Suchergebnisse

Purpose: We study the influence and impact of regulations and highlight the barriers to market entry faced by Australian professional service firms in the European Union (EU) and their strategies to manage and transfer tacit knowledge. Design/methodology/approach: We collected data by reviewing relevant regulatory documents and conducting semi-structured interviews with key informants from Australian architecture firms and senior representatives from the professional, trade, and regulatory bodies in Australia and Europe. Findings: Historically, Australian professional service firms use the United Kingdom (UK) as their EU base. The mutual recognition of qualifications and prior experiences are barriers to intra-organizational expatriation and knowledge transfer. The study identifies the dual nationality of the architects as a way of circumventing the residency/nationality restrictions. Originality: The study discusses Brexit and how the uncertainty surrounding the UK and EU's services' agreement adds to the complexity for non-European firms' market entry and operations in the region.

Regulation has been claimed to be acquired by the industry, yet while the economic regulation was often established with the approval and encouragement of the regulated industry, social regulation has usually been thrust upon industry following demands by public interest groups. Why would the social regulation still fail to produce behaviour, or results in accordance with the public interest, if the public interest groups initiated it? The failure to define clearly the concept of 'public interest' and the absence of adequately clear regulatory objectives would not provide all the convincing answers. The wish of the politicians to respond to a mischief before public concern dies down, seems to point towards the symbolic politics claims. Although lobbying is integral to democratic politics, it challenges the policy making process as the risks and opportunities associated with policy change are large. Lobbying regulations, belonging to the social regulations fold, have been observed as symbolic in Israel and are diluted by tricky loopholes. Recent research has used data from Centre of Public Integrity (CPI) in order to theoretically classify different regulatory environments. The CPI measures only what the law says, but it does not measure the outcome -- the application of the law. This paper points out that the possible interaction of symbolic politics with social regulation may lead to the reoccurring legislative void, resulting in the dilution effect of the lobbying regulations, and it highlights the need to review the theoretical classification, and thereby, also the actual strength of the different regulatory environments. [Copyright John Wiley and Sons, Ltd.]

Regulation has been claimed to be acquired by the industry, yet while the economic regulation was often established with the approval and encouragement of the regulated industry, social regulation has usually been thrust upon industry following demands by public interest groups. Why would the social regulation still fail to produce behaviour, or results in accordance with the public interest, if the public interest groups initiated it? The failure to define clearly the concept of 'public interest' and the absence of adequately clear regulatory objectives would not provide all the convincing answers. The wish of the politicians to respond to a mischief before public concern dies down, seems to point towards the symbolic politics claims.Although lobbying is integral to democratic politics, it challenges the policy making process as the risks and opportunities associated with policy change are large. Lobbying regulations, belonging to the social regulations fold, have been observed as symbolic in Israel and are diluted by tricky loopholes. Recent research has used data from Centre of Public Integrity (CPI) in order to theoretically classify different regulatory environments. The CPI measures only what the law says, but it does not measure the outcome—the application of the law. This paper points out that the possible interaction of symbolic politics with social regulation may lead to the reoccurring legislative void, resulting in the dilution effect of the lobbying regulations, and it highlights the need to review the theoretical classification, and thereby, also the actual strength of the different regulatory environments. Copyright © 2013 John Wiley & Sons, Ltd.

Recent research has shown that many of the accidents and incidents that occur on mine-sitesare caused, at least in part, by problems with rules and regulations. This research aimsto determine how the regulatory environment (both government and mine site) can be moreeffective in improving mine safety.Responses to a questionnaire involving 33 mines in Australia, Sweden and Canadaprovided an insight into the attitudes of the mining workforce towards the effectiveness ofthe regulatory environment. A rule involving a high-risk task in an underground coalminewas then further examined in a series of investigations involving interviewing personnel,observing behaviour, and testing knowledge and understanding by a variety of means. Itwas found that there is a very low level of knowledge and awareness of both rules ingeneral and specific rules. An outcome of this part of the research is a set of guidelines forthe formulation and implementation of more effective mine safety rules.The questionnaire responses were also used to compare and contrast mineworker attitudesamongst various industry sectors and employee groups. A measure of attitudes towardsrules and regulations was developed and subjected to statistical analysis. The measureconsisted of five subscales: knowledge, communication, compliance, risk perception andfatalism. The measure exhibited acceptable reliability and validity. The relationshipbetween attitudes and safety performance was investigated using lost time injury andfatality data for individual mine sites and industry-wide groupings. It was found that a weakrelationship exists between mine-site LTIFR and attitudes, however a stronger relationshipexists between attitudes and fatalities. It was also found that there was a strong correlationbetween the knowledge subscale and safety performance.Using a four stage skills-based learning model, individual mine-sites were classifiedaccording to the safe behaviour characteristics of their workforces. The relationshipbetween safety behaviour and safety performance was investigated in a regression analysisand a relationship observed.The thesis demonstrated that the regulatory environment does influence safety performanceon mine-sites. Further research, particularly in alternative regulatory environments such asSweden and Canada, is recommended.

