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1

Liu, Ning, Carlos Wing-Hung Lo, and Xueyong Zhan. "Regulatory Ties and Corporate Compliance Strategies." Public Performance & Management Review 42, no. 3 (October 10, 2018): 580–605. http://dx.doi.org/10.1080/15309576.2018.1486214.

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Haines, Fiona. "Regulatory Failures and Regulatory Solutions: A Characteristic Analysis of the Aftermath of Disaster." Law & Social Inquiry 34, no. 01 (2009): 31–60. http://dx.doi.org/10.1111/j.1747-4469.2009.01138.x.

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This article analyzes the regulatory reform and implementation process in Australia following three event clusters: an industrial explosion, recent terrorist attacks, and a corporate collapse. The research employed a characteristic analysis where the compliance challenge on the ground is understood as affected not only by the enforcement efforts of the regulator, but also the reform process and the structure of the industry concerned. In each of the cases studied, preferred reforms could be understood as “metaregulatory” and framed around outcomes, principles, and processes rather than a preoccupation with adherence to prescriptive rules. Metaregulation was seen as the most appropriate regulatory framework to maintain the integrity between regulatory goal, regulatory regime, and compliance behavior. Yet, reform pressures that shaped the causal narrative associated with the particular risk, the emotional work involved in compliance, and success strategies of sites all affected what risks were actually reduced and hence the likelihood of a repeat disaster.
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Kwon, Juhee, and M. Eric Johnson. "Health-Care Security Strategies for Data Protection and Regulatory Compliance." Journal of Management Information Systems 30, no. 2 (October 2013): 41–66. http://dx.doi.org/10.2753/mis0742-1222300202.

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4

Karassin, Orr, and Aviad Bar-Haim. "How Regulation Effects Corporate Social Responsibility: Corporate Environmental Performance under Different Regulatory Scenarios." World Political Science 15, no. 1 (May 27, 2019): 25–53. http://dx.doi.org/10.1515/wps-2019-0005.

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AbstractIn a multilevel corporate social performance model we examine the effects of three different regulatory scenarios on corporate environmental performance (CEP) (relating to compliance and beyond compliance behaviors) as a measure of CSR. The empirical state defined as a “cooperative regulator” is assessed against three simulated scenarios: a “coercive regulator” (more punitive), a “demanding regulator” (strengthened standards) and a “lax regulator” (less punitive and less demanding). The relative effect of different regulatory scenarios is examined within a multilevel multivariate model. The model allows for the estimation of the role of regulatory strategies in relation to other CEP antecedents. The model includes the principal driving factors effecting CEP and incorporates three levels of analysis: institutional, organizational, and individual. The multilevel nature of the design allows for the assessment of the relative importance of the levels and their components in the achievement of CEP. Included in the institutional level are stakeholder expectations, regulatory demands and regulatory power. Included in the organizational level are corporate organizational culture, CSR orientation of managers and organizational leadership. Included in the individual level are personal workplace behaviors and norms, namely: job satisfaction, organizational commitment and organizational citizenship behavior. The simulation of regulatory scenarios shows that the empirical “cooperative regulator” has the strongest positive effect on CEP. Contrarily, coercive regulatory practices reduce the internal motivation for compliance and beyond compliance action, although they may increase the external incentives. Laxer regulatory practices reduce the credibility of the normative effect of the regulatory regime and weaken the internal motivation for CEP. While findings show that regulation does play a key role in CEP performance, the organizational level has the strongest and most positive significant relationships with CEP. Organizational culture and manager’s attitudes and behaviors are significant driving forces. Generally, the individual level, depicting workers’ attitudes toward their workplace, is found as insignificant in promoting CEP.
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Prorokowski, Lukasz, and Hubert Prorokowski. "Organisation of compliance across financial institutions." Journal of Investment Compliance 15, no. 1 (February 27, 2014): 65–76. http://dx.doi.org/10.1108/joic-12-2013-0041.

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Purpose – Compliance is defined as conforming to a rule, such as a policy framework, standard or law. Regulatory compliance encompasses all processes that require an entity to be aware of and conform to relevant regulations. As a result, organisation of compliance function remains complex due to the overwhelming set of compliance requirements that exert pressure on various business segments. This report aims to investigate how banks and financial services firms are responding to the regulatory-driven changes to the current compliance landscape, with particular attention paid to nascent challenges and structural changes affecting the organisation of compliance. Design/methodology/approach – The current research project is based on in-depth, semi-structured interviews with five universal banks and three financial services firms to pursue the best practices of adapting to the accelerating change in the regulatory-driven compliance landscape. Findings – In the aftermath of the global financial crisis, banks and financial institutions across the globe have been required to adapt to numerous regulatory reforms that are exerting increased pressure on compliance functions. Amid recent events of multi-million fines to banks that displayed flawed surveillance systems and control failings, the changing regulatory landscape has shown that the relationship with the regulators and compliance with the new regulatory frameworks is a difficult process even for the tier-1 global banks. Originality/value – Embarking on a peer review of the structures, roles, strategies and responsibilities of different compliance functions across banks and financial services institutions, this paper provides advice to financial institutions on ways of dealing with the complex emerging issues to ensure that the regulatory and compliance arrangements do not turn detrimental. At this point, the paper recognizes that the precise design of a compliance function will vary across individual banks and financial services firms. Nonetheless, this paper addresses the root issues and characteristics that are commonly shared despite the differences in organisations of compliance.
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Ciarlo, Gregorio, Daniele Angelosante, Marco Guerriero, Giorgio Saldarini, and Nunzio Bonavita. "Enhanced PEMS Performance and Regulatory Compliance through Machine Learning." Sustainability in Environment 3, no. 4 (November 2, 2018): 329. http://dx.doi.org/10.22158/se.v3n4p329.

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<p><em>Modeling technologies</em><em> can pro</em><em>vide strong support to existing emission management systems, by means of what is known as a Predictive Emission Monitoring System (PEMS). These systems do not measure emissions through any hardware device, but use computer models to predict emission concentrations on the ground of process data (e.g., fuel flow, load) and ambient parameters (e.g., air temperature, relative humidity). They actually represent a relevant application arena for the so-called Inferential Sensor technology which has quickly proved to be invaluable in modern process automation and optimization strategies (Qin et al., 1997; Kadlec et al., 2009). While lots of applications demonstrate that software systems provide accuracy comparable to that of hardware-based Continuous Emission Monitoring Systems (CEMS), virtual analyzers are able to offer additional features and capabilities which are often not properly considered by end-users. Depending on local regulations and constraints, PEMS can be exploited either as primary source of emission monitoring or as a back-up of hardware-based CEMS able to validate analyzers’ readings and extend their service factor. PEMS consistency (and therefore its acceptance from environmental authorities) is directly linked to the accuracy and reliability of each parameter used as input of the models. While environmental authorities are steadily opening to PEMS, it is easy to foresee that major recognition and acceptance will be driven by extending PEMS robustness in front of possible sensor failures. Providing reliable instrument fail-over procedures is the main objective of Sensor Validation (SV) strategies. In this work, the capabilities of a class of machine learning algorithms will be presented, showing the results based on tests performed actual field data gathered at a fluid catalytic cracking unit.</em></p>
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McKay, Stephen, and Geraint Ellis. "Reparation or Retribution: An Investigation into Regulatory Compliance in Planning." Environment and Planning A: Economy and Space 37, no. 7 (July 2005): 1249–62. http://dx.doi.org/10.1068/a36288.

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It is an axiom of good planning practice that procedure is informed by up-to-date research. Consequently, it is surprising to discover that there remains a dearth of specialised planning-enforcement literature relating to theory and implementation. In this paper an evaluation is given of the effectiveness of planning enforcement in Britain by reviewing existing legislative mechanisms and strategies employed by officials. Theoretical perspectives are drawn upon to suggest how the system might be improved through attention to the structural factors underpinning it.
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8

Chinander, Karen R., Paul R. Kleindorfer, and Howard C. Kunreuther. "Compliance Strategies and Regulatory Effectiveness of Performance-Based Regulation of Chemical Accident Risks." Risk Analysis 18, no. 2 (April 1998): 135–43. http://dx.doi.org/10.1111/j.1539-6924.1998.tb00925.x.

