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Journal articles on the topic 'Regulatory compliance and cost indicators'
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Cabukel, Ridvan. "Regulatory Compliance Costs on International Banks in Turkey." International Journal of Finance & Banking Studies (2147-4486) 6, no. 1 (February 18, 2017): 11. http://dx.doi.org/10.20525/ijfbs.v6i1.637.
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<p>The Turkish government set a policy to become a regional financial center in 2007. This policy involved encouraging international banks to enter Turkey and take a more prominent role in the Turkish banking industry. Since then the progress has been slow to achieve this policy objective. The primary indicator of being a financial center is to have the presence of international banks. Even though there are many representative offices in Turkey, few of them changed their status to subsidiary or branch to this day. On the contrary, some international banks announced that they would downsize their operations. Representative offices have lower investment and compliance cost than that of branches and subsidiaries. Banking regulations in Turkey does not differentiate much by type, operations and size. Also international banks have to comply their head office rules in line with regulators in their home countries. In this article, we focus on the regulatory compliance costs on international banks to open branches and to establish subsidiaries with niche market strategy in Turkey. We argue that regulatory compliance costs play a major role on the reluctance of international banks’ lack of enthusiasm.</p>
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Olufemi Amos, Akinbola, Issa Abdulraheem, and Brimah Aminu Nassir. "Commercial Policy’s Trade Facilitation Effects on Cost of Operations as Determinants of Multinational Corporations Employability." Scholedge International Journal of Management & Development ISSN 2394-3378 4, no. 11 (March 28, 2018): 111. http://dx.doi.org/10.19085/journal.sijmd041101.
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This study examined commercial policy’s trade facilitation effects on employability of multinational corporations in Nigeria considering whether trade facilitation(TF), has a significant effect on the multinational Corporations employability expressed in cost of operation (COP). The study adopted cross sectional research design and considered 5 multinational corporations in the food and beverage and conglomerate sub-sector in Nigeria based on random sampling technique by employing primary data. The sample size constituted the lower, middle and senior level staff of the multinational Corporations at their headquarters and plants to achieve the objectives of this study based on the hypothesis that was formulated. Both descriptive and inferential statistical techniques were employed. The statistical tools used included cross tabulations, Mean, Regression and Correlation analysis with the aid of SPSS computer packages. The results showed that trade facilitation (TF) have significant effect on cost of operation (at P=0.000). In conclusion, the study reflected that each of the performance indicators under consideration related with commercial policy and employability implies the need for compliance by multinational corporations to be ensured as governmental follow up in areas of trade facilitation is pertinent to employment creation. The study recommends that; government is encouraged to continue to play her regulatory, facilitating and participatory roles to foster an enabling operating environment as it will contribute towards firm competitiveness in the domestic and global marketplace.
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Makarynska, A., and N. Vorona. "OPTIMIZATION OF FEED COMPOSITION FOR TURKEYS." Grain Products and Mixed Fodder’s 19, no. 4 (February 7, 2020): 46–50. http://dx.doi.org/10.15673/gpmf.v19i4.1592.
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The article describes that domestic feed products cannot always compete with high quality products of foreign firms. However, the use of imported feed leads to a significant increase in their value and, as a consequence, to an increase in the cost price of the final product. It is established that for the normal development and realization of productivity, turkeys should receive quality and balanced for all indicators of compound feed. Therefore, the task was to develop recipes for turkeys using high quality domestic raw materials. The necessity to determine the complete components characteristics of compound feeds for the finished products production, which meets the requirements of regulatory documents and the consumer, has been proved. There are many indicators and factors that are not taken into account when calculating recipes, but significantly affect the compound feed quality. We have developed compound feed recipes for heavy type turkeys aged 1…4 weeks, 5…13 weeks, 14…17 weeks, 18…30 weeks and over 31 weeks using the “Korm Optima Expert” software complex. The program incorporates the principle of calculating recipes at minimum cost, taking into account the restrictions on the input of each component and the nutrition of the finished product using linear programming by formulas. The expediency of replacing soybean meal in poultry feed due to its high cost for cheaper protein components is substantiated. In order to reduce the cost of compound feed, we have proposed the optimal composition of protein feed additive (PFA) for replacement soybean meal in feed recipes. On the basis of the developed recipes of compound feeds for heavy type turkeys we calculated similar recipes of compound feeds with replacement of soybean meal for PFA in their composition according to the norms of its introduction The quality indicators of finished products are in compliance with the minimum nutritional requirements of compound feeds for heavy type turkeys of a given age. The cost of compound feeds with PFA is much lower than similar with soybean meal. We determined the annual feed consumption of turkeys by growing periods based on the daily feed intake and the duration of each fattening period.
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BRYN, Mikhail Ya, Dinara R. BASHIROVA, and Artur G. BAGISHYAN. "Comparative evaluation of mobile laser scanning, aerial photography from an unmanned aircraft system and surveying from an integrated road laboratory when performing diagnostics of highways." Proceedings of Petersburg Transport University 2021, no. 2 (June 2021): 211–21. http://dx.doi.org/10.20295/1815-588x-2021-2-211-221.
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Objective: To compare the possibilities of using mobile laser scanning (MLS) and aerial photography (AFS) from an unmanned aircraft system (UAS) and to make a survey from an integrated road laboratory when performing diagnostics of highways. Methods: For the analysis, a section of the regional road in the Kursk region was selected, on which the survey was carried out using considered methods. The main characteristics were identified when performing the diagnostics, their values were obtained on the basis of data from the integrated road laboratory, aerial photography with UAS, as well as ILS, and the accuracy of the results obtained, the compliance of the data with the requirements of regulatory documents were assessed. Results: Based on the work performed, the following conclusions were made: the determination of identified diagnostic parameters by the methods of ILS and APS with UAS is correct and aerial photography with UAS at the cost of equipment, the cost of shooting is the most profitable when drawing up topographic road plans. It is noted that in terms of accuracy, the APS method meets the requirements for plans at a scale of 1:500, MLS – 1:1000. Practical importance: Not all indicators required for diagnostics can be obtained with APS with ALS and MLS, since they require specialized equipment and direct interaction with the road surface, however, the range of application of the selected methods can be significantly expanded. Adhesion coefficient is measured using an integrated mobile road laboratory, so it is not advisable to abandon it. It was noted that the equipment of the laboratory, depending on the cost, may be different
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Belsky, A. B., A. V. Lipovich, and A. P. Moskalenko,. "Monitoring of Educational Institutions Information Resources in the Republic of Belarus as a Tool for Implementing Policies in the Field of Export of Educational Services." Digital Transformation, no. 1 (May 5, 2019): 5–20. http://dx.doi.org/10.38086/2522-9613-2019-1-5-20.
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The article considers the issues of monitoring of the educational institutions official websites in the Republic of Belarus, beginning with the 2018 interms of its influence on the potential of services export in education. Special attention is paid to a state and development of information resources of higher education institutions. Regulatory legal acts and other documents forming a normative basis of monitoring are analyzed. The organization of monitoring processes of the education institutions websites is considered in the manual regime as well as using the utomated information system for auditing education institutions information resources in the Republic of Belarus, assessment of their state and relevance is also considered (AIS Monitoring). The criteria for evaluation of the websites included in monitoring are presented and their comparison at the manual and automated way of realization is carried out. The analysis of monitoring results of the education institutions official websites in 2018 including that realized within trial operation of AIS Monitoring is produced. The correlation between the growth in the number of foreign students in higher education institutions and indicators for monitoring of information resources is assessed. The results of a quantitative assessment of the dependence of the growth rate of the number of foreign students at Belarusian universities on the level of compliance with the requirements for the informational content of official sites in terms of the list and cost of services provided in the form of a regression model are presented. Recommendations for further development and improvement of monitoring processes of information resources are formed.
