Applicable Regulatory Framework Research Articles

Мониторинг законодательства как средство совершенствования продуктов нормотворчества (на примере избирательного права)

The article uses the practice of territorial bodies of the Ministry of Justice of Russia and results of monitoring of laws in exercising and enforcement of civil electoral rights to bring forward some proposals for improvement of the applicable state regulatory framework and its application practice.

Quality Concerns of Lip Care Cosmetics and Applicable Regulatory Framework: Need for a Harmonized Cosmetovigilance Programme

Quality Concerns of Lip Care Cosmetics and Applicable Regulatory Framework: Need for a Harmonized Cosmetovigilance Programme

Encoding the Enforcement of Safety Standards into Smart Robots to Harness Their Computing Sophistication and Collaborative Potential: A Legal Risk Assessment for European Union Policymakers

Abstract Until robots and humans mostly worked in fast-paced and yet separate environments, occupational health and safety (OHS) rules could address workers’ safety largely independently from robotic conduct. This is no longer the case: collaborative robots (cobots) working alongside humans warrant the design of policies ensuring the safety of both humans and robots at once, within shared spaces and upon delivery of cooperative workflows. Within the European Union (EU), the applicable regulatory framework stands at the intersection between international industry standards and legislation at the EU as well as Member State level. Not only do current standards and laws fail to satisfactorily attend to the physical and mental health challenges prompted by human–robot interaction (HRI), but they exhibit important gaps in relation to smart cobots (“SmaCobs”) more specifically. In fact, SmaCobs combine the black-box unforeseeability afforded by machine learning with more general HRI-associated risks, towards increasingly complex, mobile and interconnected operational interfaces and production chains. Against this backdrop, based on productivity and health motivations, we urge the encoding of the enforcement of OHS policies directly into SmaCobs. First, SmaCobs could harness the sophistication of quantum computing to adapt a tangled normative architecture in a responsive manner to the contingent needs of each situation. Second, entrusting them with OHS enforcement vis-à-vis both themselves and humans may paradoxically prove safer as well as more cost-effective than for humans to do so. This scenario raises profound legal, ethical and somewhat philosophical concerns around SmaCobs’ legal personality, the apportionment of liability and algorithmic explainability. The first systematic proposal to tackle such questions is henceforth formulated. For the EU, we propose that this is achieved through a new binding OHS Regulation aimed at the SmaCobs age.

Digital Transformation in University: Enterprise Architecture and Blockchain Technology

Implementing digital transformation in higher education is now required for effective adaptation to rapid technological advances. Utilizing Enterprise Architecture (EA) with blockchain technology is a recommended strategic approach for implementing digital transformation. The college first ascertains the University's digital transformation requirements and goals, which include data management, security, operational efficiency, and transparency. In addition, formulating a strategic plan to determine the optimal integration of blockchain technology within the college's architectural framework, including the judicious selection of the most suitable blockchain platform, is essential. In addition, developing a company's architecture must prioritize seamless integration with existing systems while upholding data security and consistency principles. Consideration should be given to the significance of training and awareness building among faculty and students. In addition, the implementation process must be conducted in phases with consistent monitoring and evaluation. The success of this project is contingent upon the formation of partnerships and collaborations with blockchain technology companies, as well as a thorough understanding of the applicable regulatory framework. By adopting this methodology, the University can increase operational efficiency, bolster data security measures, and improve the educational experience. This research aims to increase efficiency, data security, transparency, and educational innovation in universities using Blockchain Technology and University Enterprise Architecture.

Feasibility Assessment of Using CDISC Data Standards for In Silico Medical Device Trials

This report summarizes the current applicable regulatory framework and CDISC data standards for in vivo and in silico medical device randomized clinical trials, with an emphasis on transcatheter aortic valve replacement devices (TAVI). Trial Implementation issues and scenarios are discussed as well. This report has been prepared within the Horizon 2020 programme ‘In-Silico testing and validation of Cardiovascular IMplantable devices‘ (SIMCOR, GAID: 101017578) project and would be of relevance for clinical development, data management, and regulatory submission teams.

Aproximação ao acordo sobre a sentença (Verständigung) no processo penal alemão: história, controvérsias e estado atual

This article provides an overview of the most relevant aspects of Verständigung in German Criminal Procedure Law. This legal institute regulates agreements between the court, the defendant, and the prosecutor, with the main objective of expediting the procedure by exchanging the defendant’s confession for a mitigation in the punishment. In the first section, the text addresses historical aspects of criminal deals in Germany, such as the public disclosure of its informal existence, the main decisions of higher courts, and the legal regulation of this kind of agreement. Next, it presents a summary of the main arguments in favor and against the institute, mainly those based on procedural principles and maxims recognized by the German law doctrine. Subsequently, the currently applicable regulatory framework is analyzed. Finally, the paper briefly assesses how the study of criminal agreements in German Law can contribute to the criminal policy discussion about deals in other countries, focusing on the Brazilian context.