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9

Njuguna, Dr James Rurigi, Prof Roselyn Gakure, Dr Anthony Gichuhi Waititu, and Dr Paul Katuse. "REGULATORY RISK MANAGEMENT STRATEGIES AND THE GROWTH OF MICROFINANCE SECTOR IN KENYA." International Journal of Finance 2, no. 4 (February 28, 2017): 76. http://dx.doi.org/10.47941/ijf.117.

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Purpose: The purpose of this study was to determine how the regulatory risk management strategies contribute to growth of MFI sector in KenyaMethodology: The study adopted a correlation survey research design. The population of this study was fifty seven (57) MFIs. The sampling frame was the list of MFIs provided in the AMFI website www.amfikenya.com. A sample of thirteen (17) MFIs was selected using the random sampling approach. A questionnaire and an interview schedule were the main data collection tools. Qualitative data was analyzed using content analysis whereas the quantitative data was analysed using Statistical Package for Social Sciences (SPSS) where descriptive and regression analysis were conducted to determine the relationship between enterprise risk management strategies and growth of MFIs.Findings: The study findings indicated that the MFI were compliant with all relevant regulations and that the regulatory environment provided an appropriate framework for the MFIs current and potential operations and legal status. The findings further indicated that the supervisory agency (CBK) provided adequate supervision of the MFI and the MFI has not in the past incurred heavy fines for violating regulations. Furthermore, the study findings indicated that the MFI has no cases pending in court over breach of contract. The regression results indicated that there was a positive effect on MFI growthUnique contribution to theory, practice and policy: it is recommended that the MFIs should continue practicing effective regulatory risk management practices such as development of appropriate regulatory framework for current and potential operations and legal status. This would significantly improve the growth of the MFI. The study also recommends that embracing supervision by the supervisory agency- CBK and honoring of contracts to avoid court cases and fines were good practices. It is recommended that compliance with all relevant regulations is crucial as it enhances the growth of MFIs. Study findings recommended that putting measures to prevent collection of illegal deposits and establishing a good working relationship with the regulatory authorities, will improve the growth of MFIs. The study recommends that encouraging open communication with regulators and provision of an opportunity to defuse any potential problems may be a crucial regulatory strategy as it improves the growth of MFIs
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Jin, Luosong, Chang He, Xiangyang Wang, Wei Wang, and Panting Zhao. "Study on the Compliance Management of the Electricity Market in China Based on the Evolutionary Game Theory." Complexity 2021 (March 12, 2021): 1–22. http://dx.doi.org/10.1155/2021/5532763.

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China’s new round of power system reform has further released market vitality, making the power market more open and diversified. Meanwhile, China’s power market faces various risks and challenges incurred by this new reform, which further highlights the importance of the compliance management. However, the study on effective compliance management of China’s power market is missing, and the way to achieving effective compliance management is still unanswered. This paper tries to fill the research gap using the evolutionary game theory. We constructed a tripartite game model to analyze the strategic choices and influencing factors of power generators, compliance departments of the trading centre, and government regulatory agencies. Furthermore, simulation analysis was conducted based on evolutionary stable strategies. The results show that effective compliance management can be achieved without government supervision if the market mechanism is properly designed. In addition, the costs and profits of market participants and regulators are important factors influencing the effectiveness of compliance management. Our findings may arouse inspiration for the policy makers to construct an effective compliance management system.
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Walton, Peter. "A Comparative Analysis of Regulatory Strategies in Accounting and Their Impact on Corporate Compliance." International Journal of Accounting 38, no. 1 (March 2003): 112–15. http://dx.doi.org/10.1016/s0020-7063(02)00212-1.

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12

Chantiri, Rouba. "A Comparative Analysis of Regulatory Strategies in Accounting and their Impact on Corporate Compliance." European Accounting Review 12, no. 2 (July 2003): 386–90. http://dx.doi.org/10.1080/0963818032000089427.

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13

Regens, James L., Ronald Keith Gaddie, and Euel Elliott. "Member Attributes and Corporate Contributions to United States Senators: Do Environmental Compliance Costs Matter?" Canadian Journal of Political Science 26, no. 2 (June 1993): 331–41. http://dx.doi.org/10.1017/s0008423900002985.

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AbstractThis study examines corporate contributions through political action committees (PACs) to US Senate incumbents from 1978 to 1988 by those industries which have sustained substantial environmental compliance costs and consequently have an incentive to develop relatively precise targeting strategies. The findings suggest that party, ideology, regulatory costs, and challenger attributes play especially important roles in corporate allocation strategies. These industries pursue relatively precise, sophisticated campaign contribution strategies, which reflect these influences.
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14

Timar, Thomas B., and David L. Kirp. "State Efforts to Reform Schools: Treading Between a Regulatory Swamp and an English Garden." Educational Evaluation and Policy Analysis 10, no. 2 (June 1988): 75–88. http://dx.doi.org/10.3102/01623737010002075.

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Since 1983, education has risen to the top of many states’ policy agendas. The level of state policy activity is unprecedented in the history of American education. While states have assumed responsibility for educational policymaking, little is known about the effects of various reform policies or strategies associated with their implementation. The authors argue that the current reform effort which aims at educational excellence will fail unless the policy culture shifts the strategic focus from regulation and compliance monitoring to mobilization of institutional capacity. This article examines reform strategies of three states—Texas, California, and South Carolina—and how those strategies relate to reform outcomes.
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Pomeranz, Jennifer L. "A Comprehensive Strategy to Overhaul FDA Authority for Misleading Food Labels." American Journal of Law & Medicine 39, no. 4 (December 2013): 617–47. http://dx.doi.org/10.1177/009885881303900403.

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The modern food environment is considered a primary driver of obesity and other nutrition-related chronic diseases. A significant contribution to this environment is the proliferation of claims on food packaging that provides a misleading picture of a product's healthfulness. The Food and Drug Administration (FDA) is the agency responsible for food labels but it lacks the regulatory authority and adequate resources to address the majority of questionable labeling practices. The FDA's current system of enforcement is thus essentially based on voluntary compliance and consumer- and manufacturer-initiated litigation has not successfully filled the regulatory gap. This manuscript reviews the current state of food labeling claims and the FDA's inadequate authority over misbranded food products. It analyzes competing views on regulatory compliance strategies and argues that a regulatory overhaul consistent with the best science and the First Amendment is necessary. With increased resources and authority, the FDA can meet current public health challenges and adequately ensure that labels are clear and consumers are properly informed and protected.
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16

Goss, Elizabeth, Michael P. Link, Suanna S. Bruinooge, Theodore S. Lawrence, Joel E. Tepper, Carolyn D. Runowicz, and Richard L. Schilsky. "The Impact of the Privacy Rule on Cancer Research: Variations in Attitudes and Application of Regulatory Standards." Journal of Clinical Oncology 27, no. 24 (August 20, 2009): 4014–20. http://dx.doi.org/10.1200/jco.2009.22.3289.

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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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Titus, Matthew J. "Benefits of Electronic Clearance for Enforcement of Motor Carrier Regulations." Transportation Research Record: Journal of the Transportation Research Board 1522, no. 1 (January 1996): 64–68. http://dx.doi.org/10.1177/0361198196152200108.

