Regulation: A Burden in Biopharmaceutical Industry? The Case of EU-Risk Management Plans

The generation of new medicinal products is both a contributor to global economic growth and a source of valuable benefits to human health. Given their direct responsibility for public health, regulatory authorities monitor closely both the development and exploitation of the underlying technologies and the products derived from them. The manner in which such regulation is implemented can result in regulators constraining or facilitating the generation of new products. This paper will study as an example the impact of EU Risk Management Plans (EU-RMPs), which have been mandatory for the approval of new medicines since 2005, on both the industry and regulatory authorities. In interviews, the responses of those who had experience of the implementation of EU-RMPs were mixed. Although the benefits of a more structured and predictable approach to the evaluation of risk were appreciated, some respondents perceived the regulation as an excessive burden on their organisations. The exploration of factors that influence how EU-RMP regulation affects individual firms provides new insights for both regulators and managers, and demonstrates one aspect of the complexity of the process by which new medicinal products are brought to market.

Regulation: A burden in biopharmaceutical industry? The case of EU-risk management plans

The generation of new medicinal products is both a contributor to global economic growth and a source of valuable benefits to human health. Given their direct responsibility for public health, regulatory authorities monitor closely both the development and exploitation of the underlying technologies and the products derived from them. The manner in which such regulation is implemented can result in regulators constraining or facilitating the generation of new products. This paper will study as an example the impact of EU Risk Management Plans (EU-RMPs), which have been mandatory for the approval of new medicines since 2005, on both the industry and regulatory authorities. In interviews, the responses of those who had experience of the implementation of EU-RMPs were mixed. Although the benefits of a more structured and predictable approach to the evaluation of risk were appreciated, some respondents perceived the regulation as an excessive burden on their organisations. The exploration of factors that influence how EU-RMP regulation affects individual firms provides new insights for both regulators and managers, and demonstrates one aspect of the complexity of the process by which new medicinal products are brought to market. © 2010 IEEE.

Managing Information Risks in asset management - Experiences from an in-depth case study in the utility industry

Information is one of the most important resources in our globalized economy. The value of information often exceeds the value of physical assets. Information quality has, in many ways, an impact on asset management organisations and asset managers struggle to understand and to quantify it, which is a prerequisite for effective information quality improvement. Over the past few years, we have developed an innovative management concept that addresses these new asset management challenges: a process for Total Information Risk Management (TIRM), which has been already tested in a number of asset management industries. The TIRM process enables to manage information quality more effectively in asset management organisations as it focuses specifically on the risks that are imposed by information quality. In this paper, we show how we have applied the TIRM process in an in-depth study at a medium-sized European utility provider, the Manx Electricity Authority (MEA), at the Isle of Man.

Remote Wireless Communications for Construction Management: A Case Study

The recent advances in urban wireless communications and protocols that spurred the development of city-wide wireless infrastructure motivated this research, since in many cases, construction sites are not conveniently located for wired connectivity. Large scale transportation projects for example, such as new highways, railroad tracks and the networks of utilities (power-lines, phone lines, mobile towers, etc) that usually follow them are constructed in areas where wired infrastructure for data exchange is often expensive and time-consuming to deploy. The communication difficulties that can be encountered in such construction sites can be addressed with a wireless communications link between the construction site and the decision-making office. This paper presents a case study on long-range, wireless communications suitable for data exchange between construction sites and engineering headquarters. The purpose of this study was to define the requirements for a reliable wireless communications model where common types of electronic construction data will be exchanged in a fast and efficient manner, and construction site personnel will be able to interact and share knowledge, information and electronic resources with the office staff.

Investigating the link between well-being and energy use; an explorative case study between passive and active domestic energy management systems

The aim of this study was to explore how the remote control of appliances/lights (active energy management system) affected household well-being, compared to in-home displays (passive energy management system). A six-week exploratory study was conducted with 14 participants divided into the following three groups: active; passive; and no equipment. The effect on well-being was measured through thematic analysis of two semi-structured interviews for each participant, administered at the start and end of the study. The well-being themes were based on existing measures of Satisfaction and Affect. The energy demand for each participant was also measured for two weeks without intervention, and then compared after four weeks with either the passive or active energy management systems. These measurements were used to complement the well-being analysis. Overall, the measure of Affect increased in the passive group but Satisfaction decreased; however, all three measures on average decreased in the active group. The measured energy demand also highlighted a disconnect between well-being and domestic energy consumption. The results point to a need for further investigation in this field; otherwise, there is a risk that nationally implemented energy management solutions may negatively affect our happiness and well-being. © 2013 Elsevier Ltd.