Actual Problems of Operation of Turbine and Pumping Equipment of Pumped Storage Power Plants

The article discusses matters concerned with the performance efficiency of pumped storage power plants (PSPP) and its governing factors. The specific features pertinent to the operation of PSPP turbine and pumping equipment are analyzed along with the approaches used at Russian power facilities to diagnose their state in line with the applicable regulatory and technical framework. Pressing matters concerned with diagnosing the state of PSPP equipment are identified with taking into account the experience gained from their operation and designing in Russia and around the world. The identified matters generate the need to carry out studies aimed at finalizing the approaches to diagnosing the technical state of turbine and pumping equipment, and perfecting the relevant regulatory and technical framework. Features and malfunctions pertinent to the operation of pumping and turbine equipment along with the related features and malfunctions of generator (motor) equipment that are encountered at PSPPs in Russia and around the world are pointed out; the most frequent of which are identified, and their causes are analyzed. In our opinion, these features should be selected taking into account in calculating the technical condition index of the PSPP turbine and pumping equipment. To achieve more efficient operation of the PSPP turbine and pumping equipment, the composition of the plant’s operating generating and pumping equipment should be selected with taking into account the effect the operation chart of the connected equipment and its technical state have on the total generation/consumption of electricity; in addition, measures for diagnostics and maintenance of PSPP equipment should be taken in a more regulated manner.

Recruitment of Full Professors According to Pre-Determined Criteria in Four Nordic Countries

This comparative legal study focuses on career advancement to a tenured full professor position according to pre-determined criteria in Denmark, Finland, Norway and Sweden. Nordic career advancement and professor recruitment practices to a large extent depend on the applicable national regulatory framework. There are fundamental differences between these countries’ practices. It is customary to use promotion to full professor positions in Norway and Sweden. In Norway, the regulation of promotion to a full professor position is complemented by the regulation of standards. Norwegian promotion practices were used as a model in Sweden, but the Swedish laissez-faire approach to common standards seems to have created problems. American-style tenure-track practices are constrained by the laws of all four countries. The Danish "forfremmelsesprogram til professor" may nevertheless have potential to develop into a close functional equivalent to American-style tenure-track practices. In Finland, tenure-track practices are widespread but not sufficiently aligned with the regulatory framework.

ELABORATION OF GUIDELINE FOR MONITORING IN RELATIVE BIOAVAILABILITY / PHARMACEUTICAL BIOEQUIVALENCE STUDY BY THE SPONSOR

For registration of generic and similar drugs, it is necessary to carry out pharmaceutical equivalence (PE) tests and pharmaceutical bioequivalence (PB). To carry out these tests, duly qualified research centers are contracted, which need to be monitored by the sponsor who is legally responsible for the activities. To this end, it is the recommendation of the Document of the Americas, periodic monitoring to verify compliance with quality requirements, Standard Operating Procedures, Good Clinical Practices (GCP), Good Laboratory Practices (GLP), of the applicable regulatory framework, as well as of compliance with the study protocol. Thus, monitoring is a methodical and documented process to evaluate the degree of adhesion of the center to the planned design for the evaluation of the formulations. To this end, the implementation of a standardized and easily completed guideline is a very important tool to guarantee a consistent evaluation and maintain the organizational memory of the evaluated items by monitors designated by the sponsor, contributing to the constant improvement of the contracted centers and supporting traceability of the studies. This work provided a systemic view of the evidence process related mainly to pharmaceutical bioequivalence, with the monitoring guideline summarizing the items of greatest relevance to be verified.

The contribution of the German building sector to achieve the 1.5 °C target

The melting greenhouse gas emissions budget of the German building sector for the 1.5 °C target requires fast counteraction. In this paper, an analysis of the applicable legal and regulatory framework, the funding situation as well as national and international strategies on a transformation towards climate neutrality elucidates that the suggested approaches do not take a holistic view into account. They neglect, that embodied emissions from construction and emissions from operations phases of buildings must be oriented on the remaining budget, as well as material and human resources associated with the required actions. Therefore a framework to decarbonise the German building sector with eleven recommendations for action, which addresses these findings, is developed with a panel of experts. The results clarify, that the focus must be on adapting the existing building stock since renovation processes release significantly fewer emissions than the construction of new buildings. Stricter legal requirements for building envelopes have no significant effect on the reduction of emissions. Instead, fast-acting measures, such as the usage of district heating, photovoltaics, heat pumps, the optimisation of building operation and digitalisation, must be implemented in a prioritised manner to save resources and maintain the emissions budget longer. To be able to align effective measures it is necessary to engage all Stakeholders and to establish reliable political guidance down to the building level.

