The native language learning in the General education system of the Russian Federation

In view of the urgency of preserving linguistic diversity in the world, the authors consider the current state of native languages of the peoples of the Russian Federation in the system of General education. The relevance of the research is confirmed by the analysis of publications carried out in the work. There is a controversy in the country about whether native languages should be included in the main educational program and whether it should be mandatory to study them. The study revealed negative trends associated with a decrease in the interest of students and their parents in learning their native languages, a decrease in the number of classes and the number of students who master the main educational program in their native language, choose it as an independent subject for study. The paper presents proposals aimed at popularizing the study of native languages in the General education system, which is the basis for their preservation and development

Promising opportunities to improve polio vaccines

Polioviruses belong to Enterovirus C species and cause severe lesions of the nervous system. In the post-polio eradication era, the World Health Organisation recommends inactivated polio vaccines for effective long-term protection of the population. In order to meet the needs of global health, it is planned to increase the use of traditional and optimised inactivated polio vaccines and introduce new types of vaccines that are being developed based on the current understanding of RNA-containing viruses. The aim of the study was to analyse ways of improving vaccine preparations and to review promising areas for polio immunoprophylaxis development. The authors considered innovations across all stages of the technological process, aimed at obtaining optimised vaccines, as well as vaccine delivery systems. The article presents information on new vaccine strains and cell lines for vaccine production. The authors summarised the results of clinical studies of inactivated vaccines, new vaccines based on genetically stable vaccine strains of poliovirus, and vaccines containing virus-like particles. The most likely candidates for introduction are the vaccines based on virus-like particles obtained from genetically modified strains of poliovirus. At the moment, many issues related to current trends in improving the immunoprophylaxis of poliomyelitis are debatable and need to be addressed in the near future

Fluorescent Nanoagents for Biomedical Applications

Fluorescence imaging is a promising method widely used for the evaluation of the biodistribution and accumulation of various fluorescent agents cross-linked to the drug for effective therapy control. This work presents the methods for the functionalization of nanomaterials to provide them with fluorescent properties. The first of these methods is a unique technology for producing porous silicon with fluorescent properties. The second approach demonstrates linking of the fluorophores to inorganic nanoparticles (NP) using a spacer molecule ending with a functional group. For all these examples of fluorophores, biodistribution studies were performed with the fluorescent imaging system IVIS Lumina LT III (PerkinElmer, USA). It was noted that the size of particles and the method of their injection affect the distribution and accumulation in organs. The resulting materials can be used to develop platforms for theranostics

Emerging issues and current trends in assistive technology use 2007-1010: practising, assisting and enabling learning for all

Following an earlier review in 2007, a further review of the academic literature relating to the uses of assistive technology (AT) by children and young people was completed, covering the period 2007-2011. As in the earlier review, a tripartite taxonomy: technology uses to train or practise, technology uses to assist learning and technology uses to enable learning, was used in order to structure the findings. The key markers for research in this field and during these three years were user involvement, AT on mobile mainstream devices, the visibility of AT, technology for interaction and collaboration, new and developing interfaces and inclusive design principles. The paper concludes by locating these developments within the broader framework of the Digital Divide

