scholarly journals Recommendations for the Contents of the “Peptide Mapping” Part of a Product Specification File

2021 ◽  
Vol 11 (4) ◽  
pp. 276-277
Author(s):  
O. A. Vaganova
Keyword(s):  
Monoclonal Antibodies ◽  
Peptide Mapping ◽  
Test Procedure ◽  
Federal State ◽  
Expert Evaluation ◽  
Medicinal Products ◽  
Additional Information ◽  
Batch Release ◽  
The Russian Federation ◽  
Product Specification

‘Identification. Peptide mapping’ is a necessary part of manufacturers’ product specification files for therapeutic proteins (active ingredients and final products of monoclonal antibodies, filgrastims, erythropoietins). The expert of the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation provides recommendations for a step-by-step presentation of the test procedure, which will allow applicants to align product specification files for Russian- and foreign-produced medicinal products, help experts to minimise or eliminate the need to request additional information from applicants, and will contribute to timely batch release of medicinal products.

scholarly journals Recommendations for the Contents of the “Glycan Profile” Part of a Product Specification File

2021 ◽  
Vol 11 (4) ◽  
pp. 273-275
Author(s):  
O. A. Vaganova
Keyword(s):  
Test Procedure ◽  
Federal State ◽  
Expert Evaluation ◽  
Medicinal Products ◽  
Active Ingredients ◽  
Glycan Profile ◽  
Additional Information ◽  
Batch Release ◽  
The Russian Federation ◽  
Product Specification

“Glycan Profile” is a necessary part of manufacturers’ product specification files for monoclonal antibody active ingredients or final products and erythropoietin active ingredients. The expert of the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation provides recommendations for a step-by-step presentation of the test procedure, which will allow applicants to align product specification files for Russian- and foreign-produced medicinal products, help experts to minimise or eliminate the need to request additional information from applicants, and will contribute to timely batch release of medicinal products.

scholarly journals Safety of Remdesivir and Tocilizumab in COVID-19 Treatment

2020 ◽  
Vol 8 (3) ◽  
pp. 160-162
Author(s):  
Article Editorial
Keyword(s):  
Adverse Reactions ◽  
Safety Data ◽  
Individual Case ◽  
Federal State ◽  
Symptomatic Therapy ◽  
Medicinal Products ◽  
Treatment Protocols ◽  
Global Database ◽  
Life Threatening ◽  
The Russian Federation

An important part of treating patients infected with SARS-CoV-2 is to ensure effective pathogenetic and symptomatic therapy before life-threatening complications, such as pneumonia, acute respiratory distress syndrome, or sepsis begin to develop. Current COVID-19 treatment protocols often use remdesivir and tocilizumab, though safety data on these drugs are insufficient. Therefore, experts of the Centre for Evaluation of Medicinal Products’ Safety of the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation studied adverse reactions to remdesivir and tocilizumab, which are registered in the VigiBase (as of August 27, 2020), the global database of individual case safety reports.

Evaluating the efficiency of the environmental security policy in the Russian regions

2020 ◽  
Vol 19 (4) ◽  
pp. 633-649
Author(s):  
G.T. Shkiperova ◽  
P.V. Druzhinin
Keyword(s):  
Environmental Policy ◽  
Russian Federation ◽  
Security Policy ◽  
Quantitative Methods ◽  
Federal District ◽  
Environmental Security ◽  
Environmental Indicators ◽  
Federal State ◽  
Environmental Situation ◽  
The Russian Federation

