practice. Twenty-five of 30 interviewees discussed legal consideration with regard to TRNA. Most participants first engaged the legal system through child protective service agencies. They considered patient age, treatment efficacy, quality of life (burden of treatment), and prognosis; family resources and social context; and preservation of therapeutic relationships and possible consequences of reporting. Experiences and outcomes of legal involvement varied. CONCLUSIONS: Clinicians struggle with the tension between obligations to report medical neglect and fears that reporting may result in more harm than benefit to the child in question. We urgently need more dialog between health care professionals and child protective services and legal professionals. Stakeholders from both groups would benefit from a greater understanding of the other's thought processes; clarity regarding the relevant facts; and mutual progress toward creative, evidence-based solutions to working out these complex challenges. [ABSTRACT FROM AUTHOR]

Background: Advanced therapy medicinal products (ATMPs) are an innovative output of biomedical research, characterized by a high level of uncertainty on long-term efficacy and safety, elevated price tags and often complex administration. All these elements compounded make their European authorization, national price negotiation for reimbursement and subsequent dispensation and administration to the patient less straightforward and often less successful than for less innovative drugs. To assess if these hurdles have affected patient access and how are ATMPs used in Italy, we have analysed availability, access and expenditure of ATMPs in the period spanning from 2016 to 2023. Methods: We have analysed real world data on the duration of ATMP regulatory evaluations for authorisation and reimbursement, time to first patient access and expenditure for ATMPs through the Italian National Health System (INHS) expenditure data flow, as well as information on patient mobility and availability of health facilities specialized in administering ATMPs. Findings: Of the 18 ATMPs currently authorized in Europe, 9 are reimbursed by the INHS, but only 6 were actually used, generating a cumulative expenditure of roughly 300 Mln€ from 2016 to 2023, largely owing to CAR-T therapies. Time to patient access reaches an average of 340.6 days from the day publication in the official Gazette of the reimbursement decision to first patient treatment in one of the 107 health facilities authorized for ATMP administration, after an even longer evaluation time by regulatory agencies. Conclusion: Since the first reimbursement decision for an ATMP in Italy, back in 2016, these innovative drugs became progressively more and more available, both in terms of numbers and in terms of coverage across the country. Almost all Italian regions have at least one centre for ATMP administration and has performed a treatment in 2023. Notwithstanding their high per-treatment prices, ATMPs currently have a rather contained expenditure, however it is bound to keep growing in the next few years. [ABSTRACT FROM AUTHOR]

This article examines the role of policy entrepreneurs in countering regulatory capture, a phenomenon whereby regulatory bodies influenced by industry lobbying often prioritize private over public interests. The study employs an abductive process‐tracing approach to investigate the 2013 drug pricing reform in Morocco, illustrating how substantial policy shifts can occur even in authoritarian contexts susceptible to regulatory capture. The findings underscore the pivotal role of Houcine El Ouardi, the former Minister of Health, whose strategic leadership exemplified policy entrepreneurship. His capacity to navigate and surmount industry resistance was instrumental to the reform's success, culminating in a significant reduction in drug prices. This case challenges conventional wisdom regarding regulatory capture, demonstrating that individual agency can reshape regulatory outcomes despite opposition. By elucidating how policy entrepreneurs can drive transformative change in resistant regulatory environments under authoritarian regimes, the study contributes to the literature on policy entrepreneurship and regulation. [ABSTRACT FROM AUTHOR]

Itinerant merchants are actively involved in various economic activities within and around African cities, albeit on a small scale. However, there remains a gap in understanding their contribution to host cities' local economic development (LED). This research aims to fill this gap by examining how itinerant immigrant retailers support LED in host cities, using Wa in Ghana. Recognising their role is essential for informing location-specific development plans to boost local economies. Employing a qualitative research approach, we interviewed 52 participants, including itinerant immigrants, city residents, and officials from relevant state agencies. Thematic analysis using NVivo version 11 was employed to analyse the responses. Itinerant merchants play a crucial role in local economies by creating employment opportunities, providing income sources for residents, ensuring convenient access to goods and services, and contributing to market diversification. We discuss how these insights could inform LED policies and planning in sub-Saharan Africa. [ABSTRACT FROM AUTHOR]

