scholarly journals Results of a Sociological Survey on the Needs of Drug Safety Monitoring Specialists for Information on the Creation of the Pharmacovigilance System Master File

2020 ◽  
Vol 8 (2) ◽  
pp. 84-89
Author(s):  
N. G. Goloenko ◽  
R. I. Yagudina ◽  
A. Yu. Kulikov ◽  
V. G. Serpik ◽  
M. V. Protsenko ◽  
...  

The Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union oblige developers and marketing authorisation holders to implement a pharmacovigilance system that has to be described in the pharmacovigilance system master file (PSMF). Analysis of public sources revealed lack of data describing the creation of a PSMF. Therefore, the creation of a PSMF and keeping it up to date may prove challenging for pharmacovigilance specialists.The aim of the study was to identify information needs of pharmacovigilance specialists by carrying out a sociological survey.Materials and methods: the authors used information analysis methods (review and analysis of regulatory documents and scientific literature) and sociological methods (a questionnaire for pharmacovigilance specialists).Results: the analysis helped to identify the following master file sections that present problems for specialists: sources of safety data; annexes to the master file; quality system; changes in the pharmacovigilance system that may result in an additional request from the competent authorities, etc.Conclusions: the authors identified the most relevant topics for additional training: “Pharmacovigilance system documents” and “Pharmacovigilance system master file”. The results of the study are helpful for elaboration and updating of additional training programmes for pharmacovigilance specialists. 

Author(s):  
Marina Y. Neshcheret

The article is devoted to the comprehensive study of the professional information needs (IN) of specialists of the central libraries of the subjects of the Russian Federation. The rapid development of high technologies in the field of accumulation, transmission and processing of information, the creation of modern telecommunications systems have led to the emergence of fundamentally new opportunities for organizing the information process. This, in turn, led to the qualitative growth of IN specialists, including those employed in the field of library activities. The specific features of IN library specialists are determined by their place and role in the modern process of cultural activity, industry orientation, nature of work and specialization. During 2018—2019, the Centre for Research of Problems of the Development of Libraries in the Information Society of the Russian State Library carried out research aimed at comprehensive study of the information needs of cultural workers employed in the library sphere. At the first stage of the research, there was comprehended the existing experience of studying professional information needs in the national library science. At the second stage, using the method of questionnaire survey, information needs of library specialists were studied in order to identify the most rational forms and methods of providing them. The analysis of the survey results made it possible to identify the sources of professional information, to reveal information resources that have the greatest importance and characterize specific features of librarians’ information needs.The author concludes on the need to expand the access to full-text databases and electronic versions of periodicals for library staff. The creation of integrated information centre could help providing library professionals with professional information. Currently, the function of such a centre is performed by the National Electronic Library, which includes the professional section for library specialists. The results of the study form theoretical and methodological basis for the rational use of resources and potential of libraries in providing information to professional information needs of library specialists and determine the prospects for further research related to improving the forms and methods of information service for this category of users.


Upravlenie ◽  
2020 ◽  
Vol 7 (4) ◽  
pp. 113-122
Author(s):  
I. V. Mishchenko ◽  
E. G. Shustova ◽  
I. V. Milkina

The development of cross-border territories and the impact of integration processes on them has been considered in the article. The creation of the Eurasian Economic Union becomes an impetus for the development of both the member states of the organization and their individual territories. This integration formation is relatively young, but today it creates a common market for the movement of goods, services, labor and capital. That is the cross-border territories, as bridges between countries, which feel the effect of the processes taking place in the common economic space: the trade turnover between the countries increases, as well as the inflow of investment and labor.The study is aimed at identifying the effect of integration processes on the development of two cross – border areas-Altai territory (Russian Federation) and East Kazakhstan region (Republic of Kazakhstan). The analysis showed, that the mutual trade turnover has increased between the countries and these territories; there is a good foundation for the development of cooperation in production. However, other indicators of socio-economic development have a negative trend. The outflow of population from these territories continues. The territories do not attract a significant amount of investment.The measures to increase the attractiveness of the Altai territory and East Kazakhstan region within the Eurasian Economic Union have been offered: strengthening production ties through the creation of industrial clusters; the inclusion of territories in the implementation of the project “economic belt of the silk road”; the use of the natural potential of the territories for the creation and development of joint tourist destinations. The measures proposed in the article will strengthen cooperation between cross-border territories, create favorable conditions for increasing the integration effect in these territories, developing infrastructure and cooperating in the main sectors of the border countries, strengthening financial ties and attracting investment.


