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This article shall – after a quick introduction into the European Medial Device Regulation – examine the duties of the so called „person responsible for regulatory compliance“ of medical device manufacturers.

Many smaller ports in Cornwall and Devon (CAD) are situated in environmentally sensitive habitats and generate benefits for stakeholders and local communities. Such ports are often embedded in tourist based economies. Increasing environmental legislation is placing a strain on the resources of smaller ports making compliance a threat to profitability and thus the future of some ports and local economies. Over-reliance on environmental management systems (EMS) across the ports industry has predominated over the importance of holistic sustainability. This project develops and disseminates a port sustainability management system (PSMS) in CAD, assisting ports to plan marine and maritime operations more sustainably, to facilitate mitigation of potential risks, to increase knowledge and awareness of port sustainability, and to promote the adoption of a proactive stance towards sustainable port management. A constructivist philosophy suited a multiple methods research design which included ethnographic content analysis (ECA), statistical verification of qualitative coding, nine scoping interviews, and eight semi-structured interviews during the main phase of data collection. The seven Harbour Masters (HMs) in this phase represented all port governance types found in the UK. Charmaz’s grounded theory (GT) methodology guided the collection and analysis of primary data between August 2012 and February 2013 to create new theory using an inductive constructivist approach. Validation by fifteen of the thirty local HMs during industry testing revealed numerous advantages and benefits of deploying PSMS which is estimated to generate £50,000 worth of benefits per port annually, and £3,865,005 for the 15 participating ports over 5 years. A new model of smaller port sustainability has emerged. PSMS has eleven pillars of sustainability which underpin the spectrum of port operations. Within this model, each pillar is equally important in contributing to the overall sustainability of a port, and neglect of one could jeopardise sustainability overall and potentially cause a chain reaction with other pillars.

Business leaders venturing in the microbrewing business sector experience long delays due to federal, state, and city requirements unique to this industry. The purpose of this multiple case study was to explore strategies used by microbrewers in cases bounded by the fulfillment of the same licensing requirements to launch a microbrewery in Madison County, Alabama. The dynamic capabilities framework served as the conceptual framework for this study. A purposive sampling of 4 microbrewers who possessed tacit knowledge about the microbrewery licensure process participated in face-to-face semistructured interviews providing in-depth information about their strategic approaches. The overarching research question addressed the strategic approaches microbrewers used to complete the microbrewery licensure process. Data analysis included the verbatim transcription of interviews coded for common patterns and themes. The following themes emerged from the data analysis: learning from other brewers, flexible strategic approach, establishing a brewery first, attaining licensing second, business planning strategies, and regulatory echelons for microbrewing licensing. The 4 participants reported that learning from other brewers and applying a flexible strategic approach were the preferred strategies to navigate the licensure process in becoming a commercial microbrewer. The implications for social change include reduction in gap between understanding and effective strategies to fulfill microbrewing licensing that could benefit communities by promoting business creation, employment, and added taxation revenue from craft beers produced, sold, and consumed locally.

Oil companies in Alberta, Canada, invested $32 billion on new oil sands projects in 2013. Despite the size of this investment, there is a demonstrable deficiency in the uniformity and understanding of environmental legislation requirements that manifest into increased project compliance risks. This descriptive study developed 2 prioritized lists of environmental regulatory compliance risks and mitigation strategies and used multi-criteria decision theory for its theoretical framework. Information from compiled lists of environmental compliance risks and mitigation strategies was used to generate a specialized pairwise survey, which was piloted by 5 subject matter experts (SMEs). The survey was validated by a sample of 16 SMEs, after which the Analytic Hierarchy Process (AHP) was used to rank a total of 33 compliance risks and 12 mitigation strategy criteria. A key finding was that the AHP is a suitable tool for ranking of compliance risks and mitigation strategies. Several working hypotheses were also tested regarding how SMEs prioritized 1 compliance risk or mitigation strategy compared to another. The AHP showed that regulatory compliance, company reputation, environmental compliance, and economics ranked the highest and that a multi criteria mitigation strategy for environmental compliance ranked the highest. The study results will inform Alberta oil sands industry leaders about the ranking and utility of specific compliance risks and mitigations strategies, enabling them to focus on actions that will generate legislative and public trust. Oil sands leaders implementing a risk management program using the risks and mitigation strategies identified in this study will contribute to environmental conservation, economic growth, and positive social change.