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Zhylinska, O., and A. Boiko. "EFFICIENCY OF THE STATE POLICY AGAINST TINIZATION ECONOMICS: QUANTITATIVE AND QUALITATIVE COMPONENT." Vìsnik Sumsʹkogo deržavnogo unìversitetu, no. 1 (2020): 147–54. http://dx.doi.org/10.21272/1817-9215.2020.1-16.
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SUMMARY The article is devoted to the study of the formation and implementation of state policy to prevent shadow financial transactions. The shadow sector of the economy is identified as one of the main threats to the country's economic security and macroeconomic stability, a prerequisite for reducing the level of its investment attractiveness and competitiveness. The article has analyzed the effectiveness of the state policy of the de-shadowing of the national economy in terms of its regulatory, institutional, and economic components. The peculiarities of constructing the legal component of the state policy of counteracting the shadowing of the economy are considered. Its advantages and disadvantages are determined. Based on the study, it has concluded the low level of compliance of the modern system with the realities of economic development and the requirements of the international community, a significant variety of regulations, and their contradictory nature. The effectiveness of the institutional component was analyzed using quantitative (number of administrative proceedings for shadow financial transactions, sentences, etc.) and qualitative (the ratio between the amount of voluntarily paid and imposed on offenders fine, between the amount of reimbursed and established pecuniary damage, duration cases by the judiciary) indicators. Within the framework of economic indicators of efficiency of construction of policy of de-shadowing of the economy the cost of registration of documents at export/import, passing of control at export/import, level of the tax burden, etc. is considered. It is concluded that the excessive level of the tax burden on economic entities and the complexity of business procedures in Ukraine. A comparative analysis of the level of the shadow economy by the electric, monetary, the method of consumption of the population-retail trade, the method of unprofitable enterprises has determined. The expediency of improving the existing policy of counteracting shadow financial transactions by developing instruments for direct and indirect influence on the economic entities' behavior is substantiated.
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Bermon, Anderson, Ana Fernanda Uribe-Rodríguez, Paula Fernanda Pérez-Rivero, David Prieto-Merino, Diana Isabel Cáceres Rivera, Elizabeth Guio, Louise Atkins, et al. "Evaluation of the efficacy and safety of text messages targeting adherence to cardiovascular medications in secondary prevention: the txt2heart Colombia randomised controlled trial protocol." BMJ Open 9, no. 12 (December 2019): e028017. http://dx.doi.org/10.1136/bmjopen-2018-028017.
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IntroductionAnti-platelet therapy, angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, beta-blockers and statins are cost-effective in patients with atherosclerotic cardiovascular diseases (ASCVD) for reducing the risk of ASCVD events. Unfortunately, there is abundant evidence that adherence to these cardiovascular medications is far from ideal. A recent Cochrane review showed a potential beneficial effect of Short Message Service (SMS) interventions on adherence to medication in ASCVD patients.Methods and analysisThe txt2heart study is a pragmatic randomised single-blind controlled trial. The objective is to evaluate the efficacy and safety of an intervention with SMS messages delivered by mobile phones to improve adherence to cardiovascular medications in patients with ASCVD. The intervention consists of behavioural techniques delivered via SMS. The primary outcome is change in blood serum low-density lipoprotein cholesterol levels as an indicator of adherence to statins. Secondary outcomes will include systolic blood pressure as an indicator of adherence to blood-lowering therapies and heart rate as an indicator of adherence to beta-blockers, urine levels of 11-dehydrothromboxane B2, self-reported adherence to cardiovascular medications and rates of cardiovascular death or hospitalisation due to cardiovascular disease.Ethics and disseminationThe study will be performed in compliance with the protocol, regulatory requirements, Good Clinical Practice and ethical principles of the Declaration of Helsinki. The Ethics Committee of Fundación Cardiovascular de Colombia evaluated and approved the trial. The txt2heart Colombia trial aims to provide robust evidence to evaluate whether SMS messages delivered through mobile telephones change the behaviour of Colombian patients who have suffered a cardiovascular event. Trial results will be presented to the local health authorities, and if the intervention is effective and safe, we hope this strategy will be implemented quickly because of its low cost and wide-reaching impact on the population.Trial registration numberNCT03098186.
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Lim, Howard John, Melissa Hunt, Julia A. Beaver, Paul Gustav Kluetz, Christopher Gravel, Andrew Raven, Dean Regier, and Cheryl Ho. "Access to new therapies: FDA accelerated approvals and the corresponding Canadian regulatory and funding decisions." Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020): e19066-e19066. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.e19066.
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e19066 Background: Accelerated approval (AA) by the FDA enables earlier access to promising new therapies while evidence generation is ongoing. Health Canada (HC) has a similar process with a Notice of Compliance conditional (NOCc) before full approval (NOC). Canada implemented health technology assessment (HTA) for determination of funding through the pan Canadian Oncology Drug Review (pCODR) in 2011. This study evaluated timelines and decisions from AA approval to HC NOC/c to HTA approval and formulary listing. Methods: FDA AA malignant hematology and oncology approvals from Jan 1 2000-Dec 31 2019 were reviewed. HC decisions were reviewed to determine submission/approval status and dates of NOC/c. pCODR decisions were reviewed to determine submission/approval status and dates of decision. First date of provincial formulary listing was collected. Results: In the 20 year time frame, there were 97 AA by the FDA. Current FDA status: 48 full approval, 44 pending verification and 5 withdrawn. Of the 92 AA that remain approved, HC status: 44 received NOC, 24 NOCc, 24 were not submitted for review, 2 currently under review. Of the 5 AA that were withdrawn; 3 were submitted to HC and received NOC/c and all were subsequently withdrawn. From 2011, 31 of 45 HC approved indications were reviewed at pCODR: 17 received a positive recommendation conditional on cost-effectiveness, 9 not recommended, 3 withdrawn by company, 2 pending final decision. Of the 10 not recommended/withdrawn, 6 were subsequently re-submitted and approved. Time from AA to NOC/c was 9.4 m, time from NOC/c to pCODR decision 15.0 m and time from pCODR decision to first formulary listing 18.4 m. Conclusions: Despite significant timeline differences between AA and HC NOC/c all indications that received AA submitted to Canada were granted regulatory approval. Since 2011, 74% of HC approved therapies submitted to pCODR were recommended and added to formularies. Collaboration between FDA and HC, independent regulatory agencies, through innovative programs such as FDA Project Orbis, may improve time from AA to NOC/c. Stringent criteria for HTA recommendation results in lower approval rates however, provision of additional data at re-submission may enable subsequent approval and adoption of treatment.
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Vorona, N., and A. Makarynska. "DEVELOPMENT OF COMPOUND FEED RECIPES FOR GEESE AND DETERMINATION OF THEIR QUALITY." Grain Products and Mixed Fodder’s 21, no. 1 (September 12, 2021): 31–36. http://dx.doi.org/10.15673/gpmf.v21i1.2094.