Beyond navigating normative developmental tasks, Black American adolescents cope with race-related experiences that are distinct to their racial-ethnic group. However, little is known about how Black American adolescents, particularly those in racially homogenous communities, experience and cope with race-related stress. Using qualitative measures, this study investigates how Black American adolescents in urban, racially homogenous environments experience race-related stress and the coping methods used to combat it. Qualitative data via individual interviews with 20 high school seniors revealed that these adolescents experience race-related stress in individual, institutional, and cultural contexts, which evoked intense negative emotions. Seeking support from family and friends and social referencing positive cultural artifacts were the most widely utilized coping strategies. Implications of the protective nature of racially homogenous environments and directions for future research are discussed. [ABSTRACT FROM AUTHOR]

Why do some elected leaders use legalistic strategies to undermine democracy from within? And under what conditions do they succeed in the use of these strategies? In this article, we argue that the abuse of law is at the center of the toolkit of emerging autocrats. Executives use an ample menu of legal tools and mechanisms (laws, constitutional amendments, executive decrees, administrative resolutions, and regulations by federal agencies) to gradually dismantle each of the components of liberal democracy. We show how the co-optation of the judiciary by the executive helps create an appearance of institutional normalcy that enhances regime legitimacy. In an era of democratic backsliding, executives capture or coerce judiciaries to neutralize opposition threats, carry out their policy agenda, secure and distribute benefits among allies, and dismantle various components that make up liberal democracies. To understand how executives have different levels of success in using multiple legal tools and mechanisms to undermine democracy, we compare three Latin American countries with disparate regime trajectories: Argentina, Ecuador, and Venezuela. Our paper situates judicial actors at the center of the legal toolkit of emerging autocrats by studying how (and in what ways) courts become illiberal tools for legal reform and implementation to dismantle liberal democracy gradually. We show how, in these cases, "legal narratives" are used to legitimize the slow undermining of democratic rule. [ABSTRACT FROM AUTHOR]

This article focuses on the governance of Granville Island, a former industrial stretch of land that operates as an arts destination abutting the City of Vancouver's waterfront. While Granville Island might look like any other neighbourhood in Vancouver, it is in fact owned and managed by the Canada Mortgage and Housing Corporation, a federal agency, on behalf of the Government of Canada. This article examines what it means, democratically speaking, for the federal government to operate public space in a city. Public entities are each legally unique, raising questions as to how they and their relationships with other entities can be understood, evaluated and adjudicated. This article animates how public entities are understood under Canadian law by demonstrating the difficulty in crafting inclusive, participatory governance models that respond to the many interests involved in public space, especially spaces that are explicitly identified as 'innovative'. Drawing on qualitative data and document review, the article highlights the manner in which Granville Island has been structured and operated by the federal government, its singular focus on commerce and tourism and its weak commitments to accountability, transparency and representation. Granville Island is rendered 'invisible' in its governance: it blends into the urban form as though part of the City of Vancouver, while at the same time lacking in accountability, transparency and representation. We conclude that while Granville Island governs public space, making it seem like a neighbourhood in a municipality, it cannot be conceptualised as a 'democratic body'. [ABSTRACT FROM AUTHOR]

Extracts made from plants are complex mixtures of substances with varying compositions depending on the plant material and method of manufacture. This complexity makes it difficult for scientists and clinicians to interpret findings from pharmacological and clinical research. We performed a narrative review summarizing information on ginkgo biloba leaf extract, its composition, pharmacological data and clinical evidence supporting its administration for the treatment of Alzheimer's disease (AD). Medicinal products containing ginkgo biloba leaf extract which are manufactured in compliance with the requirements of the European Pharmacopoeia are approved as medicinal products for the treatment of dementia and related conditions by drug regulatory agencies in Europe, Asia and South America. As multicomponent mixtures, they may affect various targets in the pathogenesis of AD, the most common form of dementia. Pharmacodynamic studies demonstrate the effects of EGb 761 and individual constituents on various pathophysiological features of experimentally induced cognitive impairment and neurodegeneration that could contribute to its clinical efficacy. The safety and efficacy in the treatment of AD and cognitive decline has been studied in randomized, placebo-controlled clinical trials. Most of the studies that investigate the effects of ginkgo biloba extract (GbE) used the special extract EGb 761, which makes it the best-researched plant preparation worldwide. It is therefore the only herbal alternative to standard-of-care anti-dementia drugs. However, the mechanism of action has not been fully elucidated yet, and the clinical studies in AD show heterogeneity. [ABSTRACT FROM AUTHOR]