Эпидемиология ротавирусной инфекции и тактика вакцинопрофилактики

Rotavirus infection is a widespread cause of severe gastroenteritis in children in low-income countries. Specific prophylaxis in young children has become the most important means of combating severe rotavirus gastroenteritis. The review presents current data on the molecular biology and genetic diversity of rotaviruses, interaction of viral proteins with host cell receptors, molecular aspects of infectivity and pathogenesis of rotavirus infection, and the development of immunity. It addresses a new approach to the epidemiology of rotavirus infection which regards it as a manageable infection, it illustrates the specificity of the epidemic process based on data gained from extensive experience in vaccination, and summarises relevant information on the introduction of rotavirus vaccines into the international healthcare practice. The paper summarises risks associated with the use of vaccines based on the analysis of WHO statistics, scientific publications on the epidemiology of rotavirus infection, and the results of vaccination. It analyses approaches of the competent authorities of some countries to the tactics of vaccination against rotavirus infection and the WHO stance on the use of existing vaccines for the prevention of rotavirus infection. A conclusion was made that it is necessary to further improve the tactics of vaccine prevention of rotavirus infection in Russia, to study the incidence of idiopathic intussusception, and to conduct further studies aimed at characterisation of existing and newly emerging genotypes of rotavirus.Ротавирусная инфекция повсеместно является причиной тяжелого гастроэнтерита, приводящего к смерти детей в странах с низким бюджетом. Специфическая профилактика среди детей младшего возраста стала важнейшим средством борьбы с тяжелой формой ротавирусного гастроэнтерита. В обзоре приведены актуальные данные о молекулярной биологии и генетическом разнообразии ротавирусов, взаимодействии вирусных белков с рецепторами клеток организма-хозяина, изучении молекулярных аспектов инфекционности и патогенеза ротавирусной инфекции и развитии иммунитета. Отражен новый подход к пониманию эпидемиологии ротавирусной инфекции как контролируемой инфекции, показаны особенности эпидемического процесса с учетом многолетнего опыта вакцинопрофилактики, обобщена актуальная информация о внедрении в практику здравоохранения вакцин против ротавирусной инфекции в мире. Уделено внимание рискам применения вакцин на основе анализа статистических материалов ВОЗ и научных публикаций об эпидемиологии ротавирусной инфекции и результатов применения вакцин. Рассмотрены подходы уполномоченных органов в области здравоохранения отдельных государств к тактике вакцинопрофилактики ротавирусной инфекции и позиция ВОЗ в отношении применения существующих вакцин для профилактики ротавирусной инфекции. Сделан вывод о необходимости дальнейшего совершенствования тактики вакцинопрофилактики ротавирусной инфекции в России, изучения уровня идиопатической инвагинации, проведения дальнейших исследований по характеристике существующих и вновь появляющихся генотипов ротавирусов

Перспективные направления в совершенствовании вакцин для профилактики полиомиелита

Polioviruses belong to Enterovirus C species and cause severe lesions of the nervous system. In the post-polio eradication era, the World Health Organisation recommends inactivated polio vaccines for effective long-term protection of the population. In order to meet the needs of global health, it is planned to increase the use of traditional and optimised inactivated polio vaccines and introduce new types of vaccines that are being developed based on the current understanding of RNA-containing viruses. The aim of the study was to analyse ways of improving vaccine preparations and to review promising areas for polio immunoprophylaxis development. The authors considered innovations across all stages of the technological process, aimed at obtaining optimised vaccines, as well as vaccine delivery systems. The article presents information on new vaccine strains and cell lines for vaccine production. The authors summarised the results of clinical studies of inactivated vaccines, new vaccines based on genetically stable vaccine strains of poliovirus, and vaccines containing virus-like particles. The most likely candidates for introduction are the vaccines based on virus-like particles obtained from genetically modified strains of poliovirus. At the moment, many issues related to current trends in improving the immunoprophylaxis of poliomyelitis are debatable and need to be addressed in the near future.Полиовирусы, принадлежащие к энтеровирусам группы С, являются причиной тяжелых поражений нервной системы. В эпоху после ликвидации полиомиелита Всемирная организация здравоохранения рекомендует для длительной эффективной защиты населения инактивированные вакцины против полиомиелита. Для обеспечения потребностей глобального здравоохранения предполагается увеличить применение традиционных и оптимизированных инактивированных вакцин против полиомиелита, а также внедрить вакцины нового типа, которые разрабатываются на основе современных представлений о РНК-содержащих вирусах. Цель работы — анализ аспектов усовершенствования вакцинных препаратов и обзор перспективных направлений развития иммунопрофилактики полиомиелита. Рассмотрены инновационные разработки на всех этапах технологического процесса, выполненные с целью получения оптимизированных вакцин, а также системы доставки вакцин. Представлена информация о новых вакцинных штаммах и клеточных линиях для производства вакцины. Обобщены результаты клинических исследований инактивированных вакцин, новых вакцин на основе генетически стабильных вакцинных штаммов вируса полиомиелита и вакцин, содержащих вирусоподобные частицы. Наиболее вероятно внедрение вакцин на основе вирусоподобных частиц генетически модифицированных штаммов вируса полиомиелита. В настоящее время многие вопросы, касающиеся актуальных направлений совершенствования иммунопрофилактики полиомиелита, являются дискуссионными и требуют решения в ближайшем будущем

