Análise do processo de conformidade das normas regulamentadoras em uma empresa de telecomunicações em Manaus / Analysis of the compliance process of regulatory standards in a telecommunications company in Manaus

This paper seeks to determine whether the existing regulatory standards and supervisory framework are adequate to ensure the viability, strength, and continued expansion of Islamic financial institutions. The reemergence of Islamic banking and the attention given to it by regulators around the globe as to the implications of a recently issued Basel II banking regulation makes this article timely. The Basel II framework, which is based on minimum capital requirements, a supervisory review process, and the effective use of market discipline, aligns capital adequacy with banking risks and provides an incentive for financial institutions to enhance risk management and their system of internal controls. Like conventional banks, Islamic banks operate under different regulatory regimes. The still diverse views held by the regulatory agencies of different countries on Islamic banking and finance operations make it harder to assess the overall performance of international Islamic banks. In light of the increased financial innovation and diversity of instruments offered in Islamic finance, the need to improve the transparency of bank operations is particularly relevant for Islamic banks. While product diversity is important in maintaining their competitiveness, it also requires increased transparency and disclosure to improve the understanding of markets and regulatory agencies. The governance of Islamic banks is made even more complex by the need for these banks to meet a set of ethical and financial standards defined by the Shari`ah and the nature of the financial contracts banks use to mobilize deposits. Effective transparency in this area will greatly enhance their credibility and reinforce their depositors and investors’ level of confidence.

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Obesity Therapy: How and Why?

Current Medicinal Chemistry ◽

10.2174/0929867326666190124121725 ◽

2020 ◽

Vol 27 (2) ◽

pp. 174-186 ◽

Cited By ~ 9

Author(s):

Sara Paccosi ◽

Barbara Cresci ◽

Laura Pala ◽

Carlo Maria Rotella ◽

Astrid Parenti

Keyword(s):

Weight Loss ◽

Lifestyle Modification ◽

Herbal Medicines ◽

The Internet ◽

Obese Patients ◽

Self Medication ◽

Pharmacological Management ◽

Regulatory Standards ◽

Meta Analyses ◽

Obesity Drugs

Background: Obesity represents the second preventable mortality cause worldwide, and is very often associated with type 2 Diabetes Mellitus (T2DM). The first line treatment is lifestyle modification to weight-loss, but for those who fail to achieve the goal or have difficulty in maintaining achieved results, pharmacological treatment is needed. Few drugs are available today, because of their side effects. Objective: We aim to review actual pharmacological management of obese patients, highlighting differences between Food and Drug Administration - and European Medicine Agency-approved molecules, and pointing out self-medications readily obtainable and widely distributed. Methods: Papers on obesity, weight loss, pharmacotherapy, self- medication and diet-aid products were selected using Medline. Research articles, systematic reviews, clinical trials and meta-analyses were screened. Results: Anti-obesity drugs with central mechanisms, such as phentermine and lorcaserin, are available in USA, but not in Europe. Phentermine/topiramate and naltrexone/bupropion combinations are now available, even though the former is still under investigation from EMA. Orlistat, with peripheral mechanisms, represents the only drug approved for weight reduction in adolescents. Liraglutide has been approved at higher dose for obesity. Anti-obesity drugs, readily obtainable from the internet, include crude-drug products and supplements for which there is often a lack of compliance to national regulatory standards. Conclusion: Mechanisms of weight loss drugs include the reduction of energy intake or the increase in energy expenditure and sense of satiety as well as the decrease of hunger or the reduction in calories absorption. Few drugs are approved, and differences exist between USA and Europe. Moreover, herbal medicines and supplements often sold on the internet and widely used by obese patients, present a risk of adverse effects.