Subject. Considering the existing environmental situation, it becomes especially important for the State to regulate the anthropogenic footprint on the environment in the Russian Federation. Current amendments to the legislative framework for environmental security are intended to ensure the innovative development of regions concurrently with a reduction in adverse environmental effects and more active environmental policy. Objectives. The research is to devise methodological tools to evaluate the efficiency of environmental policy in regions. Methods. The research employs qualitative and quantitative methods of economic analysis, including statistical and content analysis, rating, matrix zoning. The dataset proceeds from the Federal State Statistics Service, governmental reports on the current environmental situation and environmental protection in the Russian Federation. Results. We propose our own approach to evaluating the efficiency of environmental policy. It may help trace the correlation between the quality of strategic documents and changes in environmental indicators for a certain period, flag the challenging areas in terms of the environmental policy implementation and outline possible development paths. The approach extends the list of quantification indicators in line with those ones adopted internationally and presented in the Environmental Security Strategy of the Russian Federation up to 2025. We evaluated the efficiency of the environmental policy referring to the regions of the Northwestern Federal District for the period from 2012–2016. Conclusions. Having analyzed the evaluation results, most of the Northwestern regions tend to be controversial and ambivalent in setting environmental goals and achieving them. The findings may prove useful as the analytical and data basis for articulating the environmental and economic policy of the regions.

THE PRINCIPLES AND ACTIVITIES OF THE NATIONAL SCIENTIFIC DEVELOPMENT STRATEGY IN THE ARCTIC ZONE OF THE RUSSIAN FEDERATION

2017 ◽  
Author(s):  
Mikhail Bubynin ◽  
Mikhail Bubynin ◽  
Valery Abramov ◽  
Valery Abramov ◽  
Gennady Zabolotnikov ◽  
...  
Keyword(s):  
Development Strategy ◽  
Russian Federation ◽  
National Policy ◽  
Scientific Research ◽  
Point Of View ◽  
The Arctic ◽  
Scientific Development ◽  
Federal State ◽  
Arctic Zone ◽  
The Russian Federation

The paper considers the priorities of the state policy of the Russian Federation in the Arctic, from the point of view of the development of scientific research, identified by the main strategic documents of national policy and security in the Arctic zone of the Russian Federation. Measures for implementation of priorities in the development of scientific research in the Arctic can be divided into three main sections: 1. Scientific projects and expeditions in the Arctic; 2. International activities; 3. Coordination and implementation of integrated research in the Arctic. Note that currently the Ministry of education and science of the Russian Federation develops the Analytical Coordination Program “Comprehensive research of the Arctic and Antarctic”, in cooperation with the federal state bodies and Governance of the Subjects of the Arctic zone of the Russian Federation. The mechanism of the Program will ensure coordination between state bodies for integrated scientific researches in the Arctic in the interests of economic and scientific development of the region, and the creation of the scientific, technical and technological reserve in order to ensure of national security in the Arctic zone of the Russian Federation.

Features of The Proceedings on Administrative Offenses Initiated for Violation of Fire Safety Requirements

2019 ◽  
pp. 100-104
Author(s):  
A. K. Sabirova
Keyword(s):  
Russian Federation ◽  
Fire Safety ◽  
Federal State ◽  
Safety Requirements ◽  
Administrative Legislation ◽  
Administrative Punishment ◽  
The Russian Federation ◽  
Administrative Proceedings ◽  
Made In

The article is devoted to the analysis of the features of administrative proceedings instituted for violations of fire safety requirements, including important changes made in the relevant area of the administrative legislation of the Russian Federation, as well as the analysis of the legislative possibility of applying administrative punishment in the form of administrative suspension of activities for non-compliance with the requirements of the federal state firefighters oversight (including named changes).

Science. Technology. Innovation

2018 ◽  
Author(s):  
Natalia Gorodnikova ◽  
Leonid Gokhberg ◽  
Kirill Ditkovskiy ◽  
Irina Kuznetsova ◽  
Evgeniya Lukinova ◽  
...  
Keyword(s):  
Intellectual Property ◽  
International Comparisons ◽  
Federal State ◽  
Output Data ◽  
Innovation Potential ◽  
Science Technology ◽  
Foreign Countries ◽  
Statistical Studies ◽  
Data Book ◽  
The Russian Federation

The pocket data book contains main indicators characterizing S&T and innovation potential of the Russian Federation. There are the information about intellectual property, S&T output, data of international comparisons given. The data book includes information of the Federal State Statistics Service, Federal Service for Intellectual Property, Organisation for Economic Co-operation and Development (OECD), Eurostat, UNESCO, World Intellectual Property Organisation, national statistical services of foreign countries, and results of own methodological and analytical studies of the HSE Institute for Statistical Studies and Economics of Knowledge. In some cases, the presented data specify those published earlier.

