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.

Understanding luxury in the premium automotive industry

This paper summarises the findings of investigations to date in understanding what luxury and premiumness mean to the high-end automotive consumer. Existing writings on luxury and premiumness are considered. An exploratory study was carried out in two countries using 309 respondents and 18 prestige cars. A "stream of consciousness" approach was used to capture respondent's views on a selection of vehicles. The codified transcripts were used to identify key differences between the top and bottom rated vehicles, in terms of the nature and quantity of emotional responses elicited. This paper describes some of these key product differences that were self-reported to impact upon a luxury response. Finally, suggestions are made as to the next steps required for this research. © 2007 ACM.

A distributed process for the aerospace industry

In response to significant changes within the aerospace industry during recent years, a new approach is proposed for developing complex products in a globally distributed environment. Current approaches favour collocating project teams, but collocation is often not practical, nor economically justifiable. The Macro Concept is a process whereby products can be developed by globally distributed task teams, managed by a Core team. In the development of this concept, particular attention is paid to the human factors, the product decomposition and the infrastructure that supports the product introduction process in a globalized industry.

An ecodesign model based on industry experience

With the increase in environmental legislation facing many industrial sectors organisations are now looking for ways to improve their environmental performance. To a large extent organisations have tended to concentrate on their operations inside the "factory gates" with little regard to the environmental performance of the products they produce. However, this is now changing and some organisations are beginning to take a close look at their products and their effects on the environment during its use phase as well as during the manufacture and disposal phases. At Cranfield University we have carried out a 3 year survey of US, Central European and UK companies claiming to practice ecodesign has been undertaken. Thirty electrical and electronic manufacturers were studied, some through in-depth observation of design programmes, most through semi-structured interviews. The survey and action research sought to understand the way in which these companies practised ecodesign and how they .had implemented ecodesign. A common pattern emerged from the data which suggests that companies successfully implementing ecodesign have many similar experiences. The resulting ecodesign model is presented and discussed, and the factors critical to successful implementation at various stages are explored. The factors cover a range of topics including design management, motivation, design tools, design phases, communication and the designers perspective.

Frontier experiences from industry-academia consortia

Technology roadmapping has been applied successfully in many industrial organizations. Designed to facilitate and communicate technology strategy and planning, roadmaps (or, as in Europe, route maps) can take a variety of specific forms, depending on the type (opportunities, capabilities, products, technologies, etc.) and particular company context. While roadmaps are generally manifest in a number of "program elements or levels" superimposed upon a timeline, experienced mappers often claim that it is "roadmapping" rather than "the roadmap" that generates the value. This special report focuses primarily on product and technology roadmaps. Following an introduction to the evolution, purpose and applications of corporate/industry roadmapping, four industry-developed articles examine roadmapping in Lucent Technologies, Rockwell Automation, the pharmaceutical/biotechnology industry, and UK-based Domino Printing Sciences.

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.