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/IT resources and business value: Operationalization of an information oriented framework

Several studies have highlighted the importance of information and information quality in organisations and thus information is regarded as key determinant for the success and organisational performance. In this paper, we review selected contributions and introduce a model that shows how IS/IT resources and capabilities could be interlinked with IS/IT utilization, organizational performance and business value. Complementing other models and frameworks, we explicitly consider information from a management maturity, quality and risk perspective and show how the new framework can be operationalized with existing assessment approaches by using empirical data from four industrial case studies. © 2012 Springer-Verlag.

An information oriented framework for relating IS/IT resources and business value

Several studies have highlighted the importance of information and information quality in organisations and thus information is regarded as key determinant for the success and organisational performance. At the same time, there are numerous studies, frameworks and case studies examining the impact of information technology and systems to business value. Recently, several studies have proposed maturity models for information management capabilities in the literature, which claim that a higher maturity results in a higher organizational performance. Although these studies provide valuable information about the underlying relations, most are limited in specifying the relationship in more detail. Furthermore, most prominent approaches do not or at least not explicitly consider information as important influencing factor for organisational performance. In this paper, we aim to review selected contributions and introduce a model that shows how IS/IT resources and capabilties could be interlinked with IS/IT utilization, organizational performance and business value. Complementing other models and frameworks, we explicitly consider information from a management maturity, quality and risk perspective. Moreover, the paper discusses how each part of the model can be assessed in order to validate the model in future studies.

Top Management Involvement in New Product Development: A Review and Synthesis

Established literature on new product development (NPD) management recognizes top management involvement (TMI) as one of the most critical success factors. With increasing pressure to sustain competitive advantage and growth, NPD activities remain the focus of close interest from top management in many organizations. TMI in the NPD domain is receiving increasing academic attention. Despite its criticality, there is no systematic review of the existing literature to inform and stimulate researchers in the field for further investigation. This paper introduces the current state of literature on TMI in NPD, synthesizes important findings, and identifies the gaps and deficiencies in this research stream. The contents of the selected articles, which investigated TMI in NPD, are analyzed based on the type of the study, level of analysis, research methodology, operationalization of TMI, and main findings. Additionally, other studies, which did not directly investigate TMI and support in NPD, but were sufficiently related, are briefly summarized. As a result of this detailed literature review, it can be stated that both exploratory and relational studies provide rich evidence on the critical role of top management in NPD. However, the identified gaps and deficiencies in this research stream call for a better theoretical understanding and well-defined constructs of TMI in the NPD domain for different levels of analysis for future studies.

Product intelligence in warehouse management: A case study

The need for more flexible, adaptable and customer-oriented warehouse operations has been increasingly identified as an important issue by today's warehouse companies due to the rapidly changing preferences of the customers that use their services. Motivated by manufacturing and other logistics operations, in this paper we argue on the potential application of product intelligence in warehouse operations as an approach that can help warehouse companies address these issues. We discuss the opportunities of such an approach using a real example of a third-party-logistics warehouse company and we present the benefits it can bring in their warehouse management systems. © 2013 Springer-Verlag.

Exciton localization in In0.15Ga0.85As/GaAs quantum wire structures grown on (553)B-oriented GaAs substrate

Using time-resolved photoluminescence (PL) measurements, we have studied the exciton localization effect in InGaAs/GaAs quantum wire (QWR) structures formed in corrugated narrow InGaAs/GaAs quantum wells (QWs) grown on (553)B GaAs substrate. The PL decay time in the QWR structure was found to be independent of the temperature for T < 70 K, showing a typical dynamical behavior of the localized excitons. This result is in striking contrast to the corresponding quantum well structures, where a linear increase of the PL decay time was observed. In addition, an increase of the exciton lifetime was observed at low temperature for the QWR structure as compared to a reference InGaAs/GaAs quantum well sample (1200 vs 400 ps). The observed longer decay time was attributed to the reduction in the spatial coherence of excitons in the QWR-like structure. In PL measurements, a significant polarization anisotropy was also found in our narrow InGaAs/GaAs QWs grown on (553)B GaAs. (C) 2001 American Institute of Physics.