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The transparent borders concept of the Federal Highway Administration's Intelligent Transportation System for Commercial Vehicle Operations program could enhance regulatory efficiency by improving motor carrier compliance and reducing the costs of compliance. Discussion focuses on the cost of enforcement for motor carriers, which is one of the components of compliance cost. Motor carrier regulations are typically enforced concurrently with weight and safety enforcement efforts. To determine the burden, the amount and value of time spent by motor carriers on enforcement activities was estimated. Recognizing that differences among trucking firms exist, burdens were estimated separately for truckload and less-than-truckload carriers. Values were based on labor and opportunity costs. Time requirements were taken from existing literature. Current weight enforcement efforts cost the industry between $167 and $283 million annually. Furthermore, over 99.4 percent of the burden is borne by compliant carriers. Technologies and enforcement strategies that would greatly reduce the proportion of compliant vehicles subjected to enforcement are currently available and should be pursued. Complying with current safety enforcement efforts costs the industry between $14 and $25 million annually. Compliant carriers bear over 44 percent of this cost. Analysis of safety data indicates that a statistical relationship exists between out-of-service rates and accident rates. Therefore, it is possible to develop a system that would increase the proportion of noncompliant vehicles subjected to inspection relative to compliant vehicles.
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Yapp, Charlotte, and Robyn Fairman. "Factors affecting food safety compliance within small and medium-sized enterprises: implications for regulatory and enforcement strategies." Food Control 17, no. 1 (January 2006): 42–51. http://dx.doi.org/10.1016/j.foodcont.2004.08.007.

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Corsaro, Bart, Tong-yuan Yang, Rocio Murphy, Ivo Sonderegger, Andrew Exley, Sylvie Bertholet, Naveen Dakappagari, et al. "2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3 – Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays)." Bioanalysis 13, no. 6 (March 2021): 415–63. http://dx.doi.org/10.4155/bio-2021-0007.

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The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15-29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. The 14th WRIB included three Main Workshops, seven Specialized Workshops that together spanned 11 days in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy and vaccine. Moreover, a comprehensive vaccine assays track; an enhanced cytometry track and updated Industry/Regulators consensus on BMV of biotherapeutics by LCMS were special features in 2020. As in previous years, this year's WRIB continued to gather a wide diversity of international industry opinion leaders and regulatory authority experts working on both small and large molecules to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance and achieving scientific excellence on bioanalytical issues. This 2020 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the Global Bioanalytical Community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2020 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers the recommendations on Vaccine, Gene/Cell Therapy, NAb Harmonization and Immunogenicity). Part 1 (Innovation in Small Molecules, Hybrid LBA/LCMS & Regulated Bioanalysis), Part 2A (BAV, PK LBA, Flow Cytometry Validation and Cytometry Innovation) and Part 2B (Regulatory Input) are published in volume 13 of Bioanalysis, issues 4 and 5 (2020), respectively.
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Santos, Ana Cláudia, Miguel Pereira-Silva, Catarina Guerra, Diana Costa, Diana Peixoto, Irina Pereira, Inês Pita, António J. Ribeiro, and Francisco Veiga. "Topical Minoxidil-Loaded Nanotechnology Strategies for Alopecia." Cosmetics 7, no. 2 (March 27, 2020): 21. http://dx.doi.org/10.3390/cosmetics7020021.

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Androgenetic alopecia (AGA) is a multifactorial and age-related condition characterized by substantial hair loss affecting both men and women. Conventional treatments include the use of topical minoxidil (MNX) formulations to stimulate hair growth and restore hair condition. However, those treatments are associated with limited performance and a lack of tolerability and compliance due to the emergence of adverse effects. Considering that the development of nanotechnology-based formulations as hair loss therapeutic strategies has been clearly growing, topical MNX delivery by means of these innovative formulations is known to enhance MNX skin permeation and depot formation into hair follicles, allowing for MNX-controlled release, increased MNX skin bioavailability and enhanced therapeutic efficacy with minimal adverse effects. This review highlights the potential of nanotechnology-based MNX delivery formulations for improved hair loss therapeutics, including a thorough assessment of their in vitro and in vivo performances, as well as regulatory and nanosafety considerations.
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Sony, Alisa, David Ferguson, and Rian Beise-Zee. "How to go green: unraveling green preferences of consumers." Asia-Pacific Journal of Business Administration 7, no. 1 (April 7, 2015): 56–72. http://dx.doi.org/10.1108/apjba-06-2013-0067.

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Purpose – Although a company can manifest its corporate social responsibility (CSR) effort through various strategies, the challenge this presents is that not all CSR activities have identical attributes with respect to the consumers’ perception. The purpose of this paper is to examine the efficacy of four CSR initiatives – regulatory compliance, green cause-related marketing (CRM), green product, and a combination of green CRM and green product – on consumer attitude and purchase intention. Design/methodology/approach – An experiment is conducted to investigate how consumers in an emerging Asian market like Thailand respond to different environmental CSR tactics. Findings – The results of this study demonstrate that a specific environmental CSR strategy elicits more favorable response than a general approach of complying with regulations. In addition, engaging in green CRM and offering a green product concurrently is perceived as more appealing than employing only either of the two strategies. The key finding is that in the eyes of Thai consumers, green CRM and green product CSR initiatives are substitutable. Originality/value – The paper conceptualizes the difference between four environmental CSR strategies from dimensions of the firm’s discretion and commitment level and highlights the importance of using specific voluntary environmental CSR strategies over involuntary regulatory compliance. Firms are recommended to engage in either green CRM or green product initiatives. The choice depends on a firm’s resources and opportunities. The addition of green CSR initiatives increases the positive impact on consumer attitude and purchase intention.
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Drake, Sara. "Delays, cancellations and compensation: Why are air passengers still finding it difficult to enforce their EU rights under Regulation 261/2004?" Maastricht Journal of European and Comparative Law 27, no. 2 (March 30, 2020): 230–49. http://dx.doi.org/10.1177/1023263x20904235.

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The aim of this article is to identify why air passengers travelling in the European Union, endowed with the highest standard of consumer protection in the world under EU law, are still being denied their rights and finding it difficult to seek effective legal redress. This article argues that the principal cause of airlines’ non-compliance is the poor regulatory design of Regulation 261/2004, which has been compounded by inadequate application by the Member States and regulatory resistance by the airlines. This contribution will then demonstrate how the European Commission (‘Commission’) has responded through the adoption of both deterrence and compliance-based enforcement strategies, and maps out the mechanisms, tools and actors harnessed by the Commission to create a complex hybrid, multi-layered system of enforcement. The article reveals that enforcement gaps persist and argues that the effectiveness of the regime is unlikely to improve without legislative reform.
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Mohd Sulaiman, Aiman Nariman, Azza Isma Moideen, and Sharon David Moreira. "Of Ponzi schemes and investment scams." Journal of Financial Crime 23, no. 1 (December 31, 2015): 231–43. http://dx.doi.org/10.1108/jfc-05-2014-0021.

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Purpose – This paper aims to chart the enforcement actions taken by the Malaysian regulatory authorities in relation to illegal investment schemes in Malaysia, and clarifies the various strategies adopted by the Malaysian regulatory authorities to ensure protection of investors in the capital market. The enforcement actions relate to the Swisscash scheme as well as commodities futures involving crude palm oil and a more recent case involving gold futures. These schemes share similar characteristics with Ponzi schemes that were thrust into the international limelight in the notorious Madoff Ponzi scheme and its allegation of regulatory failure. Design/methodology/approach – The paper clarifies, by way of case study, public enforcement of illegal investment schemes promoted through the Internet and schemes involving cross-border investments. Findings – The enforcement powers of the regulatory authorities in Malaysia are being utilized to ensure compliance with the law. The enforcement actions by the regulatory authorities in the afore-stated cases are significant in view of the successful custodial sentence of imprisonment, the regulators’ public enforcement action intended to compensate investors and the most recent case which is unfolding, due to the large number of alleged perpetrators and significant wealth transfer involved. Originality/value – Given the allegation of regulatory failure in other jurisdictions, this paper enables a view to be formulated of the timeliness and appropriateness of the enforcement actions.
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Kawadza, Herbert. "A Discussion of Some Aspects of the Regimes for the Regulation of Insider Dealing in South Africa and the United States of America." Journal of African Law 59, no. 2 (August 11, 2015): 380–94. http://dx.doi.org/10.1017/s0021855315000145.

