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.

Evolution of soybean diseases in Argentina : past and present : contributions of FAUBA to the integrated management of plant diseases

p.37-52

Evolution of soybean diseases in Argentina : past and present : contributions of FAUBA to the integrated management of plant diseases

p.37-52

Deriving lessons relating to marine spatial planning from Canada's Eastern Scotian Shelf Integrated Management Initiative

Stakeholder participation is viewed as a key element of ecosystem-based marine spatial planning (MSP). There is much debate over the effectiveness of stakeholder participation in ecosystem-based management (EBM) in general and over the form it should take. Particular challenges relating to participation in the marine environment are highlighted. A study of the Eastern Scotian Shelf Integrated Management initiative, which uses a collaborative planning model to implement EBM, is presented in order to explore these issues further. Criteria derived from a review of collaborative planning literature are employed to evaluate the effectiveness of this model, which is found to be a useful consensus-building tool. Although a strategic-level plan has been adopted, the initiative has encountered difficulties transitioning from plan development to plan implementation. These are attributable in large measure to deficiencies in the design of the collaborative model. Useful lessons relating mainly to stakeholder engagement, the role of the lead agency, and implementation strategies are advanced for those engaging in MSP processes.

Factors Influencing the Implementation of Site Waste Management Plans on UK Projects of all sizes

The purpose of this research is to identify and assess the opportunities and challenges of implementing a Site Waste Management Plan (SWMP) on projects irrespective of size. In the UK, construction and demolition waste accounts for a third of all UK waste. There are a number of factors that influence the implementation of SWMPs. In order to identify and analyse these factors, 4 unstructured interviews were carried out and a sample of 56 participants completed a questionnaire survey. The scope of the study was limited to UK
construction industry professionals. The analysis revealed that more needs to be done if the industry is to meet government targets of reduction in construction related waste going to landfill. In addition, although SWMP may not yet be legally required on all construction projects, clients and contractors need to realise
the benefits to cut costs and implement best practice by adopting a SWMP. The benefits of implementing a SWMP will not only help to achieve this but also gain significant cost savings on projects and is also extremely beneficial to the environment. This study presents evidence that contractors need to do more to reduce waste and draws a clear link between waste reduction and the implementation of SWMPs. The findings are useful in the ongoing efforts to encourage the industry to find smarter, more efficient and less
damaging ways to operate

INTEGRATED MANAGEMENT SYSTEMS: CRITICAL SUCCESS FACTORS

The purpose of this paper is to, in a holistic way, identify and explore the critical success factors (CSFs) that are considered in the context of the growing discussions, movements, proposed models, and case studies about the integration of management systems (MSs). This work is an investigation focused on the integration of MSs into an integrated management system (IMS) and the proposed approach takes into account the literature review as well as the experience gained by the authors on researches about Portuguese enterprises. This qualitative and empirical research, investigated the integration of MSs from existing scientific publications for the period 1999 to 2014, on-going case studies and one inquiry conducted by the authors. This research contributes to a better understanding of the CSFs regarding the integration of MSs and thus provides an insight on the preventive management. This research shows an evident lack of information regarding case studies on CSFs for integrated management systems (IMSs) and has identified a set of relevant CSFs, for MSs integration and associated guidelines that organizations should take as a priority, in order to be able to manage, on a preventive way, the implementation of IMSs, and consequently to become more competitive with added value for the stakeholders.

Integrated Management of Interface Power (IMIP) Framework

La présence importante de plusieurs réseaux sans-fils de différentes portées a encouragée le développement d’une nouvelle génération d’équipements portables sans-fils avec plusieurs interfaces radio. Ainsi, les utilisateurs peuvent bénéficier d’une large possibilité de connectivité aux réseaux sans-fils (e.g. Wi-Fi [1], WiMAX [2], 3G [3]) disponibles autour. Cependant, la batterie d’un nœud mobile à plusieurs interfaces sera rapidement épuisée et le temps d’utilisation de l’équipement sera réduit aussi. Pour prolonger l’utilisation du mobile les standards, des réseaux sans-fils, on définie (individuellement) plusieurs états (émission, réception, sleep, idle, etc.); quand une interface radio n’est pas en mode émission/réception il est en mode sleep/idle où la consommation est très faible, comparée aux modes émission/réception. Pourtant, en cas d’équipement portable à multi-interfaces radio, l’énergie totale consommée par les interfaces en mode idle est très importante. Autrement, un équipement portable équipé de plusieurs interfaces radio augmente sa capacité de connectivité mais réduit sa longévité d’utilisation. Pour surpasser cet inconvénient on propose une plate-forme, qu'on appelle IMIP (Integrated Management of Interface Power), basée sur l’extension du standard MIH (Media Independent Handover) IEEE 802.21 [4]. IMIP permet une meilleure gestion d’énergie des interfaces radio, d’un équipement mobile à multi-radio, lorsque celles-ci entrent en mode idle. Les expérimentations que nous avons exécutées montrent que l’utilisation de IMIP permet d'économiser jusqu'a 80% de l'énergie consommée en comparaison avec les standards existants. En effet, IMIP permet de prolonger la durée d'utilisation d'équipements à plusieurs interfaces grâce à sa gestion efficace de l'énergie.

Integrated Management for Sustainable Development of Coastal Zones – A Gis Based Study on the Central Kerala Coast

The present study focuses on the stability of the coast, exploitation of the coastal resources, human activities within the study are that extends from Fort Cochin at north to Thottappally at south, central Kerala State and hinterlands, socio-economic problems of the coastal community and the environmental issues arising in the recent past due to human activities. The objective of the study is critically analyse the coastal zone region and prevailing situation and to propose a comprehensive management plan for the sustainable development of the region under study. The thesis covers varied aspects of coastal uses like fisheries, tourism, land use, water resources etc. To critically examine the above scenarios, the ILWIS (Integrated Land and Water Information Systems) – GIS software has been used. A satellite image of the area has been used for the coastline change detection and land use patterns. The outcome of the present study will be beneficial to the various stakeholders within the coastal region and its hinterlands. To further add, this study should find better applications to similar or near-similar situations of Southeast Asia where identical scenarios are noticeable.

Contaminants emergents i prioritaris: aportacions de la recerca científica plans de gestió fluvial = Contaminantes emergentes y prioritarios: aportaciones de la investigación científica a los planes de gestión de Cuenca = Emerging and priority pollutants: bringing science into river management plans

Recull de resums de les ponències, programa, i llista de participants de les Jornades "Contaminants emergents i prioritaris: aportacions de la recerca científica als plans de gestió fluvial" celebrades a Girona el 25 i 26 de març de 2010

Integrated management of urban wastewater systems: a model-based approach

The main objective pursued in this thesis targets the development and systematization of a methodology that allows addressing management problems in the dynamic operation of Urban Wastewater Systems. The proposed methodology will suggest operational strategies that can improve the overall performance of the system under certain problematic situations through a model-based approach. The proposed methodology has three main steps: The first step includes the characterization and modeling of the case-study, the definition of scenarios, the evaluation criteria and the operational settings that can be manipulated to improve the system’s performance. In the second step, Monte Carlo simulations are launched to evaluate how the system performs for a wide range of operational settings combinations, and a global sensitivity analysis is conducted to rank the most influential operational settings. Finally, the third step consists on a screening methodology applying a multi-criteria analysis to select the best combinations of operational settings.

Evaluating integrated management strategies for Orobanche and Striga

Abstracts EU Cost Action 849 .