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The article describes that goose farming is an important source of increasing poultry production and expanding the range of poultry products. In Ukraine, the goose breeding business is promising, profitable and underdeveloped, with low competition. The profitability of geese breeding is about 75%. In addition, goose farming is one of the possible ways to solve the problem of animal protein deficiency in the world.The high-quality calculation of recipes is a necessary part of efficient production and use of finished products at the present stage of the feed industry development.Optimization of compound feed recipes determines its composition and takes into account the impact of certain feed components on the physiology, health, growth and productivity of animals. Recipe calculation programs occupy a key place in the technological chain of animal husbandry production, combining producer and products consumer.The quality of the final product and the compliance of the calculated indicators of nutritional value with the actual depend on the accuracy of the recipes calculation and take into account all the destabilizing factors in the technological production process. Thanks to modern software optimization of recipes, it becomes possible not only to make a diet with available raw materials that is optimal in quality and cost, but also to assess the feasibility of introducing a particular additiv e, both from a biological and economic point of view.It is proven that geese must receive high quality and balanced feed by all indicators for the normal development and realization of genetic potential. Therefore, the urgent task is to develop recipes for high-quality geese feed using domestic available raw materials.With the help of the software package "Korm Optima Expert" we have developed complete feed recipes for parent flock geese aged 0… 3 weeks (starter), 4… 8 weeks (grower), 9… 26 weeks (finisher), older 27 weeks (breeder), and recipes for broiler type geese aged 0… 4 weeks (starter) and older 5 weeks (finisher). The program includes the principle of calcula ting recipes at the minimum cost, taking into account the limitations of the input of each component and the nutritional value of the finished product using linear programming formulas.Experimental samples of starter, grower, finisher and breeder were made in accordance with the developed recipes of complete feed for parent flock geese. Physical properties and chemical composition were studied in the experimental samples.It is established that the experimental samples of starter, grower, finisher and breeder are characterized by satisfactory physical properties and comply with regulatory and technical documentation. They are balanced in content of nutrients and biologically active substances and meet the physiological needs and feeding standards of the parent flock geese.
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Liubchenko, M. A., O. E. Mandrichenko, and T. P. Demidenko. "CREATION OF 3D LIBRARIES OF DIGITAL COMPONENTS FOR THE MULTISTORY BUILDING MODEL." Bulletin of Odessa State Academy of Civil Engineering and Architecture, no. 80 (September 3, 2020): 19–26. http://dx.doi.org/10.31650/2415-377x-2020-80-19-26.
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Abstract. The article is dedicated to creation of 3D libraries of building construction elements with customized annotations, analytical and other necessary parameters for interior walls, doors, windows, exterior walls, floor slabs, roof, ceiling and floor elements in REVIT software. The aim of the work is to develop a database of families of parameterized components of buildings and structures in REVIT. The research was conducted using the method of generalization, systematic approach and statistical analysis. The matter of creating families of digital components of the virtual model of construction projects in accordance to the state norms and technical requirements is relevant now. Issues of creation and application of families of digital parameterized components according to requirements of current regulatory documents, interior and exterior components, as well as the structural component of each created element are described in the article. Some of the created families conform to the specified requirements, are universal and having an ability to replace types families. For each of the loaded element, the maximum possible number of materials was selected with the inclusion in the library of all the necessary information from physical and thermal characteristics to the current price of the building materials on the Ukrainian market. Practical use of the created libraries occurs in the design of construction projects in the framework of faculty and students cooperation with the Public Union «BUILDIT UKRAINE». The information model of a multistory civil building was created by the authors. The model allows to automatically generating the necessary drawings for construction: plans, facades, schemes, sections, design specifications and other documentation. Moreover, this reduces the time for preparation of project documentation and provides control of key indicators and compliance with the deadlines. Besides, the model allows to provide information on the results of researches and tests quickly, and promptly adjust the cost of construction.
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Nouban, Fatemeh, and Nura Yunusa. "Engr. Abdulkadir Abdullahi Kure Ultra-Modern Market Fire Safety Assessment." International Journal of Innovative Science and Research Technology 5, no. 7 (July 22, 2020): 192–99. http://dx.doi.org/10.38124/ijisrt20jul190.
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Nigeria has been affected by urban fire incidences especially the markets inferno which has an enormous cost to the businesses. The incidence seems to be yearly occurrences especially Engr. A.A. Kure UltraModern Market fire outbreak which began in 2014 and repeatedly continues every year which disrupts the market activities and causes environmental hazard such as pollution. The incidence occurrence is likely perceived to be connected to the lack of following due building process or fire safety regulation procedures during the market construction. In recognizing that some certain responses needed to prevent or curtail the reoccurrences of fire incidences, the study evaluates Engr. Abdulkadir Abdullahi Kure Ultra-Modern Market fire safety by considering mitigation or prevention regulations. Based on the 2019 updated England Building Regulations, the study assessed the Engr. Abdulkadir Abdullahi Kure Ultra-Modern Market fire safety using observable and measurable criteria such as means of warning and fire protection devices, internal and external fire spreading, fireresisting doors and fire service facilities and layout accessibility. The study revealed the drawback in legislating the fire safety regulations in the country. The regulatory bodies responsible for construction control and regulations should ensure the compliances with fire safety regulation to prevent further loss of resources and human lives in the country. The study, however, recommended that construction regulations agencies in the country need to use some set of safety indicators, as shown in the study, to evaluate the fire safety of any construction work.
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Kolobov, A. Yu, and E. V. Dikoun. "INTERVAL ESTIMATION OF RELIABILITY OF ONE-OFF SPACECRAFT." Dependability 17, no. 4 (November 22, 2017): 23–26. http://dx.doi.org/10.21683/1729-2646-2017-17-4-23-26.
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Aim. Many space technology products fall into the category of one-off (unique) or are manufactured in small batches of 3 to 5. In accordance with the regulatory documentation, the design and development activities in the space industry must involve quality assurance of products with interval estimation of dependability indicators. However, for one-off unique spacecraft that account for a fair share of the overall space industry product output, acquiring such estimates is associated with the problem of availability of original statistical data. That is due to the high cost of both the spacecraft itself and its testing, which does not allow testing large numbers of samples in the process of spacecraft development. In the context of restricted funding of the space industry, a practice has arisen that involves conduction each planned type of test on a single sample. The test samples have different configurations and versions of components (dimension and mass models, thermal analogues, etc.). In this case, it is impossible to acquire homogeneous statistical data in order to substantiate the compliance with the dependability requirements.Results. The article proposes a method of interval estimation of the probability of no-failure of a one-off spacecraft based on the results of flight tests using a priori information acquired at the stage of pre-delivery and acceptance testing. The authors compare the feasibility of using computational, experimental or computational and experimental methods of spacecraft dependability indicators evaluation. As initial data, electric and radio engineering and thermal vacuum tests results of spacecraft flight model are used. The fact that only the electric and radio engineering tests results are taken into consideration is due to the dependability of spacecraft being primarily defined by the dependability of the electronic equipment. The scope of tests (normally, about 50 for each spacecraft) allows obtaining highly reliable and informative estimates. This method can also be used at the stage of operation in order to evaluate and supervise dependability, e.g. after a year of operation. The correctness of aggregation of the a priori information and the information obtained at the said stage is verified with Fisher’s Z-value.Conclusions. The proposed method allows estimating pointwise values of probability of no-failure of one-off spacecraft, lower confidence bounds and mean-square deviation of the probability of no-failure at the stages of pre-delivery and acceptance testing, flight testing and operation using a priori information. An example is given of interval estimation of probability of no-failure of one-off spacecraft based on the results of flight operations using a priori information obtained at the stages of pre-delivery and acceptance testing.
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Larionova, I. V. "Model of Efficiency Assessment of Regulation In The Banking Seсtor." MGIMO Review of International Relations, no. 1(34) (February 28, 2014): 127–35. http://dx.doi.org/10.24833/2071-8160-2014-1-34-127-135.