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AbstractGlobal regulators acknowledge the negative economic impact linked to insider dealing and have devised diverse regulatory frameworks aimed at minimizing its prevalence. Although their strategies differ, policy-makers realise that, with the inevitable internationalization of securities markets, the probability of cross-border insider trading escalates. With a view to providing a platform for regulatory re-examination and reform, this article discusses the divergent approaches that the United States and South Africa have adopted to counter the challenge of pervasive insider dealing. A paradox manifested with the US experience is that, while its theoretical prohibition of insider dealing is widely criticized as inadequate and inconsistent, robust enforcement has nonetheless led to strong institutions and a superior financial markets regime. The article concludes that the attainment of safer financial markets does not depend on the mere existence of superior proscriptions. Rather, it is the effective supervision of the sector and robust enforcement of those laws that enhance deterrence and ensure compliance.
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Al-Fayad, Fadye Saud. "The European Union’s GDPR and Its Effect on Data-Driven Marketing Strategies." International Journal of Marketing Studies 12, no. 1 (February 24, 2020): 39. http://dx.doi.org/10.5539/ijms.v12n1p39.

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This research paper analyzes the developing effect that the European Union&rsquo;s (EU) recently developed General Data Protection Regulation (GDPR) will have on the marketing strategies of firms that rely on big data. Big data is identified as consisting of data and data analytics involving a huge volume of data, a diverse variety of data, and a high velocity of data capture and collection. This analysis begins with some discussion of the concept of big data and follows this up with overviews of both the GDPR and big data use in the marketplace. The EU replaced its older Data Protection Directive or DPD with the GDPR. The GDPR consists of a series of chapters and articles that require, among other things, consent to collect and store data, the anonymization of data, announcement in 72 hours of a data breach, provision of encryption and the identification of a Data Protection Officer. Marketing and the marketing function can implement emergent technologies that augment big data and its analysis while simultaneously achieving compliance with regulatory frameworks like the GDPR. These marketing related solutions are those such as blockchain marketing applications like Brave Browser and Blockstack among others. The report also examines the way in which enterprises use big data in their marketing strategies and how they are affected by it now that it has come into effect. Some of the more marketing-oriented uses and applications of big data are found in sophisticated loyalty programs, demand forecasting and customization either of experience or product/service. This study also offers some final recommendations related to GDPR compliant marketing strategies. These include the development of a comprehensive program to purchase consumer data directly from consumers and the introduction of blockchain as a means to facilitate a smoother transition to GDPR compliance.
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Basile, Anthony, Sheila Handy, and Felisha N. Fret. "A Retrospective Look at the Sarbanes-Oxley Act of 2002- Has it accomplished its original purpose?" Journal of Applied Business Research (JABR) 31, no. 2 (March 3, 2015): 585. http://dx.doi.org/10.19030/jabr.v31i2.9155.

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As a result of notable frauds including Enron, WorldCom and Waste Management, the United States Congress enacted the Sarbanes-Oxley Act of 2002 (SOX). The Act would forever change the accounting profession. After a little more than a decade, publicly traded companies have been able to create and implement policies and procedures to ensure compliance with the Act, specifically the provisions set forth in Section 404. Since all public companies have implemented SOX compliance together with other regulations imposed by the Internal Revenue Service and other regulatory agencies into their normal reporting routines, management of these companies have realized further benefits associated with SOX compliance. Because of these reported benefits many private companies have begun to voluntarily implement SOX-like policies and procedures into their own internal framework. This paper will discuss the perceptions of the enactment and implementation of the Act, the associated benefits derived from SOX compliance and reasons why private companies have begun voluntarily adopting SOX-like policiesprocedures and strategies.
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Thomas, Alyssa S., Taciano L. Milfont, and Michael C. Gavin. "Scenario-based analyses evaluate potential outcomes of proposed regulatory changes in recreational fishery." ICES Journal of Marine Science 77, no. 6 (July 19, 2019): 2333–43. http://dx.doi.org/10.1093/icesjms/fsz141.

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Abstract Understanding current and predicting future behaviour of fishers is fundamental to designing effective management strategies. The management of most recreational fisheries requires releasing fish not meeting size or daily limits, and assuming the majority survive. In the Marlborough Sounds, New Zealand, a maximum size limit imposed on the blue cod (Parapercis colias) fishery aimed to achieve a more balanced sex ratio for this hermaphroditic species. We tested three alternative size limit scenarios (current, increased, and no maximum size) in a study with recreational fishers (N = 420) to investigate whether regulation change would influence their intentions to discard fish and fishing satisfaction. Increasing or eliminating the maximum size led to lower discard intentions and greater fishing satisfaction, suggesting strategies to achieve both management goals (e.g. more large fish) and increased fisher satisfaction (potentially increasing compliance). More broadly, the results demonstrate the benefits of using scenarios to evaluate potential regulatory changes prior to implementation.
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Armstrong, Louis J., and Steven E. James. "ENVIRONMENTAL MANAGEMENT: NEW STRATEGIES FOR COMPANIES OPERATING IN DEVELOPING NATIONS." International Oil Spill Conference Proceedings 1997, no. 1 (April 1, 1997): 727–29. http://dx.doi.org/10.7901/2169-3358-1997-1-727.

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ABSTRACT As oil exploration and development move into less developed countries, many companies are faced with the problem of environmental compliance. New countries, such as Azerbaijan, and rapidly developing countries, such as Indonesia, have the potential to change the structure of oil supply and demand in the future, but have not yet fully developed the environmental parameters that will govern oil and gas operations. Environmental managers of companies doing business or considering investing in these new markets now have new environmental issues to consider. The types of issues often encountered include the following:Should companies apply the same environmental standards and environmental management to their activities in less developed countries as they do in their own country?How do companies protect themselves from evolving and changing regulations in developing nations?What is the role of Western companies in transferring environmental technologies to developing nations? To answer these questions, companies need to apply new techniques for understanding environmental regulations. They need to not only collect information on applicable environmental rules and regulations but also understand the history or background of the regulations; the external forces, both regional and international, driving the regulations; the institutional capabilities of the regulatory bodies; and the regulatory standards being applied by their peers. Once the regulatory climate is understood, companies need to develop a strong environmental management strategy that should include, incorporate, or allow for the development of an environmental management system; the prioritization of short-term liabilities, such as oil spills or accidental releases; the development and application of appropriate standards when none exist; and the development and implementation of an institutional strengthening program.
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Pastory, Parestico. "Inter-governmental relations and procurement non-compliance in African local government systems." Journal of Public Procurement 19, no. 4 (November 4, 2019): 277–94. http://dx.doi.org/10.1108/jopp-01-2019-0001.

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Purpose The purpose of this study is to examine the implications of inter-governmental relations on procurement compliance in local government. Design/methodology/approach A total of 68 in-depth interviews with local government officials and councillors in four different local government authorities, members of parliament in the local authorities accounts committee and a committee clerk were carried out in addition to documentary review. Findings Evidences from in-depth interviews and documentary analysis point to central government as one of key reasons for procurement non-compliance. The nature of inter-governmental relations enables the central government to issue encroaching directives on local government procurement plans or take handicapping actions on the financial ability of the local governments to execute procurement plans. Practical implications The study adds inter-governmental relations on strategies for improving procurement compliance in African local government systems. Originality/value Despite increasing research on procurement compliance, the complexity of regulatory non-compliance in local government procurement has not been adequately analysed. The current study uses an inter-governmental relations perspective to contribute knowledge on procurement compliance in local government systems of the Third World, sub-Saharan Africa in particular.
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Othman, Muhamad Badri. "Development and Shari'ah issues of the Takaful industry in Malaysia – Effects of the Regulatory Framework on the Implementation and Growth." Journal of Finance and Banking Review Vol.2(1) Jan-Mar 2017 2, no. 1 (March 9, 2017): 38–43. http://dx.doi.org/10.35609/jfbr.2017.2.1(6).

