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With the application of the two-tier capital agreement and the introduction of the three-tier capital agreement, the discussion of the role of banks’ capital in the monetary transfer mechanism and banks’ lending decisions has become more important. In this regard, in this research, the effect of the legal requirements of the Basel III Agreement on the lending power and financial stability of the banking sector in Iran has been investigated using the system of simultaneous equations. For this purpose, the data from 19 selected banks and financial institutions were used during the period of 2011-2019. The findings of the research showed that the legal requirements of Basel III had negative and significant effects on bank lending. It was also observed that the legal requirements of Basel III had positive and significant effects on the financial stability of banks. [ABSTRACT FROM AUTHOR]

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

New political objectives, emerging regulatory regimes for the digital sphere, and higher penalties for violations have intensified the pressure to develop lawful IT artefacts. As the adaptation of existing IT artefacts to new regulations can be expensive and arduous, a more attractive approach would be to design IT artefacts lawfully from the beginning. A major challenge is that the law is generally technology-neutral, and lawful design requires legal expertise throughout the development, which is costly and time consuming due to communication challenges between legal experts and developers. One possible approach to proactively consider IT regulations in the systems development is design patterns that convey legal design knowledge and support developers in determining the appropriate design options. Consequently, we develop a framework for lawful design patterns and demonstrate their feasibility and advantages using the example of developing AI-based assistants and the regulation of the General Data Protection Regulation (GDPR). Using the design pattern framework, we develop design patterns for lawful AI-based assistants and evaluate them using (a) an experimental approach to show the usefulness of the patterns for developers and (b) rely on a legal simulation study to holistically evaluate how design patterns contribute to lawful IT. [ABSTRACT FROM AUTHOR]

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

Copyright of Management & Quality / Zarządzanie i Jakość is the property of Scientific Society of Organization & Management / Towarzystwo Naukowe Organizacji i Kierownictwa and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

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

Copyright of Zentralblatt fuer Arbeitsmedizin, Arbeitsschutz und Ergonomie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Purpose: The purpose of the study is to present the changes resulting from the publication of Regulation 2023/1230/EU in the field of essential requirements for machinery. Design/methodology/approach: As part of the conducted analyses, the changes resulting from the publication of the new Machinery Regulation 2023/1230/EU were summarized and the manufacturers' obligations regarding the conformity assessment process were summarized, as well as the possibilities of supporting work in the field of essential requirements using computer software. Findings: Based on the analyzes carried out, differences in the scope of legal acts were summarized. It was also found that the new regulation's requirements include an additional group of products that the Machinery Directive did not explicitly cover. Research limitation/implications: The conducted analyzes were limited to EU law requirements specified in the Machinery Directive and the regulation. Practical implications: The research carried out may provide important information for manufacturers and employers regarding the changes resulting from the publication of the Machinery Regulation 2023/1230/EU, also adapted to the evolving technological changes. The study also summarizes additional aspects resulting from, among others, taking into account: new definitions, the introduction of a new conformity assessment procedure, third-party participation in the conformity assessment process, and digital instructions. Originality/value: The article refers to the changes resulting from the 2023/1230/EU machinery regulation. [ABSTRACT FROM AUTHOR]

This paper emphasises the importance of — and the complexity inherent in — the navigation of regulatory oversight and legal requirements in the area of electric utility performance. With a particular focus on utility companies in New York State, it discusses recent measures taken to adapt to the changing demands of regulatory compliance. [ABSTRACT FROM AUTHOR]

