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.