The Basel Committee on Banking Supervision has defined operational risk, legal risk and compliance risk. However, the definitions might not be adequate for countries with a hybrid legal system, such as South Africa. This study aims to provide a practical solution to the problems faced by countries with a hybrid legal system wishing to comply with the Basel Committee’s standards. It is argued that compliance, compliance risk and regulatory risk should all be viewed as constituent components of legal risk, and in turn necessarily also of operational risk in a hybrid legal system. Legal risk is a wide concept which includes all aspects of a legal system, while compliance risk is a narrower concept which only includes the codified aspects of a legal system. Legal risk therefore includes compliance risk. However, the opposite is not true as compliance risk does not include legal risk, and the two concepts are decidedly shown not to be synonymous in a mixed legal system. / Thesis (PhD (Law))--North-West University, Potchefstroom Campus, 2013.

The Basel Committee on Banking Supervision has defined operational risk, legal risk and compliance risk. However, the definitions might not be adequate for countries with a hybrid legal system, such as South Africa. This study aims to provide a practical solution to the problems faced by countries with a hybrid legal system wishing to comply with the Basel Committee’s standards. It is argued that compliance, compliance risk and regulatory risk should all be viewed as constituent components of legal risk, and in turn necessarily also of operational risk in a hybrid legal system. Legal risk is a wide concept which includes all aspects of a legal system, while compliance risk is a narrower concept which only includes the codified aspects of a legal system. Legal risk therefore includes compliance risk. However, the opposite is not true as compliance risk does not include legal risk, and the two concepts are decidedly shown not to be synonymous in a mixed legal system. / Thesis (PhD (Law))--North-West University, Potchefstroom Campus, 2013.

Submitted by Priscilla Araujo (priscilla@ibict.br) on 2017-09-25T18:49:05Z No. of bitstreams: 2 license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) O marco regulatório da indústria de petróleo sob o prisma do regime de informação.pdf: 6573579 bytes, checksum: 6ab0fa4741f6aca9566e8828d29a00ab (MD5) / Made available in DSpace on 2017-09-25T18:49:06Z (GMT). No. of bitstreams: 2 license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) O marco regulatório da indústria de petróleo sob o prisma do regime de informação.pdf: 6573579 bytes, checksum: 6ab0fa4741f6aca9566e8828d29a00ab (MD5) Previous issue date: 2016-09-26 / Esta pesquisa tem como foco analisar papel das dinâmicas de produção e circulação da informação e do conhecimento na indústria de petróleo e gás natural no Brasil. Supõe-se que exista um regime de informação associado às formas de regulação nessa indústria, no Brasil e no mundo. Compreende-se que o marco regulatório é um conjunto de normas, leis e diretrizes que agem como dispositivos de regulação e funcionamento de um setor específico. Para compreendermos as mudanças ocorridas recentemente no marco regulatório local, será necessário compreendermos que o Brasil recebeu e recebe influências diretas dos modelos globais de regulação na produção de petróleo, principalmente com as divulgações das grandes descobertas na camada pré-sal que estão sendo noticiadas pela mídia ao público não especializado. A escolha do tema para esta pesquisa se deu principalmente pelo reconhecimento do papel fundamental da informação, do conhecimento e da inovação nos processos produtivos da indústria de petróleo, se forem considerados tanto a concorrência e a vantagem competitiva de uma ou poucas empresas sobre as demais, como a abertura de novos mercados, expansão de novas fronteiras em decorrência de descobertas em potencial e valor de mercado. É nesse contexto e diante dessas questões que entendemos a configuração de um possível regime de informação na indústria do petróleo e gás natural. Além disso, a escolha pelo tema desenvolvido se deu pela proximidade do autor ao desenvolver atividades profissionais em uma companhia petrolífera. / Esta pesquisa tem como foco analisar papel das dinâmicas de produção e circulação da informação e do conhecimento na indústria de petróleo e gás natural no Brasil. Supõe-se que exista um regime de informação associado às formas de regulação nessa indústria, no Brasil e no mundo. Compreende-se que o marco regulatório é um conjunto de normas, leis e diretrizes que agem como dispositivos de regulação e funcionamento de um setor específico. Para compreendermos as mudanças ocorridas recentemente no marco regulatório local, será necessário compreendermos que o Brasil recebeu e recebe influências diretas dos modelos globais de regulação na produção de petróleo, principalmente com as divulgações das grandes descobertas na camada pré-sal que estão sendo noticiadas pela mídia ao público não especializado. A escolha do tema para esta pesquisa se deu principalmente pelo reconhecimento do papel fundamental da informação, do conhecimento e da inovação nos processos produtivos da indústria de petróleo, se forem considerados tanto a concorrência e a vantagem competitiva de uma ou poucas empresas sobre as demais, como a abertura de novos mercados, expansão de novas fronteiras em decorrência de descobertas em potencial e valor de mercado. É nesse contexto e diante dessas questões que entendemos a configuração de um possível regime de informação na indústria do petróleo e gás natural. Além disso, a escolha pelo tema desenvolvido se deu pela proximidade do autor ao desenvolver atividades profissionais em uma companhia petrolífera.

