Electronic Submission of New Drugs in Europe

2011 ◽  
pp. 255-261
Author(s):  
A. Susanne Eslinger ◽  
Daniela Marschall
Keyword(s):  
Pharmaceutical Industry ◽  
International Standards ◽  
New Drugs ◽  
Process Time ◽  
Economic Perspective ◽  
Electronic Submission ◽  
Electronic Form ◽  
The World ◽  
Time Savings ◽  
Admission Office

All over the world, drugs and drug applications have to be submitted to and approved by an admission office before they may be sold on the market. All procedures are extensive, time-consuming, and costly. To simplify the process, it could be organised electronically. In an economic perspective, there are many benefits by using the electronic form for the pharmaceutical industry: managing knowledge, cost advantages, and time savings. All, pharmaceutical industry and institutions have undertaken lots of efforts to enforce the electronic solutions. They focus on international standards in order to harmonise structures and processes. It would be necessary to reduce paper and copies, especially if the electronic solution takes place. This method will simplify the way to deal with data and documents and reduce process time and costs.

scholarly journals PROTECTION OF INTELLECTUAL PROPERTY IN PHARMACEUTICAL INDUSTRY

2010 ◽  
Vol 2 (4) ◽  
pp. 62-64
Author(s):  
Vitalija Česiulytė ◽  
Eligijus Toločka ◽  
Rolandas Strazdas
Keyword(s):  
Intellectual Property ◽  
Pharmaceutical Industry ◽  
New Drugs ◽  
High Demand ◽  
Disease Treatment ◽  
Treatment And Prevention ◽  
The World ◽  
Different Types ◽  
Substantial Investment

The development of pharmaceutical and biotechnology industries indicates that people around the world use different types of drugs for disease treatment and prevention. In the case of high demand for medicines, great attention to pharmacy industry is paid. Since the drugs are directly linked to human health and life, the state pays special attention to the safety of medicines and the quality of eligibility. Therefore, the companies wishing to become a part of this area are to obtain and then keep the license. The protection of intellectual property allows companies to use substantial investment in new drugs and treatment methods and to conduct research in the future. This is a particular concern for originator companies. Undefended patents also inhibit the creativity of local people as local innovators know that their products can be immediately copied, thus discouraging investment in new investigation.

Non-observed Economy in the CIS Countries

2009 ◽  
pp. 86-95
Author(s):  
Yu. Ivanov
Keyword(s):  
International Standards ◽  
General Level ◽  
National Accounts ◽  
System Of National Accounts ◽  
The World ◽  
Cis Countries ◽  
Key Indicators

The article contains a review of underlying concepts and definitions of non-observed economy which are formulated in the international standards on this topic and used by the CIS countries for computation of GDP and other key indicators of the System of National Accounts. The article considers the methods used for measuring non-observed economy and some figures on the share of non-observed economy in GDP of the CIS countries and other selected countries of the world. Perfection of methods of measuring non-observed economy and raising reliability of its estimates requires improvement of general level of work on compilation of national accounts.

TO THE QUESTION OF RESPONSIBILITY FOR TORTURE IN THE RUSSIAN FEDERATION

2020 ◽  
Vol 10 (2) ◽  
pp. 103-106
Author(s):  
ASTEMIR ZHURTOV ◽  
Keyword(s):  
Human Rights ◽  
Russian Federation ◽  
Large Scale ◽  
Human Life ◽  
International Standards ◽  
World Community ◽  
The World ◽  
Long Time ◽  
Protection Of Human Rights ◽  
The Russian Federation

Cruel and inhumane acts that harm human life and health, as well as humiliate the dignity, are prohibited in most countries of the world, and Russia is no exception in this issue. The article presents an analysis of the institution of responsibility for torture in the Russian Federation. The author comes to the conclusion that the current criminal law of Russia superficially and fragmentally regulates liability for torture, in connection with which the author formulated the proposals to define such act as an independent crime. In the frame of modern globalization, the world community pays special attention to the protection of human rights, in connection with which large-scale international standards have been created a long time ago. The Universal Declaration of Human Rights and other international acts enshrine prohibitions of cruel and inhumane acts that harm human life and health, as well as degrade the dignity.Considering the historical experience of the past, these standards focus on the prohibition of any kind of torture, regardless of the purpose of their implementation.

