Approval Procedures Research Articles

Pregled nacionalnoga građevinskog tržišta u Republici Hrvatskoj

A trend of strong construction works prices’ growth has been noticed from 2018. This is particularly challenging from a strategic perspective for the Republic of Croatia in the context of complex infrastructure projects co-financed by the European Union, given the rules for implementing EU co-financed projects - primarily the implementation period, eligibility of costs, and achievement of performance indicators. Increasing costs on these projects generally requires an increase in the amount of national co-financing, with implementation difficulties arising from the necessary approval procedures for such increases. To analyse this trend in detail and elaborate its possible antecedents, an overview of national construction market up to 2020 is given in this paper. Results of construction industry indicators’ analysis are shown, as well as their synthesis in accordance to the relationship between supply and demand. By exploring this market trend from technical and economical side, an unique overview for understanding it from perspective of historical trends is given; and possible factors that may contribute to a significant increase in the average offered prices of construction work in the Republic of Croatia are listed.

DRAFT OF THE UPDATED VERSION OF THE STRATIGRAPHIC CODE OF UKRAINE (2012) ON TYPES OF STRATIGRAPHIC SCALES AND SCHEMES, AS WELL AS RULES FOR THE PREPARATION AND APPROVAL OF STRATIGRAPHIC SCHEMES

Definitions of the concepts “stratigraphic scale” and “stratigraphic scheme”, outlining the scope of their application, establishing the rules for their preparation and the procedure for approval are set out in the provisions (articles) of the current Stratigraphic Code of Ukraine (Stratigraphic…, 2012, see Section 4, pp. 30–31 and Annex 3, pp. 39–42; after this referred to as SCU-2012). This ensures the unification/standardization of stratigraphic information that is mandatory for use in any scientific stratigraphic research and geological survey work on the territory of Ukraine. The analysis of the relevant articles of the 2012 edition of the SCU-2012 has shown that they need to be improved. The basis of this development is the principle of imitation: to preserve the general content of the stratigraphic classification and nomenclature, the updated texts of Section 4 and Annex 3 retain the information contained in the SCU-2012 and its previous editions. That is the terms and content of individual articles, if possible, have been left unchanged (or taken as a basis with minor changes) from previous editions of the Stratigraphic Code (Stratigraphic…, 1977, 1988; Stratigraphic…, 1997, 2012), as well as from the International Stratigraphic Guide (https://stratigraphy.org/guide/). In addition, new separate formulations and provisions were proposed by the current state of development of stratigraphic classification and nomenclature and based on the author’s own experience of conducting stratigraphic studies and participating in geological surveys, e.g., Anistratenko et al., 2006, 2012; Vernyhorova et al., 2009, 2012; Vernyhorova, 2014–2016. Thus, the main changes and additions to Section 4 “Stratigraphic scales and schemes” and Annex 3 “Rules for drawing up and approval of stratigraphic schemes” of the current Stratigraphic Code of Ukraine, 2012 are as follows: the structure of Section 4 has been updated: all definitions of “stratigraphic scale” (and its types), and “stratigraphic scheme” (and its types) are collected exclusively in this section, Fig. 1; the structure of Annex 3 has been updated: it contains only the rules for the preparation and approval of stratigraphic schemes, Fig. 2; the existing provisions set out in Section 4 and Annex 3 of the SCU-2012 were partially corrected;- some provisions from the previous editions of the Stratigraphic Code, which remain relevant and are used in stratigraphic research in Ukraine, were added to the texts; the rules for drawing up and approving stratigraphic diagrams (Annex 3), especially in terms of graphic design of stratigraphic schemes, explanatory notes, and rules for approving stratigraphic schemes were expanded; two figures from the graphic design of scaled and non-scaled stratigraphic schemes were added.

Features of the Documentation Approval Procedure on Territorial Planning a Linear Facility Placement

The article studies the problem of planning and land surveying projects’ approval procedure for the purpose of placement the linear facilities. Its relevance is induced by the high complexity and large volume of work performed. The present study is aimed at finding the possible ways to optimize and improve the documentation approval procedure on territorial planning. For this purpose, technical specifications of the engineering structures affecting the features of documentation approval procedure have been determined, and information on the timeline and the order of going through the approval procedure at various state government bodies having the power in the field of control and management of the territories and for which the documentation on the territorial planning is being prepared was analysed.