Aims: The present analysis estimated the cost‐effectiveness of treatment with the Tandem t: slim X2 insulin pump with Control IQ technology (CIQ) in children with type 1 diabetes in Sweden. Methods: A four‐state Markov model and probabilistic sensitivity analyses (PSA) were used to assess the cost‐effectiveness of CIQ use compared with treatment with multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII) in conjunction with CGM. Data sources included clinical input data from a recent retrospective, observational study, cost data from local diabetes supply companies and government agencies, and published literature. Outcomes measures were quality adjusted life years (QALYs) at 10, 20 and 30‐year time horizons based on cost per QALY and incremental cost‐effectiveness ratio (ICER). Results: A total of 84 type 1 diabetes children were included (CIQ, n = 37; MDI, n = 19; CSII, n = 28). For all time horizons, the use of CIQ was a dominant strategy (e.g. more effective and less costly) compared with MDI or CSII use: 10‐year ICER, SEK ‐88,010.37 and SEK ‐91,723.92; 20‐year ICER, SEK −72,095.33 and SEK −87,707.79; and 30‐year ICER, SEK −65,573.01 and SEK ‐85,495.68, respectively. PSA confirmed that CIQ use was less costly compared with MDI and CSII. Conclusions: Initiation of CIQ use in children with type 1 diabetes is cost‐saving, besides previously shown improved glycaemic control, and increased quality of life. Further investigations are needed to more fully elucidate the cost‐effectiveness of these technologies in different countries with existing differences in payment models. [ABSTRACT FROM AUTHOR]

The article discusses the ongoing struggles within French pediatric nephrology, highlighting a survey revealing that many pediatric nephrologists work excessively long hours and face mental health challenges, reflecting a broader crisis in the field. It mentions the "Assises de la Pédiatrie et de la Santé de l'Enfant," launched on December 7, 2022, by the French Health Ministry, aimed at addressing pediatric healthcare issues.

The outbreak of Covid-19 holds important lessons for general understandings of specialised agencies and their interactions with the political executive in a context of high political salience and uncertainty of the knowledge upon which agencies can base its professional decisions and pursue its policy preferences vis-à-vis the political principal. This case study analyses the behaviour of the Danish Health Authority (DHA) during two critical series of events in 2020 and 2021. Based on unique document access and interviews with key actors, the article makes a triple contribution to the literature on agencies by showing that: (1) interactions within the governmental hierarchy are transactional rather than rule-bound; (2) agency impact in interactions with the political executive depends on the agency head's skill in forming a strategically neutral approach; (3) a strong agency reputation with key audiences is not sufficient for ensuring political influence or avoiding political interference. [ABSTRACT FROM AUTHOR]

The globalization and rapid advancements in medical technologies necessitate the harmonization of international regulatory frameworks to ensure the efficient and timely clinical application of medical products, including pharmaceuticals and medical devices. Regulatory reliance, a critical component of this harmonization process, is a powerful tool that provides efficient access for economic entities and regulatory authorities, promoting predictable decision-making and accelerating approvals. The Medical Device Single Audit Program (MDSAP) serves as a regulatory reliance framework for medical device inspections. Implemented by countries including Japan, the United States, Canada, Australia, and Brazil, MDSAP allows third-party certification bodies, recognized by these regulatory authorities, to conduct audits on medical device manufacturers. The outcomes of these audits are shared with the regulatory authorities, who use them for regulatory assessments and decision-making. Since transitioning to its implementation phase in 2017, MDSAP has been widely utilized in various countries. This review provides an overview of the adoption and utilization of MDSAP in major countries, exploring the program's impact on regulatory processes and its potential as a method of regulatory reliance to facilitate timely access to effective and safe medical devices. [ABSTRACT FROM AUTHOR]