State Marketing as a Factor in the Strengthening of Macroeconomic Indicators

2015 ◽  
Author(s):  
Anara Kamalova
Keyword(s):  
Foreign Trade ◽  
Public Services ◽  
International Standards ◽  
Effective Control ◽  
Kyrgyz Republic ◽  
Quality And Safety ◽  
External Market ◽  
The World ◽  
Macroeconomic Indicators ◽  
Internal Potential

This article deals with the state of marketing and its role in strengthening macroeconomic indicators of the Kyrgyz Republic, but it does not apply in the country properly. The need for the use of state marketing is intensifying with the entering of Kyrgyzstan to EEU as a member. To improve the structure of foreign trade, it is proposed marketing initiatives and research on the study of the external market, the internal potential of the country, specialization of production, the creation of "umbrella brand" for the country, the best way of satisfying consumers of public services, effective control of the quality and safety of products, regulation of the relevant parameters, that meet international standards, the fight against counterfeit, creating a positive image of Kyrgyzstan in the world and others.

scholarly journals Assessing the impact of libraries – the role of ISO 16439

2018 ◽  
Vol 119 (1/2) ◽  
pp. 87-93 ◽  
Author(s):  
Claire Creaser
Keyword(s):  
Design Methodology ◽  
International Standards ◽  
Content Type ◽  
International Standard ◽  
The World ◽  
The Difference ◽  
Library Impact ◽  
The Impact

Purpose Library impact and how to evaluate it has been debated for a number of years. While the activity – the busy-ness – of the library is now routinely measured and described, the difference the library makes is less tangible and harder to measure. Libraries in all sectors and worldwide are grappling with this issue, and the purpose of this paper is to summarise international standards available to support them. Design/methodology/approach The first international standard concerning library impact, ISO 16439 Information and documentation – methods and procedures for assessing the impact of libraries, was published in 2014 after several years in development. Findings The standard describes a range of methods for assessing library impact which have been used across the world in a variety of libraries in all sectors. Originality/value This paper summarises the key methods described in the standard, and gives references for further reading.

scholarly journals Monoterpenes and Sesquiterpenes of Essential Oils from Psidium Species and Their Biological Properties

Molecules ◽  
2021 ◽  
Vol 26 (4) ◽  
pp. 965
Author(s):  
Renan Campos e Silva ◽  
Jamile S. da Costa ◽  
Raphael O. de Figueiredo ◽  
William N. Setzer ◽  
Joyce Kelly R. da Silva ◽  
...  
Keyword(s):  
Essential Oils ◽  
Biological Activities ◽  
Biological Properties ◽  
Chemical Diversity ◽  
New Drugs ◽  
Natural Sources ◽  
Biological Potential ◽  
The World ◽  
Review Reports ◽  
Collection Sites

Psidium (Myrtaceae) comprises approximately 266 species, distributed in tropical and subtropical regions of the world. Psidium taxa have great ecological, economic, and medicinal relevance due to their essential oils’ chemical diversity and biological potential. This review reports 18 Psidium species growing around the world and the chemical and biological properties of their essential oils. Chemically, 110 oil records are reported with significant variability of volatile constituents, according to their seasonality and collection sites. Monoterpenes and sesquiterpenes with acyclic (C10 and C15), p-menthane, pinane, bisabolane, germacrane, caryophyllane, cadinane, and aromadendrane skeleton-types, were the primary constituents. The essential oils showed various biological activities, including antioxidant, antifungal, antibacterial, phytotoxic, larvicidal, anti-inflammatory, and cytotoxic properties. This review contributes to the Psidium species rational and economic exploration as natural sources to produce new drugs.