Marine plastic debris in the Arabian/Persian Gulf: Challenges, opportunities and recommendations from a transdisciplinary perspective

In recent years, the amount of plastic waste entering the marine environment around the world has gained increasing attention. Yet certain areas and regions remain relatively undocumented. Research findings on this topic within the countries adjacent to the Arabian/Persian Gulf comprised of Iran, Iraq, Bahrain, Saudi Arabia, Kuwait, Qatar, Oman and the United Arab Emirates is relatively sparse. Significant gaps remain regarding the precise details on the quantity, sources and impacts of plastic marine debris as well as appropriate management responses. This article addresses these shortcomings from a transdisciplinary perspective, drawing on science, engineering and law. Based on an analysis and overview of the scientific research on plastic pollution in the region, an estimate of mismanaged waste is developed, both on a national level as well as for selected coastal cities. The article then explores the applicable international and regional regulatory framework to address marine debris in the Arabian/Persian Gulf region. It provides one of the first accounts of this regional sea from a comprehensive marine litter regulatory perspective, incorporating scientific findings as well as modelling techniques. The article suggests possible ways to achieve synergies and cooperation among actors and proposes novel approaches on methods to address the problem with a view to the transboundary nature of the issue. The key to success lies in dedicated cooperative efforts within the region, both between the public and private sector and between government and civil society.

Usklađenost regulatornog okvira računovodstva dugotrajne materijalne imovine poduzeća u Republici Hrvatskoj i Bosni i Hercegovini

Predmet ovoga rada je utvrđivanje razine usklađenosti, odnosno harmonizacije primjenjivoga regulatornog okvira (računovodstvenih standarda) kod priznavanja i mjerenja različitih kategorija dugotrajne materijalne imovine u Republici Hrvatskoj (RH) te Bosni i Hercegovini (BiH). Provedenim istraživanjem utvrđena je 93 %-tna harmonizacija regulatornog okvira te je dokazano kako se regulatorni okvir računovodstvenog priznavanja i mjerenja dugotrajne imovine u RH i BiH poklapa u 13 od 14 analiziranih područja vrednovanja dugotrajne imovine. Empirijska verifikacija korištenih računovodstvenih politika među listanim poduzećima u RH i BiH potvrdila je postojanje značajnih razlika u računovodstvenim politikama vrednovanja nekretnina, postrojenja i opreme te poljoprivrede, konkretno biološke imovine. S druge strane, u području naknadnog vrednovanja ulaganja u nekretnine, primijenjenih metoda amortizacije te vrednovanju poljoprivrednih proizvoda proizišlih iz biološke imovine, utvrđeno je nepostojanje statistički značajnih razlika u korištenim računovodstvenim politikama između poduzeća u RH i BiH. Dobiveni rezultati bi u prvom redu trebali olakšati usporedivost financijskih izvještaja poduzeća iz RH i BiH, a time posljedično i pozitivno utjecati na povećanje tokova kapitala između ovih dviju susjednih zemalja. U znanstvenom kontekstu predmetno istraživanje značajan je doprinos oskudnoj literaturi navedene tematike.

Considerations Regarding the Establishment and Modification, by Government Decision, of the Rules Regarding the Career and Mobility of Senior Civil Servants

One of the categories of civil servants for whom essential changes in the applicable regulatory framework have taken place over time, is the category of senior civil servants. Many of these changes were determined by the interference between the members of this category and policy makers. The recent Government Decision no.934/2020, dedicated, amongst others, to the career and mobility of senior civil servants, was the starting point of our analysis that aims to answer some questions regarding especially the solutions chosen to regulate, at secondary level, the applicable regulatory framework. This endeavor takes into consideration the fact that several decisions of the Romanian Constitutional Court specify, for other categories of civil servants, that such rules are essential to the status of civil servant and that, in accordance with constitutional provisions, they must be regulated by Organic Law. At the same time, in our analysis we emphasize the importance of predictable regulations, given that legal uncertainty affects the career and, implicitly, the lives of senior civil servants, and we propose some solutions for a coherent regulation that provides legal security.