Protective Role of Jimson Weed in Mitigating Dyslipidemia, Cardiovascular, and Renal Dysfunction in Diabetic Rat Models: In Vivo and in Silico Evidence

Background Diabetes mellitus (DM) is characterized by irregular carbohydrate, protein, and fat metabolism, leading to elevated blood glucose levels. DM patients are at a high risk of developing dyslipidemia and cardiovascular and chronic kidney diseases. This study evaluated the impact of Jimson weed on blood glucose, lipid profile, and renal indices using rat models. Methodology The rats were divided into six classes, with rats in each class receiving alloxan intraperitoneally orally twice daily for 14 days. The rats were assigned into six classes (A-F), (n = 6). Rats in classes A-E were intraperitoneally injected with 2 g of alloxan dissolved in 20 mL of distilled water (100 mg/kg body weight). Rats in class F received neither alloxan nor any form of treatment. Rats in classes A, B, and C were given 100, 200, and 400 mg/kg of Jimson weed leaf extract, while rats in class D received 5 mg/kg body weight of Glibenclamide. Rats in class E were given normal saline (0.1 mL) only. Blood glucose levels were measured using a Glucometer, and lipid profile and renal markers were assayed using approved procedures. Docking analysis targeted key proteins with potential roles in lipid dysregulation and renal dysfunction associated with diabetes. Results The study found that diabetes in the rats led to abnormalities in lipid profiles, electrolytes, urea, and creatinine serum levels. In diabetic control rats, the level of total cholesterol increased by over 216.67%, while the concentrations of triacyglycerol and low density lipoprotein also showed a similar trend. Notably, there was a reciprocal impact on the high-density lipoprotein, which decreased by a similar magnitude in diabetic controls compared to normal control rats. In the other calculated indices; atherogenic and coronary risk indices, Cl-, urea, and creatinine levels were elevated, and a decreased cardio-protective index, Na+, and K + . Jimson weed ethanol extract alleviated these impacts. The study also investigated compounds’ molecular properties and docking results targeting key proteins in lipid metabolic pathways and immune response. The compounds showed promising binding affinities to acetyl-CoA carboxylase (ACC), fatty acid synthase (FASN), 3-hydroxyl-3-methyl-glutaryl-CoA reductase (HMG-CoAR), and melanoma 2 (AIM2) proteins. Conclusion Jimson weed offers a promising option for treating T2DM, cardiovascular, and renal complications, as it exhibits hypolipidemic, cardioprotective, and renal protective properties, overcoming limitations in traditional medicines.

Why are organisational approvals needed for low-risk staff studies in the UK? Procedures, barriers, and burdens

BackgroundHealth care staff should be given the opportunity to participate in research, but recruiting clinicians via their employing organisation is not always straightforward or quick in the UK. Unlike many countries outside the UK, very low-risk survey, interview or focus group studies can be subject to some of the same governance approval procedures as interventional studies. An exemplar study carried out by the NIHR funded Palliative Care Research Partnership North West Coast is used to highlight the challenges still faced by researchers and health care organisations when setting up a low-risk staff study across multiple NHS and non-NHS sites.MethodsA study database was created and information was collected on the first point of contact with the clinical site, Health Research Authority (HRA) and local organisational approval times, time from trust or hospice agreement to the first survey participant recruited and overall site survey recruitment numbers. Descriptive statistics (median, range) were used to analyse these data.ResultsAcross participating NHS trusts, it took a median of 147.5 days (range 99–195) from initial contact with the local collaborator to recruitment of the first survey participant and hospice sites mirrored these lengthy timescales (median 142 days, range 110–202). The lengthiest delays in the HRA approval process were the period between asking NHS trusts to assess whether they had capacity and capability to support the research and them granting local agreement. Local approval times varied between trusts and settings which may indicate organisations are applying national complex guidance differently.ConclusionsThere is the potential for HRA processes to use more NHS resources than the research study itself when recruiting to a low-risk staff study across multiple organisations. There is a need to reduce unnecessary administrative burden and bureaucracy to give clinicians and research staff more opportunities to participate in research, and to free up NHS R&D departments, research nurses and clinicians to focus on more demanding and patient focused research studies. Hospices need standardised guidance on how to assess the risk of being involved in low-risk research without adopting the unnecessarily complex systems that are currently used within the NHS.