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

The article examines the foreign experience of legislative consolidation of the prosecutor's legitimate requirements and identifies the prospects for its adoption in Ukraine. It is emphasized that the legal requirements of the prosecutor are aimed at protecting the rights and freedoms of citizens, and their failure to fulfill them entails liability under Ukrainian law. It is emphasized that the adoption of an effective model of prosecutorial activity can be implemented by Ukraine and will contribute to the unification of legislation for Ukraine's accession to the EU as a member state. The author summarizes that: a) the legislation on prosecution, as well as the name and system of such bodies, may differ significantly, but the essence of the principles and tasks of the prosecution is unified in accordance with EU policy; b) the absence of requirements defined in the relevant legislation on prosecution does not mean their automatic absence in the legislation. Relevant legal requirements and other tools of prosecutorial response are specified and supplemented in national legislation, depending on the tasks and functions of the prosecution service in a particular state; c) the most appropriate for Ukraine to adopt as a basis is the positive experience of post-Soviet states that have demonstrated successful implementation of democratic reforms (primarily the Baltic states - Latvia, Lithuania, Estonia); d) at the national level, it is advisable to specify and enshrine in a separate article the requirements which may be made by the prosecutor within the framework of exercising his/her powers. The author concludes that specifying the legal requirements of the prosecutor in the Law of Ukraine "On the Prosecutor's Office" from 14.10.2014 may in the future contribute to improving the efficiency of pre-trial investigation, eliminating the possibility of abuse by prosecutors and better protecting the rights of persons to whom the relevant requirements are addressed. [ABSTRACT FROM AUTHOR]

Objectives: This study aimed to assess compliance with legal requirements, safe medication storage and staffing standards in community pharmacies in Punjab, Pakistan. Method: We conducted a three-step cross-sectional study using observations, questionnaires and face-to-face interviews in 544 systematically-selected community pharmacies. We used descriptive statistic and one-way ANOVA to assess the data. Results: Only 23 (4.2 %) pharmacies had accurate area and only 3.9 % had appropriate walls. In total, 23.3 % had glass-fronted shelves and 38.2 % had a glass door. More than half (53.8 %) had separate narcotics shelves and 43.0 % a separate shelf of expired medicines. Less than half (47.5 %) of the pharmacies were able to maintain hygiene. About 36.2 % of the pharmacies segregated different types of product. Drugs were protected from direct sunlight in most (61.3 %) pharmacies, but the refrigerator was working properly in less than half (43.4 %) and only a very small number (2.4 %) had an alternative power supply for the refrigerator. Only 37 (6.8 %) were able to maintain an appropriate room temperature. The vast majority (93.0 %) displayed a valid drug sale license, but a qualified person/pharmacist was only present in 4.8 %. The average number of employees was 4.2, and more than 71.0 % of staff had 10–12 years of formal education. Only 0.2 % of employees could explain term “PRN”, although 57.3 % explained “IV” correctly. About 22.8 % replied correctly about the room temperature but the vast majority (97.6 %) did not know about cold chain temperature. The location of the pharmacy (p-value = 0.045) affected its performance. Conclusions: Noncompliance with legal requirements, unsafe drug storage and limited human resources reflect the poor enforcement of drug laws in Pakistan. The findings suggest that there is a need to strengthen inspection and management of community pharmacies.

Copyright of Uzhhorod National University Herald Series Law is the property of Uzhhorod National University, State Higher Educational Establishment and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Journal of Islamic & Religious Studies / Majallah-yi ʿUlūm-i Islāmiyyah va Dīniyyah is the property of University of Haripur, Pakistan and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Abstract Introduction An important dimension of care and case managers is to support geriatric patients in obtaining social services in medical, nursing, therapeutic and social fields. To this, they advise and represent their patients. Methods The documentation of patient contacts with case managers of a network of physicians was evaluated. In particular, activities involving legal advice were analysed in detail, compared with the current legal situation in Germany and evaluated. In addition, qualitative expert interviews were conducted. The content and the legal requirements of legal services law were determined by applying legal interpretation methods (esp. wording, telos, systematics). The results of the evaluation of the documentation were compared with legal requirements. Results Care and case management touches activities in some fields of action without having a legal basis in legal services law. This leads to the fact that these services may not be provided and to - uninsured and uninsurable - liability risks. Discussion With the introduction of care and case management into standard care, both social law and the Legal Services Act must be adapted to enable the legally compliant use of care and case managers. Otherwise, certain services that are useful for the care of patients may not be provided.