Methodological issues in the study of e-government in the Republic of Bulgaria

The digital transformation of processes and services is a priority for the Bulgarian society and economy. This is especially true in the context of a global pandemic. Online work and training require state and municipal administration to provide additional efforts for digitalization. In this context, the main methodological issues in the study of the e-government system in the Republic of Bulgaria will be presented. The applied methods are related to: analysis and evaluation of the applicable regulatory framework; analysis of the possible technological solutions for conducting surveys among the municipal administration; methods related to the possibilities for statistical analysis of the obtained results. The main results are in the direction of clarifying the applicable methodological and technological tools for studying the degree of development of the e-government system. The conclusions are in the direction of the achieved methodological and technological readiness for conducting a survey in the local administration.

Risks for the Successful Implementation of Projects Related to the Use of Natural Resources

The article examines the specifics of projects related to the use of natural resources for economic purposes. Up-to-date statistical information on their application in modern economy is presented, which reveals the trends in this regard. By reviewing the applicable regulatory framework, at constitutional and legal level, the article outlines the basic requirements for activities related to the use of natural resources, the relevant regulatory regimes, the procedures for granting rights of use, exploitation and extraction, the competent authorities, deadlines for implementation of granted rights, etc. The features of the different types of uses, which arise from the specifics of each natural resource, the different aspects of their management and the risks that accompany their life cycle are studied. Practical examples of the impact of some major risks on the use of natural resources for economic purposes are presented. The general framework for the management of projects related to the use of natural resources is examined, including: identification of project objectives and possible sources of funding; planning of the activities and the budget of the project; assessment and planning of the necessary resources for its implementation; specifics related to the completion of such projects. The main focus of the article is the risks for the implementation of such projects, whose specific features stem from the depletion of natural resources, the strong legal regulation in the sector and the strict environmental requirements of the applicable legislation. The main risks in the management of projects related to the use of natural resources have been identified: regulatory, political, financial, operational, etc., and the effect on their implementation has been studied.

Socio-economic parameters that influence the disposal of refrigerators and televisions in an urban area of Colombia

The article presents a correlational study conducted in 2018, with people from different socioeconomic strata in the city of Armenia, Quindío; intermediate city of Colombia, developing country. The study allows associating socioeconomic variables with the efficient management of waste from refrigerators and televisions, through the use of the Pearson coefficient, determination and the Durvin-Watson test.The results show that people located in socioeconomic strata four, five and six are more willing to have direct control strategies applied to them, such as payment of penalties (through taxes), when making a non-efficient final disposal (against the applicable regulatory framework), while those located in strata one to three, the preference is given to non-economic sanctions and receiving subsidies as an incentive for their actions in favor of the ecosystem.

Bringing Code to Data: Do Not Forget Governance.

Developing or independently evaluating algorithms in biomedical research is difficult because of restrictions on access to clinical data. Access is restricted because of privacy concerns, the proprietary treatment of data by institutions (fueled in part by the cost of data hosting, curation, and distribution), concerns over misuse, and the complexities of applicable regulatory frameworks. The use of cloud technology and services can address many of the barriers to data sharing. For example, researchers can access data in high performance, secure, and auditable cloud computing environments without the need for copying or downloading. An alternative path to accessing data sets requiring additional protection is the model-to-data approach. In model-to-data, researchers submit algorithms to run on secure data sets that remain hidden. Model-to-data is designed to enhance security and local control while enabling communities of researchers to generate new knowledge from sequestered data. Model-to-data has not yet been widely implemented, but pilots have demonstrated its utility when technical or legal constraints preclude other methods of sharing. We argue that model-to-data can make a valuable addition to our data sharing arsenal, with 2 caveats. First, model-to-data should only be adopted where necessary to supplement rather than replace existing data-sharing approaches given that it requires significant resource commitments from data stewards and limits scientific freedom, reproducibility, and scalability. Second, although model-to-data reduces concerns over data privacy and loss of local control when sharing clinical data, it is not an ethical panacea. Data stewards will remain hesitant to adopt model-to-data approaches without guidance on how to do so responsibly. To address this gap, we explored how commitments to open science, reproducibility, security, respect for data subjects, and research ethics oversight must be re-evaluated in a model-to-data context.