semantic oriented ontology cohesion metrics for ontology-based systems

Ontologies play a core role to provide shared knowledge models to semantic-driven applications targeted by Semantic Web. Ontology metrics become an important area because they can help ontology engineers to assess ontology and better control project management and development of ontology based systems, and therefore reduce the risk of project failures. In this paper, we propose a set of ontology cohesion metrics which focuses on measuring (possibly inconsistent) ontologies in the context of dynamic and changing Web. They are: Number of Ontology Partitions (NOP), Number of Minimally Inconsistent Subsets (NMIS) and Average Value of Axiom Inconsistencies (AVAI). These ontology metrics are used to measure ontological semantics rather than ontological structure. They are theoretically validated for ensuring their theoretical soundness, and further empirically validated by a standard test set of debugging ontologies. The related algorithms to compute these ontology metrics also are discussed. These metrics proposed in this paper can be used as a very useful complementarity of existing ontology cohesion metrics.

a dynamic model to handle defect-oriented processes

Tongji Univ, Inst Dev Study, Syst Engn Soc China, Comm Syst Dynam, Syst Dynam Soc, China Chapter, Shanghai Inst Foreign Trade, Syst Dynam Soc, Chapters Asia Pacific Area

Novel < 110 >-oriented organic-inorganic perovskite compound stabilized by N-(3-aminopropyl) imidazole with improved optical properties

In the organic-inorganic perovskites family, the < 100 >-oriented type has been extensively investigated as a result of its unique magnetic, optical, and electrical properties, and only one type of < 110 >-oriented hybrid perovskite stabilized by methylammonium and iodoformamidinium cations or the latter themselves has been known so far. In this paper, another novel < 110 >-oriented organic-inorganic perovskite (C6H13N3)-PbBr4 (compound 1) has been prepared by reacting N-(3-aminopropyl)imidazole (API) with PbBr2 in hydrobromic acid. The crystal structure is determined, which indicates that the perovskite is stabilized by API. The introduction of the optically active organic ligand API into the hybrid perovskite results in a red shift and a great enhancement of photoluminescence in the perovskite with respect to organic ligand API itself. These results have been explained according to calculation based on density-functional theory. Moreover, the excellent film processing ability for the perovskite (C6H13N3)PbBr4 together with the improved optical properties makes it have potential application in optoelectronic devices.

Controlling factors for the occurrence of heteroepitaxy of polyethylene on highly oriented isotactic polypropylene

The controlling factors for the epitaxial crystallization of high-density polyethylene (HDPE) on highly oriented isotactic polypropylene (iPP) substrates have been studied in detail by means of transmission electron microscopy and electron diffraction. The results obtained in this work indicate that the crystallization process must be considered in the investigation of epitaxial growth of polymers on polymeric substrates, because of the unique morphological and crystallization characteristics of polymers. Crystallization rate has an important effect on the epitaxial crystallization of polymers. Higher rates result in the formation of thicker epitaxial layers. Isothermal crystallization temperature is another factor affecting epitaxial growth of polymers. Lower temperatures are favorable to epitaxial crystallization of polymers. There exists a critical epitaxial temperature at given experimental conditions, above which no epitaxial growth occurs at all. The influence of crystal dimensions of both the substrates and the deposited polymers on epitaxial growth confirms that secondary nucleation is an important controlling factor for the occurrence of epitaxial crystallization in polymers. The requirement satisfying the secondary nucleation criterion is that the substrate crystal dimension in the matching direction must be greater than the crystal thickness of the deposited polymer. Once the requirement of the secondary nucleation is satisfied, subsequent epitaxial growth is based on the lamellar growth habit of the deposited polymer itself. (C) 1998 Published by Elsevier Science Ltd. All rights reserved.

IN-SITU SCANNING-TUNNELING-MICROSCOPY IMAGE OF A HIGHLY ORIENTED PYROLYTIC-GRAPHITE ELECTRODE MODIFIED WITH POTASSIUM BIS(11-MOLYBDOSILICATO) DYSPROSATE(III) IN SODIUM-SULFATE SOLUTION

The variation in molecule adsorption mode on pretreated highly oriented pyrolytic graphite electrodes, modified with the title complex K10H3[Dy(SiMo11O39)(2)] by cyclic voltammetry in the title complex solution, was observed in situ by electrochemical scanning tunnelling microscopy (ECSTM) with molecular resolution in sodium sulphate solution. According to the ECSTM images and the known molecular structure we conclude that the adsorption mode of the title complex modified electrode changed during potential cycling from ''vertical'' to ''inclined'' and then ''horizontal'' or ''flat'' mode, i.e. the title complex adsorbed on the surface of electrode by one ligand of the complex at first, then began to incline and was finally adsorbed by two ligands of the complex. This result indicates that the adsorption mode on the modified electrode surface changed during potential cycling in the sulphate solution and a much more stable molecular layer was formed. The change in adlattice of adsorbates on the modified electrode surface from hexagonal to rectangular was also observed by ECSTM. A plausible model was given to explain this process.