Product intelligence in warehouse management: A case study

The need for more flexible, adaptable and customer-oriented warehouse operations has been increasingly identified as an important issue by today's warehouse companies due to the rapidly changing preferences of the customers that use their services. Motivated by manufacturing and other logistics operations, in this paper we argue on the potential application of product intelligence in warehouse operations as an approach that can help warehouse companies address these issues. We discuss the opportunities of such an approach using a real example of a third-party-logistics warehouse company and we present the benefits it can bring in their warehouse management systems. © 2013 Springer-Verlag.

Heritage interpretation challenges and management issues at film-induced tourism heritage attractions: Case studies of Rosslyn Chapel and Alnwick Castle

Although previous research has widely acknowledged the phenomenon of film-induced tourism, there is a paucity of research in relation to management of film-induced tourism at built heritage sites. This research, underpinned by a constructivist paradigm, draws on three distinct fields of study – heritage tourism management, film-induced tourism and heritage interpretation – in order to provide a contribution to the heritage management field and address this particular gap in knowledge. Relying on the method of semi-structured interviews with managers, guides and visitors at Rosslyn Chapel (RC) and Alnwick Castle (AC), this thesis provides a rich understanding of how heritage interpretation can address a range of management challenges at heritage sites where film-induced tourism has occurred. These heritage visitor attractions (HVAs) were specifically selected as case studies as they have played different roles in media products. Rosslyn Chapel (RC) was an actual place named in The Da Vinci Code (TDVC) book and then film, whereas Alnwick Castle (AC) served as a backdrop for the first two Harry Potter (HP) films. Findings of this research include a range of management challenges at both RC and AC such as an increase in visitor numbers; seasonality issues; changes in visitor profile; revenue generation concerns; conservation, access, and visitor experience; and the complex relationship between heritage management and tourism activities. The findings also reveal film-induced tourism’s implications for heritage interpretation such as the various visitors’ expectations for heritage interpretation, changes to heritage interpretation as a result of film-induced tourism, and issues with commodification. These findings also demonstrate that film-induced tourism to some extent influenced visitors’ preferences for heritage interpretation, though visitors’ preferences differed from one to another. This thesis argues that, in the context of film-induced tourism at HVAs, as evident from the two case studies considered, heritage interpretation can be a valuable management tool and can also play a significant role in the quality of the visitors’ experience.

The impact of new public management on the roles of elected councillors, management and the community sector in Irish local government: a case study of Cork County Council

The fundamental aim of this thesis is to examine the effect of New Public Management (NPM) on the traditional roles of elected representatives, management and community activists in Irish local government. This will be achieved through a case study analysis of one local authority, Cork County Council. NPM promises greater democracy in decision-making. Therefore, one can hypothesise that the roles of the three key groupings identified will become more influenced by principles of participatory decision-making. Thus, a number of related questions will be addressed by this work, such as, have the local elected representatives been empowered by NPM? Has a managerial revolution taken place? Has local democracy been enhanced by more effective community participation? It will be seen in chapter 2 that these questions have not been adequately addressed to date in NPM literature. The three groups identified can be regarded as stakeholders although the researcher is cautious in using this term because of its value-laden nature. Essentially, in terms of Cork County Council, stakeholders can be defined as decision-makers and people within the organization and its environment who are interested in or could be affected directly or indirectly by organizational performance. This is an all-embracing definition and includes all citizens, residents, community groups and client organizations. It is in this context that the term 'stakeholder' should be understood when it is occasionally used in this thesis. In this case, the perceptions of elected councilors, management and community representatives with regard to their changing roles are as significant as the changes themselves. The chapter begins with a brief account of the background to this research. This is followed by an explanation of the methodology which is used and then concludes with short statements about the remaining chapters in the thesis.

