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.