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.

Beyond theory: An examination of lean new product introduction practices in the UK

Interest is growing around the application of lean techniques to new product introduction (NPI). Although a relatively emergent topic compared with the application of 'lean' within the factory, since 2000 there has been an exponential rise in the literature on this subject. However, much of this work focuses on describing and extolling the virtues of the 'Toyota approach' to design. Therefore, by way of a stock take for the UK, the present authors' research has set out to understand how well lean product design practices have been adopted by leading manufacturers. This has been achieved by carrying out in-depth case studies with three carefully selected manufacturers of complex engineered products. This paper describes these studies, the detailed results and subsequent findings, and concludes that both the awareness and adoption of practices is generally embryonic and far removed from the theory advocated in the literature. © IMechE 2007.

Photomechanically Induced Phase Transitions in Ferroelectric Liquid Crystals

We report optically induced phase transtions occurring in two different host ferroelectric liquid crystals; SCE13 a multicomponentmixture optimised for room temperature performance, and CE8 a single component liquid crystal. These act as host liquid crystals for a novel guest azo dye, which can be made to photoisomerise using low power density U.V. illumination, resulting in dramatic changes in sample properties. We have shown that the magnitude of spontaneous polarisation of systems can be isothermally and reversibly induced or reduced, with the consequent appearance or disappearance of optical switching hysteresis. We discuss the parameters controlling the behaviour of the systems under U.V. illumination and suggest mechansims by which the transitions may occur. © 1993, Taylor & Francis Group, LLC. All rights reserved.

High power, low-jitter encoded picosecond pulse generation using an rf-locked self-q-switched multicontact GaAs/GaAlAs diode laser

The RF locking of a self-Q-switching diode laser is shown to reduce the jitter of a 2.48 GHz train of 1 W peak power picosecond pulses to less than 300 fs. By using direct modulation of the loss in the Q-switched laser, direct encoding of data has been achieved at rates in excess of 2 Gbit/s.