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.

Consumption of fa cai Nostoc soup: A Potential for BMAA exposure from Nostoc cyanobacteria in China?

Grown in arid regions of western China the cyanobacterium Nostoc flagelliforme - called fa cai in Mandarin and fat choy in Cantonese - is wild-harvested and used to make soup consumed during New Year's celebrations. High prices, up to $125 USD/kg, led to overharvesting in Inner Mongolia, Ningxia, Gansu, Qinghai, and Xinjiang. Degradation of arid ecosystems, desertification, and conflicts between Nostoc harvesters and Mongol herdsman concerned the Chinese environmental authorities, leading to a government ban of Nostoc commerce. This ban stimulated increased marketing of a substitute made from starch. We analysed samples purchased throughout China as well as in Chinese markets in the United States and the United Kingdom. Some were counterfeits consisting of dyed starch noodles. A few samples from California contained Nostoc flagelliforme but were adulterated with starch noodles. Other samples, including those from the United Kingdom, consisted of pure Nostoc flagelliforme. A recent survey of markets in Cheng Du showed no real Nostoc flagelliforme to be marketed. Real and artificial fa cai differ in the presence of beta-N-methylamino-L-alanine (BMAA). Given its status as a high-priced luxury food, the government ban on collection and marketing, and the replacement of real fa cai with starch substitutes consumed only on special occasions, it is anticipated that dietary exposure to BMAA from fa cai will be reduced in the future in China.

2-D and 3-D processing and interpretation of multi-fold ground penetrating radar data:a case history from an archaeological site

A 2.5-D and 3-D multi-fold GPR survey was carried out in the Archaeological Park of Aquileia (northern Italy). The primary objective of the study was the identification of targets of potential archaeological interest in an area designated by local archaeological authorities. The second geophysical objective was to test 2-D and 3-D multi-fold methods and to study localised targets of unknown shape and dimensions in hostile soil conditions. Several portions of the acquisition grid were processed in common offset (CO), common shot (CSG) and common mid point (CMP) geometry. An 8×8 m area was studied with orthogonal CMPs thus achieving a 3-D subsurface coverage with azimuthal range limited to two normal components. Coherent noise components were identified in the pre-stack domain and removed by means of FK filtering of CMP records. Stack velocities were obtained from conventional velocity analysis and azimuthal velocity analysis of 3-D pre-stack gathers. Two major discontinuities were identified in the area of study. The deeper one most probably coincides with the paleosol at the base of the layer associated with activities of man in the area in the last 2500 years. This interpretation is in agreement with the results obtained from nearby cores and excavations. The shallow discontinuity is observed in a part of the investigated area and it shows local interruptions with a linear distribution on the grid. Such interruptions may correspond to buried targets of archaeological interest. The prominent enhancement of the subsurface images obtained by means of multi-fold techniques, compared with the relatively poor quality of the conventional single-fold georadar sections, indicates that multi-fold methods are well suited for the application to high resolution studies in archaeology.

治理水土流失 再造山川秀美延安——对中尺度生态环境建设中落实总理指示的认识与思考

通过分析黄土高原生态环境和生态建设的现状 ,进一步理解在中央决定实施西部大开发战略的新形势下 ,朱钅容基总理有关加强生态环境建设指示的重要意义。并以延安 6 5 0 km2 山川秀美示范区建设为例 ,探讨了生态环境建设的阶段、目标、模式及科技试验示范的主要任务

欧洲景观条约与景观生态学研究

In view of the growing social demand, the Council of Europe's Congress of Local and Regional Authorities (CLRAE) drew up the European Landscape Convention to promote landscape protection, management and planning, and to organize European co-operation on landscape issues in Europe. This paper summarizes the properties, origins, structure and content of the convention, and discusses the definitions on landscape and landscape policy to which the convention refers. Moreover, this paper sums up and concludes the perspective of landscape ecology in Europe.