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Objective - This paper aims to discuss and analyse whether the participation of long established conventional insurance conglomerates will be positive towards the development of the Takaful, particularly in the aspect of the operators' compliance towards Shari'ah requirements. Methodology/Technique - The study reviews literature in related area. Findings - Findings indicate that the merger and acquisition (M&A) which have taken place recently by other foreign insurers with our local Takaful operators show that the growth of this industry is promising for years to come for the foreign insurers to tap into our Takaful market. Novelty - The study attempts to provides insight on effect of foreign companys' merger and acquisition strategies in Takaful market. Type of Paper: Review Keywords: Islamic finance; Islamic Financial Services Act 2013; merger and acquisition; Shari'ah compliance; Takaful.
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Reyes López, Felipe, Yaneth Betancurt Domínguez, Ingrid Lucia Muñoz Periñán, and Andrés Felipe Paz Loboguerrero. "Support tool for verifying the compliance of standards and regulations in implementations of strategies for information security." Sistemas y Telemática 13, no. 32 (March 30, 2015): 27–39. http://dx.doi.org/10.18046/syt.v13i32.2032.

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Organizations are increasingly concerned about ensuring the security of their information. In addition, government regulations and the market itself are demanding compliance with appropriate levels to remain in operation. This article presents a support tool to the process of gap analysis on the current state of the company and the specifications of the most recognized referents in the Colombian scope in the subject of information security. The tool allows for the evaluation of an organization’s level of compliance with regard to the ISO 27001 and ISO 27002 standards in their 2013 versions and Notices 038 and 042 of the financial regulatory authority of Colombia (Superintendencia Financiera de Colombia). The tool conceives a data model that incorporates the results of a comparative analysis between the ISO 27001:2013 and ISO 27002:2013 standards and the Notices 038 and 042, and allows the inclusion of new referents and relates them to the existing ones. Several evaluation scenarios were created to validate the functional completeness and precision of the implemented prototype.
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Akilu Aliyu Shinkafi, Sani Yahaya, and Ahmad Muhammad Gusau. "Legal and Regulatory Strategies of Islamic Banking System in Malaysia: A Reflection for Nigeria." Journal of Economic Info 7, no. 1 (May 3, 2020): 40–55. http://dx.doi.org/10.31580/jei.v7i1.1350.

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Effective strategies on the legal and regulative framework of Islamic banks are very critical to the endurance of the Islamic banking sector. In fact, legal place and regulatory structure of every industry determine the healthy standing of its stability, sustainability, and success. The major objective of this study is to explore the legal and regulatory strategies of the Islamic banking system in Malaysia and proffer it as a reflection for Nigeria. The study is qualitative in nature, it employed two instruments (document technique and interview instrument) for the data collection. Thematic and descriptive analysis were used where themes and sub-themes were depicted as they emerged from the data. The outcome of the study reveals that Malaysia has strengthened its legal strategies by promulgating several acts, legal reforms, provisions, and promulgation of certain acts of law, amendments of laws, passing bills, and enactment of new laws such as IBA, IFSA, ICMA, CBMA, GIA, GFA, Mu’amalat bench, and etcetra with the view to ensure the free hit of the legal hiccups, best practices, effective corporate governance, and proper risk management in the financial industry. The outcome of the study further show that BNM has significant influence in the regulations, supervision, and control of IBs. These roles include the formation of SAC and Shari’ah committees for IBs; establishment of Islamic financial service board IFSB, spelling effective Shari’ah governance framework SGF; services, and compliance to Shari’ah regulatory standards, and creating talents such as ISRA, INCEIF, and several others.
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Rush, Danielle, Sean Macintyre, Jane Mc Kay, and Stephen Mc Kay. "Conundrums in Conservation: Complexity in Control." Urban Studies Research 2012 (August 27, 2012): 1–14. http://dx.doi.org/10.1155/2012/378326.

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The departure point for this investigation is to highlight the centrality of regulation theory as a praxis in planning enforcement. The value of the conceptual framework is demonstrated by application in the problematic arena of conservation regulatory compliance, where there is currently a dearth of investigation. It is evidenced that this thematic approach provides a lens to scrutinise problematic areas of control and provides a deeper understanding of the difficulties faced by planning enforcement operational practice generally and heritage regimes specifically. The utility of the proposed mechanism is that it remedies the current, well documented, pitfalls of disjointed, piecemeal strategies by providing a framework for robust, coherent decision making not only in planning but in the wider regulatory arena.
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McDermott, Ronan, and Patrick Gibbons. "Risk and Compliance with Normative Frameworks Relating to Disaster Management." Journal of International Humanitarian Legal Studies 6, no. 2 (August 27, 2015): 345–76. http://dx.doi.org/10.1163/18781527-00602005.

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This article adopts a comparative socio-legal approach in exploring the relationship between disaster risk and compliance with normative frameworks concerning disaster management. Risk colonisation is the term given to the phenomenon whereby societal risks such as those posed by disasters create further risks, institutional in nature, to disaster management systems themselves. Disaster management systems are exposed to institutional risks, including those that arise from non-compliance with the range of laws and guidelines relating to disaster management developed in recent years. Grounded in exploratory case studies drawn from Indonesia and Ireland, it is suggested that the consequences of this phenomenon is that, in circumstances in which disaster risk is perceived to be high, patterns of compliance with regulatory frameworks are likely to be characterised by recourse to scientific expertise. Blame avoidance and defensive compliance strategies are also likely to occur. Conversely, in circumstances in which disaster risk is perceived to be relatively low, compliance patterns are likely to be ad hoc in nature and allow for significant governmental discretion. The implications of such consequences for the normative underpinning of disaster management are addressed.
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Bhagat, Seema, Vaibhavi K. Kapatkar, Ashish Mane, Colette Pinto, Devang Parikh, Gaurav Mittal, and Rishi Jain. "An Industry Perspective on Risks and Mitigation Strategies Associated with Post Conduct Phase of Clinical Trial." Reviews on Recent Clinical Trials 15, no. 1 (February 14, 2020): 28–33. http://dx.doi.org/10.2174/1574887114666191016103332.

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Aim/objective: To discuss the potential risks and their mitigation strategies in the post-conduct phase of the trial. Background: Risk management is very important for the clinical trial (CT) to ensure that the trial delivers its desired outcome(s) in terms of achieving protocol objective and regulatory compliance. Methodology: Experienced members of the clinical operation team of a pharmaceutical major underwent a series of sessions to identify risks associated with the post-conduct phase of CT and developed mitigation strategies based on own experiences and guidance documents. The risks were categorized into major, minor and critical risks. Results: In the post-conduct phase of a clinical trial, critical risk identified were; failure to communicate to the stakeholder about premature termination of the trial, mismatch of statistical analysis results and protocol objective/ regulatory requirement, clinical study report (CSR) noncompliant with regulatory requirements or delay in CSR preparation. Safety checks suggested to mitigate these risks including the development of related checklist or shell of relevant documents and its review by clinical development, quality assurance (QA) and regulatory affairs (RA) team prior to finalization. Additionally, six major and five minor risk areas were identified and safety checks were suggested. Conclusion: Sponsors must act proactively to ensure a systematic approach to conduct various post conduct trial activities and the plans to mitigate the risks that could affect the quality and outcome of the clinical trial. Future Perspective: A close coordination with all stakeholders for timely anticipation of risks and execution of mitigation strategies are required for successful CT outcomes.
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Stickler, Claudia M., Daniel C. Nepstad, Andrea A. Azevedo, and David G. McGrath. "Defending public interests in private lands: compliance, costs and potential environmental consequences of the Brazilian Forest Code in Mato Grosso." Philosophical Transactions of the Royal Society B: Biological Sciences 368, no. 1619 (June 5, 2013): 20120160. http://dx.doi.org/10.1098/rstb.2012.0160.