Risk-oriented Model of the Organization and Implementation of the Federal State Energy Supervision

2021 ◽  
pp. 76-81
Author(s):  
F.V. Matveenkov ◽  
◽  
D.A. Tolstova ◽  
O.V. Masharova ◽  
O.V. Sachkova ◽  
...  
Keyword(s):  
Russian Federation ◽  
State Energy ◽  
Federal State ◽  
Economic Damage ◽  
Risk Category ◽  
State Control ◽  
Federal Law ◽  
Emergency Situations ◽  
Vital Functions ◽  
The Russian Federation

Risk-oriented approach in the implementation of control (supervision) activities is an important state task that affects the country economy. As part of the implementation of the priority area of reforming control and supervision activities, the Federal Law «On the state control (supervision) and municipal control in the Russian Federation» was adopted, which comes into force on July 1, 2021. In order to implement the Federal Law «On state control (supervision) and municipal control in the Russian Federation», it is advisable to revise the regulation on the federal state energy supervision. It is required to study the issue of taking into account the risks of causing harm (damage) to legally protected values when carrying out control (supervision) activities in relation to the subjects (objects) of the energy sector, as well as criteria for assigning it to the risk category and indicators of the risk of mandatory requirements violation. Currently, the only criterion for assigning the harm (damage) to the risk category is the dependence on the established and (or) transmitted capacity of the energy facilities used, which is nonobjective due to the changes in the normative-regulatory framework for the implementation of control and supervision activities. It is required to study the issue of categorization depending on the established (transmitted) capacity of the object, the amount of economic damage as a result of the implementation of emergency situations and (or) emergency incidents (in value terms), the number of people killed (irretrievable losses), the number of people whose vital functions were disrupted as a result of the implementation of emergency situations and (or) emergency incidents.

Analysis of the hop production and processing market in the Russian food security system

2021 ◽  
pp. 95-101
Author(s):  
О.В. Чеха
Keyword(s):  
Food Security ◽  
Russian Federation ◽  
Security System ◽  
Annual Reports ◽  
Federal State ◽  
State Program ◽  
Internet Portal ◽  
Chuvash Republic ◽  
The Russian Federation ◽  
Comprehensive Study

В статье представлены результаты комплексного исследования на рынке производства и переработки хмеля. Проанализированы отчеты фирмы «Барт» и годовые отчеты International Hop Growers’ Convention в период 2007-2020 гг. Приведены и систематизированы данные Федеральной службы государственной статистики Российской Федерации, по Чувашской Республике и официального интернет-портала органов власти Чувашской Республики по формированию внутреннего рынка хмеля. Предложены меры регионального регулирования отрасли, которые согласованы с утверждённой Концепцией развития хмелеводства в Чувашской Республике на 2020-2025 гг. в рамках государственной программы. The article presents the results of a comprehensive study on the market of hop production and processing. The reports of the company «Bart» and the annual reports of International Hop Growers'are analyzed Convention in the period 2007-2020. The data of the Federal State Statistics Service of the Russian Federation on the Chuvash Republic and the official Internet portal of the authorities of the Chuvash Republic on the formation of the domestic hop market are presented and systematized. The measures of regional regulation of the industry are proposed, which are coordinated with the approved Concept of hop growing development in the Chuvash Republic for 2020-2025 within the framework of the state program.

Sign in / Sign up

Export Citation Format

Share Document