Population dynamics and responses to management of plateau pikas Ochotona curzoniae

1. Plateau pikas Ochotona curzoniae are considered a pest species on the Tibetan Plateau because they compete with livestock for forage and their burrowing could contribute to soil erosion. The effectiveness of pest control programmes in Tibet has not been measured, and it is not known whether changes in livestock management have exacerbated problems with plateau pikas or compromised their control. This study measured the impact of control programmes and livestock management for forage conservation on populations of plateau pikas in alpine meadow in Naqu District, central Tibet, during 2004 and 2005.2. Current techniques for controlling plateau pikas in spring cause large reductions in abundance, but high density-dependent rates of increase result in no differences between treated and untreated populations by the following autumn. Rates of increase from spring to autumn are not influenced by standing plant biomass or concurrent grazing by yaks Bos grunniens and Tibetan sheep Ovis aries.3. In autumn there was significantly lower biomass outside fenced areas with year-round livestock grazing compared with inside fenced areas with equivalent or higher numbers of plateau pikas but predominantly winter grazing by livestock. Inside fenced areas, control of plateau pikas in spring produced no detectable effect on standing plant biomass at the end of the following summer compared with uncontrolled populations of plateau pikas.4. Regardless of their initial density, populations of plateau pikas declined rapidly over winter outside fenced areas where there was very low standing plant biomass in autumn. However, inside fenced areas with higher plant biomass in autumn, low-density populations of plateau pikas declined more slowly than high-density populations.5. Synthesis and applications. Current control programmes have limited effect because populations of plateau pikas can recover in one breeding season. There was no apparent increase in forage production in areas where plateau pikas were controlled. However, plateau pikas appear to benefit from changes in grazing management, with low-density populations declining less over winter inside fenced areas than elsewhere. It was not evident that control programmes are warranted or that they will improve the livelihoods of Tibetan herders.

Heritage interpretation challenges and management issues at film-induced tourism heritage attractions: Case studies of Rosslyn Chapel and Alnwick Castle

Although previous research has widely acknowledged the phenomenon of film-induced tourism, there is a paucity of research in relation to management of film-induced tourism at built heritage sites. This research, underpinned by a constructivist paradigm, draws on three distinct fields of study – heritage tourism management, film-induced tourism and heritage interpretation – in order to provide a contribution to the heritage management field and address this particular gap in knowledge. Relying on the method of semi-structured interviews with managers, guides and visitors at Rosslyn Chapel (RC) and Alnwick Castle (AC), this thesis provides a rich understanding of how heritage interpretation can address a range of management challenges at heritage sites where film-induced tourism has occurred. These heritage visitor attractions (HVAs) were specifically selected as case studies as they have played different roles in media products. Rosslyn Chapel (RC) was an actual place named in The Da Vinci Code (TDVC) book and then film, whereas Alnwick Castle (AC) served as a backdrop for the first two Harry Potter (HP) films. Findings of this research include a range of management challenges at both RC and AC such as an increase in visitor numbers; seasonality issues; changes in visitor profile; revenue generation concerns; conservation, access, and visitor experience; and the complex relationship between heritage management and tourism activities. The findings also reveal film-induced tourism’s implications for heritage interpretation such as the various visitors’ expectations for heritage interpretation, changes to heritage interpretation as a result of film-induced tourism, and issues with commodification. These findings also demonstrate that film-induced tourism to some extent influenced visitors’ preferences for heritage interpretation, though visitors’ preferences differed from one to another. This thesis argues that, in the context of film-induced tourism at HVAs, as evident from the two case studies considered, heritage interpretation can be a valuable management tool and can also play a significant role in the quality of the visitors’ experience.