Regulatory Concepts Research Articles

State Feedback Via Judicious Pole Placement and Linear Quadratic Regulator – Application to Rotary Inverted Pendulum

In the control system regulatory concept, placing closed loop poles too far from the origin in the stability region produces fast regulation time but requires huge forcing energy as a trade-off. As such, stabilizing an unstable system with minimum energy is needed, though this presents a challenge to the designer. At the design phase, the designer may ponder the optimized energy while compromising the possibility of catastrophic stabilization phenomena due to minimal forcing thrust towards the poles. In this manuscript, a simple Linear Quadratic Regulator (LQR) is proposed as an alternative to full state feedback (FSF) with judicious pole placement. The efficacy of both approaches was observed by exploiting a Rotary Inverted Pendulum (RIP) as a testbed. Beforehand, the RIP system dynamics were developed in the time domain. RIP is an under-actuated mechanical system that is inherently nonlinear and unstable. The main control objectives of RIP are swing-up control, stabilization control, switching control, and trajectory control. The methodology involved the appearance of weighted matrices that were necessary for the minimum cost function. The Riccati and Lyapunov criteria are also exploited to facilitate design. The result shows the comparative transient performances of the two approaches, where the LQR outperforms the FSF in many aspects.

The Restructuring Righteous Foreign Worker Regulations: The Challenge of Enormous Influx of Foreign Workers

Foreign workers are needed to overcome the challenge of a shortage of professional workers. However, the ineffectiveness of foreign worker licensing regulations in Indonesia hampers the supply of qualified foreign workers and impacts regional levy revenues. This research aims to structure the rules for the fair use of foreign workers. This is normative juridical research with conceptual, statutory, and comparative approaches. The results of a comparison of foreign worker regulations in Indonesia and Singapore are used to develop a regulatory concept that is more responsive to the use of foreign workers, especially in the health sector. The idea of licensing law and justice theory is used for analysis. The research results show that the regulations on using foreign workers in Indonesia are not yet comprehensive regarding the rules for qualifying foreign workers as a condition for issuing permits and justifying good public services. The issuance of permits to use foreign workers has been hampered because several regions do not yet have implementing regulations that impact the collection of regional levies. Second, setting up mechanisms for utilizing foreign workers in Singapore is relatively easy and successful with strict digital-based permit requirements. Thus, Indonesia needs to adopt a foreign labor policy system with strict requirements for issuing permits that are accessible in terms of bureaucracy, changes to laws, implementation of regulations, and drafting of regional regulations.

Multihierarchical Regulation To Achieve Quantum Dot Nanospheres with a Photoluminescence Quantum Yield Close to 100.

Quantum dots (QDs) exhibit superior brightness and photochemical stability, making them the preferred option for highly sensitive single-molecule detection compared with fluorescent dyes or proteins. Nevertheless, their high surface energy leads to nonspecific adsorption and poor colloidal stability. In the past decades, we have found that QD-based fluorescent nanoparticles (FNs) can not only address these limitations but also enhance detection sensitivity. However, the photoluminescence quantum yield (PLQY) of FNs is significantly lower compared with that of original QDs. It is urgent to develop a strategy to solve the issue, aiming to further enhance detection sensitivity. In this study, we found that the decrease of PLQY of FNs prepared by free radical polymerization was attributed to two factors: (1) generation of defects that can cause nonradiative transitions resulting from QD-ligands desorption and QD-shell oxidation induced by free radicals; (2) self-absorption resulting from aggregation caused by incompatibility of QDs with polymers. Based on these, we proposed a multihierarchical regulation strategy that includes: (1) regulating QD-ligands; (2) precisely controlling free radical concentration; and (3) constructing cross-linked structures of polymer to improve compatibility and to reduce the formation of surface defects. It is crucial to emphasize that the simultaneous coordination of multiple factors is essential. Consequently, a world-record PLQY of 97.6% for FNs was achieved, breaking through the current bottleneck at 65%. The flexible application of this regulatory concept paves the way for the large-scale production of high-brightness QD-polymer complexes, enhancing their potential applications in sensitive biomedical detection.

The “Safe and Sustainable by Design” Concept – A Regulatory Approach for a More Sustainable Circular Economy in the European Union?