Abstract Consent in medical practice is a process riddled with layers of complexities. To some extent, this is inevitable given that different medical conditions raise different sets of issues for doctors and patients. Informed consent and risk assessment are highly significant public health issues that have become even more prominent during the course of the Covid-19 pandemic. In this article we identity relevant factors for clinicians to consider when ensuring consent for solid organ transplantation. Consent to undergo solid organ transplantation is more complex than most surgical and other clinical interventions because of the many factors involved, the complexity of the options and the need to balance competing risks. We first out the context in which consent is given by the patient. We then outline the legal principles pertaining to consent in medical practice as it applies in the UK and the implication of recent legal judgments. The third section highlights specific complexities of consent in organ transplantation and identifies relevant factors in determining consent for organ transplantation. The fourth section offers practical recommendations. We propose a novel ‘multi-factor approach’ to informed consent in transplantation which includes understanding risk, effective communication, and robust review processes. Whilst understanding risk and communication are a given, our suggestion is that including review processes into the consent process is essential. By this we specifically mean identifying and creating room for discretion in decision-making to better ensure that informed consent is given in practice. Discretion implies that health care professionals use their judgement to use the legal judgements as guidance rather than prescriptive. Discretion is further defined by identifying the relevant options and scope of clinical and personal factors in specified transplantation decisions. In particular, we also highlight the need to pay attention to the institutional dimension in the consent process. To that end, our recommendations identify a gap in the current approaches to consent. The identification of areas of discretion in decision-making processes is essential for determining when patients need to be involved. In other words, clinicians and healthcare professionals need to consider carefully when there is room for direction and where there is little or no room for exercising discretion. In sum, our proposed approach is a modest contribution to the on-going debate about consent in medicine.

Europe is currently facing the potentially biggest energy crisis in history. There are many reasons for this, and the current geopolitical situation makes it clear that we are being forced to take immediate action to ensure sufficient energy supplies to consumers. Until recently, the European Union was dependent on Russian energy resources (mainly oil and gas). For many years, the EU countries had been shutting down their own production and importing much cheaper raw material from Russia. The threat of a blackout is becoming increasingly possible. European governments are preparing businesses and households for the energy crisis in various ways, but there is also a great deal of mobilization to accelerate the development of renewable energy sources (RES). The aim of this study was to identify the barriers and prospects for RES development in Poland in the current geopolitical conditions. The reasons for insufficient grid HC were analyzed. Additionally, the article aimed to assess the prospects for solar energy development in Poland. Wind power was discussed only in general terms because the development of wind farms is inhibited by the regulatory framework. Particular attention was paid to hosting capacity (HC) and the condition of the power infrastructure as the main determinants of RES development in Poland. Numerous documents developed by power companies and government agencies responsible for implementing and managing energy in Poland were analyzed. Special attention was paid to legal regulations and the need for legislative changes. As a country, Poland has one of the highest growth rates in photovoltaic (PV) installations. The forecasts for increasing HC, as a prerequisite for RES development in Poland, are not promising. [ABSTRACT FROM AUTHOR]

The provision and sustainability of water and sanitation services in many countries is compromised by poor accountability for investment and maintenance programmes. Previous work has largely been concerned with processes, tools, and initiatives which support wider accountability without considering the ways in which accountability is formalised in law and regulations. We use a structured content analysis of 17 legislative and policy documents from Uganda to identify the evidence for de jure accountability across 21 key water and sanitation functions using the following four accountability themes: rules, process, and standards; responsibilities and duties; performance monitoring; and corrective measures, incentives, and sanctions. Results indicate that there is a strong provision for accountability across two of the four themes but also weaknesses relating to lack of complaint mechanisms, limited stakeholder engagement in regulation formulation, and weak performance monitoring. These findings are contextualised by reference to previous work in the field with particular emphasis on the discontinuities between legal requirements and local initiatives. HIGHLIGHTS First study of de jure accountability for water and sanitation services in Uganda.; Number of weaknesses in the provision and implementation of social accountability identified.; Study exposes the need for improved understanding of how legally sanctioned and local or citizen-initiated accountability processes interact.;

Introduction: An important dimension of care and case managers is to support geriatric patients in obtaining social services in medical, nursing, therapeutic and social fields. To this, they advise and represent their patients.Methods: The documentation of patient contacts with case managers of a network of physicians was evaluated. In particular, activities involving legal advice were analysed in detail, compared with the current legal situation in Germany and evaluated. In addition, qualitative expert interviews were conducted. The content and the legal requirements of legal services law were determined by applying legal interpretation methods (esp. wording, telos, systematics). The results of the evaluation of the documentation were compared with legal requirements.Results: Care and case management touches activities in some fields of action without having a legal basis in legal services law. This leads to the fact that these services may not be provided and to - uninsured and uninsurable - liability risks.Discussion: With the introduction of care and case management into standard care, both social law and the Legal Services Act must be adapted to enable the legally compliant use of care and case managers. Otherwise, certain services that are useful for the care of patients may not be provided. [ABSTRACT FROM AUTHOR]