Environmental drivers and sustainable transition of dachas in Eastern Europe: An analytical overview

Dachas (collective gardens with summer houses in post-Soviet countries) is one of the most common features of peri-urban landscapes within the region that is the erstwhile USSR, with dacha conglomerates constituting half of the areas in the exurbs of major cities. In Belarus, Russia and Ukraine dachas largely preserved their original form and function. Arguably, they are at the turning point now, and can be further transformed sustainably if appropriate incentive structures will be created within national governance systems. The central objective of this study therefore is to understand the origin and transition of dacha’s form, process and function in terms of their environmental and social impact, as well as opportunities for transformative change towards sustainability under various governance conditions in the three countries.Building on field data from three suburban locations in Belarus, Russia and Ukraine, as well as analysis of applicable regulatory frameworks and institutions in the three countries, we analysed social and behavioural background of dachas, management practices relevant to their environmental footprint, as well as governance frameworks, actors and power relations. Findings were further discussed in terms of governance barriers and solutions for sustainability transformation of dachas in a broader context of peri-urban transformation, and provide a comparative perspective across Eastern Europe. As such, none of the pathways have emerged as better than the rest in terms of sustainability. Variability of socio-economic and political contexts found in the region suggests that no “one size fits all” governance approach can be recommended. Any solutions paving the way for transformative changes would require proper information and knowledge systems with a smoother regulatory framework, and a purposeful restructuring of existing actor relationships.

REVISIÓN CRÍTICA DE LA MIGRACIÓN IRREGULAR COMO RIESGO A LA SEGURIDAD NACIONAL

El fenómeno de las “caravanas migrantes” ha generado que el estado Mexicano gestione los flujos acogiéndose al mandato de seguridad nacional pues ejecuta acciones que se sustentan en su defensa, como lo evidencia la participación activa de las fuerzas armadas bajo la figura de la Guardia Nacional. A partir de ello se analizan los marcos normativos aplicables, a fin de determinar la dualidad de su carácter: el atinente al discurso de prevalencia irrestricta de los Derechos Humanos y el que se refiere a la naturaleza securitaria y policiaca tanto del (INM Instituto Nacional de Migración) como de la política migratoria en su conjunto. Dualidad que se percibe como contradictoria, excluyente, pero sobre todo difusa, ante la variedad, oscuridad y ambigüedad del discurso normativo relativo a la(s) seguridad(es) en México. Aquí se analiza a través de la teoría de la Encriptación del Poder (Méndez y Sanín, 2012) la función de la noción de seguridad nacional en el derecho migratorio y la elasticidad de la misma para adecuarse a las situaciones históricas concretas, teniendo en cuenta que dicha noción, podría ubicarse entre aquéllas que resultan impensables fuera de la simbiosis modernidad-colonialidad que articula la teoría a utilizar.

Performance Assessment of BIPV Systems: From Current Normative Framework to Next Developments

The growing demand for the use of photovoltaic (PV) systems integrated in buildings, having the need to be versatile, to provide design and multifunctional features more evolved than the only energy production, is imposing a profound change in the sector of Building Integrated Photovoltaics (BIPV), with major challenges to be addressed in the coming years. Supported by an increasing technological development, by digitization and process innovation, such systems will progressively be implemented in the construction market allowing the achievement of the nZEB policies. BIPV products are evolving from the basic architectural integration towards multifunctional products, aggregating essential PV requirements with additional requirements from the building skin such as thermal insulation, solar control, fire safety, water tightness, etc. However, to effectively enter the building market, the BIPV products will necessarily have to respect the goal of cost-effectiveness as well as the compliance with adequate quality, safety and reliability levels. In this context, the H2020 project BIPVBOOST is focused on obtaining a reduction in costs along the entire value chain by pursuing product and process innovation, thus supporting the BIPV implementation in a wider mass market of the built environment. In addition to a technological development, it is essential to solve the interconnection between PV product standards, construction industry standards and specific rules for the installation and use in buildings. The EN 50583-1:2016 and EN 50583-2:2016 made a first step in this direction by defining the properties and the applicable regulatory framework for PV systems modules used as construction products. Nevertheless, the current regulatory framework collects norms created for standard PV or, on the other hand, for “non-active” building elements, so that a significant progress regarding BIPV qualification is still needed, and it represents a current barrier for the market access. It arises the need to identify new “multi-disciplinary” reference requirements, to improve the definition of the performance levels and to develop new test methodologies better suited to the use of PV in the building skin. Therefore, these issues will be addressed within the project by identifying the gaps in the current standards and by implementing a performance-based approach for the qualification of BIPV products. The paper, summarizing the first investigations of the project, will provide an overview on the current normative framework, reporting the main missing gaps and a roadmap to define new reference procedures for BIPV products qualification, setting the basic ground for next developments in the coming years.