Abstract The creation of a more sustainable economy is one of the main targets of the European Green Deal and the new Circular Economy Action Plan. Technological innovation is needed, among other things, to render materials, products, and production processes more sustainable. Given the goals of the European Green Deal, the regulatory concept of “Safe and Sustainable by Design” is increasingly receiving attention. The concept is (arguably) a precautionary and preventative measure that is implemented at the early stages of the design of a technology. Therefore, it is often described as a tool for lowering the risks that follow from efforts to create a more circular economy. The concept was included in the European Chemicals Strategy of the European Commission. The aim of the strategy is to accelerate progress towards the discovery of more sustainable chemicals and towards a toxicity-free environment. In this paper, we will explore the benefits and disadvantages of integrating the “Safe and Sustainable by Design” concept into the regulation of technology. As a form of regulation by technology, this concept can enhance sustainability. We will first describe the origins of the concept and its current use. Then, we will analyse its implications for the circular economy.

Breaking the pH Limitation of Nanozymes: Mechanisms, Methods, and Applications.

Although nanozymes have drawn great attention over the past decade, the activities of peroxidase-like, oxidase-like, and catalase-like nanozymes are often pH dependent with elusive mechanism, which largely restricts their application. Therefore, a systematical discussion on the pH-related catalytic mechanisms of nanozymes together with the methods to overcome this limitation is in need. In this review, various nanozymes exhibiting pH-dependent catalytic activities are collected and the root causes for their pH dependence are comprehensively analyzed. Subsequently, regulatory concepts including catalytic environment reconstruction and direct catalytic activity improvement to break this pH restriction are summarized. Moreover, applications of pH-independent nanozymes in sensing, disease therapy, and pollutant degradation are overviewed. Finally, current challenges and future opportunities on the development of pH-independent nanozymes are suggested. It is anticipated that this review will promote the further design of pH-independent nanozymes and broaden their application range with higher efficiency.

Entrepreneurial growth: Bridging experiential learning, ecological systems analysis and governance of entrepreneurship center environments

This paper delves into the intricate interplay of leadership dynamics, governance, and regulatory concepts within a South African university-based entrepreneurship center (EC). Guided by Kolb’s (2014) experiential learning model (Kolb, 2014), the research aims to understand how experiential learning shapes leadership and the “self” within the EC, unraveling the nuanced relationship between leadership, personal mastery, governance, and regulatory compliance. The methodology integrates experiential insights, literature reviews, and systems analysis. Key findings highlight the implicit integration of governance and regulatory concepts, ensuring ethical standards adherence. Senge’s (2006) fifth discipline model emphasizes the pivotal role of a learning culture, while concepts of governance structure learning processes and ensure compliance. Personal mastery aligns with governance, emphasizing leaders’ responsibility for ethical standards and continuous self-improvement. Short’s (1998) insights on learning in relationships and Kaner’s (2014) facilitation guide contribute to the governance of participatory decision-making processes within the EC. The methodology contributes to a conceptual framework exploring the reciprocal influence between leadership and the “self”. The study concludes by offering actionable strategies for EC leaders, emphasizing adaptability, collaboration, and a profound understanding of leadership dynamics, governance, and regulatory concepts. Its relevance lies in guiding EC leaders toward sustained growth in the ever-evolving entrepreneurship ecosystem.

Digital Revolution, Institutional Coevolution, and Legal Innovations

The digital transformation “revolutionizes” entire economies and societies in a Schumpeterian sense. This paper analyzes three current policy debates with respect to the question, whether and to what extent also radical legal innovations might be necessary for ensuring a proper coevolution of the legal and regulatory framework with respect to the disruptive technological and economic change on digital markets. These discussions encompass (1) the new challenges for competition policy through the large tech firms with far-reaching reforms, e.g., the EU Digital Markets Act, (2) the new huge threats to privacy, and the serious concerns whether the data protection law instrument of “consent” can deal with this problem effectively, and (3) entirely new questions about the governance of data (data access/sharing etc.) with the development of a new (so far not existing) field of data law. In all three of these policy fields traditional legal and regulatory concepts do not seem to be sufficient any more, leading to the conclusion of the need for developing new concepts and policy approaches for ensuring a proper coevolution of the institutional framework for the economy and society. Digitisation, digital platforms, Big Tech, market power, competition, privacy, data protection, data governance, legal innovation, legal evolution