国有企业管理者裁员决策特征及其对留岗者心理影响的研究

In China, orgnizational change and downsizing are the primary topics studied in I/O psychology and Human Resource Management. Due to the great need in reality, both theorists and practitioners raised the same questions: Does downsizing increase the organizational performance? What is the relationship between organizational downsizing strategies and survivors' psychological reations? Which factors influence managers' downsizing decision-making most? How can managers manage the process successfully? The purpose of this study is trying to answer these questions, and then to establish the downsizing decision-making model of China's SOE (State owned enterprise) managers. The hypothetical model of SOE managers' downsizing decision-making was put forward, based on a tremendous amount of literature on downsizing decision-making, especially on the downsizing decision-making model built by B. Shaw, and also based on the results of the interviews conducted to the SOE managers who have the downsizing decision-making experiences. In order to test and verify the model, 322 SOE managers were investigated by a questionnaire study. And the statistic results supported the hypothetical downsizing decision-making model. Further, 259 survivors (those who are still working in the SOEs) from 7 downsized SOEs and 1 non-downsizing SOE, were also investigated by a questionnaire study. The statistic results also supported the hypothetical downsizing decision-making model. A subsequent case study was performed upon one downsized SOE; and a deliberate focus group interview study within 6 SOE mangers from another downsized SOE was also conducted. Both fundings from the two studies surported the hypothetical model again. Thus, China's SOE managers' downsizing decision-making model was established. This China's SOE managers' downsizing decision-making model suggests the following: Firstly, the characteristics of managers'downsizing decision-making were the center of the model. Those characteristics displayed during the process of the downsizing decision planning, the participation of downsizing decision-making and the communication concerning downsizing events, were influenced by managers' sense of crisis, controlling factors out of the organization and the managing experience within it. Especially, the latter two factors were more important. Secondly, in downsizing decision-making problems, the perceived crisis of China's SOE managers was mainly influenced by the outer factors, esp. the controlling factors from the government or the high authorities, but not by the inner factors including manufacturing management, HRM skills and organizational competition strategies. Thirdly, survivors'psychological reactions (including job satisfaction, job motivation, team working cooperation, etc) were mainly influenced by the characteristics of the managers' downsizing decision-making, at the same time, also by the outer factors (including controlling and social security factors) and the inner factors (including competition strategy and HRM skills). Finally, according to the model and the results from this study, the conclusions were reached in the followings: The stronger the controlling effort upon the SOE managers, the worse the effect displayed during the downsizing process. And in order to improve the effect and quality of downsizing decision-making, SOE managers need a lot of training to ameliorate their competencies such as competition strategies and HRM skills.

Job change and workplace learning in the public sector: the significance of new technology for unskilled work.

Focussing here on local authorities and health services, this paper examines the significance of new technology to unskilled work in the public sector as it is developing and the implications for workplace learning. An argument is developed that new technology is central to a minority of examples of job change, although, significantly, it is more important to staff–initiated change and to workers’ ability to fully participate in life beyond the workplace.

Scottish Community Councils online: the 2014 survey.

This document reports the results of a survey, carried out in late spring 2014, of the public web presences of potentially over 1300 Scottish Community Councils (CCs). It follows on from similar survey in summer 2012. The report reviews content-types associated with up-to-date presences and examines Community Councils’ social media use, using three archetypes which may be used to derive models and examples of good practice, and create recommendations for Community Councils and their Local Authorities (LAs). The research found that there has little change overall since 2012, which combined with a high level of churn implies an increasing number of digitally disengaged Community Councils. A good way forward would be for to CCs emulate and adapt the examples of good practice identified, by publishing minutes, news, planning and local area information, limiting publication of other types of content, and using social media to engage with citizens. A number of broader recommendations are made to LAs, including that that they publish CC schemes on their websites, provide training in online methods and work together via their CCLOs and IT teams to support CCs

Reader development and ICT: an overview of projects in Welsh public libraries

Bird, A.,& Tedd, L. (2004). Reader development and ICT: an overview of projects in Welsh public libraries. Journal of Librarianship and Information Science, 36(4), 159-174.