Consent in medical practice is a process riddled with layers of complexities. To some extent, this is inevitable given that different medical conditions raise different sets of issues for doctors and patients. Informed consent and risk assessment are highly significant public health issues that have become even more prominent during the course of the Covid-19 pandemic. In this article we identity relevant factors for clinicians to consider when ensuring consent for solid organ transplantation. Consent to undergo solid organ transplantation is more complex than most surgical and other clinical interventions because of the many factors involved, the complexity of the options and the need to balance competing risks. We first out the context in which consent is given by the patient. We then outline the legal principles pertaining to consent in medical practice as it applies in the UK and the implication of recent legal judgments. The third section highlights specific complexities of consent in organ transplantation and identifies relevant factors in determining consent for organ transplantation. The fourth section offers practical recommendations. We propose a novel 'multi-factor approach' to informed consent in transplantation which includes understanding risk, effective communication, and robust review processes. Whilst understanding risk and communication are a given, our suggestion is that including review processes into the consent process is essential. By this we specifically mean identifying and creating room for discretion in decision-making to better ensure that informed consent is given in practice. Discretion implies that health care professionals use their judgement to use the legal judgements as guidance rather than prescriptive. Discretion is further defined by identifying the relevant options and scope of clinical and personal factors in specified transplantation decisions. In particular, we also highlight the need to pay attention to the institutional dimension in the consent process. To that end, our recommendations identify a gap in the current approaches to consent. The identification of areas of discretion in decision-making processes is essential for determining when patients need to be involved. In other words, clinicians and healthcare professionals need to consider carefully when there is room for direction and where there is little or no room for exercising discretion. In sum, our proposed approach is a modest contribution to the on-going debate about consent in medicine. [ABSTRACT FROM AUTHOR]

Copyright of Journal for Religion in Education / Religionspädagogische Beiträge is the property of Arbeitsgemeinschaft Katholische Religionspadagogik & Katechetik (AKRK) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Numerous factors in the world contribute to the formation of social heritage for human beings. One of these factors, depending on the condition, can be diseases, such as coronary heart disease. But how coronary heart disease can underlie social heritage is unclear. In response to this issue, we undertook a research, which was descriptive-analytical and was done according to the rules of cognitive science and especially linguistic theories that imply a change in theoretical concepts. The authors concluded that Corona disease, due to being able to change various common concepts in the field of jurisprudence and law, can create social heritage in two ways. First, the disease causes jurists to pay attention to social history in order to apply similar examples in order to issue rulings and fatwas and make laws. This, as the case may be, reflects the sequence or transformation of social behavior, or, according to the requirements of the circumstances, jurists create legal jurisprudential requirements which pave the way for similar behaviors for people in later generations against infectious diseases. In this case, coronary heart disease will literally be the basis of social heritage.

The aim of the present study was to compare a new housing (NC) for rabbit does and their kits that complies with German welfare regulations with established wire mesh cages (CC) on a commercial rabbit farm. Rabbit does were single-housed from five days antepartum until weaning at 31 d postpartum either in large pens (80×80 cm with an open top) with slatted plastic flooring (11 mm slats and 11 mm gaps), nestbox, elevated platform (15% perforated) and different manipulable materials (NC) or in cages (70×50×30 cm) with wire mesh flooring (12×70 mm holes and 3 mm wire diameter), nestbox and one gnawing stick (CC). Skin lesions, weight development, fertility, morbidity, cleanliness and kit performance of 272 rabbit does in a total of six batches were investigated. While there was no difference in performance of their kits, rabbit does showed an impaired performance with less weight gain and less body weight at weaning, lower fertility, more injuries and a higher incidence of mastitis and diarrhoea at the end of the rearing period in NC housing compared to CC housing. Additionally, soiling of hind feet was higher in NC than in CC housing. Overall, the poor hygienic conditions may have affected the animals’ health and make an improvement in the new housing system necessary, especially with regard to the floor design.