Post-approval changes (PACs) to marketed products are routinely introduced to continuously enhance the product lifecycle management. However, bringing a chemistry, manufacturing and control (CMC) change through the global health authorities can be a complex and lengthy process taking up to several years, therefore negatively impacting supply continuity. In order to accelerate the review and approval of regulatory submissions and ensure continuous supply to patients, the World Health Organization (WHO) is strongly supporting the implementation of reliance among National Regulatory Authorities (NRAs). While some promising developments have been made with the use of reliance pathways for initial marketing authorizations, reliance is still not widely used for PACs. With the support of the European Medicines Agency (EMA) and WHO, Roche launched a reliance pilot based on EMA approval to file a supply critical variation for a monoclonal antibody. The variation constitutes major changes to the approved manufacturing process. Sameness of the product is ensured by submitting to all participants the same variation package as in the EU. The objectives of the pilot are to ensure continuous supply of this critical medicine by targeting global approval in 6.5 months, to promote regulatory convergence by waiving country specific requirements, and enhance greater transparency by sharing EMA Committee for Medicinal Products for Human Use (CHMP) final assessment report and Q&As to participating NRAs. Globally 48 NRAs have agreed to join the pilot. This article outlines the process of establishing the pilot project, including a planning phase and an engagement phase with the EMA, WHO and the participating NRAs. [ABSTRACT FROM AUTHOR]

Recently, there is a surge in ransomware activities that encrypt users' sensitive data and demand bitcoins for ransom payments to conceal the criminal's identity. It is crucial for regulatory agencies to identify as many ransomware addresses as possible to accurately estimate the impact of these ransomware activities. However, existing methods for detecting ransomware addresses rely primarily on time-consuming data collection and clustering heuristics, and they face two major issues: (1) The features of an address itself are insufficient to accurately represent its activity characteristics, and (2) the number of disclosed ransomware addresses is extremely less than the number of unlabeled addresses. These issues lead to a significant number of ransomware addresses being undetected, resulting in a substantial underestimation of the impact of ransomware activities. To solve the above two issues, we propose an optimized ransomware address detection method based on Bitcoin transaction relationships, named XRAD, to detect more ransomware addresses with high performance. To address the first one, we present a cascade feature extraction method for Bitcoin transactions to aggregate features of related addresses after exploring transaction relationships. To address the second one, we build a classification model based on Positive-unlabeled learning to detect ransomware addresses with high performance. Extensive experiments demonstrate that XRAD significantly improves average accuracy, recall, and F1 score by 15.07%, 19.71%, and 34.83%, respectively, compared to state-of-the-art methods. In total, XRAD detects 120,335 ransomware activities from 2009 to 2023, revealing a development trend and average ransom payment per year that aligns with three reports by FinCEN, Chainalysis, and Coveware. [ABSTRACT FROM AUTHOR]

The Government Performance and Results Modernization Act (GPRAMA) of 2010 established new requirements to encourage performance measure development in US government agencies. This study empirically tests if the implementation of the requirements resulted in the development of performance indicators on customer service, efficiency, output, quality and outcome. By examining this neglected research area, this study finds that the familiarity of government employees with the requirements had little impact on the development of measures. This implies that the GPRAMA has been reduced to a means to maintain ceremonial legitimacy. The research also finds that managerial factors are positive predictors of the development of performance measures. [ABSTRACT FROM AUTHOR]

How transparent are state governments in the United States? This Article explores the functioning of important, but often underappreciated, actors in the American constitutional system - state administrative agencies - and examines variation in the existence and implementation of transparency regimes across and within all 50 states. This Article first highlights differences that exist among state freedom of information ("FOI") laws, focusing on three components: who can submit requests; the requirements for and exemptions to public release; and the process for appeal of agency decisions not to disclose information. Because FOI laws require the public to request access to information and permit state agencies to refuse release of records, these laws constitute "passive" transparency and have little effect without a strong administrative apparatus to facilitate implementation. Simply, FOI laws rely on administrators to interpret statutory language in ways that provide access to government information. Because passive transparency regimes like state FOI laws require high-quality administration in order to be effective, this Article presents a novel exploratory field experiment of administrative performance across all 50 states. Specifically, this Article evaluates state implementation of FOI laws using an original empirical study of 248 state agencies' fulfillment of the same FOI request. This study illustrates that agency-level factors such as administrative function, policy mission, and leadership influence information disclosure. As a whole, this Article suggests the stringency of transparency law in the states only partially explains government provision of information to the public. Instead, how administrators react to internal and external pressures as they utilize their discretion to fill FOI requests constitutes a key aspect of open government. [ABSTRACT FROM AUTHOR]