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Measuring Effectiveness

10.1093/oso/9780198747048.003.0008 ◽

2018 ◽

Author(s):

Jacob Stegenga

Keyword(s):

Outcome Measures ◽

Relative Risk Reduction ◽

Drug Approval ◽

Target Population ◽

Risk Difference ◽

General Context ◽

Measuring Instruments ◽

Clinical Settings ◽

Medical Interventions ◽

Regulatory Standards

There are three methodological challenges to measuring the effectiveness of medical interventions: the choice of good measuring instruments, the use of appropriate analytic measures, and the use of a reliable method of extrapolating measures from an experimental context to a more general context. In practice each of these challenges contributes to overestimating the effectiveness of medical interventions. These challenges suggest corrective principles. The instruments employed in clinical research should measure patient-relevant and disease-specific parameters. Effectiveness always should be measured and reported using absolute outcome measures (such as ‘risk difference’), and we should employ caution when interpreting relative outcome measures (such as ‘relative risk reduction’). Extrapolating from research settings to clinical settings should more rigorously take into account possible ways in which interventions can fail to be effective in a target population. Current regulatory standards for drug approval are insufficient to manage these problems of measurement.

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Technology assessment framework for precision health applications

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462321000350 ◽

2021 ◽

Vol 37 (1) ◽

Author(s):

M. Sazzad Hussain ◽

David Silvera-Tawil ◽

Geremy Farr-Wharton

Keyword(s):

Emerging Technologies ◽

Mobile Apps ◽

Scientific Evidence ◽

Wearable Sensors ◽

Assessment Process ◽

Assessment Framework ◽

Response Options ◽

Regulatory Standards ◽

Precision Health ◽

Health Applications

Abstract Objective Established and emerging technologies—such as wearable sensors, smartphones, mobile apps, and artificial intelligence—are shaping positive healthcare models and patient outcomes. These technologies have the potential to become precision health (PH) innovations. However, not all innovations meet regulatory standards or have the required scientific evidence to be used for health applications. In response, an assessment framework was developed to facilitate and standardize the assessment of innovations deemed suitable for PH. Methods A scoping literature review undertaken through PubMed and Google Scholar identified approximately 100 relevant articles. These were then shortlisted (n = 12) to those that included specific metrics, criteria, or frameworks for assessing technologies that could be applied to the PH context. Results The proposed framework identified nine core criteria with subcriteria and grouped them into four categories for assessment: technical, clinical, human factors, and implementation. Guiding statements with response options and recommendations were used as metrics against each criterion. Conclusion The proposed framework supports health services, health technology innovators, and researchers in leveraging current and emerging technologies for PH innovations. It covers a comprehensive set of criteria as part of the assessment process of these technologies.

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Regulatory Arbitrage and Non-Judicial Debt Collection in Central and Eastern Europe - Tax Sheltering and Potential Money Laundering

Accounting Economics and Law - A Convivium ◽

10.1515/ael-2019-0055 ◽

2020 ◽

Vol 0 (0) ◽

Author(s):

Catalin-Gabriel Stanescu ◽

Camelia Bogdan

Keyword(s):

Eastern Europe ◽

Money Laundering ◽

Central And Eastern Europe ◽

Regulatory Arbitrage ◽

Legal Provisions ◽

Regulatory Standards ◽

Debt Collectors ◽

Illegal Activities ◽

Collection Practices ◽

Debt Collection

AbstractNon-judicial recovery of debts is now rampant in Central and Eastern Europe (CEE). The reason is two-fold. On the one hand, the significant number of defaults in the poorer areas of Europe makes the CEE region a very attractive market for debt-collection. On the other hand, the activity is almost entirely unregulated, especially regarding abusive debt collection practices. The CEE region still lacks mature, strong, and experienced supervisory agencies that could tackle borderline activities. This enables companies involved in debt collection to comply easily with the minimal legal provisions and to circumvent the actual purpose of the law, including through tax sheltering and money laundering. The main argument developed in the paper is that the debt collection system it is designed to maximize profits, minimize tax base and, potentially, can serve as money laundering mechanism. The system functions in a triadic relationship: the debt-seller (a credit institution), the debt-buyer (usually an investment company), and the debt-administrator (a debt-collection agency, either fully owned by, or under the control of the debt-buyer), where debt portfolios are purchased at huge discounts (varying between 90 and 95% of face value). By revealing the mechanism used by debt-collectors, the paper calls for legislative intervention to seal the gap and ensure adequate taxation of debt-collection activities. The nature of regulatory arbitrage involved relates both to tax law as well as to regulatory standards, such as licensing requirements. Debt buyers benefit from the EU passport rule, make high returns on their 'investments' and optimize their taxes on profits obtained. Debt administrators perform their activity at almost no liability and no tax payable to the state. This mechanism creates favorable premises for money laundering and financing of illegal activities, as the web of offshore companies behind the debt-buyer renders the verification of the origin of their investment money extremely difficult. Using Romania as a case study, the paper addresses not only the aforementioned practices and risks, but also the potential reasons behind the state's inability either to adopt adequate legislation, or to enforce it. In doing so, the paper employs empirical evidence regarding the activity of ten Romanian debt collection agencies and relevant case law thereof. The paper concludes with the authors' proposal for a potential solution, which can be extended beyond Romania.