Внесение изменений в документы регистрационных досье на вакцины: анализ нормативно-методических подходов в Российской Федерации и за рубежом

The management of post-approval changes to registration dossiers for medicinal products is one of the most important factors for ensuring sustainable quality, safety and efficacy of medicines. Competent authorities that use the module format of the registration dossier, i.e. the regulatory authorities of the European Union, USA and other members of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and the Eurasian Economic Union (EEU), issue guidelines on changes to registration dossiers for pharmaceuticals and biologicals (immunological products). Vaccines (finished dosage forms) and vaccine antigens (active ingredients) are a specific group of immunobiological products which have great prophylactic importance for healthcare, and which are associated with challenging development and specific methods of manufacturing and quality control. The procedure of introducing post-approval variations to dossiers for immunobiological medicinal products is poorly reflected in the current Russian and EEU regulations. The World Health Organization (WHO) established a procedure described in the «Guidelines on procedures and data requirements for changes to approved vaccines». The purpose of the present study was to compare current Russian and international legislation in terms of regulatory requirements for post-approval сhanges to dossiers for immunobiological products. The Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation is drafting Guideline on introducing post-approval changes into dossiers for immunobiological medicines. The draft includes a detailed review of various categories of changes based on their importance, and a list of conditions and required documents for specific groups of medicines. This article summarises scientific and methodological approaches to evaluation of changes introduced in registration dossiers for vaccines in order to further improve the regulatory framework of the Russian Federation and the EEU.Регулирование процесса внесения изменений в документы регистрационного  досье является одним из важных факторов обеспечения стабильности качества, безопасности и эффективности лекарственных препаратов. Уполномоченные органы государств, поддерживающих модульный формат регистрационного досье: Европейского Союза, США, других стран-участниц Международного совета по гармонизации технических требований к лекарственным средствам для медицинского применения и Евразийского экономического союза (ЕАЭС), издают руководящие документы о внесении изменений в документы регистрационных досье на химико-фармацевтические и биологические (иммунологические) лекарственные средства. Вакцины (готовые формы) и вакцинные антигены (действующие вещества) представляют собой особую группу иммунобиологических лекарственных средств, характеризующихся высокой профилактической значимостью для здравоохранения, сложностью разработки, особыми методами производства и контроля. Порядок внесения изменений в документы регистрационного досье на иммунобиологическое лекарственное средство недостаточно отражен в действующих нормативно-правовых документах Российской Федерации и ЕАЭС. Всемирная организация здравоохранения рекомендует процедуру, описанную в документе «Руководство по процедурам и требованиям к данным, связанным с внесением изменений в зарегистрированные вакцины». Цель работы – проведение сравнительного анализа действующих отечественных и международных нормативно-методических документов в части регуляторных требований к процедуре внесения изменений в регистрационные досье зарегистрированных иммунобиологических лекарственных препаратов. В ФГБУ «НЦЭСМП» Минздрава России разрабатывается Проект методических рекомендаций по внесению изменений в регистрационные досье на зарегистрированные иммунобиологические препараты, который включает в себя детальное рассмотрение категорий значимости вносимых изменений, содержит условия и перечень необходимых документов для данной группы препаратов. В статье обобщены научно-методические подходы к экспертизе изменений, вносимых в регистрационное досье вакцины с целью дальнейшего совершенствования нормативно-правовой базы Российской Федерации и ЕАЭС