To encourage small business inclusion in public procurement, the U.S. federal government has established the set-aside program that mandates government agencies to award a portion of their contracts to small businesses. We study whether and to what extent the performance of R&D contracts awarded through this program differs from those awarded through open competition. Analyzing a large dataset of federal R&D contracts, we find that despite restricting competition to small businesses, set-aside R&D contracts experience lower schedule and cost overrun than R&D contracts awarded through open competition. Furthermore, although set-aside R&D contracts experience lower schedule and cost overrun when they are awarded to more experienced contractor firms, this benefit arises primarily from a contractor firm's experience in executing R&D contracts across different agencies compared to the firm's experience with the same agency. Finally, set-aside R&D contracts awarded early in a fiscal year experience lower schedule and cost overrun than those awarded later. Post-hoc analysis examining the underlying dimensions of different-agency experience highlights the asymmetric effects of related-agency experience and unrelated-agency experience of contractor firms on the performance of set-aside R&D contracts awarded by the Department of Defense. While related-agency experience improves contract performance, unrelated-agency experience has a detrimental effect on contract performance. These findings demonstrate that small business inclusion policies may not necessarily compromise contract performance. Importantly, they emphasize the need for federal agencies and contracting officers to consider the underlying dimensions of contractor firm experience and contract award timing to improve contract performance and taxpayer money utilization. [ABSTRACT FROM AUTHOR]

Bangladesh's agriculture is highly rice-centric. Although economically rational, this is also risky, and arguably unsustainable. As a result, there is increasing interest in crop diversification (CD). This study examines the policy environment and the implementation of projects promoting CD in Bangladesh from 1971 to the present. An integrated analytical framework, developed by the International Wheat and Maize Improvement Center (CIMMYT) was used. Despite numerous policies and projects aimed at promoting CD, progress remains limited due to historical biases and various challenges. This research identifies a significant gap in existing approaches, which primarily focus on production aspects while neglecting market systems for new crops. Additionally, inadequate coordination among government agencies has impacted the effectiveness of projects implemented by development partners. The study highlights that CD efforts have been largely project-driven and short-lived, emphasizing the need for mainstreaming CD with dedicated annual funding to ensure long-term sustainability. Key challenges in funding, market development, and implementation are identified. The study recommends mainstreaming CD through annual budgets and enhancing market linkages. Furthermore, it provides actionable guidelines for policymakers and practitioners to effectively promote and sustain crop diversification in Bangladesh's agriculture. [ABSTRACT FROM AUTHOR]

AbstractIn these comments, I engage with Ulrike Bialas’s book, Forever 17: Coming of Age in the German Asylum System, to highlight some of its most significant contributions to the scholarship on immigration and categorization. Bialas advances this scholarship in critical ways, with generative potential far beyond this case study. Based on rich and deep ethnographic knowledge, Bialas integrates analytically and theoretically the experiences of young asylum seekers in Berlin as they navigate the asylum bureaucracies with the professional work of the state agents who meticulously assess and determine minority age. We learn about the bureaucracies, the creation of the categories into which asylum seekers are placed, and the crafting of new, formal identities among asylum seekers. This remarkable book, written with humanity and candor, inspires and invites questions that will guide research in this area for years to come. [ABSTRACT FROM AUTHOR]

AbstractUnited States (US) federal agencies are endorsing public-private partnerships (PPPs) to link public institutions with industry to develop local supplies of biofuel and build a domestic bioeconomy. Although trust is a critical factor within effective PPPs, few studies have addressed the different types of trust needed to cultivate these partnerships. Employing a mixed-method design, we explore a PPP in the Southeast US through the lens of trust ecology. We describe how participants perceive trust types within different project spaces and how trust changed during the partnership. Our findings highlight the role that different interactive spaces can play in cultivating types of trust that accumulate in an additive fashion. We offer insights on process-design mechanisms and project management strategies that can bolster trust in PPPs. [ABSTRACT FROM AUTHOR]