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In this article, the modern system of regulation of the national banking sector is viewed, which, according to the author, needs theoretical judgment, structuring, disclosure of the maintenance of efficiency of functioning is considered. The system of regulation reveals on a system basis, it is offered to consider it as set of elements and the mechanism of their interaction which are formed taking into account target reference points of regulation. Thus it is emphasized that for regulation the contradiction is concluded: achievement of financial stability of functioning of the banking sector, as a rule, contains economic growth. The need for development of theoretical ideas of efficiency of regulation of the banking sector gains special relevance taking into account the latest events connected with revocation of licenses of commercial banks on implementation of bank activity, the high cost of credit resources for managing subjects, an insignificant contribution of the banking sector to ensuring rates of economic growth. The author offered criteria of efficiency of regulation of the banking sector to which are referred: functional, operational, social, and economic efficiency. Functional efficiency opens ability of each subsystem of regulation to carry out the functions ordered by the law. Operational efficiency describes correctness suffered by the regulator and commercial banks of the expenses connected with regulating influence. At last, social and economic efficiency is connected with degree of compliance of a field of activity of the banking sector to requirements of national economy, and responsibility of banking business before society. For each criterion of efficiency of regulation of the banking sector the set of the quantitative and quality indicators, allowing to give the corresponding assessment of the working model of crediting is offered. The aggregated expert assessment of the Russian system of regulation of the banking sector which is characterized as compensatory and satisfactory is given in article.
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Wintoki, M. Babajide, and Yaoyi Xi. "Friendly directors and the cost of regulatory compliance." Journal of Corporate Finance 58 (October 2019): 112–41. http://dx.doi.org/10.1016/j.jcorpfin.2019.04.011.
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YAKIMOVA, VILENA ANATOLYEVNA. "EXPERT-ANALYTICAL INSTRUMENTATION COMPLIANCE CONTROL." Messenger AmSU, no. 91 (2020): 95–100. http://dx.doi.org/10.22250/jasu.16.
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The article presents the directions of development of the methodology of compliance control as one of the forms of control and audit activities of organizations. A system of expert-analytical methods and tools is proposed, a feature of which is the grouping of methods by types and functions of compliance control. In the course of the study, it was found that analytical indicators play the role of indicators indicating possible risks of violation of regulatory legal acts, and make it possible to quickly predict and assess the financial losses of an organization.
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Lavrik, Evgeny P., Galina M. Trukhina, Anna G. Kravchenko, Sergey A. Vysotin, Alina T. Vysotina, and Natalya A. Dmitrieva. "Sanitary and epidemiological features of recreational water use of the Tuapse district of the Krasnodar region." Hygiene and sanitation 100, no. 9 (September 20, 2021): 910–16. http://dx.doi.org/10.47470/0016-9900-2021-100-9-910-916.
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Introduction. The state of the recreational system of the Black Sea coast of the Krasnodar Territory is of particular interest and great importance for the development of the medical and health complex in Russia. Currently, the Krasnodar Territory has a state task to develop beach tourism on the sea coast, one of the priority sectors of the Russian economy. Considering the territorial features of the Municipal Formation Tuapse region of the Krasnodar Territory, the priority direction in the work of the Tuapse branch of the Center for Hygiene and Epidemiology in the Krasnodar Territory is water protection measures aimed at ensuring the safety of public health. The study of the causal relationships of health and the environment based on the materials of social and hygienic monitoring and analysis of information data on indicators of human health and the environment determines the tactics of developing regional short-term and long-term preventive measures and programs to improve the environment and optimize the health of the population. Purpose of the study. studying the sanitary and epidemiological state of the recreation zones (beaches) of the Tuapse district of the Krasnodar region. Materials and methods. the work is based on the materials of annual reports on sanitary and epidemiological well being in the Tuapse region of the Krasnodar Territory, the analysis of expert opinions and laboratory studies carried out by employees of the Tuapse branch of the Center for Hygiene and Epidemiology in the Krasnodar Territory, the analysis of infectious morbidity, and the analysis of legislative and other regulatory requirements for the establishment and control of the state of recreation zones was also carried out Results and discussion. difficulties with the implementation of sanitary and epidemiological control (supervision) over recreation areas are associated with: the imperfection of modern legislation on recreation zones, lack of publicly available information on the state of recreation areas and programs (plans) of sanitary and recreational activities, need for significant material resources to bring the existing and replace outdated sewage water treatment systems that pollute the water area of recreational areas in compliance with the regulatory requirements. Conclusions. The paper presents the features of the recreational water use of the Tuapse region of the Krasnodar Territory, describes the problems of the improvement of the recreational zones of the region. An analysis of laboratory studies of the recreational waters of the Black Sea over the past ten years and an analysis of the incidence of intestinal and enteroviral infections in the population of the Tuapse region of the Krasnodar Territory were carried out, seasonal fluctuations in the incidence rate were identified (an increase during July-August). The increase in the morbidity rate in the summer is due to the influx of vacationers. The expediency of developing a draft system for assessing the sanitary and epidemiological reliability (disadvantage) of the recreation zone for ranking objects and creating an electronic database of objects is considered. This set of measures will effectively provide a risk-oriented model of sanitary and epidemiological control (supervision) over recreation areas.
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Henn, A. E., and W. R. Marhoffer. "Cost of U.S. Coast Guard Regulations to the U.S. Maritime Industry and Coast Guard Initiatives to Reduce These Costs." Journal of Ship Production 9, no. 04 (November 1, 1993): 203–9. http://dx.doi.org/10.5957/jsp.1993.9.4.203.
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For a number of years it has been alleged that compliance with U.S. Government regulations—specifically those of the U.S. Coast Guard—adds so much to the cost of a new U.S.-flag vessel that U.S. shipyards are rendered noncompetitive. An often touted figure is an average 15% cost increase due to ship design and construction regulations. Case studies and owners' reports have also identified incremental costs associated with both reflaggings to U.S.-flag and the construction of U.S.-flag ships in foreign shipyards. It is the purpose of this paper to summarize past studies addressing the cost of regulatory compliance, discuss possible explanations for the variations between the conclusions of these studies, identify factors other than regulatory compliance which impact the competitiveness of the U.S. shipbuilding industry, and describe several recent Coast Guard initiatives to further reduce the already low cost of compliance with Coast Guard regulations
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Marx, Johan, and Ronald Henry Mynhardt. "The cost of compliance: The case of South African banks." Corporate Ownership and Control 8, no. 3 (2011): 435–42. http://dx.doi.org/10.22495/cocv8i3c4p1.
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Compliance cost is expenditure of time or money in conforming to government requirements such as regulation or legislation. In the press it is stated that the cost of compliance is much too high in South Africa. Some South African regulatory authorities agreed with this opinion. To this end, research was conducted in South Africa to establish whether these opinions are accurate. The study found that the cost of compliance with regulations was unacceptably high for South African banks. The study concluded that banks needed assistance to reduce the cost of compliance. Following the recommendations of the study, calculations indicated that the implementation of these recommendations could reduce the cost of compliance by as much as 40 per cent.
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Boland, Colleen M., Chris E. Hogan, and Marilyn F. Johnson. "Motivating Compliance: Firm Response to Mandatory Disclosure Policies." Accounting Horizons 32, no. 2 (February 1, 2018): 103–19. http://dx.doi.org/10.2308/acch-52037.
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SYNOPSIS Mandatory existence disclosure rules require an organization to disclose a policy's existence, but not its content. We examine policy adoption frequencies in the year immediately after the IRS required mandatory existence disclosure by nonprofits of various governance policies. We also examine adoption frequencies in the year of the subsequent change from mandatory existence disclosure to a disclose-and-explain regime that required supplemental disclosures about the content and implementation of conflict of interest policies. Our results suggest that in areas where there is unclear regulatory authority, mandatory existence disclosure is an effective and low cost regulatory device for encouraging the adoption of policies desired by regulators, provided those policies are cost-effective for regulated firms to implement. In addition, we find that disclose-and-explain regulatory regimes provide stronger incentives for policy adoption than do mandatory existence disclosure regimes and also discourage “check the box” behavior. Future research should examine the impact of mandatory existence disclosure rules in the year that the regulation is implemented. Data Availability: Data are available from sources cited in the text.
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Zhampeiis, N. B. "Analysis of Compliance Services in Banks of the Republic of Kazakhstan in Current Situation." KnE Social Sciences 3, no. 2 (February 15, 2018): 22. http://dx.doi.org/10.18502/kss.v3i2.1520.