INVESTIGATING THE CONNECTION BETWEEN INVESTMENT INTENTIONS AND LAND STATUS

The subject of investigating the connection between investment intentions and land status is analyzing the main procedures for preparation, approval and implementation of development plans with the objective of changing the purpose designation of agricultural land into urbanized territory. By using a project for a Detailed Development Plans – Plan for Regulation and Construction, an examination is performed of the processes related to the preparation and coordination of the plan, including the change of purpose designation of the agricultural land into land for non-agricultural uses, in accordance with the legislation.

Unraveling Social Health Inequalities during COVID-19 in Belgium: The Vital Role of Data Linkages

Abstract Background During the COVID-19 crisis, data linkages were set up to efficiently monitor the outbreak and identify vulnerable population groups. Yet, considerable technical, administrative and data security issues have hindered the effectiveness of data linkages as a critical instrument during public health emergencies. This workshop aims to provide a practical demonstration of the challenges encountered in a Belgian data linkage during the COVID-19 crisis, along with the strategies implemented to overcome these challenges. This case study offers insights into the development of a highly sensitive linkage between COVID-19 hospital data and information related to social and health use in Belgium. Methods The HELICON data linkage is developed at the individual level to investigate the risk of COVID-19 hospitalization and the influence of various social and biomedical factors during and after the crisis. Data are drawn from data collections on hospitalization from the COVID-19 health surveillance (Sciensano), on the socioeconomic and sociodemographic context (Statistics Belgium), and on healthcare use and reimbursement (InterMutualistic Agency). Results A representative case-cohort study is established comprising 1,149,264 million randomly selected Belgians and 44,508 hospitalized patients. Annual follow-up is scheduled over a four-year span, allowing the investigation of pre- and post-pandemic health data from July 2020 to January 2026. Conclusions The HELICON data linkage took 3.5 years to complete. Among the many challenges, we were faced with complicated approval procedures, ambiguous data security guidelines, unclear cost estimates, and technical issues related to the analysis environment. Building on these experiences, we explore the strengths and weaknesses of data linkages as a research instrument during the COVID-19 pandemic and discuss which lessons should be drawn to for the post-pandemic era.

Genomic Analysis of Aeromonas salmonicida ssp. salmonicida Isolates Collected During Multiple Clinical Outbreaks Supports Association with a Single Epidemiological Unit.

Outbreaks of furunculosis cause significant losses in salmonid aquaculture worldwide. With a recent rise in antimicrobial resistance, regulatory measures to minimize the use of antibiotics in animal husbandry, including aquaculture, have increased scrutiny and availability of veterinary medical products to control this disease in production facilities. In such a regulatory environment, the utility of autogenous vaccines to assist with disease prevention and control as a veterinary-guided prophylactic measure is of high interest to the producers and veterinary services alike. However, evolving concepts of epidemiological units and epidemiological links need to be considered during approval and acceptance procedures for the application of autogenous vaccines in multiple aquaculture facilities. Here, we present the results of solid-state nanopore sequencing (Oxford Nanopore Technologies, ONT) performed on 54 isolates of Aeromonas salmonicida ssp. salmonicida sampled during clinical outbreaks of furunculosis in different aquaculture facilities from Bavaria, Germany, from 2017 to 2020. All of the performed analyses (phylogeny, single nucleotide polymorphism and 3D protein modeling for major immunogenic proteins) support a high probability that all studied isolates belong to the same epidemiological unit. Simultaneously, we describe a cost/effective method of whole genome analysis with the usage of ONT as a viable strategy to study outbreaks of other pathogens in the field of aquatic veterinary medicine for the purpose of developing the best autogenous vaccine candidates applicable to multiple aquaculture establishments.