La culture de sécurité s'impose à l'agenda des entreprises. Cette notion n'est pas nouvelle puisque le terme est apparu dès la fin des années 80 suite à l'accident de Tchernobyl. L'existence d'une culture de sûreté défaillante a été la principale cause expliquant la catastrophe.L'usage du terme s'est très largement répandu et les définitions sont nombreuses. En croisant différents travaux, trois grands facteurs explicatifs se révèlent prédominants dans la culture de sécurité : les facteurs « organisationnel », « comportemental » et « psychologique ».L'objectif de ce travail de thèse est de concevoir un « système » de modèles permettant de décrire et d'évaluer sur le terrain chacun des trois facteurs. Pour ce faire, des « raccourcis » (ou « réductions » théorique et méthodologique), qui seront discutées et justifiées, ont été explorés.Ainsi, le facteur « organisationnel » est traduit selon le processus de l'analyse des conformités légales (le rapport au prescrit). ». Le facteur « comportemental » quant à lui assimilé au processus de maîtrise des risques (le rapport au réel). Enfin, le facteur « psychologique » est directement relié au processus d'évaluation du « climat de sécurité ».Chaque processus a fait l'objet d'un effort de modélisation. Chacun des modèles a permis de repérer des variables descriptives et explicatives. Certaines ont été reliées dans le but de traduire la relation entre les trois facteurs.Le « système » de modèles ainsi constitué a fait l'objet d'une expérimentation à grande échelle conduite en partenariat avec une entreprise française de rang mondial. Deux sites ont été impliqués. La thèse détaille le cadre théorique et méthodologique. Elle présente la démarche de modélisation mise en œuvre et discute amplement des résultats de l'expérimentation. Elle propose enfin des pistes de généralisation du dispositif constitué. / Safety culture is increasingly important to the corporate agenda. The SafetyCulture concept is not new, but gained popularity in the late 80s following the Chernobyl accident. The main cause of the disaster was said to be a deficient Safety culture.The term is now used widely and definitions are numerous. The Safety culture literature contains three major explanatory factors shaping the formation of a safety culture: "organizational", "behavioural" and "psychological".The objective of this thesis is to develop a "system" of models which will enable description and evaluation of these three factors in applied settings. To achieve this goal, theoretical and methodological "shortcuts", or mappings, were developed and explored. The "organizational" factor is mapped with the process of compliance management. Similarly, the "behavioural" factor is likened to the process of risk management. Finally, the "psychological" factor is directly related to the assessment process of the "safety climate". The implications of these translations are discussed in this thesis.Each of these processes has been modelled. Every model has allowed the identification of descriptive and explanatory variables. Some have been linked to each other in order to translate the relationship between the three factors. The "system" of models was tested on a large sample in partnership with a global French company. Two locations were involved.This thesis describes the theoretical and methodological framework. It describes the modelling process that has been implemented and discusses the results of the experimentation. Finally it proposes possibilities for the enhancement of the models that have been developed.

In the year 2008, world markets suffered a huge economic crisis. The extent of the economic crisis has been so severe and has had a global impact. As a contingency strategy, governments of wealthy nations have resorted to extensive bailouts and rescue packages to stop organisations from going bankrupt. A skyrocketing amount of money has been spent on rescue packages and bailouts for the tumbling organisations. However, this could not stop some of the world’s wealthiest financial institutions e.g. Lehman Brothers, Northern Rock, etc from collapsing. Most of the surviving organisations froze their expenditure, implemented cost-cutting measures and in the process, numerous employees lost their jobs. Executives were compelled to ‘achieve more with less’ in order to save their organisations from going bankrupt. It is on this premise that this research proposed the BC3I (Broad Control Category Cost Indicators) model, which is a step towards ‘achieving more with less’ within information security budgeting. The tumbling world markets and increased requirements for legal and regulatory compliance have made this a timely and relevant research that addressed a current, spot-on and global problem. The BC3I model as the main outcome of this research has indeed come at the right time. The BC3I model as proposed in this research makes a real contribution towards assisting information security managers as they make informed decisions regarding the optimal and cost-effective allocation of financial resources to information security activities. The proposed model can be argued to be a good start towards the selection of appropriate controls to optimally and cost-effectively protect organisations’ information assets and simultaneously achieve compliance with legal and regulatory mandates. As a proof of concept, the practicality of the BC3I model has been demonstrated in three different scenarios. The model has been illustrated for an organisation chosen from the financial sector; being the hardest hit by the economic crisis. Furthermore, the financial sector is chosen because of its high reliance on information security for the most obvious reasons that of dealing with money and confidential customer information. Finally and for acceptance purposes, the model has been discussed and reviewed by industry experts from the financial sector. Copyright / Dissertation (MSc)--University of Pretoria, 2010. / Computer Science / unrestricted