An exploration of risk management in global industrial investment

This article explores risk management in global industrial investment by identifying linkages and gaps between theories and practices. It identifies opportunities for further development of the field. Three related bodies of literature have been reviewed: risk management, global manufacturing and investment. The review suggests that risk management in global manufacturing is overlooked in the literature; that existing theoretical risk management processes are not well developed in the global manufacturing context and that the investment literature applies mainly to financial risk assessment rather than investment risk management structures. Further, there appears to be a serious lack of systematic industrial risk management in investment decision making. This article highlights the opportunities to deploy current good practices more effectively as well as the need to develop more robust theories of industrial investment risk management. The approach adopted to investigate this multidisciplinary topic included a historical review of literature to understand the diverse background of theoretical development. A case study research approach was adopted to collect data, involving four global manufacturing companies and one risk management advisory company to observe the patterns and rationale of current practices. Supporting arguments from secondary data sources reinforced the findings. The research focuses risk management in global industrial investment. It links theories with practice to understand the existing knowledge gap and proposes key research themes for further research. © 2013 Macmillan Publishers Ltd. 1460-3799 Risk Management.

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.

Is performance measurement and management fit for the future?

Performance measurement and management (PMM) is a management and research paradox. On one hand, it provides management with many critical, useful, and needed functions. Yet, there is evidence that it can adversely affect performance. This paper attempts to resolve this paradox by focusing on the issue of "fit". That is, in today's dynamic and turbulent environment, changes in either the business environment or the business strategy can lead to the need for new or revised measures and metrics. Yet, if these measures and metrics are either not revised or incorrectly revised, then we can encounter situations where what the firm wants to achieve (as communicated by its strategy) and what the firm measures and rewards are not synchronised with each other (i.e., there is a lack of "fit"). This situation can adversely affect the ability of the firm to compete. The issue of fit is explored using a three phase Delphi approach. Initially intended to resolve this first paradox, the Delphi study identified another paradox - one in which the researchers found that in a dynamic environment, firms do revise their strategies, yet, often the PMM system is not changed. To resolve this second paradox, the paper proposes a new framework - one that shows that under certain conditions, the observed metrics "lag" is not only explainable but also desirable. The findings suggest a need to recast the accepted relationship between strategy and PMM system and the output included the Performance Alignment Matrix that had utility for managers. © 2013 .