Conducting randomized controlled trials for medications targeting rare diseases presents significant challenges, due to the scarcity of participants and ethical considerations. Under such circumstances, leveraging real-world data (RWD) to generate supporting evidence may be accepted by the regulatory agency. Constructing an external control arm (ECA) from RWD for a single-arm trial has been conducted occasionally. A complication in this design is that patients from RWD may be eligible at multiple time points. Most studies approach this by selecting one time point as the index date for ECA patients. Here, we propose a novel design for externally controlled trials that permits the inclusion of ECA patients at various entry points. Accompanying this design, we make recommendations for statistical methods to account for measured confounders, limited sample size, within-subject correlation, and potential overdispersion inherent in count data. Furthermore, we present an idea for the blinding process for this type of study. We have conducted a series of simulations to assess the performance of the design and statistical methods in terms of bias, type I error, and efficiency, as compared to the approach of selecting only one entry per ECA patient. The study and parameter setup were based on a hypothetical case inspired by a rare disease study. The results indicate that allowing multiple entries for ECA patients can lead to enhanced performance in many aspects. It provides a controlled type I error, robustness against certain model misspecifications, and a moderate power improvement compared with selecting a single entry per ECA patient. [ABSTRACT FROM AUTHOR]

Malaysia has initiated a roadmap aligned with the United Nations’ 17 Sustainable Development Goals (SDGs) to integrate them into its national development strategy. Chaired by the Prime Minister, the National SDG Council has established a participatory governance structure to foster collaboration among government agencies, civil society, and the private sector, promoting understanding of the SDGs’ interconnectedness. National symposiums and focus group sessions have been conducted to raise awareness and gather stakeholder input in formulating SDG-related policies and programs. Collaboration with NGOs, civil society, and the private sector has been prioritized, with initiatives integrated into the 11th Malaysian Plan to incorporate sustainable development into the national strategy. The creation of a national SDG Roadmap will offer a systematic approach to realizing the UN’s 2030 Agenda for SDGs. Chemistry serves as a crucial element in advancing SDGs by addressing pressing challenges and exploring new avenues for sustainable development. This article examines Malaysia’s sustainable development journey through a chemical lens, addressing 12 of the 17 SDGs. Malaysia aims to play a pivotal role in achieving these goals, addressing environmental, social, and economic challenges by leveraging scientific knowledge and innovation in chemistry. The recommendations underscore Malaysia’s potential to become a more resilient and sustainable nation, contributing significantly to global sustainability efforts. [ABSTRACT FROM AUTHOR]

The concept of frugal innovation has gained significant traction in low middle-income countries due to its potential to contribute to sustainable development goals (SDGs). This study examines the role of universities in promoting frugal innovation and their capacity to drive socio-economic development through entrepreneurial initiatives. The objective is to explore how universities can serve as both entrepreneurial and development-focused institutions and to develop a conceptual framework to guide their efforts. The study utilizes an exploratory single case study methodology, focusing on the American University of Nigeria (AUN), a leading institution in Nigeria known for its development and entrepreneurship programs. Drawing on data from the AUN THE global impact ranking 2024, the results of the study indicate that the ability of a university to effectively manage technology and skills transfer in frugal innovations is influenced by six university capabilities, and the generation of frugal innovations is moderated by policy and innovation ecosystems involving government agencies, regulatory bodies, and policymakers. This study contributes to the existing body of knowledge by initiating a discussion on how development and entrepreneurship can support frugal innovation, and offers practical insights to inspire other universities to develop their own models for societal and economic impact. The study underscores the necessity of integrating "development" into the vision of universities, particularly in low middle-income and developing economies, and emphasizes the significance of universities embracing both entrepreneurial and development-focused roles. The findings highlight the potential of universities in advancing sustainable development goals, particularly in low middle-income and developing economies, as they work towards meeting the global SDGs by 2030. [ABSTRACT FROM AUTHOR]

I define territory as embodied, relational, processual, and imaginative: power enacted upon and through place. In the following article, I use this generative definition of territory as a lens to interrogate how memory becomes placed and bounded at Somerset Place, a historic plantation site in North Carolina. Through archival research into the negotiations between two state government agencies on the legal status of Somerset Place between 1939-1965, as well as analysis of the gendered and racialized criteria for inclusion on the National Register of Historic Places, I uncover how historic space was defined against recreational space – not only in the creation of Somerset Place, but in the heritage boom of the mid-twentieth century more broadly. In addition, by understanding territory as the historicized and ongoing enactment of power upon and through place, I reveal how formal and informal territories of public memory and public space are continuously defined, negotiated, and claimed. [ABSTRACT FROM AUTHOR]