Local studies collections online: an investigation in Irish public libraries

Barry, L., Tedd, L.A. (2008). Local studies collections online: an investigation in Irish public libraries. Program: electronic library and information systems, 42(2), 163-186.

MUES (Mid Wales - Users - Ethnic Services) Ethnic services provision 2007-08. Report for Libraries for Life: Delivering the entitlement agenda for library users in Wales 2007-09

Thomas, R., Urquhart, C., Crossan, S. & Hines, B. (2008). MUES (Mid Wales - Users - Ethnic Services) Ethnic services provision 2007-08. Report for Libraries for Life: Delivering the entitlement agenda for library users in Wales 2007-09. Aberystwyth: Department of Information Studies, Aberystwyth University. Related policy guidance published separately Sponsorship: CyMAL

Rural information needs. Final report for Mid Wales Library and Information Partnership

Thomas, R., Crossan, S., Urquhart, C. & Hines, B. (2008). Rural information needs. Final report for Mid Wales Library and Information Partnership. Aberystwyth: Department of Information Studies, Aberystwyth University Sponsorship: Mid Wales Library and Information Partnership

Kształtowanie systemu politycznego Kazachstanu w latach 1991-2000. Kontekst historyczno-kulturowy

Wydział Historyczny

Obwód Kaliningradzki a bezpieczeństwo Polski

Obwód Kaliningradzki Federacji Rosyjskiej (FR) odgrywa istotną rolę dla bezpieczeństwa Polski, Litwy oraz państw regionu Morza Bałtyckiego. Ten najbardziej na zachód wysunięty obszar Rosji otoczony jest państwami UE i NATO i nie posiada bezpośredniej styczności z FR. Na obszarze obwodu zgromadzone są pokaźne siły zbrojne, w tym wyrzutnie rakiet średniego i dalekiego zasięgu, które mogą być uzbrojone w głowice atomowe. Władze w Moskwie traktują potencjał wojskowy zgromadzony w obwodzie jako element nacisku na opinię publiczną, tak by zniechęcić władze RP do budowy na terytorium Polski amerykańskiej tarczy antyrakietowej.

The Iranian Foreign Policy in the Persian Gulf Region under the Rule of President Hassan Rouhani: Continuity of Change

Although Iran borders with many states and has direct access to the Caspian Sea as well as the Indian Ocean, the Persian Gulf region seems to be the most vital area to its security and prosperity. Yet since the 70’s Iran’s relations with the Arab states in the region have been rather strained and complex. The main reason for that had been the success of the Islamic revolution in 1979 which later resulted in a new dimension of Sunni-Shia rivalry. Moreover, post-revolutionary Iranian authorities also intended to maintain the regional hegemony from the Imperial State of Iran period. As a result, successive Iranian governments competed for hegemony in the Persian Gulf with the littoral Arab states which consolidated their regional positions due to close links and intensive cooperation with the West especially with the United States. Despite some political and economic initiatives which were undertaken by President Mahmoud Ahmadinejad, this rivalry was also evident between 2005–2013. The main aim of this article is to find out whether Iranian foreign policy towards the Arab states in the Persian Gulf region has undergone any significant changes since Hassan Rouhani became the President of the Islamic Republic of Iran in August 2013. According to Mohammad Reza Deshiri, the Iranian foreign policy after 1979 can be divided into so-called waves of idealism and realism. During dominance of idealism values and spirituality are more important than pragmatism while during the realistic waves political as well as economic interests prevail over spirituality. Iranian idealism is connected with export of revolutionary ideas, Shia dominance as well as the restoration of unity among all muslims (ummah). On this basis both presidential terms of Mahmoud Ahmadinejad can be classified as ‘waves of idealism’, albeit some of his ideas were very pragmatic. The question is if Hassan Rouhani’s foreign policy represents a continuity or a change. Is the current Iran’s foreign policy towards the Persian Gulf region idealistic or rather realistic? The main assumption is that there will be no Arab-Iranian rapprochement in the Persian Gulf without a prior normalization of political relations between Iran and the West especially the United States.