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The article highlights and describes the specifics of compliance in regulated banks of the Republic of Kazakhstan. Comparison of economic indicators, regulatory documentation, violations and sanctions for internal control, as well as a survey of the studied banks were conducted. Particular attention is paid to problematic issues in compliance control activities and recommendations for improving the AML/CFT system. Keywords: banks, Republic of Kazakhstan, AML/CFT system, compliance service
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Bortsova, E. L., and L. Yu Lavrova. "Analysis of requirements of regulatory documents regulating confirmation of shelf life of bakery products." Khleboproducty 30, no. 5 (2021): 54–55. http://dx.doi.org/10.32462/0235-2508-2021-30-5-54-55.
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The article presents biological hazards that are assessed as part of the confirmation of shelf life using the example of frozen Carponat pizza, in accordance with the current regulatory documentation. Physicochemical quality indicators are considered, which are also monitored within the framework of this program. Their compliance with regulatory documents has been established. The analysis conducted by the authors showed the existence of contradictions in the current regulatory documents not only in terms of quality and safety indicators, but also in accordance with the basic principle of the Federal Law of 31.07.2020 № 247-FZ «On Mandatory Requirements in the Russian Federation».
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Turner, B. G., and M. C. Boner. "Watershed monitoring and modelling and USA regulatory compliance." Water Science and Technology 50, no. 11 (December 1, 2004): 7–12. http://dx.doi.org/10.2166/wst.2004.0666.
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The aim of the Columbus program was to implement a comprehensive watershed monitoring-network including water chemistry, aquatic biology and alternative sensors to establish water environment health and methods for determining future restoration progress and early warning for protection of drinking water supplies. The program was implemented to comply with USA regulatory requirements including Total Maximum Daily Load (TMDL) rules of the Clean Water Act (CWA) and Source Water Assessment and Protection (SWAP) rules under the Safe Drinking Water Act (SDWA). The USEPA Office of Research and Development and the Water Environment Research Foundation provided quality assurance oversight. The results obtained demonstrated that significant wet weather data is necessary to establish relationships between land use, water chemistry, aquatic biology and sensor data. These measurements and relationships formed the basis for calibrating the US EPA BASINS Model, prioritizing watershed health and determination of compliance with water quality standards. Conclusions specify priorities of cost-effective drainage system controls that attenuate stormwater flows and capture flushed pollutants. A network of permanent long-term real-time monitoring using combination of continuous sensor measurements, water column sampling and aquatic biology surveys and a regional organization is prescribed to protect drinking water supplies and measure progress towards water quality targets.
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Rees, Hubert L., Jeffrey L. Hyland, Ketil Hylland, Colleen S. L. Mercer Clarke, John C. Roff, and Suzanne Ware. "Environmental indicators: utility in meeting regulatory needs. An overview." ICES Journal of Marine Science 65, no. 8 (November 1, 2008): 1381–86. http://dx.doi.org/10.1093/icesjms/fsn153.
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Abstract Rees, H. L., Hyland, J. L., Hylland, K., Mercer Clarke, C. S. L., Roff, J. C., and Ware, S. 2008. Environmental indicators: utility in meeting regulatory needs. An overview. – ICES Journal of Marine Science, 65: 1381–1386. The utility of environmental indicators in meeting regulatory needs was addressed at an international symposium held in November 2007. This paper summarizes the attributes and range of uses of indicators and highlights key points from theme sessions and a workshop on unifying concepts. The symposium attracted regulators and scientists, who supported the need to promote dialogue during the construction of indicator-based management frameworks and at key stages towards operational use. Scientists expressed willingness to engage with the wider societal context for indicator applications, which is essential to the development of ecosystem-based management. For the latter to be effective, more effort is needed to combine indicators with thresholds to guide management actions and, in the process, to assess the full range of consequences of non-compliance. There are clear benefits to periodic interdisciplinary reviews of progress in this area, and a follow-up event with a regulatory emphasis is suggested.
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Rawling, Alan K. "Information Technology/Laboratory Information Management Systems: Problems of Regulatory Compliance." Journal of AOAC INTERNATIONAL 77, no. 3 (May 1, 1994): 782–85. http://dx.doi.org/10.1093/jaoac/77.3.782.
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Abstract Despite the attention paid to the regulatory requirements for computer systems, recent inspections continue to report basic failings in the standards of validation and documentation. This paper describes the need for validation of vendor-supplied software such as Laboratory Information Management Systems and the procedures necessary for control of the production phase in a regulated environment. Whereas these requirements may be considered “good computing practices,” their adherence remains a management challenge at odds with pressures of cost, business need, and time.
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Windapo, Abimbola Olukemi. "Relationship between degree of risk, cost and level of compliance to occupational health and safety regulations in construction." Construction Economics and Building 13, no. 2 (June 18, 2013): 67–82. http://dx.doi.org/10.5130/ajceb.v13i2.3270.
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This paper investigates the role of statutory health and safety (H&S) regulations in managing construction project risks. The study examines whether the decision made by contractors to comply with the regulations, the cost of compliance and savings of H&S regulatory requirements is influenced by the degree or level of risk, which the regulations are trying to prevent. The rationale for the examination stems from previous studies which establish that building designers and contractors perceive the cost of complying with regulations as additional burdens, which they have to conform to, and which are in some cases unnecessary, and also the fact that construction related injuries and fatalities are on the increase. Qualitative and quantitative data obtained from a descriptive survey and H&S site audit by the Master Builder Association of the Western Cape (MBAWC) were used as the measurements of risk, level of compliance to regulations, cost of compliance and savings. By correlating the quantitative and qualitative data, there is empirical evidence to support a negative relationship between the degree of risk, level and cost of compliance and cost savings. Based on the study’s findings, this paper concludes that the decision made by contractors to comply with H&S regulatory requirements is influenced by the perceived cost saving on account of compliance and that cost savings are influenced by the probability of accident occurrence which is an element of the degree of risk which the regulation is trying to prevent or control.
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Wolverton, Ann, Ann E. Ferris, and Nathalie B. Simon. "Retrospective Evaluation of the Costs of Complying with Light-Duty Vehicle Surface Coating Requirements." Journal of Benefit-Cost Analysis 10, no. 1 (December 19, 2018): 39–64. http://dx.doi.org/10.1017/bca.2018.25.
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This paper compares the U.S. Environmental Protection Agency’s (EPA) ex ante compliance cost estimates for the 2004 Automobile and Light-Duty Truck Surface Coating National Emission Standards for Hazardous Air Pollutants to ex post evidence on the actual costs of compliance based on ex post cost data gathered from a subset of the industry via pilot survey and follow-up interviews. Unlike many prior retrospective studies on the cost of regulatory compliance, we use this newly gathered information to identify the key drivers of any differences between the ex ante and ex post estimates. We find that the U.S. EPA overestimated the cost of compliance for the plants in our sample and that overestimation was driven primarily by differences in the method of compliance rather than differences in the per-unit cost associated with a given compliance approach. In particular, the U.S. EPA expected facilities to install pollution abatement control technologies in their paint shops to reduce emissions of hazardous air pollutants, but instead these plants complied by reformulating coatings.
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RASERA, DENISE, TASSIA GASPAR MENDES, TIAGO BALIEIRO CETRULO, MARIA PAULA CARDOSO YOSHII, TADEU FABRÍCIO MALHEIROS, RODRIGO MARTINS MOREIRA, ALEJANDRA DANIELA MENDIZÁBAL-CORTÉS, and ESTER FECHE GUIMARÃES. "WATER SUPPLY AND SEWAGE SERVICES REGULATION INDICATORS IN POVERTY AREAS: STRUCTURE AND APPLICATION PROCESS IN CUBATÃO-SP, BRAZIL." Ambiente & Sociedade 20, no. 4 (December 2017): 61–84. http://dx.doi.org/10.1590/1809-4422asoc0020r4v2042017.