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Land-use regulations are a critical component of forest governance and conservation strategies, but their effectiveness in shaping landholder behaviour is poorly understood. We conducted a spatial and temporal analysis of the Brazilian Forest Code (BFC) to understand the patterns of regulatory compliance over time and across changes in the policy, and the implications of these compliance patterns for the perceived costs to landholders and environmental performance of agricultural landscapes in the southern Amazon state of Mato Grosso. Landholdings tended to remain in compliance or not according to their status at the beginning of the study period. The perceived economic burden of BFC compliance on soya bean and beef producers (US$3–5.6 billion in net present value of the land) may in part explain the massive, successful campaign launched by the farm lobby to change the BFC. The ecological benefits of compliance (e.g. greater connectivity and carbon) with the BFC are diffuse and do not compete effectively with the economic benefits of non-compliance that are perceived by landholders. Volatile regulation of land-use decisions that affect billions in economic rent that could be captured is an inadequate forest governance instrument; effectiveness of such regulations may increase when implemented in tandem with positive incentives for forest conservation.
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Oyetayo, Yeside. "Principles-Based Regulations: A Model for Legal Reform in the Nigerian Insurance Industry." Journal of African Law 59, no. 1 (March 19, 2015): 64–84. http://dx.doi.org/10.1017/s0021855315000029.

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AbstractThe development of global standards has led to a convergence in domestic regulations in the financial services sectors. Principles-based regulations (PBRs) have become essential for effective regulatory efforts in insurance and other financial services because of their flexibility, support for regulatory efficiency and the development of a good compliance culture amongst the regulated. The legal framework of the Nigerian insurance industry mainly contains prescriptive and performance-based regimes that have become ineffective as regulatory strategies. This article recommends the adoption of PBRs from available models found in international standard setting organizations such as the International Association of Insurance Supervisors, other jurisdictions such as the UK's Prudential Regulation Authority and Financial Conduct Authority, together with international trade regimes such as the General Agreement on Trade in Services. It reviews aspects of Nigerian insurance industry regulations supporting PBRs and highlights laws not supportive of PBRs and therefore requiring reform.
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Krushelnitskaya, O. B., T. Y. Marinova, A. V. Pogodina, M. N. Raskhodchikova, and N. N. Tolstykh. "Regulatory Behavior in the COVID-19 Pandemic: How to Get Students to Comply with It?" Social Psychology and Society 12, no. 1 (2021): 198–221. http://dx.doi.org/10.17759/sps.2021120113.

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Regulatory Behavior in the COVID-19 Pandemic: How to Get Students to Comply with It? Objective. Determine the targets and methods of psychological and pedagogical work that aimed increasing the specific normativity of students' behavior during the COVID-19 pandemic, in particular, on compliance with the mask regime. Background. Due to the situation with COVID-19 pandemic many countries all over the world, including in Russia, introduced the number of tough measures which restricted the behavior and interaction of people. The study focuses on such acute issues as the attitudes of different social groups toward both the disease itself and the measures to combat it, clarification of the reasons and motivations for individuals’ compliance/non-compliance with normative behavior during the pandemic. The coronavirus pandemic actualizes the problems of providing practical psychological assistance to people, including young people, who experience stress and who have difficulties with coping with this situation. Study design. The study was conducted during the increasing spread of the disease and the introduction of an isolation regime. The data obtained was analyzed with reference to the time of the research participants’ questionnaire completion: the first group of students filled the Google forms from 9th to 23rd November 2020 (stage 1); the second group — from 24th November to 8th December 2020 (stage 2). The research analyzed students’ social representations of the pandemic and measures to combat it; peculiarities of attitudes toward various aspects of COVID-19 and toward the normative behavior of young people during the pandemic; subjective experience of danger of the disease and the dominant coping strategies associated with them. Participants. 565 undergraduate students from various faculties of the Moscow State University of Psychology and Education (MGPPU): 504 females, 61males. Measurements. Anonymous survey included closed questions; method of prototypical analysis of social representations (P. Verges); Self-perceived flexible coping with stress (SFCS); The Fear of COVID-19 Scale; SPSS Statistics 20 package (contingency tables with the calculation of the Pearson χ2 test, Spearman's correlation coefficient, Kruskal-Wallis and Friedman tests). Results. Students showed a diverse and often controversial views on COVID-19 and ways prevent its spread. At the core of social representations of the pandemic and protective masks, the most popular are those that reflect the personal restrictions imposed by the pandemic, the inconvenience and displeasure resulted from the compliance with these restrictions . To a smaller extent, there is a fear of getting sick. There are practically no social representations associated with concern over other people, that express a pro-social position. In relation to the mechanisms of compliance with restrictive measures, the opinions of students are heterogeneous: some support the introduction of strict restrictions and consider it rational to have strict external control, while others believe that the fulfillment of sanitary and epidemiological requirements should be an independent decision of a person. The study found the predominant choice of situational and multiple coping strategies by students in response to the emergence of the pandemic situation and the relationship between these types of coping with low level of subjective fear. Nevertheless, with the deterioration of the pandemic situation, students' assessments of the means of informing about COVID-19 and strategies to combat it changed: at the first stage of the study students considered specialists (doctors, scientists) as a reference group, at the second stage — parents and close circle. Social media turned out to be the most insignificant source of information. Main conclusions. The data obtained make it possible to identify the main targets of psychological and pedagogical work with students and to determine the main methods of this work which should include the activity-based inclusion in the solution of group tasks aimed at optimizing the life of people in a pandemic. According to the results of the study, a group of students stood out with a high level of fear experience (32%) and a tendency to non-constructive ways of coping. These students require targeted psychological assistance. As an illustration of the active involvement of students to the problem of COVID prevention, the article describes a competition of creative works of different directions organized by the Faculty of Social Psychology of Moscow State University of Psychology and Education on the topic medical masks use in the context of the "Marathon of Masks" pandemic.
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Ibrahim, Mohammed, Justice Nyigmah Bawole, Theresa Obuobisa-Darko, Abdul-Bassit Abubakar, and Anthony Sumnaya Kumasey. "The legal regime and the compliance façade in public procurement in Ghana." International Journal of Public Sector Management 30, no. 4 (May 8, 2017): 370–90. http://dx.doi.org/10.1108/ijpsm-09-2016-0156.

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Purpose The extant literature posits several claims about the equitable resources allocation through compliance in public procurement management. Notwithstanding, there are hardly any empirical studies that explore the link between the causes and extent of compliance on one hand and value for money (VfM) on the other hand. The purpose of this paper is to investigate the efficacy of public procurement laws in ensuring VfM in a developing country context. Design/methodology/approach The study employs a qualitative case study approach involving three local government agencies in Ghana. Purposive and stratified random sampling strategies were used in selecting respondents who were interviewed through focused group discussions, semi-structured and open-ended questionnaires. The study utilizes an interpretivist/constructivist paradigm which allows for the co-creation of knowledge and subjectivity in knowledge acquisition. Findings The study finds that the presence of a legal and regulatory framework does not ipso facto guarantee compliance and VfM. Additionally, a possible reason why even reported cases of compliance do not translate into VfM is that evidence of compliance, especially in a developing country setting, is often a façade. Practical implications Public procurement entities in developing countries stand little chance of achieving accountability and VfM gains if they continue to rely on compliance as a micro-management tool. Originality/value The paper challenges the dominant assumptions in the public procurement management discourse by drawing attention to the quality of reported compliance and its implication for VfM.
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C Angoissa Minsoko, Pamela, and Selidji T Agnandji. "PO 8538 STRENGTHENING SOCIAL STRATEGIES TO ENGAGE SUB-SAHARAN AFRICAN SOCIETIES TO VALUE CLINICAL RESEARCH: THE EXPERIENCE IN CONDUCTING CLINICAL TRIALS IN LAMBARéNé." BMJ Global Health 4, Suppl 3 (April 2019): A51.1—A51. http://dx.doi.org/10.1136/bmjgh-2019-edc.133.

