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.

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.

A workbook-based methodology for implementing concurrent engineering

Concurrent Engineering demands a new way of working and many organisations experience difficulty during implementation. The research described in this paper has the aim to develop a paper-based workbook style methodology that companies can use to increase the benefits generated by Concurrent Engineering, while reducing implementation costs, risk and time. The three-stage methodology provides guidance based on knowledge accumulated from implementation experience and best practitioners. It encourages companies to learn to manage their Concurrent Engineering implementation by taking actions which expose them to new and valuable experiences. This helps to continuously improve understanding of how to maximise the benefits from Concurrent Engineering. The methodology is particularly designed to cater for organisational and contextual uniqueness, as Concurrent Engineering implementations will vary from company to company. Using key actions which improve the Concurrent Engineering implementation process, individual companies can develop their own 'best practice' for product development. The methodology ensures that key implementation issues, which are primarily human and organisational, are addressed using simple but proven techniques. This paper describes the key issues that the majority of companies face when implementing Concurrent Engineering. The structure of the methodology is described to show how the issues are addressed and resolved. The key actions used to improve the Concurrent Engineering implementation process are explained and their inclusion in the implementation methodology described. Relevance to industry. Implementation of Concurrent Engineering concepts in manufacturing industry has not been a straightforward process. This paper describes a workbook-style tool that manufacturing companies can use to accelerate and improve their Concurrent Engineering implementation. © 1995.

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 global network operations along the engineering value chain

Purpose: This paper aims to improve understanding of how to manage global network operations from an engineering perspective. Design/methodology/approach: This research adopted a theory building approach based on case studies. Grounded in the existing literature, the theoretical framework was refined and enriched through nine in-depth case studies in the industry sectors of aerospace, automotives, defence and electrics and electronics. Findings: This paper demonstrates the main value creation mechanisms of global network operations along the engineering value chain. Typical organisational features to support the value creation mechanisms are captured, and the key issues in engineering network design and operations are presented with an overall framework. Practical implications: Evidenced by a series of pilot applications, outputs of this research can help companies to improve the performance of their current engineering networks and design new engineering networks to better support their global businesses and customers in a systematic way. Originality/value: Issues about the design and operations of global engineering networks (GEN) are poorly understood in the existing literature in contrast to their apparent importance in value creation and realisation. To address this knowledge gap, this paper introduces the concept of engineering value chain to highlight the potential of a value chain approach to the exploration of engineering activities in a complex business context. At the same time, it develops an overall framework for managing GEN along the engineering value chain. This improves our understanding of engineering in industrial value chains and extends the theoretical understanding of GEN through integrating the engineering network theories and the value chain concepts. © Emerald Group Publishing Limited.

Modelling information requirements in complex engineering services

Services based around complex engineering equipment and systems provide substantial challenges in both the long-term management of the equipment and the need for guaranteed delivery of the related service. One of the challenges for an organisation providing these services is the management of the information that is required to design, deliver and subsequently assess the success of the service. To assist in this process this paper develops a model for capturing, organising and assessing information requirements for these Complex Engineering Services in which information required to support key decisions in the life cycle of the service is identified. The model – referred to as The 12-Box Model for Service Information Requirements – is embedded in a three-phase procedure for providing an assessment of information requirements of a service contract which also provides insight into the capabilities of available information systems in supporting the contract. An illustrative example examining service information in an aircraft availability contract is used to demonstrate the use of the 12-Box Model and associated assessment procedure.

The impact of government policy on technology transfer: An aircraft industry case study

This case study explores the interaction between domestic and foreign governmental policy on technology transfer with the goal of exploring the long-term impacts of technology transfer. Specifically, the impact of successive licensing of fighter aircraft manufacturing and design to Japan in the development of Japan's aircraft industry is reviewed. Results indicate Japan has built a domestic aircraft industry through sequential learning with foreign technology transfers from the United States, and design and production on domestic fighter aircraft. This process was facilitated by governmental policies in both Japan and the United States. Published by Elsevier B.V.