The contribution of enterprise systems to core capabilities: the case of asset lifecycle management in the utilities sector

The desire to obtain competitive advantage is a motivator for implementing Enterprise Resource Planning (ERP) Systems (Adam & O’Doherty, 2000). However, while it is accepted that Information Technology (IT) in general may contribute to the improvement of organisational performance (Melville, Kraemer, & Gurbaxani, 2004), the nature and extent of that contribution is poorly understood (Jacobs & Bendoly, 2003; Ravichandran & Lertwongsatien, 2005). Accordingly, Henderson and Venkatraman (1993) assert that it is the application of business and IT capabilities to develop and leverage a firm’s IT resources for organisational transformation, rather than the acquired technological functionality, that secures competitive advantage for firms. Application of the Resource Based View of the firm (Wernerfelt, 1984) and Dynamic Capabilities Theory (DCT) (Teece and Pisano (1998) in particular) may yield insights into whether or not the use of Enterprise Systems enhances organisations’ core capabilities and thereby obtains competitive advantage, sustainable or otherwise (Melville et al., 2004). An operational definition of Core Capabilities that is independent of the construct of Sustained Competitive Advantage is formulated. This Study proposes and utilises an applied Dynamic Capabilities framework to facilitate the investigation of the role of Enterprise Systems. The objective of this research study is to investigate the role of Enterprise Systems in the Core Dynamic Capabilities of Asset Lifecycle Management. The Study explores the activities of Asset Lifecycle Management, the Core Dynamic Capabilities inherent in Asset Lifecycle Management and the footprint of Enterprise Systems on those Dynamic Capabilities. Additionally, the study explains the mechanisms by which Enterprise Systems sustain the Exploitability and the Renewability of those Core Dynamic Capabilities. The study finds that Enterprise Systems contribute directly to the Value, Exploitability and Renewability of Core Dynamic Capabilities and indirectly to their Inimitability and Non-substitutability. The study concludes by presenting an applied Dynamic Capabilities framework, which integrates Alter (1992)’s definition of Information Systems with Teece and Pisano (1998)’s model of Dynamic Capabilities to provide a robust diagnostic for determining the sustained value generating contributions of Enterprise Systems. These frameworks are used in the conclusions to frame the findings of the study. The conclusions go on to assert that these frameworks are free - standing and analytically generalisable, per Siggelkow (2007) and Yin (2003).

Implementation of customer relationship management and inventory control software: a multiple case study of small retailers

Gemstone Team Small Business Solutions

Botulinum toxin type A injections for the management of muscle tightness following total hip arthroplasty: a case series.

BACKGROUND: Development of hip adductor, tensor fascia lata, and rectus femoris muscle contractures following total hip arthroplasties are quite common, with some patients failing to improve despite treatment with a variety of non-operative modalities. The purpose of the present study was to describe the use of and patient outcomes of botulinum toxin injections as an adjunctive treatment for muscle tightness following total hip arthroplasty. METHODS: Ten patients (14 hips) who had hip adductor, abductor, and/or flexor muscle contractures following total arthroplasty and had been refractory to physical therapeutic efforts were treated with injection of botulinum toxin A. Eight limbs received injections into the adductor muscle, 8 limbs received injections into the tensor fascia lata muscle, and 2 limbs received injection into the rectus femoris muscle, followed by intensive physical therapy for 6 weeks. RESULTS: At a mean final follow-up of 20 months, all 14 hips had increased range in the affected arc of motion, with a mean improvement of 23 degrees (range, 10 to 45 degrees). Additionally all hips had an improvement in hip scores, with a significant increase in mean score from 74 points (range, 57 to 91 points) prior to injection to a mean of 96 points (range, 93 to 98) at final follow-up. There were no serious treatment-related adverse events. CONCLUSION: Botulinum toxin A injections combined with intensive physical therapy may be considered as a potential treatment modality, especially in difficult cases of muscle tightness that are refractory to standard therapy.

The role of economics in ecosystem based management: The case of the EU Marine Strategy Framework Directive, First lessons learnt and way forward

The EU Marine Strategy Framework Directive (MSFD) sets out a plan of action relating to marine environmental policy and in particular to achieving ‘good environmental status’ (GES) in European marine waters by 2020. Article 8.1 (c) of the Directive calls for ‘an economic and social analysis of the use of those waters and of the cost of degradation of the marine environment’. The MSFD is ‘informed’ by the Ecosystem Approach to management, with GES interpreted in terms of ecosystem functioning and services provision. Implementation of the Ecosystem Approach is expected to be by adaptive management policy and practice. The initial socio-economic assessment was made by maritime EU Member States between 2011 and 2012, with future updates to be made on a regular basis. For the majority of Member States, this assessment has led to an exercise combining an analysis of maritime activities both at national and coastal zone scales, and an analysis of the non-market value of marine waters. In this paper we examine the approaches taken in more detail, outline the main challenges facing the Member States in assessing the economic value of achieving GES as outlined in the Directive and make recommendations for the theoretically sound and practically useful completion of the required follow-up economic assessments specified in the MSFD.