Canines are used by both government agencies and industries for their keen olfactory capability as well as selectivity, reliability, versatility, and speed. Within the last decade, canines have been used for the detection of on-shore crude oil. They were previously shown to find these deposits with high accuracy, providing increased confidence with little risk to oil spill response survey teams. In order to efficiently train canines, it is important to understand the odorants or groups of odorants that such canines use when locating subsurface crude oil deposits, as well as track how the odorant profile changes as the crude oil undergoes degradation. In this study, headspace solid phase microextraction (HS-SPME) was used in combination with gas chromatography-mass spectrometry (GC-MS) to extract and separate odorants from the headspace of various crude oils. After, eluent fractions of the crude oil odor profile were separated and collected onto sorbent materials, which were then used as canine testing probes in a series of trials. These probes, along with negative and positive controls were presented to three previously-trained and operational crude oil detection canines. Three eluent fractions of both fresh and weathered samples were presented, resulting in a 100% response rate from the canines on all three fractions from both the fresh and weathered samples. These results indicated that canines are capable of detecting crude oil from any fraction of the odor profile demonstrating the potential of the canines to generalize across a variety of crude oils and stages of weathering. [ABSTRACT FROM AUTHOR]

In 2004/5 the Aboriginal and Torres Strait Islander Commission was abolished after 15 years of operation. The longest running and most innovative representative body in the postwar era, its abolition has reverberated to this day.1 This article explores the role of the media in its abolition. It shows how the non-Indigenous media created an image of Indigenous dysfunction such that ATSIC’s abolition was understood as the only viable option. It did so by perpetuating untruths about Indigenous capacity for governance and leadership, suggesting that ATSIC’s alleged failure was self-inflicted. Such representation, including deeply offensive caricatures, worked to support government aims and amounted to institutional bullying. By situating this representation within the wider policy landscape, I show how the media not only created ideational frameworks necessary to project ATSIC as unfit but also helped to deflect attention from the government’s own non-accountability in this space. As a counterpoint to what became a dominant view about ATSIC, I recover the representation of its abolition in the Indigenous media, allowing Indigenous views to be heard for the first time. This case study is of critical importance in the context of today’s concern with both truth-telling and truth-denying. [ABSTRACT FROM AUTHOR]

The use of immunophenotyping during immunotoxicity investigations was first popularized in the 1980 s and has since become more integrated into diagnostic and non-clinical assessments. The data provided from immunophenotyping can serve as an initial source of information to guide decisions for additional, more advanced, immunotoxicity testing as well as for human health safety and risk assessment of drugs and chemicals. However, comprehensive guidance describing applications of immunophenotyping data in immunotoxicity investigations is lacking, particularly among regulatory bodies. Therefore, a critical examination is needed for the appropriate interpretations and potential misinterpretations of such data during the assessment of drug safety and chemical risk. As such, the current uses and implications of immunophenotyping data in human health safety and risk assessments has been evaluated to provide additional context for the application of current methodologies and guidelines. In addition, case studies are presented to highlight the challenges of interpreting immunophenotyping results along with incorporating the findings into immunotoxicity investigations. Based on the analyses of current approaches and methodologies, a decision flow is presented for use of immunophenotyping data during risk informed decision making. [ABSTRACT FROM AUTHOR]

ABSTRACT This Practice Insight presents a reflective analysis of a collaborative project launched in early 2020, initially aimed at comparing in‐person, video, and telephone mediation modalities. That project shifted its focus to the implementation of remote mediation through videoconferencing during the Covid‐19 pandemic. Through firsthand experiences and observations, this essay offers a unique, dual perspective: from within a U.S. Federal agency managing an established mediation program through the pandemic, and from within an academic clinic engaged in dispute systems design. These reflections on the 2020 project and its aftermath illuminate the challenges and learnings from transitioning to remote mediation, offering insights into adapting dispute resolution mechanisms to unforeseen circumstances and how technological change can spur new insights into general practices of mediation. This work not only contributes to the understanding of mediation modalities today but also underscores the importance of flexibility and innovation in dispute system design during crises. [ABSTRACT FROM AUTHOR]

We examined the properties in orienting visual attention that are triggered by social cues (eye gaze or pointing finger) and nonsocial cues (an arrow). Particularly, we investigated whether the mental state of others would be modulated by any social cue. We presented an occluder between the cue and target to manipulate the mental state of an agent in cues (i.e., whether the agent is aware of the target). For Experiment 1, the reaction time (RT) to detect the target was prolonged when the target side was occluded only in the gaze‐cue condition, but not for the arrow or the pointing finger. For Experiment 2, the RT of a discrimination task, which demanded greater cognitive demand, was not prolonged for any cue type. These results suggest that the mental state attribution for the agency of the cue, which is affected by an occluder, is specific to the gaze cue, and suggest that it is under top‐down control that requires cognitive resources. [ABSTRACT FROM AUTHOR]