Lex Russica ◽  
2021 ◽  
pp. 138-153
Author(s):  
A. O. Chetverikov

The paper examines the little-known pages of the legal regulation of international integration in Europe: the project of the creation in the middle of the 20th century of the European Health Community (EHC) and its relationship to the current project for the establishment of the European Health Union. The introduction examines the reasons for the ineffective response of the modern European Union (EU) to the global coronavirus pandemic, mainly due to the lack of European institutions, in contrast to the economy and a number of other spheres of public life, supranational powers in the field of health.The first section analyzes the main provisions of the draft EHC presented by the French Government in 1952 and became the subject of an international "preparatory conference" with the participation of 16 European countries at the end of the same year. The author gives special attention to the legal consolidation in the EHC draft founding treaty of "sanitary activities" (prevention and counteraction of various types of diseases); "cultural provisions" dedicated to the collection of information, the development of scientific research and education in the field of health; provisions on the creation of a common therapeutic and research infrastructure of the EHC; the political and legal nature of the EHC as a supranational organization with restrictions in its favor of the sovereign rights of the participating states.The second section describes and evaluates the domestic, foreign, and economic factors that prevented the creation of the EHC.The final section examines the impact of the EHC on the law-making and law-enforcement activities of the modern EU, and compares the legal model of the EHC with the model of the European Health Union, which was established in the end of 2020. There are also proposals for using the experience of European integration in the field of healthcare for the development of integration processes in a similar field between Russia and other former Soviet republics, including the creation of common medical and research centers under the auspices of the Union State of Russia and Belarus and (or) the Eurasian Economic Union, equipped with mega-science facilities (synchrotrons, etc.), other advanced infrastructure of scientific theoretical and scientific applied nature.


Author(s):  
Lex Mcdonald

For special education in New Zealand, 1994 was a year in limbo as educators, parents and students awaited the Government’s policy statement and intentions. The issues of funding and contestability of service remained central to the proposed reorganisation with considerable apprehension expressed at the direction of change. It was indicated that teachers were needing and seeking professional development in the area of special education and a number of exemplary inservice training programmes were being offered. Many special educators believe that additional training and assistance should be provided to deal with the problem of our disaffected youth but Government policy has precluded adequate interventions in this area. Research studies and projects in 1994 reflected the wide nature of the ongoing issues and concerns in special education.


2014 ◽  
Author(s):  
Margaret Sampson ◽  
Marnie Potter ◽  
Heather Bragg ◽  
Corrine Langill

Introduction: Pediatric specialty hospitals may be experiencing increases in the number of lesbian, gay, bisexual transgender and queer (LGBTQ) patients and parents seen. There is no published information on the attitudes, beliefs and information needs of the broad range of staff and physicians that provide care in a hospital context, although recent surveys have considered individual professional groups. We undertook such a hospital-wide survey to assess the climate and information needs of care providers. Methods: A web-based survey was opened to all staff and physicians at a tertiary care pediatric hospital in Ottawa, Canada in June 2013. Results: 315 completed surveys were analyzed. Most respondents identified as heterosexual and none identified as transgender. Approximately half were directly involved in patient care. Approximately 90% were fully comfortable around LGBTQ patients and coworkers and most felt the hospital provided fair and equitable care for all. LGBTQ-identified respondents were somewhat less positive about the climate than heterosexual respondents, and front line staff less positive than managers. Many respondents identified knowledge deficits and were receptive to additional training. Conclusions: In the context of a socially and legally liberal jurisdiction, most pediatric hospital staff are accepting of LGBTQ clientele and co-workers while some identify areas where knowledge and skill could be improved and are willing to undergo additional training in working with LGBTQ clientele. Survey results can inform policy and procedural changes as well as training initiatives.