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A Risk Assessment for Ozone Regulation Based on Statistical Rollback

Applied Sciences ◽

10.3390/app11052388 ◽

2021 ◽

Vol 11 (5) ◽

pp. 2388

Author(s):

Yongku Kim ◽

Jeongjin Lee

Keyword(s):

Public Health ◽

Risk Assessment ◽

Human Health ◽

Air Pollutants ◽

Hierarchical Bayesian Models ◽

Health It ◽

Matching Method ◽

Regulatory Standards ◽

Ozone Regulation ◽

Ozone Levels

In environmental studies, it is important to assess how regulatory standards for air pollutants affect public health. High ozone levels contribute to harmful air pollutants. The EPA regulates ozone levels by setting ozone standards to protect public health. It is thus crucial to assess how various regulatory ozone standards affect non-accidental mortality related to respiratory deaths during the ozone season. The original rollback approach provides an adjusted ozone process under a new regulation scenario in a deterministic fashion. Herein, we consider a statistical rollback approach to allow for uncertainty in the rollback procedure by adopting the quantile matching method so that it provides flexible rollback sets. Hierarchical Bayesian models are used to predict the potential effects of different ozone standards on human health. We apply the method to epidemiologic data.

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A Mechanistic Model to Assess the Fate of Naphthalene and Benzo(a)pyrene in a Chilean WWTP

Processes ◽

10.3390/pr9081313 ◽

2021 ◽

Vol 9 (8) ◽

pp. 1313

Author(s):

Antonia Arroyo ◽

Fabián Provoste ◽

Montserrat Rodríguez ◽

Ana L. Prieto

Keyword(s):

Wastewater Treatment Plants ◽

Mechanistic Model ◽

Treated Wastewater ◽

Urban Centers ◽

Potable Reuse ◽

Conventional Activated Sludge ◽

Regulatory Standards ◽

Polycyclic Aromatic ◽

De Facto Reuse

Polycyclic aromatic hydrocarbons (PAHs) are a family of organic compounds of widespread presence in the environment. They are recalcitrant, ubiquitous, prone to bioaccumulation, and potentially carcinogenic. Effluent from wastewater treatment plants (WWTPs) constitutes a major source of PAHs into water bodies, and their presence should be closely monitored, especially considering the increasing applications of potable and non-potable reuse of treated wastewater worldwide. Modeling the fate and distribution of PAHs in WWTPs is a valuable tool to overcome the complexity and cost of monitoring and quantifying PAHs. A mechanistic model was built to evaluate the fate of PAHs in both water and sludge lines of a Chilean WWTP. Naphthalene and benzo(a)pyrene were used as models of low-MW and high-MW PAHs. As there were no reported experimental data available for the case study, the influent load was determined through a statistical approach based on reported values worldwide. For both naphthalene and benzo(a)pyrene, the predominant mechanism in the water line was sorption to sludge, while that in the sludge line was desorption. Compared to other studies in the literature, the model satisfactorily describes the mechanisms involved in the fate and distribution of PAHs in a conventional activated sludge WWTP. Even though there is evidence of the presence of PAHs in urban centers in Chile, local regulatory standards do not consider PAHs in the disposal of WWTP effluents. Monitoring of PAHs in both treated effluents and biosolids is imperative, especially when considering de facto reuse and soil amendment in agricultural activities are currently practiced downstream of the studied WWTP.