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BackgroundOver the last two decades, clinical research activities have increased significantly in sub-Saharan Africa but societal engagement to make research socially and economically valuable is limited. Thus, engaging communities when designing clinical research and promoting social impacts of research are becoming key objectives among stakeholders involved in clinical research in sub-Saharan Africa. However, there is a need to define concepts and indicators to assess the strength of community engagement as well as the social impacts of clinical research.Here, we hypothesised that the social meanings of willingness to participate and compliance to clinical trial procedures are relevant indicators to assess community engagement.MethodsWe conducted a retrospective, prospective case study of clinical trials conducted in CERMEL between 1995 and 2017. We performed a social meaning framework analysis of the following processes: protocol design, ethical and regulatory clearance, informed consent and medical study procedures. We identified the social meanings of each procedure according to the involvement of social components (actors, ideas, communication strategies).ResultsA total of 42 clinical trials were identified in the ClinicalTrials.gov and Pan-African Clinical Trials Registry databases and confirmed by the top management of CERMEL. Between 1995 and 2004, there was little social meaning connected to trial procedures. This period was associated with poor compliance to study procedures. Between 2005 and 2017, compliance to study procedures improved. Detailed results will be presented during the meeting.ConclusionThe rise in willingness to participate in clinical research and improved compliance with study procedures were associated with the introduction of social components to medical procedures. Both indicators may be relevant to assess the strength of community engagement.
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Goldstein, Barry, Michael Malavazos, Belinda Hayter, James Coda, Michael Jarosz, Alexandra Wickham, David Cockshell, and Joe Zabrowarny. "Regulatory nirvana for low-permeability gas reservoir development." APPEA Journal 52, no. 1 (2012): 351. http://dx.doi.org/10.1071/aj11028.

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‘Trusted land access is both the first factor and the final outcome of a virtuous exploration and production life-cycle’ (Goldstein et al, 2007). Governments are under pressure to deploy trusted regulatory frameworks that enable profitable and environmentally sustainable development of unconventional gas resources for matters including, but not limited to, fracture stimulation operations. Nirvana regulation will entail: attractive licence tenure; regulatory certainty and efficiency without taint of capture; regulators and licensees with trustworthy capabilities (competence and capacity); effective (informative) stakeholder consultation well-ahead of land access; public access to details of risks and reliable research to reduce key uncertainties, and to back-up risk management strategies so the basis for regulation is contestable anytime, everywhere; timely notice of entry with sufficient operational details to effectively inform stakeholders; potentially affected people and organisations who can object to land access without support for vexatious objections; fair and expeditious dispute resolution processes; fair compensation to affected land-users for costs, losses, and deprivation due to operations; risks that are reduced to low or as low as reasonably practicable (ALARP) while also meeting community expectations for net outcomes; licensees who monitor and report on the efficacy of their risk management processes, while the regulator probes the same; regulators who can prevent and stop operations, require restitution, levy fines and cancel licences; and, industry compliance records, which are made public so the efficacy of regulation is transparent. This paper will describe how these principles are deployed in SA where: 24 unconventional gas play-trends are being explored, each with giant gas potential; hundreds of wells have been safely hydraulically fracture stimulated to enhance flow rates from both petroleum and geothermal reservoirs, and in doing so, enable economic development; and, since implementing SA’s Petroleum and Geothermal Energy Act 2000, more than 11,000 notices of entry for petroleum operations have led to just one court action, and that was to establish legal precedent that geophysical surveys can extend outside a licence to attain full-fold control in a licence. The introduction of new energy development technologies is inevitable, so regulatory nirvana will remain an aspiration. Regulation for compatible, multiple-use of land in Australia is undertaken with community ownership of subsurface resources in mind. SA aspires to achieve regulatory nirvana for the upstream petroleum sector. Expeditious, welcomed access to land for compatible, multiple uses is the metric for performance, and leading practice is based on the principle that trust is the most valuable lead factor and lag outcome in sustaining welcomed land access for resource exploration, development and production.
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Ray, Jessica M., Raj M. Ratwani, Christine A. Sinsky, Richard M. Frankel, Mark W. Friedberg, Seth M. Powsner, David I. Rosenthal, Robert M. Wachter, and Edward R. Melnick. "Six habits of highly successful health information technology: powerful strategies for design and implementation." Journal of the American Medical Informatics Association 26, no. 10 (July 2, 2019): 1109–14. http://dx.doi.org/10.1093/jamia/ocz098.

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Abstract Healthcare information technologies are now a routine component of patient–clinician interactions. Originally designed for operational functions including billing and regulatory compliance, these systems have had unintended consequences including increased exam room documentation, divided attention during the visit, and use of scribes to alleviate documentation burdens. In an age in which technology is ubiquitous in everyday life, we must re-envision healthcare technology to support both clinical operations and, above all, the patient–clinician relationship. We present 6 habits for designing user-centered health technologies: (1) put patient care first, (2) assemble a team with the right skills, (3) relentlessly ask WHY, (4) keep it simple, (5) be Darwinian, and (6) don’t lose the forest for the trees. These habits should open dialogues between developers, implementers, end users, and stakeholders, as well as outline a path for better, more usable technology that puts patients and their clinicians back at the center of care.
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RYNGELBLUM, ARNALDO L., PAULO C. DUARTE de OLIVEIRA, RENATO TELLES, and MAYLA C. COSTA. "Evasão estratégica das regulações: a judicialização do sistema privado de saúde brasileiro." Cadernos EBAPE.BR 17, no. 3 (September 2019): 623–38. http://dx.doi.org/10.1590/1679-395175094.

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Abstract The article aims to advance the understanding of the successive circumvention of regulations by organizations, to determine whether it is possible to characterize them as purposeful actions, while the institutional literature analyzes decoupling and circumvention as sporadic activities. It analyzes the responses adopted by health plan companies to favor their interests, responses that often fail to comply with the rules of the institutional context, and which boosted the phenomenon known as ‘judicialization’. The study analyzed 158 lawsuits collected from the electronic archives of the Court of Justice of São Paulo, where beneficiaries sue health plan companies because of treatment coverage denial. Using correspondence and thematic analysis, some associations between denials and allegations showed to be significant, suggesting companies’ strategic patterns. It was possible to identify different strategic practices adopted by companies to avoid complying with institutional guidelines, and to observe that certain regulatory features can contribute to non-compliance strategies. The article contributes to the institutional literature by identifying organizational practices meant to successively circumvent and confront institutional prescriptions, indicating that health plan companies apparently design specific strategies to respond to beneficiaries’ demands.
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Frentzen, Hendrik, and Evripidis Lampadarios. "Evaluating SMEs Growth Strategies: The Case Study of A Medium-sized UK Specialty Chemical Distributor." Case Studies in Business and Management 3, no. 2 (September 27, 2016): 122. http://dx.doi.org/10.5296/csbm.v3i2.9944.

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The UK chemical distribution industry, a well-established, highly fragmented, subject to strong consolidation and significant part of the chemical industry, is a major contributor to the UK economy and employment. The ever increasing regulatory compliance requirements pose a significant challenge to all companies in general but more so to SMEs which have a strong presence in this industry. Even though there has been considerable research in the area of small business growth, best practices for SMEs in the chemical distribution industry are scarce. This is one of the few research papers that address this gap in knowledge in a case study context in the specific industry, arguing that a mix of inorganic and organic growth is the best way to achieve growth. Findings suggest that the strategy depends on the vision of the owner/manager, strategies in place, access to human resources and finance, past experiences, industry characteristics and company structure. Despite the methodological limitations of this study, this can be used as the basis for future research and to inform key stakeholders and policy makers.
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Cramer, Martin, Bridget O’Farrell-Villareal, Guy Miller, Niell Irvin, Phil Smith, Dennis Johnson, Earnest Bush, et al. "CAN OIL SPILL RESPONSE PLANS BE FUNCTIONAL AND REGULATORY COMPLIANT?" International Oil Spill Conference Proceedings 2014, no. 1 (May 1, 2014): 1846–58. http://dx.doi.org/10.7901/2169-3358-2014.1.1846.