Reassessment of views on public administration in the field of physical culture and sports in Ukraine under martial law

The scientific research is aimed at determining the forms of public administration in the field of physical culture and sports, in particular, at clarifying the peculiarities of this field in the conditions of martial law. In order to fulfill the tasks of the research, the author analyzed the forms and means of public administration in the field of physical culture and sports, determined the state of their legal regulation, taking into account the substantiated provisions regarding the need to increase the efficiency of the use of some of them in wartime conditions. According to the results of the conducted research, it has been established that public administration in the field of physical culture and sports is the activity of public administration subjects regulated by laws and other normative legal acts, aimed at the implementation of laws and other normative legal acts, including making administrative decisions, provision of administrative services established by legislation regarding the development of physical culture and sports. Forms of public administration in the field of physical culture and sports are systematized, in particular: issuance of normative acts of public administration in the field of physical culture and sports, their application and implementation of material and technical measures; provision of administrative services by carrying out registration, permit (licensing) and approval procedures in the field of physical culture and sports; conclusion of administrative contracts in the field of physical culture and sports regarding the delegation of management powers to local sports federations with the minimization of centralized management; implementation of public control over compliance with legislation in this area, detection, recording of violations and application of measures of legal responsibility. It has been established that in the conditions of martial law and post-war period, there will be following most effective forms of public administration in the field of physical culture and sports: attraction of investments in the reconstruction of destroyed or damaged infrastructure; further development and investment of veteran sports and sports aimed at restoring the physical and psychological shape of military personnel, involving the military in the sports movement and reviving the country on the international arena, as well as simplifying the system of providing administrative services in the specified areas.

Investigating the barriers and strategies for establishing desalination plants to mitigate water scarcity in Sri Lankan dry zones

PurposeIn response to water scarcity in Sri Lanka, the government is implementing strategies such as rainwater harvesting, efficient irrigation, wastewater treatment and desalination. Initial efforts include the establishment of a desalination plant in Jaffna, with additional plans for the dry zones (DZ). The study aims to comprehensively identify the barriers to establishing desalination plants in the DZ and provide recommendations to mitigate these barriers. Additionally, this research provides valuable insights aimed at minimizing barriers to the construction of future desalination plants within Sri Lanka.Design/methodology/approachThe study used qualitative methods, using an expert survey to identify current and future barriers, along with strategies for overcoming them. The collected data were analysed using the template analysis technique.FindingsRegarding desalination plant establishment, various barriers such as high capital costs, high energy expenses, brine discharge, pollution, emissions, technical challenges, health concerns and waste disposal have been identified. However, specific strategies exist to address and mitigate each of these obstacles.Practical implicationsThe study offers recommendations to environmental experts and government on expediting the approval procedures for desalination plants in Sri Lanka’s DZ. Adapted to Sri Lanka’s specific challenges, it highlights strategies and barriers essential for upcoming desalination projects. Furthermore, it emphasizes the financial advantages such as increased production and job creation resulting from establishing desalination facilities.Social implicationsThrough this study, promoting sustainable practices and fostering community involvement, it aims to enhance livelihoods, accelerate economic development and improve overall well-being through reliable access to water. Additionally, the study aims to enhance understanding of the importance of desalination in alleviating water scarcity, promoting community engagement and ultimately facilitating improved living conditions, health outcomes and economic opportunities in Sri Lanka’s DZs.Originality/valueThis study provides crucial direction for decision-makers by highlighting the main barriers to the establishment of desalination plants in Sri Lanka and outlining practical solutions. Implementing these strategies helps meet the region’s increasing water demands, advance sustainable water management, improve the standard of living for nearby communities and promote the socioeconomic development of desalination plants in Sri Lanka’s DZ.

A Comparative Analysis of the Regulatory Framework and Collaborative Environment for Pediatric Medical Device Development in Japan and the United States: Identifying Challenges, Support Mechanisms, and Emerging Opportunities.

There are specific obstacles to designing medical devices for children, such as commercial distortions and regulatory hurdles. This study compares the regulatory frameworks and collaborative ecosystems of the United States (US) and Japan, enabling the development of pediatric medical devices. The study illustrates the differences as well as parallels between the two countries by outlining their primary obstacles, channels of assistance, and prospects. The regulatory regimes of the US and Japan pose substantial challenges due to their intricate approval procedures and the dearth of pediatric-specific guidelines. However, while Japan's ecosystem is more dispersed, the US offers more well-established support mechanisms, such as funding initiatives and research alliances. Despite these difficulties, there are still prospects for innovative thinking and collaborative work. The article demonstrates successful partnerships between business, academia, and government in both countries, which have helped propel the advancement of pediatric devices. For stakeholders endeavoring to maneuver through thecomplex terrain of pediatric medical device development, this study offers valuable insights. With a comprehensive understanding of the regulatory and collaborative frameworks in Japan and the US, developers can more effectively leverage resources, overcome obstacles, and bring vital technology to market. The study's findings have implications for researchers, industry leaders, and policy regulators, providing recommendations for strategies aimed at stimulating innovation and enhancing children's healthcare outcomes internationally.