This research develops an approach to a cartography of competitive research projects on artificial intelligence applied to journalism in Spain granted in the last decade. A query has been made in the database of the State Research Agency, in the section of grants awarded, using as search keywords: robot journalism, algorithmic journalism, automated journalism, computational journalism, augmented journalism, artificial journalism, and high-tech journalism. The findings indicate that 15 competitive projects have been granted between 2013 and 2023. On the methodological level, there is a trend towards documentary analysis work [ABSTRACT FROM AUTHOR]

This study analyzes the implementation of Egypt's targeted fiscal stimulus to the irregular workforce in response to the COVID-19-induced partial shutdown in 2020. We utilize theoretical insights from the literature on administrative campaigns and the interagency coordination literature, as well as insights from the polycentric governance literature, to identify the approach to coordinating the work of the multiple agencies that participated in implementing the initiative and situate it within the implementation literature. We conclude that the complexity of public administration initiatives in semi-authoritarian regimes could create a pretext for expanding access to decision-making and implementation. The need for input from diverse actors creates an environment conducive to expanding participation that combines the characteristics of top-down and bottom-up approaches to policy implementation. Access to decision-making and implementation structures by non-state actors, however, remains dependent on relations with state bureaucratic agencies, both civilian, security-, and military-affiliated. The regime's interest in maintaining control, especially control over data, and the participants' attention to following the official line, creates a need for a dominant actor to perform certain functions beyond the ability of the participating members to accomplish. This expansion in participation therefore does not reflect an expansion in political participation. [ABSTRACT FROM AUTHOR]

Medical devices play a crucial role in human health. These are instruments, machines or even software programs used to diagnose, treat, monitor or prevent health conditions. They are designed to help improve patients' quality of life and range from simple items, such as thermometers, to more advanced technologies, such as pacemakers. In order to guarantee the safety and efficacy of medical devices intended for use on patients, the establishment of appropriate regulatory frameworks is crucial to ascertain whether devices function as intended, comply with safety standards and offer benefits that outweigh the associated risks. Depending on the country, different regulatory agencies are responsible for the evaluation of these products. The regulatory landscape for medical devices varies significantly across major markets, including the European Union, the United States of America and Japan, reflecting diverse approaches aimed at ensuring the safety and efficacy of medical technologies. However, these regulatory differences can contribute to a "medical device lag," where disparities in approval processes and market entry timelines driven by strict regulatory requirements, increasing device complexity and the lack of global harmonization, result in delays in accessing innovative technologies. These delays impact patient access to cutting-edge medical devices and competitiveness in the market. This review aims to address the regulatory framework of medical devices and the approval requirements by the European Commission (EC), the Food and Drug Administration (FDA) and Pharmaceuticals and Medical Device Agency (PMDA). [ABSTRACT FROM AUTHOR]

Background: In the last three decades, Electronic Health Records Systems (EHRSs) have become one of the top priorities of policymakers globally. Nowadays, EHRS reform is fast becoming a priority in developed countries. The introduction of EHRSs in Saudi healthcare organizations is considered one of the highest priorities of policymakers. Saudi Arabian e-health strategy pays reasonable attention to the EHRS implementation project. According to Saudi Vision 2030, the e-health transformation will be on top of IT projects in the country. However, an estimated 50% of EHRS implementations have failed. Project leadership and type of project management have been found to be crucial components of effective EHRS implementation. Aim of the study: To evaluate the role of centralized project management (CPM) in the implementation of large-scale EHRSs in Primary Healthcare Centers (PHCs) in Saudi Arabia (SA). Methods: A sequential explanatory mixed-methods approach involving a survey and semi-structured qualitative interview methods were utilized. Results: A total of 39 (75%) out of 53 policymakers at the Saudi Ministry of Health completed the survey, and 14 project team members were interviewed. Findings from both illustrated that adopting centralized project management approaches to implementation was beneficial in facilitating large-scale EHRS implementation and helped to overcome barriers that may have otherwise led to the failure of the project. EHRS interoperability and software selection were the factors that CPM influenced most positively. [ABSTRACT FROM AUTHOR]