Objective: To perform a qualitative and quantitative comparison of the practice and infrastructure with applicable legislations governing hospital pharmacy while the secondary objective was to calculate the average dispensing time of a prescription in the hospital pharmacy. Materials and methods: A prospective observational study was carried out in the hospital pharmacy for one year. A blend of quality control parameters was drafted after referring various guidelines put forward by the statutory bodies. Qualitative data was collected by continuous observation, physical inspection and after a thorough interview of hospital pharmacists. The collected data was summarized and compared with the standards. Quantitative data on the minimum requirement of hospital pharmacy infrastructure and dispensing time was collected by using the designed data collection form and analysis was performed using SPSS (version 20.0). Results: The hospital pharmacy met all the criteria that are necessary to satisfy legal requirements, availability of medicine, medicine and general safety and most of the quality parameters. However, few deviations were observed in the management of the drug store. The shortage in the floor space and waiting area was identified. The average dispensing time without waiting was 113.93 ± 28.92 s and the time spent collectively for dispensing and waiting was measured to be 533.13 ± 128.51 Sec. The average waiting time in the hospital pharmacy was approximately around 419 Sec. Conclusion: Majority of the quality parameters were noted to be compliant with the standards. Few deviations were identified and measures to improve them were suggested.

MSCs products as well as their derived extracellular vesicles, are currently being explored as advanced biologics in cell-based therapies with high expectations for their clinical use in the next few years. In recent years, various strategies designed for improving the therapeutic potential of mesenchymal stromal cells (MSCs), including pre-conditioning for enhanced cytokine production, improved cell homing and strengthening of immunomodulatory properties, have been developed but the manufacture and handling of these cells for their use as advanced therapy medicinal products (ATMPs) remains insufficiently studied, and available data are mainly related to non-industrial processes. In the present article, we will review this topic, analyzing current information on the specific regulations, the selection of living donors as well as MSCs from different sources (bone marrow, adipose tissue, umbilical cord, etc.), in-process quality controls for ensuring cell efficiency and safety during all stages of the manual and automatic (bioreactors) manufacturing process, including cryopreservation, the use of cell banks, handling medicines, transport systems of ATMPs, among other related aspects, according to European and US legislation. Our aim is to provide a guide for a better, homogeneous manufacturing of therapeutic cellular products with special reference to MSCs. [ABSTRACT FROM AUTHOR]

Copyright of Management & Quality / Zarządzanie i Jakość is the property of Scientific Society of Organization & Management / Towarzystwo Naukowe Organizacji i Kierownictwa and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Section 1 of this paper follows entirely a scenario from the article “Engineering Compliant Software: Advising Developers by Automating Legal Reasoning” by D. Oberle, F. Drefs, R. Wacker, C. Baumann and O. Raabe, SCRIPTed (2012) 9:3, 280–313, where it serves as a running example. It demonstrates that data transfer violates the law. This motivating scenario has added value in the education of software developers and is worth sharing with the computer communities of other countries including Lithuania. In the scenario, the continental law and EU law sways the particularities of the German law. The motivation for teaching the scenario can be compared with teaching concrete cases in the study of law. Legal reasoning is demonstrated by supplementing the provisions of the German Federal Data Protection Act (FDPA) with those of the Lithuanian Law on Legal Protection of Personal Data, which have the same meaning. In Section 3, we attempt to formulate the software compliance problem. Finally, we explain the notion of subsumption – a legal qualification of facts according to a norm’s circumstance. We consider subsumption to consist of two notions: terminological subsumption and normative subsumption.