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Abstract The sanitation regulatory milestone in Brazil was established in 2007; regulatory agencies are responsible for assuring that service providers work in compliance with sanitation plans. The Water Supply and Sanitation Services (WS&SS) provided to subnormal clusters present peculiar features that require regulatory agencies to have appropriate tools to perform such monitoring. The aim of the current article is to build and present a system of indicators used for this purpose. A combination of traditional and participatory approaches was used to collect the indicators. Eleven indicators were proposed in the participatory approach and twelve were inserted in the traditional approach. These indicators were assessed by experts and applied to Cubatão County. Thus, a system comprising twenty-three indicators is herein presented to help monitoring the contractual and planning goals of WS&SS provided to subnormal clusters. The model is innovative and can be used in Incentive-based or in Sunshine regulations.
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Rhee, Hyok-Joo. "A Microeconomics of Land Use Regulations and the Measurement of Regulatory Compliance Cost." Journal of korea Planners Association 50, no. 2 (February 28, 2015): 5. http://dx.doi.org/10.17208/jkpa.2015.02.50.2.5.
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McCarthy, Claudine. "Conduct survey to gain insight into cost of regulatory compliance on your campus." Student Affairs Today 18, no. 9 (November 19, 2015): 5. http://dx.doi.org/10.1002/say.30141.
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Glass, J. Colin, Donal G. McKillop, and Syamarlah Rasaratnam. "Irish credit unions: Investigating performance determinants and the opportunity cost of regulatory compliance." Journal of Banking & Finance 34, no. 1 (January 2010): 67–76. http://dx.doi.org/10.1016/j.jbankfin.2009.07.001.
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Reznichenko, Irina, and Maria Kondratieva. "Authenticity Identification of Carbonated Alcochol-Free Beverages." Food Industry 5, no. 1 (March 17, 2020): 16–22. http://dx.doi.org/10.29141/2500-1922-2020-5-1-2.
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The article concerns the counterfeiting problem of non-alcoholic drinks sold on the consumer market of the Russian Federation; provides data on drinks fraud methods (assortment, qualitative, quantitative and informational types). Strengthening quality control of soft drinks is one of the main directions of providing consumers with qualitative products. The authors presented authenticity identification results of carbonated soft drinks sold on the Kemerovo consumer market for compliance with the current regulatory documents requirements; run the consumer criteria analysis for the drinks identification of various brands. They obtained data on the labeling and packaging identification of selected non-alcoholic carbonated drinks samples for the compliance with current regulatory documents. A man recorded the compliance. There was an absence of the quantitative counterfeiting identification. The study described results of the organoleptic and physico-chemical quality indicators research. According to the GOST 28188-2014 “Non-Alcoholic Beverages. General Technical Conditions” the authors evaluated beverages quality by such physical and chemical indicators as the mass fraction of dry substances, acidity, and the mass fraction of carbon dioxide. The researchers run the organoleptic indicators analysis according to a score system. Authenticity identification of the selected drinks samples showed that there are no signs of counterfeiting and the products are of high quality.
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Marx, Johan, and Ronald Henry Mynhardt. "Private hospitals in South Africa: A compliance framework." Corporate Ownership and Control 9, no. 4 (2012): 145–53. http://dx.doi.org/10.22495/cocv9i4c1art2.
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The primary compliance risks faced by private hospitals in South Africa were analysed. Compliance for private hospitals fell into three categories: patient care, regulatory compliance and human resources. The results of this study indicated that these hospitals are struggling to ensure compliance as a result of the complexity of and constant changes to applicable legislation. The study confirmed that private hospitals face compliance risk. A compliance framework was developed, which could reduce compliance risk of private hospitals in South Africa. Outsourcing could be considered in order to focus on core business activities and to reduce the cost of compliance.
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Belfield, Clive R., A. Brooks Bowden, and Viviana Rodriguez. "Evaluating Regulatory Impact Assessments in Education Policy." American Journal of Evaluation 40, no. 3 (July 18, 2018): 335–53. http://dx.doi.org/10.1177/1098214018785463.
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Benefit–cost analysis is an important part of regulatory decision-making, yet there are questions as to how often and how well it is performed. Here we examine 28 Regulatory Impact Assessments performed by the federal government on education regulations since 2006. We find many Regulatory Impact Assessments estimated costs, albeit using informal methods, but most failed to adequately report benefits. Also, most studies did not estimate net present value or clearly report methodological assumptions. In reviewing the relatively high quality studies we identified a number of discrepancies from best practice. Most importantly, few Regulatory Impact Assessments attempted a social benefit–cost analysis: Most examined “administrative burdens” from compliance with legislation. This alternative focus on administrative burdens has significant implications for economic evaluation in practice.
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Sufian, Fadzlan. "Developments in the performance of the Malaysian banking sector: opportunity cost of regulatory compliance." International Journal of Business Competition and Growth 1, no. 1 (2010): 85. http://dx.doi.org/10.1504/ijbcg.2010.032830.
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Kopits, Elizabeth, Al McGartland, Cynthia Morgan, Carl Pasurka, Ron Shadbegian, Nathalie B. Simon, David Simpson, and Ann Wolverton. "Retrospective cost analyses of EPA regulations: a case study approach." Journal of Benefit-Cost Analysis 5, no. 2 (June 2014): 173–93. http://dx.doi.org/10.1515/jbca-2014-0024.
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Abstract:EPA has conducted several ex post assessments of regulatory compliance costs, with the ultimate goal of identifying ways to improve ex ante cost estimation. The work to date has culminated in four case studies that examine five regulations using a common conceptual framework. The standardized framework provides a systematic way to investigate key drivers of compliance costs to see if judgments can be made about why and how ex ante and ex post estimates of costs differ. In addition to describing this conceptual framework, we describe the criteria used to select the rules to be analyzed, summarize the main hypotheses for why ex ante and ex post cost estimates may differ and discuss some of the challenges encountered in conducting these ex post analyses.
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Chuck, Anderson, Philip Jacobs, J. Wayne Logus, Donald St Hilaire, Chester Chmielowiec, and Alexander J. B. McEwan. "Marginal cost of operating a positron emission tomography center in a regulatory environment." International Journal of Technology Assessment in Health Care 21, no. 4 (October 2005): 442–51. http://dx.doi.org/10.1017/s0266462305050610.
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Objectives: Cost studies of positron emission tomography (PET) imaging are important for resource and operational planning; the most relevant cost analysis in this regard is the marginal cost. Operating within a regulatory environment can add considerably to the costs of providing PET services. Previously published research has not examined the marginal cost structure of PET nor have they described the implications of regulatory compliance to operational costs. The purpose of this study was to conduct a comprehensive cost estimation of PET imaging with 18F-fluorodeoxyglucose (18F-FDG) to better identify the fixed and variable cost components, the marginal cost structure, and the added costs of satisfying regulatory requirements.Methods: Financial data on capital and operating expenses were collected for the PET center at the Cross Cancer Institute in Edmonton, Alberta, Canada.Results: The total per-service cost for clinical operations ranged between $7,869 (400 annual scans) and $1,231 (3,200 annual scans). The marginal cost for the center remained steady as volume increased up to the throughput capacity.Conclusions: Results indicate that economies from increased volumes did not arise. Regulatory requirements added significant costs to operating an 18F-FDG-PET center.
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Yusuf, Ismaila, and Damola Ekundayo. "Regulatory non-compliance and performance of deposit money banks in Nigeria." Journal of Financial Regulation and Compliance 26, no. 3 (July 9, 2018): 425–41. http://dx.doi.org/10.1108/jfrc-04-2017-0041.