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ABSTRACT In the event of an oil spill, rapid and effective response actions are the key to minimizing impacts to the environment and local communities. Consequently, oil spill response plans (OSRPs) should be prepared in a user friendly format that maximizes access to crucial information and focuses on the critical first few hours or days of a response. While existing OSRPs are generally adequate, they typically are not organized logically and contain fairly general information that focuses on the overall response rather than the initial stages. For many plan holders the primary, or in some cases the only, objective when preparing OSRPs is obtaining regulatory approval and believe there is little latitude in deviating from the format or content of previously approved plans to make them more functional. Following the 2010 Macondo incident in the Gulf of Mexico, the American Petroleum Institute (API) sponsored Joint Industry Task Force (JITF) identified the need to enhance the usefulness of OSRPs. A workgroup was convened consisting of representatives from integrated and independent oil companies and spill response planning consultants to develop a guidance document for preparing OSRPs that are highly functional and regulatory compliant. The JITF guidance document includes a detailed OSRP outline that provides the intended purpose and recommended content and format for each section. The primary features include:Information presented in the general order required when responding to an oil spillFocus is on the first 24 hours when guidance is needed the mostKey information is provided in tabular or graphical formats at the front of each sectionInitial responder health and safety issues are addressed that are often missing in OSRPsSimilar information is located in the same section to avoid searching multiple sectionsMore expansive and detailed information, response guidance and specific cleanup strategies are referenced, as appropriate, in other documents The guidelines were designed to be Gulf of Mexico centric with the concepts being applicable to all industry sectors and regions of the world. Similar to the Integrated Contingency Plan concept developed in 1996, they can be adapted to comply with multiple oil spill planning regulations. They were, however, designed specifically to comply with the Bureau of Safety and Environmental Enforcement (BSEE) 30 Code of Federal Regulations (CFR) Part 254 and Notice to Lessees NTL 2012-N06. The draft guidelines were reviewed and well received by BSEE and the few regulatory compliance issues they identified were addressed in the final document. Therefore, it is possible to prepare OSRPs that are both functional and regulatory compliant.
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Ben Rejeb, Samuel, Bruce Lauer, John Salminen, Irene Roberts, Ashwani Wadhera, Michael Abbott, David Davies, et al. "Regulatory and Compliance Activities to Protect Food-Allergic Consumers in Canada: Research in Support of Standard Setting and Consumer Protection." Journal of AOAC INTERNATIONAL 87, no. 6 (November 1, 2004): 1408–16. http://dx.doi.org/10.1093/jaoac/87.6.1408.

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Abstract An overview is presented of the activities of Health Canada and the Canadian Food InspectionAgency (CFIA) in the area of food allergens. Since the 1990s, changes were made in the Food and Drug Regulations in order to better protect allergic consumers by imposing labeling requirements to clearly identify sources of priority food allergens in prepackaged foods. Policies of application as well as risk management strategies are discussed with some statistics on allergen-related food recalls in Canada for the years 1997–2001. Health Canada's allergen method development program is a pioneering research initiative that was developed in the early 1990s in support of the changing Canadian regulatory environment. The objectives and some of the accomplishments of this program are presented. The development of the CanadianCompendium of Allergen Methodologies under aWeb-based application to compile data on evaluated allergen detection methods will provide further support to compliance activities nationally, as well as to the international analytical community in both government and the food industry. Some emerging techniques for the confirmation of results generated by enzyme-linked immunosorbent assays are also discussed.
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47

Zawide*, Firdu, and Wondwossen Birke. "Evaluation of the Effect of Interventions upon Hygiene Compliance of Food Establishments in Jimma town Implications for Food Safety Regulatory and Enforcement Strategies." ISEE Conference Abstracts 2014, no. 1 (October 20, 2014): 1571. http://dx.doi.org/10.1289/isee.2014.p3-567.

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48

Indregard, Anne-Marthe R., Stein Knardahl, Jan Shahid Emberland, Øivind Skare, and Håkon A. Johannessen. "Effectiveness of the Labour Inspection Authority’s regulatory tools for work environment and employee health: study protocol for a cluster-randomised controlled trial among Norwegian home-care workers." BMJ Open 9, no. 11 (November 2019): e031226. http://dx.doi.org/10.1136/bmjopen-2019-031226.

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IntroductionThere is a need to evaluate whether, and to what degree, labour inspections or other regulatory tools have the desired effects on psychosocial, organisational and mechanical work environment, and employee health. The Norwegian Labour Inspection Authority (NLIA) uses different tools and strategies to enforce compliance with occupational safety and health (OSH) legislation. The aim of the present study is to evaluate the effects of labour inspections and other regulatory tools employed by the NLIA. The home-care service is one of the fastest growing occupations and a prioritised area for the NLIA, hence the present study will investigate regulatory tools in this sector.Methods and analysisThe research project has been designed as a longitudinal, cluster-randomised, controlled trial and will be conducted among Norwegian home-care workers. The objective of the research project is to evaluate the effects of the NLIA’s regulatory tools (inspection and guidance) on: (1) compliance with OSH legislation and regulation; (2) psychosocial, organisational and mechanical work environment; (3) employee health in terms of musculoskeletal and mental health complaints; and (4) sickness absence. Public home-care services have been randomised to three intervention groups and one control group. Home-care services in the intervention groups will receive one of three intervention activities from the NLIA: (1) inspection from the Labour Inspection Authority; (2) guidance through an online interactive risk-assessment tool; and (3) guidance on psychosocial, organisational and mechanical work environment through workshops. The interventions will be performed at the organisational level (home-care service), and the effects of the interventions on the working environment and health complaints will be measured at the individual level (home-care employees).Ethics and disseminationThis project has been approved by the Regional Committees for Medical and Health Research Ethics (REC) in Norway (REC South East) (2018/2003/REK sør-øst C), the Norwegian Center for Research Data (566128), and will be conducted in accordance with the World Medical Association Declaration of Helsinki. The results will be reported in international peer-reviewed journals.Trial registration numberNCT03855163.
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G, Srinivasan, and Shah N. "KAIZEN AND LEAN IMPLEMENTATION IN PHARMACEUTICAL INDUSTRIES: A REVIEW." Asian Journal of Pharmaceutical and Clinical Research 11, no. 7 (July 7, 2018): 57. http://dx.doi.org/10.22159/ajpcr.2018.v11i7.24722.

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Kaizen is one of the most commonly used words in all kind of industries. It has been implemented in organizations around the world as a way to improve production values while also improving employee morale and safety. The kaizen process brings about improvements that are small and incremental, and significant results can be seen only after a certain period of time. Many organizations across the world have adopted kaizen management philosophy and have successfully increased the efficiency of their end-to-end supply chains. With a focus on quality and regulatory compliance that are getting stringent day by day, pharmaceutical companies have been adopting these new strategies. This review focuses on basic aspects of Kaizen and Lean implementation and highlights few examples from pharmaceutical industry.
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Schiavone, Francesco, and Michele Simoni. "Strategic marketing approaches for the diffusion of innovation in highly regulated industrial markets: the value of market access." Journal of Business & Industrial Marketing 34, no. 7 (August 5, 2019): 1606–18. http://dx.doi.org/10.1108/jbim-08-2018-0232.

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Purpose In industrial markets, different players concur to diffuse the new products and services. However, in high-regulated industries, firms might find substantial limitations to their usual strategies. This paper aims to analyze the strategic marketing approaches adopted by firms to overcome these limitations. Design/methodology/approach The authors used a case study approach to explore the strategies adopted by two multinational health-care companies to promote their new products in the Italian health-care market. Findings The two firms adopted three specific strategic marketing approaches: educational activities for all the different players of the market with the involvement of highly reputed partners (e.g. opinion makers, scientific societies and patients’ associations); simulation of the innovation’s impact on the entire system realized; and creation of an ad hoc organizational unit, called market access unit, to deal with the specific issues of this highly regulated market. Originality/value The study contributes to the literature on marketing strategies aimed at promoting the diffusion of new products in highly regulated industrial markets by illustrating the strategic approaches that innovative firms can adopt to both achieve regulatory compliance and promote the diffusion of their new products.
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