Review of the Monograph “Linguistic Transformation of Reality” by V.I. Karasik

The monograph discusses the issues of lingua-semiotics, linguaculturology, axiological linguistics and discourse studies. The characteristics of linguistic and cultural concepts, dramatic plots and types of discourse on the material of the Russian, English and German languages are considered. The monograph consists of three sections: “Conceptual Functionality of Language”, “Narrative Functionality of Language” and “Discourse Functionality of Language”. The basic parametric concepts of space and time (infinity and eternity), regulatory concepts of behavior (power, perseverance and stubbornness, style and reputation), the concept of the mastered world (house, garden, merry-go-round) and natural phenomena (fire and ice) are described. As illustrative material, the plots “journey into the past”, “flight into space”, “eternal youth”, “meeting or joint adventures of twins” are considered. When describing the discourse potential of language, the modes of self-expression in communication, the illogical varieties of world perception in different types of discourse (participation), the peculiarities of mystification, discourse accuracy and inaccuracy, the unification of different types of discourse in a speech act (discourse convergence) are shown. It is meant for philologists and a wide range of researchers developing the foundations of the integral science of man.

Regulatory considerations for medical imaging AI/ML devices in the United States: concepts and challenges.

To introduce developers to medical device regulatory processes and data considerations in artificial intelligence and machine learning (AI/ML) device submissions and to discuss ongoing AI/ML-related regulatory challenges and activities. AI/ML technologies are being used in an increasing number of medical imaging devices, and the fast evolution of these technologies presents novel regulatory challenges. We provide AI/ML developers with an introduction to U.S. Food and Drug Administration (FDA) regulatory concepts, processes, and fundamental assessments for a wide range of medical imaging AI/ML device types. The device type for an AI/ML device and appropriate premarket regulatory pathway is based on the level of risk associated with the device and informed by both its technological characteristics and intended use. AI/ML device submissions contain a wide array of information and testing to facilitate the review process with the model description, data, nonclinical testing, and multi-reader multi-case testing being critical aspects of the AI/ML device review process for many AI/ML device submissions. The agency is also involved in AI/ML-related activities that support guidance document development, good machine learning practice development, AI/ML transparency, AI/ML regulatory research, and real-world performance assessment. FDA's AI/ML regulatory and scientific efforts support the joint goals of ensuring patients have access to safe and effective AI/ML devices over the entire device lifecycle and stimulating medical AI/ML innovation.

The role of replication-induced chromosomal copy numbers in spatio-temporal gene regulation and evolutionary chromosome plasticity.

For a coherent response to environmental changes, bacterial evolution has formed a complex transcriptional regulatory system comprising classical DNA binding proteins sigma factors and modulation of DNA topology. In this study, we investigate replication-induced gene copy numbers - a regulatory concept that is unlike the others not based on modulation of promoter activity but on replication dynamics. We show that a large fraction of genes are predominantly affected by transient copy numbers and identify cellular functions and central pathways governed by this mechanism in Escherichia coli. Furthermore, we show quantitatively that the previously observed spatio-temporal expression pattern between different growth phases mainly emerges from transient chromosomal copy numbers. We extend the analysis to the plant pathogen Dickeya dadantii and the biotechnologically relevant organism Vibrio natriegens. The analysis reveals a connection between growth phase dependent gene expression and evolutionary gene migration in these species. A further extension to the bacterial kingdom indicates that chromosome evolution is governed by growth rate related transient copy numbers.

ABUSE OF AUTHORITY BY THE REGIONAL GOVERNMENT FOR THE CONSTRUCTION OF NATIONAL ROADS

Roads as one of the transportation infrastructure are important elements in building the life of the nation and state. The government has an important role in providing investment for road construction in accordance with its authority as regulated in Law Number 2 of 2022 on the Second Amendment to Law Number 38 of 2004 concerning Roads. However, there are district governments carrying out the construction of national roads which should be the authority of the central government. This writing uses a normative research method with a statutory approach and a conceptual approach related to regulations and regulatory concepts over the authority of local governments in the construction of national roads. Besides that, it uses a conceptual approach , namely the approach taken to the concept of regional government authority in road construction . The purpose of this study is to analyze the abuse of authority by the Regional Government for the construction of National Roads. The results of the study stated that the Regency/City Regional Government carried out the construction of national roads , The regency /city regional government fulfills the element of abusing authority or exceeding authority . For this reason, the central and regional governments can carry out road construction, but this must be in accordance with their respective authorities.