EFFECTS OF CREDIT REFERENCE BUREAU PROCEDURES ON PERFORMANCE OF LOAN PORTFOLIO: A CASE OF SELECTED COMMERCIAL BANKS IN TANZANIA

This study investigates the impact of credit reference bureau (CRB) procedures on the performance of loan portfolios at selected commercial banks in Tanzania. A cross-sectional research design was adopted, with data collected through questionnaires and interviews involving 95 respondents from selected commercial banks. The findings show that the procedure to accessing loans had a positive and significant relationship with loan portfolio performance at these banks (β = 0.835, p = 0.000), as did loan approval procedures (β = 0.789, p = 0.001) and quality control procedures (β = 0.768; p = 0.002). All were significant at 5% level. The study concludes that using credit reference bureau services allows banks and other credit providers to assess potential clients, track their financial performance, and manage any accumulated debts. The study recommends that the government of Tanzania work closely with listed commercial banks and other financial institutions to ensure compliance with legal requirements specifically policies and procedures that assist in screening and monitoring clients from the initial stage of lending by using credit reference bureau procedures to improve decisions on loan provision.

Development of Driving Robot and Driver Model Applied Regenerative Brake Control of Electrified Vehicles

Real driving emissions (RDE) test procedures for type approval were initiated in Japan in 2022. In Japan, the test vehicle is driven on a test road (test course) by tracing the speed pattern prepared for each RDE test. The vehicle needs to trace the patterns in the same manner as in the conventional chassis dynamometer test. The use of a driving robot is effective for reproducibility in precisely tracing the target vehicle speed during these tests. In this study, we developed a driving robot for electrified vehicles (HEV, plug-in HEV, BEV, and FCV), which have regenerative brake-control systems. We applied a new logic to our robot that was developed in-house for conventional engine vehicles. We focused on braking deceleration of the regenerative brake control to change the operation timing from the accelerator pedal to the brake pedal. We verified the improvement of speed traceability of the driving robot installed with the proposed logic on the chassis dynamometer and test road.

Algorithm for Providing Assistance to the Wounded on the Battlefield and the Possibility of its Application for Employees of Organizations and Enterprises in Accordance with the New Approved First Aid Procedure

Many of the principles and methods of the battlefield first aid algorithm can be useful and applicable in peacetime in accordance with the new approved first aid procedure.

The Legal Status and Improvement Path of Human Genetic Data in Gene Therapy in China.

In the legal context of Chinese law, genetic data are an object of complex rights. At the level of private law, genetic data contain personal information, thus being protected by the Civil Code and the Personal Information Protection Law. At the level of public law, genetic data are important genetic resource that embody both public and national interests, which should also be regulated by public laws such as the Biosecurity Law and the Data Security Law. The recently issued Regulation on the Administration of Human Genetic Resources have refined the approval and record procedure, in order to promote the utilization of genetic data in China. At present, China still lacks sufficient protection for genetic data privacy, and the "informed consent" and "anonymization" system cannot work effectively. On the path of improvement, we should break constraints of individualism and start from the following three levels to strengthen genetic data privacy protection: formulating specialized legislation and leveraging the functions of group organizations and public interest litigation systems.

Weathering tests to investigate the durability of anti-corrosion coatings and on-site repair materials

Steel structures are exposed to multiple environmental impacts that lead to reduced durability. Organic paint systems are a resilient mechanism to protect hydraulic steel structures from corrosion. Coatings lead to a decreased corrosion progress at damaged areas. In this work, we investigated the time dependency of undercoating corrosion in the neutral salt spray test in detail by conducting a long-term experiment. Thereby, the fundamental model of corrosion progress was investigated, leading to an increased reliability in approval procedures of coatings and in the choice of test parameters.Additionally, repair materials for on-site repair of damaged coatings were investigated in weathering tests to compare their performance with conventional coatings. These materials are used for short-term repairs of small damaged areas in order to postpone replacement of ailing structures, thus enhancing the durability of steel structures.