Abstract Background This study aimed to reflect on scientific experts’ and executive stakeholders’ opinions on how charitable organizations can participate in the health care system properly and cope with problems, challenges, strategies, and executive requirements at three major levels of prevention, treatment, and rehabilitation. Methods A total number of 20 semi-structured interviews were conducted with scientific experts and executive stakeholders, selected for this qualitative study, based on an interview guide. Using the purposeful sampling method, we selected scientific experts with 5 years of experience in the health care system and executive stakeholders who had 5 years of experience in charitable activities. We applied a framework method for data analysis, and the main themes were extracted through MAXQDA software. Results Our findings revealed that charitable organizations at the major levels of the health care system, i.e., prevention, treatment, and rehabilitation, possessed the necessary capacities to provide services effectively. Nevertheless, charities encountered some problems, e.g., financial instability, non-recognition of donors’ legal status, non-involvement in policy-making, inadequate cooperation from other agencies, absence of transparent programs and goals, together with weaknesses in advertising and attracting donations. It was noted that the government should take more operational steps towards supporting such organizations, e.g., by granting special facilities and exemptions, engaging charities in policy-making and training processes, and empowering them in terms of the production of resources. Charitable organizations are also recommended to establish external communications with other bodies such as municipalities, secretaries of state, governorate offices, welfare organizations, relief committees, and medical sciences universities. Conclusions Charitable organizations have the potentials to provide health care services at prevention, treatment, and rehabilitation levels. Thus, it is of utmost importance to adopt strategies such as creating sustainable funding sources, training charity managers with a wide variety of scientific management techniques, and implementing their intellectual capacities in legislative and planning processes.

MSCs products as well as their derived extracellular vesicles, are currently being explored as advanced biologics in cell-based therapies with high expectations for their clinical use in the next few years. In recent years, various strategies designed for improving the therapeutic potential of mesenchymal stromal cells (MSCs), including pre-conditioning for enhanced cytokine production, improved cell homing and strengthening of immunomodulatory properties, have been developed but the manufacture and handling of these cells for their use as advanced therapy medicinal products (ATMPs) remains insufficiently studied, and available data are mainly related to non-industrial processes. In the present article, we will review this topic, analyzing current information on the specific regulations, the selection of living donors as well as MSCs from different sources (bone marrow, adipose tissue, umbilical cord, etc.), in-process quality controls for ensuring cell efficiency and safety during all stages of the manual and automatic (bioreactors) manufacturing process, including cryopreservation, the use of cell banks, handling medicines, transport systems of ATMPs, among other related aspects, according to European and US legislation. Our aim is to provide a guide for a better, homogeneous manufacturing of therapeutic cellular products with special reference to MSCs.

To allow for adequate and safe reprocessing of reusable medical devices, the device manufacturer should provide instructions for use (IFU). This should include instructions for cleaning, disinfection, packaging and (where sterility is required), a method of sterilization. These instructions should be clear and relevant in the regions where they are marketed. They must not be too vague, however if they are too detailed, reprocessing of the device may be effectively restricted if a very specific process step is not available. This article summarizes IFU requirements for every process step and shows the available options if there are issues with the IFUs. [ABSTRACT FROM AUTHOR]

This article has the goal of determining the judicial effects produced by the acts of a union organization created and operating without the fulfilment of its legal obligations. This research's approach is hermeneutical-documentary, given how it was performed using bibliographic inquiries, compilation of literature on fundamental law in union association and regulatory jurisprudence on the matter in accordance with the specific analytical needs of the research. As a main conclusion, the research states that the actions carried out by a union association that are contrary and overreach the legal terms established for them do not produce any judicial effect whatsoever, taking into account that the labour legislation is defined as a public order normativity and that disposition does not produce any affect or act that disown them without needing a judicial declaration for it. [ABSTRACT FROM AUTHOR]

In the sale of private vehicles used in the automotive sector of the department of Quindío, the practice is to divide the transfer fees between the buyer and seller in equal parts; However, it is not certain whether said practice meets the requirements that the law requires to be considered a customary legal norm. Therefore, in the present investigation, the commercial practice of the division of the transfer costs of used private vehicles will be analyzed, to verify compliance with the requirements of uniformity, reiteration, validity, publicity and obligation, to determine if it can be subject to certification as a commercial custom by the Chamber of Commerce oAf rmenia and Quindío. [ABSTRACT FROM AUTHOR]

The INCOTERMS terms are described and updated by the International Chamber of Commerce to regulate and interpret the responsibilities of the subjects in the contracts for the sale of goods. Given the importance and recognition they have in the context of international trade, the purpose of this investigation is to verify whether the practice of the term EXW used in contracts for the international sale of goods entered into in Armenia is the INCOTERMS described by the International Chamber of Commerce. and if it can reach the category of commercial custom by meeting the requirements of uniformity, reiteration, validity, publicity and obligation to be certified by the Chamber of Commerce of Armenia and Quindío. [ABSTRACT FROM AUTHOR]