Social Licence as a Regulatory Concept: An Empirical Study of Australian Company Directors

Growth of ‘social licence to operate’ (‘SLO’) may reflect an evolution of the stakeholder-shareholder debate, and an expansion of the power of employees, investors and society generally, described by the smart regulatory model as third-party or ‘surrogate’ regulators of corporate activity. Despite the broad implications of SLO for regulation, little is known about the perceptions of company directors in relation to SLO. This article reports on an empirical investigation of Australian directors’ perspectives, undertaken after the Australian Securities Exchange’s proposal to formalise regulatory use of SLO. Directors’ responses provide support for theoretical models of third-party regulators. They identify SLO and concepts of trust, relationships and reputation as important and, crucially, part of the future. However, responses also reveal potential limitations in SLO’s contours that impact its use as a regulatory concept. Regulatory systems must account appropriately for the complex phenomenon of SLO, so its potential benefits are harnessed effectively.

Functional paradigm in Russian studies: from the functioning of units to the regulatory concept of language

Today the Russian language has gone beyond Russia and forms the planetary Russian-speaking world, so Russian language studies, whose subject matter is traditionally considered the literary form of the language, seeks to reach a new level of comprehension of both the language and individual facts. The relevance of the study is due to the fact that at the present stage ideas of synthesis come to the fore in linguistics, there are tendencies to develop a theory of language integrating the latest achievements of different areas of linguistics on a single basis. In accordance with this, the aim of the research is to compare the regulative concept of language in the works of A.N. Rudyakov with the works of other linguists in order to establish the key features and principles of a new linguistic paradigm and define language as a regulatory system based on linguistic functionalism. Deductive, analytical-theoretical and modeling methods describe the current state of the scientific linguistic paradigm and general linguistic problems associated with the concepts under study. The key features of the modern scientific linguistic paradigm are established, since without defining theoretical guidelines, modern language science loses its practical value. As a result, the authors substantiated that the new paradigm is not only an appeal to new material and new research methods, but the creation of a fundamentally new theory that will take into account the role of language in society, its ontological, functional essence. Based on the definition of the key features of the functional approach to the language and its units, the authors demonstrate that linguistics not only borders on other sciences, but is in some way an integral part of them, the basis of the human Universe. In the future, the presented material allows us to see that the change of the scientific paradigm, despite the objective difficulties, today is a prerequisite for the further development of linguistics. It also outlines a range of theoretical and practical tasks that modern linguistics faces and which can be solved within the framework of a new paradigm.

Small RNAs, Large Networks: Posttranscriptional Regulons in Gram-Negative Bacteria.

Small regulatory RNA (sRNAs) are key mediators of posttranscriptional gene control in bacteria. Assisted by RNA-binding proteins, a single sRNA often modulates the expression of dozens of genes, and thus sRNAs frequently adopt central roles in regulatory networks. Posttranscriptional regulation by sRNAs comes with several unique features that cannot be achieved by transcriptional regulators. However, for optimal network performance, transcriptional and posttranscriptional control mechanisms typically go hand-in-hand. This view is reflected by the ever-growing class of mixed network motifs involving sRNAs and transcription factors, which are ubiquitous in biology and whose regulatory properties we are beginning to understand. In addition, sRNA activity can be antagonized by base-pairing with sponge RNAs, adding yet another layer of complexity to these networks. In this article, we summarize the regulatory concepts underlying sRNA-mediated gene control in bacteria and discuss how sRNAs shape the output of a network, focusing on several key examples.

Risk Management in the Artificial Intelligence Act

Abstract The proposed Artificial Intelligence Act (AI Act) is the first comprehensive attempt to regulate artificial intelligence (AI) in a major jurisdiction. This article analyses Article 9, the key risk management provision in the AI Act. It gives an overview of the regulatory concept behind the norm, determines its purpose and scope of application, offers a comprehensive interpretation of the specific risk management requirements and outlines ways in which the requirements can be enforced. This article can help providers of high-risk systems to comply with the requirements set out in Article 9. In addition, it can inform revisions of the current draft of the AI Act and efforts to develop harmonised standards on AI risk management.

Partie 2. Exigences réglementaires en médecine nucléaire

In terms of design and operating rules, there are to date a large number of applicable texts and related prescriptions, complicating the overall understanding of the requirements in this area. Thanks to the latter, however, it is possible to identify the optimal requirements in terms of radiation protection, both in terms of design and operation, in order to develop and structure a nuclear medicine department that adapts to the risks of exposure to ionizing radiation in accordance with the “ALARA” radiation protection principle. For this, many instances are involved and the precise chronology of the various filings of files and procedures, also relatively difficult to understand and yet essential to the development of an NM service. Several documents exist to guide nuclear physicians in their approach, sometimes serving as a “reference” and allowing certain regulatory concepts to be defined.