2020 ◽  
Vol 210 ◽  
pp. 13025
Author(s):  
Anastasiуa Vorona ◽  
Lyudmila Kopteva ◽  
Anna Trushevskaya

Currently the Eurasian Economic Union defines its main tasks as the creation of an image of the significant center for the development of international trade, enhancement of mutually beneficial partnership with member states and other countries, the creation of new formats for international cooperation. At the present days the Eurasian Economic Union is filled with real economic content. Multilateral projects are being implemented, primarily in key sectors of the economy, that are energy and transport. In the long run, the formation of a monetary union is possible. Development of currency integration, as a component of economic unity, presupposes the process of implementing a coordinated policy of the EAEU countries, as well as the creation and functioning of the organizations performing interstate currency regulation. In the article the dynamics of the main economic indicators of the Eurasian Economic Union functioning is considered. The data on the trade turnover of the EAEU member countries for 2019 is provided. The main directions of EAEU cooperation with third countries and integration associations are revealed, with particular attention being paid to the creation of free trade zones with Vietnam and Singapore. In the context of the organization and functioning of interstate unions, each of the member states of such unions, while ensuring their own security, also needs to manage both the threats to the security of other partners that have an indirect adverse effect and the threats that directly impact the whole union. The directions of digital transformation of the economies of the Eurasian Economic Union member states are considered. The problematic aspects of its functioning are highlighted.


Author(s):  
Vicenta Verdugo Martí ◽  
Patricia Moraga Barrero

This paper describes the creation of Florida Universitaria CRAI’s Catálogo de la mujer. Florida is an educational cooperative set up in the region of Valencia in the 1970s, a time when many projects were launched in an attempt to change and modernize approaches to teaching. Since its inception, the values that have underpinned its work have been a management style based on democratic practices, secularism, the promotion of the Valencian language and coeducation, and the application of the Mondragón business model. These values have also shaped the creation of the bibliographical archives belonging to the CRAI-Bibilioteca and the rest of the cooperative’s libraries. Since the first professional training programmes in 1977-1978, the cooperative has adapted the courses on offer to the needs of its public (and also in line with its budget). Florida Universitària came into being in the early 1990s, as an associated centre attached to the Valencia’s two main universities (the University of Valencia and the Polytechnic University). Finally, the language centre was founded in 1994. La Florida is based in Catarroja, a town in the Horta Sud of Valencia, where secondary school studies, language teaching and university courses are taught at three different sites. These centres were created at different stages of the cooperative’s history, building on the original secondary school and expanding to cover the teaching needs of a group of villages located some way away from the city, and responding to the rising demands of the area’s industrial sector.


Author(s):  
E. A. Zubova ◽  
A. A. Izmailov ◽  
L. A. Tutov

The work is devoted to a review of the results of the 147rd meeting of the Dispute Club “Eco- nomic Policy Knots” of the Association of Russian Economic Think Tanks (hereinafter referred to as ARETT) on the topic " Problems and Prospects for the Development of the Eurasian Economic Un- ion". The purpose of the event was to discuss a number of issues related to the creation of the EAEU, integration processes within the union, as well as barriers to its development. The debaters were Igor V. Pilipenko, Director of the Institute for Competitiveness and Integration, and Evgeny Y. Vinokurov, Chief Economist of the Eurasian Fund for Stabilization and Development. The review presents the key ideas of the disputants, and also summarizes the main results of their answers to questions.


2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  

Purpose The goal was to study how entrepreneurship education and training programmes (EETPs) influence the development of entrepreneurial competencies and creation of business venture Design/methodology/approach The authors tested a series of hypotheses on the EETPs designed for the Sabor Entrepreneurship Programme (SEP), in northern Portugal. They used a detailed questionnaire. At the time of the research (2018), the SEP had had five editions across Sabor’s five municipalities. The main aim of the EETPs was to train participants to run their own companies. Findings The study showed that the entrepreneurship education and training programmes (EETP) developed in the Sabor Region in the north helped participants to develop entrepreneurial skills. Despite these positive results, the researchers were unable to prove statistically that the programme had a definite influence on the creation of companies. Too many other factors, such as financing, bureaucracy and access to information proved critical in the formation of new businesses. Originality/value The researchers were motivated to carry out their research because EETPs have been rapidly expanding throughout the world, but there is no consensus about their effectiveness, or about the best elements to include. To bridge the gaps, the authors examined the role of EETPs in the development of entrepreneurial skills and the creation of businesses.


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