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MICS Transceivers: Regulatory Standards and Applications

Proceedings. IEEE SoutheastCon, 2005. ◽

10.1109/secon.2005.1423241 ◽

2005 ◽

Cited By ~ 23

Author(s):

H.S. Savci ◽

A. Sula ◽

Zheng Wang ◽

N.S. Dogan ◽

E. Arvas

Keyword(s):

Regulatory Standards

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RINNO: Towards an Open Renovation Platform for Integrated Design and Delivery of Deep Renovation Projects

Sustainability ◽

10.3390/su13116018 ◽

2021 ◽

Vol 13 (11) ◽

pp. 6018

Author(s):

Theo Lynn ◽

Pierangelo Rosati ◽

Antonia Egli ◽

Stelios Krinidis ◽

Komninos Angelakoglou ◽

...

Keyword(s):

Value Chain ◽

Residential Buildings ◽

Integrated Design ◽

Energy Performance ◽

Building Stock ◽

Existing Building ◽

Horizon 2020 ◽

Regulatory Standards ◽

Automation Systems ◽

Wide Range

The building stock accounts for a significant portion of worldwide energy consumption and greenhouse gas emissions. While the majority of the existing building stock has poor energy performance, deep renovation efforts are stymied by a wide range of human, technological, organisational and external environment factors across the value chain. A key challenge is integrating appropriate human resources, materials, fabrication, information and automation systems and knowledge management in a proper manner to achieve the required outcomes and meet the relevant regulatory standards, while satisfying a wide range of stakeholders with differing, often conflicting, motivations. RINNO is a Horizon 2020 project that aims to deliver a set of processes that, when working together, provide a system, repository, marketplace and enabling workflow process for managing deep renovation projects from inception to implementation. This paper presents a roadmap for an open renovation platform for managing and delivering deep renovation projects for residential buildings based on seven design principles. We illustrate a preliminary stepwise framework for applying the platform across the full-lifecycle of a deep renovation project. Based on this work, RINNO will develop a new open renovation software platform that will be implemented and evaluated at four pilot sites with varying construction, regulatory, market and climate contexts.

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The Impact of the Privacy Rule on Cancer Research: Variations in Attitudes and Application of Regulatory Standards

Journal of Clinical Oncology ◽

10.1200/jco.2009.22.3289 ◽

2009 ◽

Vol 27 (24) ◽

pp. 4014-4020 ◽

Cited By ~ 6

Author(s):

Elizabeth Goss ◽

Michael P. Link ◽

Suanna S. Bruinooge ◽

Theodore S. Lawrence ◽

Joel E. Tepper ◽

...

Keyword(s):

Cancer Research ◽

Future Research ◽

Research Committee ◽

Data Repositories ◽

Privacy Rule ◽

Regulatory Standards ◽

American Society ◽

Definition Of ◽

High Level ◽

The Impact

Purpose The American Society of Clinical Oncology (ASCO) Cancer Research Committee designed a qualitative research project to assess the attitudes of cancer researchers and compliance officials regarding compliance with the US Privacy Rule and to identify potential strategies for eliminating perceived or real barriers to achieving compliance. Methods A team of three interviewers asked 27 individuals (13 investigators and 14 compliance officials) from 13 institutions to describe the anticipated approach of their institutions to Privacy Rule compliance in three hypothetical research studies. Results The interviews revealed that although researchers and compliance officials share the view that patients' cancer diagnoses should enjoy a high level of privacy protection, there are significant tensions between the two groups related to the proper standards for compliance necessary to protect patients. The disagreements are seen most clearly with regard to the appropriate definition of a “future research use” of protected health information in biospecimen and data repositories and the standards for a waiver of authorization for disclosure and use of such data. Conclusion ASCO believes that disagreements related to compliance and the resulting delays in certain projects and abandonment of others might be eased by additional institutional training programs and consultation on Privacy Rule issues during study design. ASCO also proposes the development of best practices documents to guide 1) creation of data repositories, 2) disclosure and use of data from such repositories, and 3) the design of survivorship and genetics studies.

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