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Purpose The purpose of this study is to examine regulatory sanctions from an emerging economy perspective and analyzing the impact of regulators imposed monetary sanctions on banks’ performance. Design/methodology/approach The study adopted correlational research design to examine the effect of regulatory penalties on the performance of deposit money banks in Nigeria. This study used panel data from a sample of 15 deposit money banks in Nigeria for the period of 2006-2015. Multiple regression analysis was carried out. Findings Results showed that penalties imposed by regulators in the Nigerian banking industry have no significant impact on the bottom line of the defaulters. Penalties imposed on foreign exchange and international trade related infraction showed that the cost of penalties is below the benefits enjoyed from such infractions. Practical implications The insignificant impact of penalties on performance implies that deposit money banks have considered penalties imposed by regulators as operational expenses and transferred such to customers. Originality/value The study differs from other studies that examined regulatory penalties on performance by focusing on financial performance and using data from an emerging economy perceived to have weak regulatory environment.
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Tietjen, Andrea, Rebecca Hays, Gwen McNatt, Robert Howey, Ursula Lebron-Banks, Christie P. Thomas, and Krista L. Lentine. "Billing for Living Kidney Donor Care: Balancing Cost Recovery, Regulatory Compliance, and Minimized Donor Burden." Current Transplantation Reports 6, no. 2 (April 27, 2019): 155–66. http://dx.doi.org/10.1007/s40472-019-00239-0.
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Prorokowski, Lukasz. "MiFID II compliance – are we ready?" Journal of Financial Regulation and Compliance 23, no. 2 (May 11, 2015): 196–206. http://dx.doi.org/10.1108/jfrc-02-2014-0009.
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Purpose – This paper aims to discuss the impact of nascent Markets in Financial Instruments Directive (MiFID II) initiatives and, thus, to deliver practical insights into MiFID II implementation, compliance and cost reduction MiFID II constitutes the backbone for the upcoming financial market reforms. With the first proposal of MiFID drafted in October 2011, this regulatory framework has undergone over 2,000 amendments. As MiFID II currently stands, this Directive attempts to address issues exposed by the global financial crisis. Design/methodology/approach – This study, based on secondary research and an in-depth analysis of the MiFID II framework, investigates structural and technological challenges entailed by this Directive. The analysis is broken down into the following sections: technological and structural challenges; costs of implementation; MiFID II teams; facilitating near real-time regulatory reporting; increased transparency requirements; and information technology (IT) initiatives for MiFID II compliance. Findings – MiFID II commands significant changes in business and operating models. With this in mind, the study indicates current technological and structural challenges faced by financial institutions and advises on ways of mitigating MiFID II risks. Although it is too early to assess the costs of implementing MiFID II, this paper suggests ways of reducing MiFID II-related costs. The study also advises on organising dedicated teams to deal with MiFID II. Furthermore, this paper argues that early investments in IT systems and processes would allow financial services firms to gain a competitive advantage and, hence, scoop up market share or launch new, lucrative services – especially in the area of collateralisation and market data processing. Originality/value – This paper shows that the current version of MiFID II still requires a great deal of attention from the regulators that need to readdress contentious issues revolving around the links between MiFID II and other regulatory frameworks such as European Market Infrastructure Regulation and Dodd–Frank. This study addresses the MiFID II compliance issues by adopting European Union and non-European Union banks’ and asset managers’ perspectives and, hence, delivers practical implications for risk managers and compliance officers of various financial institutions.
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Bergonzoni, Giacomo, Valentina Marino, Mohamed Elagiry, and Andrea Costa. "Assessing Residential Buildings Compliance with Sustainability Rating Systems through a BIM-Based Approach." Proceedings 65, no. 1 (January 6, 2021): 22. http://dx.doi.org/10.3390/proceedings2020065022.
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Using the semantic information available in building information models (BIM) during the whole project lifecycle enables faster, safer, and efficient construction, cost-effective operation and maintenance, and cost-effective eventual decommissioning. This paper aims to provide a systematic review of how sustainability rating systems can exploit the BIM approach for an easy collection of data and information and assessment of indicators to reach building certification. This paper is a part of the BIM4REN project, which is dedicated to developing an open-access platform of tools for the digitalization of the building renovation process specifically tailored for SMEs (Small and medium-sized enterprises).
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Jin, Shuai, Yanlin Zhang, and Zhaohan Sheng. "The Regulatory Strategy in Emissions Trading System under Costly Enforcement." Mathematical Problems in Engineering 2014 (2014): 1–10. http://dx.doi.org/10.1155/2014/487912.
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In a two-stage dynamic game of regulator and polluting firms, the optimal regulatory strategy to achieve a fixed aggregate emissions target cost-effectively in emissions trading system was studied under the context of costly monitoring and sanctioning, including the monitoring level, the aggregate supply of permits, and the penalty shape for noncompliance. Based on gaming analysis, a heterogeneous agent-based experiment platform for regional emissions trading system was established using computational experiment. Then further analyses were done from perspectives of dynamic and bounded rationality. The results show that the optimal strategy to achieve target is to induce full compliance. This is not simply setting severe punishment, but seeking tradeoff between the level of monitoring and punishment. Finally, integrating the permit price directly into the penalty shape allows the policy objective to be achieved more cost-effective.
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Potter, John A. "Laboratory 2000 - The challenge of achieving efficiency and compliance." Journal of Automated Methods and Management in Chemistry 23, no. 6 (2001): 189–90. http://dx.doi.org/10.1155/s1463924601000244.
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Significant advances within the field of laboratory automation and instrumentation have greatly benefited the pharmaceutical industry in its quest to discover, develop and monitor the quality of its products. Necessitated by the need for efficiency and greater productivity, faster and more cost-effective means of analyses exist in the form of devices made up of complex electromechanical components, all logically controlled and most with the capability to interface with sophisticated information systems. This benefit does come with a price, a greater responsibility to ensure data quality while complying with increased regulatory requirements. Commitment to this responsibility presents a substantial challenge to scientists and managers throughout the industry. Due diligence must be demonstrated. A comprehensive evaluation of every laboratory system utilized, a solid plan of action for correcting any known deficiencies including upgrades or complete replacement, and an accurate monitoring procedure with the ability to measure progress are all absolute necessities to ensure success. Crossfunctional team effott and communication must transpire with full managerial support. Vendors need to be audited, made aware of any functional or quality inadequacies they possess as well as the pharmaceutical industry's expectation for these shortcomings to be rapidly corrected. Suppliers of these systems should also be encouraged to provide complete off-the-shelf solutions to eliminate the need for in-house customization. The requirements for regulatory compliance in today's electronic environment have been well publicized. The players involved are not only listening, but also taking the necessary steps to retain and improve efficiency without sacrificing quality. With the proper measures, planning and action, a highly automated, cost-effective and compliant laboratory operation can become a reality.
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Gupta, Rajkumar. "PIC/S: TRAINING THE REGULATORS TO REGULATE cGMP COMPLIANCE." International Journal of Drug Regulatory Affairs 2, no. 3 (February 13, 2018): 48–51. http://dx.doi.org/10.22270/ijdra.v2i3.141.
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PIC/S is an international Organization for implementing cGMP standards in its member countries. The basic objective of PIC/S is to improve and standardize cGMP compliance in member countries. Their aim is to enhance GMP intelligence via sharing of GMP inspection reports. Further it wants to reduce duplication of inspections to save the cost and time.
Their regulations are directed to promote harmony in GMP standards and to train national regulatory authorities for cGMP vigilance. They requires that every nation shall empower the legislation to inspect the facilities as per definite program, to issue notices for noncompliance, to impart regular training to all concerned employees.
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Bansal, Anshul, Vikesh Kumar Shukla, and Shikha Chauhan. "A comprehensive study of Regulatory compliance for Biosimilars in US, EU and India." International Journal of Drug Regulatory Affairs 7, no. 2 (June 16, 2019): 17–34. http://dx.doi.org/10.22270/ijdra.v7i2.313.