Analysis of Non-Road Mobile Machinery Homologation Standards in Relation to Actual Exhaust Emissions

This article presents issues related to the current approval procedures in the group of off-road vehicles. Our research aimed to demonstrate significant differences between actual railway vehicle operation and stationary homologation tests regarding exhaust emissions. The research cycle consisted of analyzing emissions of toxic compounds from exhaust systems under real operating conditions, supplemented by a temporal share analysis based on the denormalized NRTC test upon which the tested object was homologated. Based on the conducted analyses, a significant difference was found between the actual operation of the tested railway vehicle and the stationary homologation test. By interpreting emission intensities within the parameter ranges of the propulsion unit’s operation, key areas with a significant impact on the vehicle’s overall emissions were identified. Based on the obtained results, a critical opinion is expressed regarding current homologation standards for the off-road vehicle group and the necessity for further empirical research in the area of actual operation of the tested vehicle group.

Early Access for Medicines in ITALY: The Case of Ruxolitinib for Patients with Graft-Versus-Host Disease.

After European Medicines Agency (EMA) approval, national pricing and reimbursement procedures are necessary to guarantee access to drugs, based on the willingness to pay and the recognition of therapeutic value. These can result in delays in drug availability for patients, even for those with important unfmet needs for whom it may be necessary and ethical to ensure access. The objective of this study was to evaluate the use of ruxolitinib for patients with graft-versus-host disease (GvHD) after EMA approval at the University Hospital of Catania. We analysed data about the use of ruxolitinib in patients with GvHD, describing their basic characteristics, their outcomes and the cost of the treatment. In the reference period, 24 ruxolitinib treatments were started according to the Summary of Product Characteristic. The average treatment duration was 10 months. Twenty patients showed a response, maintained over time, with no adverse reactions. The total expenditure amounts to EUR 963,424. The use of ruxolitinib in a real population confirms its role in an important therapeutic need. The quantification of costs requires a reflection on the sustainability of early access to medicines authorised by the EMA for serious diseases and in the absence of therapeutic alternatives.

О системности процессуальных гарантий на этапе окончания различных видов предварительного расследования

This article examines the stage of completing the preliminary investigation, inquiry in the general order, inquiry in an abbreviated form (before sending the criminal case to the prosecutor with an indictment, indictment, indictment resolution) as an element of a unified system for completing the preliminary investigation. Attention is drawn to the fact that currently the criminal procedural law at the final stage of the preliminary investigation does not provide for a uniform procedure for approval (coordination) and presentation of final procedural documents to participants in criminal proceedings, which affects the legality of criminal proceedings. The procedure for procedural activities at the stage of completing a preliminary investigation without sufficient grounds varies significantly. It is concluded that the rights and legitimate interests of participants in criminal proceedings at the stage of completion of the inquiry in the general order, inquiry in an abbreviated form are not properly ensured. Proposals are formulated to improve criminal procedural legislation aimed at increasing the level of guarantees of both the rights and legitimate interests of participants in the process, and the implementation of the control and security role of this stage of the preliminary investigation.

Key Points and Difficulties in the Management of a New Guangzhou 12th People’s Hospital Branch

During the 13th Five-Year Plan period, to improve medical and health services, the Guangzhou Municipal government invested billions in medical construction. During that time, Guangzhou was renewing its approval procedures for construction projects, and the COVID-19 outbreak changed the requirements of hospital construction. In addition to focusing more on spatial planning and layout, the integration of specialized departments, large-scale medical equipment, and numerous intelligent systems increased the complexity of hospital construction projects. The success of these projects often hinges on the quality of the management team. If a hospital construction project manager lacks experience and an understanding of the project’s key aspects, they may struggle with organization, management, and problem-solving, leading to rework, resource waste, and delays. This paper uses the construction of a new Guangzhou 12th People’s Hospital branch as an example to describe the key points and difficulties in each stage of project construction and proposes solutions for the management of similar projects in the future.