Green Manufacturing for Herbal Remedies with Advanced Pharmaceutical Technology.

Herbal remedies are in most cases still manufactured with traditional equipment installations and processes. Innovative chemical process engineering methods such as modeling and process intensification with green technology could contribute to the economic and ecologic future of those botanicals. The integration of modern unit operations such as water-based pressurized hot water extraction and inline measurement devices for process analytical technology approaches in traditional extraction processes is exemplified. The regulatory concept is based on the quality-by-design demand for autonomous feed-based recipe operation with the aid of digital twins within advanced process control. This may include real-time release testing to the automatic cleaning of validation issues. Digitalization and Industry 4.0 methods, including machine learning and artificial intelligence, are capable of keeping natural product extraction manufacturing and can contribute significantly to the future of human health.

Persistence and Mobility (defined as organic‑carbon partitioning) do not correlate to the detection of substances found in surface and groundwater: Criticism of the regulatory concept of Persistent and mobile substances

The Chemical Strategy for Sustainability (CSS) includes actions to ensure the protection of drinking water resources from chemical pollution. To proactively identify potential pollutants, the German Environment Agency (UBA) proposed the Persistent and Mobile (PM) concept according to which Persistence (criteria of REACH Annex XIII) and Mobility (log Koc < 4) would be proxies for a substance's degradation potential and transport velocity, two processes believed to drive the potential for contamination of surface and groundwater as drinking water sources. Two studies identified hundreds of PM substances while three subsequent studies have selected some of these substances for monitoring in surface, ground- and/or drinking water to support the concept. In the present work, the Persistence of the aforementioned substances was reassessed based on all experimental data publicly available. Depending on the exact study examined, it was found that 15 % to 40 % of the substances were erroneously concluded as P. The reinterpretation of the data indicates that a PM substance does not have a higher likelihood to be detected in surface or groundwater than a non-PM substance. In addition, the PM properties do not have any influence on the level of contamination. Twenty-six to 75 % of the substances selected because they were identified as PM were not found in surface or ground water despite being selected for their high emission pattern. Regulations based primarily on the PM concept, like the CLP and possibly REACH and UN-GHS, are unlikely to appropriately identify substances of concern for drinking water sources. It is more likely that chemical presence in surface and groundwater is driven by emission patterns or local factors. The development of specific exposure models would better contribute to the protection of drinking water resources and consumers.

Transformer-based approach for automated context-aware IFC-regulation semantic information alignment

One of the main challenges of automated compliance checking systems is aligning the semantics of the building information models (BIMs), in Industry Foundation Classes (IFC) format, and the semantics of the regulations, in natural language, to allow for checking the compliance of the BIM with the regulations. Existing information alignment methods typically require intensive manual effort and their ability to deal with the complex regulatory concepts in the regulations is limited. To address this gap, this paper proposes a deep learning method for IFC-regulation semantic information alignment. The proposed method uses a relation classification model to relate and align the IFC and regulatory concepts. The method uses a transformer-based model and leverages the definitions of the concepts and an IFC knowledge graph to provide additional contextual information and knowledge for improved classification and alignment. The proposed method was evaluated on IFC concepts from IFC 4 and regulatory concepts from different building codes and standards. The experimental results showed good information alignment performance.

THE EXISTENCE OF PANCASILA IN RESOLVING CONFLICTS OF DIFFERING VIEWS ON RELIGIOUS RIGHTS IN INDONESIA

This research investigates how Pancasila (the Five Principles) could serve as an equilibrium in regulating the freedom of religion in Indonesia and how these five principles could negotiate the concept of this freedom within the coverage of national Human Rights affected by western human rights related to the concept of the freedom of religions within the scope of Islam. The three different regulatory concepts regarding freedom of religion in Indonesia, constituting Islamic law, International Human Rights, and Particular Human Rights, have always sparked conflict unless these three concepts are accommodated by law. The analysis was performed by employing the doctrine of margin of appreciation. This research reveals that Pancasila could serve as the fundamental of Indonesia in facilitating the freedom of religion. This research also employed a normative-juridical method, interdisciplinary, statutory, and conceptual approaches.