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The biopharmaceutical industry has gained significant interest in the last decade as the numbers of blockbuster biologic products are losing their patent rights. The regulatory authority is also providing marketing approval for Biosimilar products. Biological medicines are biotechnology developed drugs having large molecule which is complex in nature and are very sensitive to manufacturing conditions and parameters. Even a minor change in manufacturing conditions alters the quality and safety aspects of end product owing to increased risk for immune response. Biopharmaceutical companies use information technology such as molecular modelling and statistical data for drug development. Biosimilar drugs have moderate marketing cost which is alluring and generally 40 to 50 % less to that of originator drug product. Biosimilars are also known as “follow on biologics” or “similar biologics”. The following points needs consideration such as global harmonization, extrapolation studies, interchangeability study, long term post marketing studies to gain physician confidence in biosimilars.
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Waddell, A. W. "Practical Quality Improvement Applied to Toxicology Studies." Journal of the American College of Toxicology 10, no. 3 (May 1991): 387–91. http://dx.doi.org/10.3109/10915819109079820.
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Elements that are required for regulatory compliance can be used as powerful resources to achieve quality improvement. One such approach, using the output from a Good Laboratory Practice quality assurance program, is described and has produced marked improvements in the conduct and reporting of toxicology studies. The cost effectiveness of quality assurance programs under such circumstances is discussed.
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Prasad, S. Nagaraja, and Vedavathi H. "Pharmacoeconomic study of antipsychotic drugs in India." International Journal of Basic & Clinical Pharmacology 6, no. 2 (January 28, 2017): 377. http://dx.doi.org/10.18203/2319-2003.ijbcp20170333.
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Background: Schizophrenia is a disorder of relatively high point prevalence, low incidence and high disability. It accounts for nearly 1.5-3% of total national expenditure on health care. There is a gross variation in the cost of various branded and generic versions of antipsychotics available in India. This can lead to decreased patient compliance. The present study was undertaken to highlight this variation in the cost of various preparations of antipsychotics (branded and generic) available in India.Methods: Cost ratio and Percentage variation in cost of various antipsychotics available were calculated by standard formulae and analysed.Results: There is a very high variation in the cost of various antipsychotics available in India. The highest variation in cost ratio was seen with risperidone 2mg, 3mg and olanzapine 10mg, while the highest percentage cost variation was seen with risperidone 3mg, 4mg, 1mg; olanzapine 2.5mg, 5mg, 50mg, 100mg; levosulpiride 25mg and chlorpromazine 20mg. The lowest percentage cost variation was seen with Flupenthixol 3mg and Amisulpiride 300mg.Conclusions: There is a definite need to further strengthen the Drug Price Regulatory Mechanisms with regard to antipsychotics available in India in order to improve the patient compliance and thus cure rates of this burdensome and costly illness.
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N. Davilas, Christina. "AML compliance for foreign correspondent accounts: a primer on beneficial ownership requirements and other challenges." Journal of Investment Compliance 15, no. 1 (February 27, 2014): 4–16. http://dx.doi.org/10.1108/joic-01-2014-0003.
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Purpose – To educate on AML legal requirements and issues relative to foreign correspondent accounts, and give practical advice on relatively low-burdensome measures firms can take to help them achieve compliance in this challenging area. Design/methodology/approach – Summarizes AML requirements relevant to foreign correspondent accounts, discusses two related FINRA settlements involving the alleged failure to obtain and verify beneficial ownership information, reviews ongoing regulatory and legislative initiatives (including a FinCEN initiative to require firms to identify beneficial owners and verify their identities), and suggests certain due diligence procedures firms can use to screen foreign correspondent accounts. Findings – One of the fundamental risks that firms face when dealing with foreign correspondent accounts is not knowing their customers' customers. While the current regulatory framework does not, in most cases, explicitly require firms to obtain beneficial ownership information, the practical reality seems to be that obtaining and verifying such information, where possible, could pay substantial dividends in terms of risk assessment and avoidance. Practical implications – In some cases, a variety of cost-effective screening measures can be sufficient for a firm to identify concrete risks so that it may take steps to reduce its own regulatory exposure. Firms should not discount the simple for the elaborate, and should take advantage of the several, cost-effective AML tools and resources that are readily available. Originality/value – Practical guidance for AML officers and other compliance and legal professionals by an experienced financial institutions lawyer.
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PANDEY, RITA, and GEETESH BHARDWAJ. "Comparing the cost effectiveness of market-based policy instruments versus regulation: the case of emission trading in an integrated steel plant in India." Environment and Development Economics 9, no. 1 (January 19, 2004): 107–22. http://dx.doi.org/10.1017/s1355770x03001104.
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Cost-effective policies allow for minimizing the compliance costs associated with reaching a desired environmental quality target. In this paper a conceptual model has been developed to examine the compliance costs under an intra-plant emission trading system for a non-uniformly mixed assimilative pollutant. The model incorporates the number of emission sources, the concentration of pollutants emitted at each source, the marginal cost of abatement for each source, the transfer coefficient that relates emission at each source with the impact on ambient air quality, and the desired ambient air quality target. The model is applied to an integrated steel plant in India. Results of this study demonstrate that emission trading is more cost effective than the existing regulatory system. Further, intra-plant trades would result in significant savings to the steel plant while securing an improvement in ambient air quality in the studied geographical area.
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Yap, Crystal, Ken Foster, Paul Preckel, Otto Doering, and Brian Richert. "Mitigating the Compliance Cost of a Phosphorus-Based Swine Manure Management Policy." Journal of Agricultural and Applied Economics 36, no. 1 (April 2004): 23–34. http://dx.doi.org/10.1017/s1074070800021830.
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Regulatory changes by federal and state agencies portend a switch from nitrogen-based livestock manure disposal policies to phosphorus-based policies. This paper estimates the compliance costs of such a policy change for a hypothetical hog-grain farm in North Central Indiana. The farm includes 1,500 acres of cropland and has the capacity to raise 11,970 grow-finish hogs annually. The farm model also has the potential to produce four different crops on six different land types. A nonlinear math-programming model was developed to determine the optimal mix of management activities for a phosphorus-based regulation. The model allows mitigation of compliance costs via the choice between four different pig diets, three alternative methods of manure disposal, changes in timing of manure application, and crop pattern adjustments. This analysis concludes that the new regulation will result in a decrease in whole-farm returns above variable costs, the use of phytase enzyme in pig diets, and an increase in wheat acreage. The model also reveals that it is optimal for the farmer to hire a custom hauler to assist in application of manure in an effort to reduce the degree to which available field days constrain farming activities and land application of manure. The estimated cost to the farmer, as a result of the policy change, ranges between $0.56 and $21.74 per unit of pig production capacity.
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Joshi, Satish, Ranjani Krishnan, and Lester Lave. "Estimating the Hidden Costs of Environmental Regulation." Accounting Review 76, no. 2 (April 1, 2001): 171–98. http://dx.doi.org/10.2308/accr.2001.76.2.171.
Full textAbstract:
This paper examines the extent to which accounting systems separately identify all the costs of environmental regulation. We estimate the relation between the “visible” costs of regulatory compliance (costs that firms' accounting systems correctly classify as “environmental”) and “hidden” environmental costs embedded in other accounts. We use plant-level data from 55 steel mills to estimate hidden costs, and we follow up with structured interviews of corporate-level managers and plant-level accountants. Empirical results show that a $1 increase in the visible cost of environmental regulation is associated with an increase in total cost (at the margin) of $10–$11, of which $9–$10 are hidden in other accounts. The findings suggest that inappropriate identification and accumulation of the costs of environmental compliance are likely to distort costs in firms subject to environmental regulation.