A new survey of over 2000 jurisdictions across all major housing markets in the US documents how regulation of residential building varies across space. New evidence on what a `typical' degree of local regulation entails is provided. In addition, data on how the stringency of land use control varies across markets are analysed. Coastal markets tend to be more highly regulated, with communities in the Northeast region of America being the most highly regulated on average, followed by those in the West region (California especially).

Products of genome editing as the most promising "New Plant Breeding Technology" (NPBT) have made the transition from the lab to the market in a short time. Globally, research activities employing genome editing are constantly expanding and more and more plants with market-oriented traits are being developed, and companies have already released the first genome edited crops to the market. Few countries, most of which are located in the Americas, have adapted legislations to these technologies or released guidelines supporting the use of genome editing. Other countries are debating the path to come either because there is no clarity on the legal classification or due consensus is hampered by a renewed GMO debate. In recent years (2017−2020), eight countries have introduced guidelines clarifying the legal status of genome edited products and many of those are actively committed to international harmonization of their policies. In this publication we give an overview on the current and potentially future international regulatory environment and an update on plants derived by genome editing with market-oriented traits.

Products of genome editing as the most promising "New Plant Breeding Technology" (NPBT) have made the transition from the lab to the market in a short time. Globally, research activities employing genome editing are constantly expanding and more and more plants with market-oriented traits are being developed, and companies have already released the first genome edited crops to the market. Few countries, most of which are located in the Americas, have adapted legislations to these technologies or released guidelines supporting the use of genome editing. Other countries are debating the path to come either because there is no clarity on the legal classification or due consensus is hampered by a renewed GMO debate. In recent years (2017−2020), eight countries have introduced guidelines clarifying the legal status of genome edited products and many of those are actively committed to international harmonization of their policies. In this publication we give an overview on the current and potentially future international regulatory environment and an update on plants derived by genome editing with market-oriented traits.

National regulatory authorities (NRAs) are responsible for the evaluation of medicines and for ensuring that only those products which meet the requirements of quality, safety and efficacy are registered and made available to patients. The NRAs are required to effect such regulatory mandates efficiently and ensure timely patients' access to medicines. Many NRAs, especially in resource-limited settings or emerging markets face challenges in fulfilling these mandates as resources are stretched to capacity. Adopting a risk-based approach to medicine evaluation can provide relief for NRAs striving towards improved regulatory performance. The NRAs may implement facilitated regulatory pathways, appropriate frameworks for benefit-risk (BR) assessment and abridged review processes in order to leverage reliance mechanisms and good regulatory practices to improve regulatory efficiencies. The aim of this research was to evaluate the regulatory environment in South Africa with a view to improve the review process for medicines and to ensure their timely access by patients. This was achieved through a review of the legislative framework and historical context supporting the new regulatory environment in South Africa and the transition from the Medicines Control Council (MCC) to South African Health Products Regulatory Authority (SAHPRA). The regulatory performance of the South African regulatory authority and how it compared to that of other agencies was evaluated and the strategies supporting enhanced BR assessment and reliance mechanisms were appraised. Various methodologies were considered in determining an appropriate study design and a mixed method approach, including a combination of self-administered questionnaires, focus groups and a case study, was adopted to support achieving the study objectives. A questionnaire was used to evaluate the review process of the MCC and the results demonstrated that the MCC was not able to meet target timelines for the review of new active substances (NASs). A comparison was made between the MCC and other similar NRAs using the same questionnaire. The results indicated that the MCC had similar requirements to other agencies and all the NRAs conducted a full assessment of applications for the registration of NASs. However, the approval times for the MCC were considerably longer. Further investigation into these lengthy timelines resulted in the analysis of the performance metrics of the MCC between 2015-2017 and of SAHPRA in 2018. A case study approach and focus group were used to evaluate strategies for enhanced communication of BR assessments and a questionnaire and two focus groups were conducted to understand the implications of the application of an abridged review in the evaluation of NASs. The results of these studies culminated in the development of a proposed improved model for the regulatory review process of new active substance (NASs) for SAHPRA. This programme of research has presented, in a seminal piece of work, key recommendations for the improvement of the regulatory review process as it may be applied by SAHPRA. The results from this work provide, for the first time, a baseline against which future improvements, implemented by SAHPRA, may be measured. The implementation of these recommendations will contribute towards an enhanced regulatory performance, underpinned by good regulatory, good review and good reliance practices. This will result in a stream-lined review process, improved regulatory responsiveness, consistency, transparency and accountability and ultimately patients' timely access to medicines.

Speculative housebuilding in the United Kingdom faces an ever tighter regulatory environment owing to the increasing impact of the sustainable development agenda. For example, 60% of all new homes in England are now expected to be constructed on previously developed land or provided through the conversion of existing buildings. As speculative housebuilders are responsible for about 80% of all new dwellings built in the United Kingdom, the achievement of this important government target is critically dependent on the ability and willingness of the private sector to respond to public policy. By exploring the main components of the residential development process, the author investigates how far speculative housebuilding will need to change to ensure the successful implementation of the government's brownfield housing target. He suggests that those speculative housebuilders that are enthusiastically building up core competencies in brownfield housing are likely to emerge as the market leaders of the future whereas those companies that continue to rely on past practices and technologies will face an uncertain future as greenfield development opportunities begin to reduce.