Alternative Visualization of Textual Information for People with Sensory Impairment

Assistive technology has been developed to provide access to information sources for people with sensory impairment. Disabled people can benefit from the use of existing alternative methods and techniques with some producing output with fairly high accuracy. Nevertheless, the problem of synthesizing a suitable method for proper information imaging to the sensory impaired user still remains unsolved. For this reason, assistive techniques undergo continuous experimentation and usability research in order to resolve this issue. The summary of the dissertation provides an analytical survey of the currently existing assistive methods and techniques for imaging textual information that employ the residual senses of the impaired user. The problematic aspects affecting the use of computer help for people having ocular pathology and hearing disorders were the particular subject of this study. These issues have to be taken into account by the developers of advanced assistive user interfaces. Eight internationally published studies represent the main scientific contribution of the dissertation. They illustrate how novel assistive techniques could be introduced and exploited by people with sensory impairment. Four ways to display textual information for people with a sensory impairment were investigated. They are: 1. Dynamic imaging of the symbolic information (electromagnetic textured element); 2. Color blinking alphabet and low cost peripheral monitor to deliver textual information to the visually impaired persons and music notation to the visually impaired musicians; 3. Hearing communication aid based on pseudo-graphic typeface; 4. A set of vibro-tactile composite patterns which can further be employed to assign alphabet characters, words, abbreviations or symbols to convey textual or symbolic information to the deaf or hearing impaired people. Two prototypes of the wearable assistive devices for the visually impaired people and several software tools for visually impaired and hearing impaired people were designed to examine which of the assistive methods and techniques developed could be introduced to compensate for the sensory deficit. Series of extensive empirical and usability studies were performed to evaluate the strength, usefulness and appropriateness of implemented assistive aids. The basic concepts, interaction techniques implemented and the practical consequences of the empirical studies were discussed as well as some improvements that were or could be applied to the techniques presented. The following applications may result based on this research: 1. New assistive aids and games for sensory impaired people intended for the use in mobile wearable systems, and 2. Multimodal educational software tools for sensory impaired people.The summary of the dissertation provides an analytical survey of the currently existing assistive methods and techniques for imaging textual information that employ the residual senses of the impaired user. The problematic aspects affecting the use of computer help for people having ocular pathology and hearing disorders were the particular subject of this study. These issues have to be taken into account by the developers of advanced assistive user interfaces. Eight internationally published studies represent the main scientific contribution of the dissertation. They illustrate how novel assistive techniques could be introduced and exploited by people with sensory impairment. Four ways to display textual information for people with a sensory impairment were investigated. They are: 1. Dynamic imaging of the symbolic information (electromagnetic textured element); 2. Color blinking alphabet and low cost peripheral monitor to deliver textual information to the visually impaired persons and music notation to the visually impaired musicians; 3. Hearing communication aid based on pseudo-graphic typeface; 4. A set of vibro-tactile composite patterns which can further be employed to assign alphabet characters, words, abbreviations or symbols to convey textual or symbolic information to the deaf or hearing impaired people. Two prototypes of the wearable assistive devices for the visually impaired people and several software tools for visually impaired and hearing impaired people were designed to examine which of the assistive methods and techniques developed could be introduced to compensate for the sensory deficit. Series of extensive empirical and usability studies were performed to evaluate the strength, usefulness and appropriateness of implemented assistive aids. The basic concepts, interaction techniques implemented and the practical consequences of the empirical studies were discussed as well as some improvements that were or could be applied to the techniques presented. The following applications may result based on this research: 1. New assistive aids and games for sensory impaired people intended for the use in mobile wearable systems, and 2. Multimodal educational software tools for sensory impaired people