scholarly journals Designed to deter: Barriers to facilities at secondary schools in Ghana

2012 ◽  
Vol 1 (1) ◽  
Author(s):  
Anthony K. Danso ◽  
Frances E. Owusu-Ansah ◽  
Divine Alorwu
Keyword(s):  
Built Environment ◽  
Secondary Schools ◽  
Students With Disabilities ◽  
Present Situation ◽  
International Standards ◽  
The World ◽  
Research Outcome ◽  
Building Standards ◽  
Urgent Action ◽  
Building Elements

Background: There are varied and complex problems associated with the admission of students with disabilities into secondary (senior high) schools all over the world. This situation is further complicated by difficulties encountered in the built environment of these institutions and, in this, Ghana is no exception. Objectives: This exploratory study investigated the level of accessibility of the built environment in secondary schools in eight out of the ten regions of Ghana, in order to determine whether they conform to guidelines provided in international building standards and also assess the extent to which they have been designed and constructed to meet the provisions of the Persons with Disability Act 2006, which allows for equal access to public buildings in Ghana.Method: In total, 705 building elements in 264 facilities were surveyed using international standards, building codes, regulations and guidelines. These facilities included car parks, classrooms, dormitories, assembly halls, telephone booths and administration blocks.Results: Our findings revealed that most of the building elements were barring and not disability-friendly. Just to name a few: there were obstructions on access routes to and around buildings, absence of designated car parks, unfriendly vertical and horizontal means of circulation in buildings and lack of accessible sanitary accommodations. In addition, the general lighting and signage were poor. As a result, very few students with disabilities are admitted and retained in these schools.Conclusion: Mainstreaming of people with disabilities into the Ghanaian educational system remains impossible unless urgent action is taken to alter the facilities at secondary schools. Based on this research outcome, recommendations have been made to the Ghanaian government and the Ghana Education Service, as well as non-governmental organisations and relevant professional bodies for the amelioration of the present situation in our secondary schools.

scholarly journals Bright Side of Fusarium oxysporum: Secondary Metabolites Bioactivities and Industrial Relevance in Biotechnology and Nanotechnology

2021 ◽  
Vol 7 (11) ◽  
pp. 943
Author(s):  
Sabrin R. M. Ibrahim ◽  
Alaa Sirwi ◽  
Basma G. Eid ◽  
Shaimaa G. A. Mohamed ◽  
Gamal A. Mohamed
Keyword(s):  
Fusarium Oxysporum ◽  
Cyclic Peptides ◽  
Pathogenic Fungi ◽  
New Drugs ◽  
Biotechnological Applications ◽  
The World ◽  
Different Types ◽  
Bright Side ◽  
Reported Data ◽  
Industrial Relevance

Fungi have been assured to be one of the wealthiest pools of bio-metabolites with remarkable potential for discovering new drugs. The pathogenic fungi, Fusarium oxysporum affects many valuable trees and crops all over the world, producing wilt. This fungus is a source of different enzymes that have variable industrial and biotechnological applications. Additionally, it is widely employed for the synthesis of different types of metal nanoparticles with various biotechnological, pharmaceutical, industrial, and medicinal applications. Moreover, it possesses a mysterious capacity to produce a wide array of metabolites with a broad spectrum of bioactivities such as alkaloids, jasmonates, anthranilates, cyclic peptides, cyclic depsipeptides, xanthones, quinones, and terpenoids. Therefore, this review will cover the previously reported data on F. oxysporum, especially its metabolites and their bioactivities, as well as industrial relevance in biotechnology and nanotechnology in the period from 1967 to 2021. In this work, 180 metabolites have been listed and 203 references have been cited.

scholarly journals 來自「東方」的聲音圖景：江文也作品的異國情調與民族追尋

2020 ◽  
Vol 36 (36) ◽  
pp. 081-106
Author(s):  
張琬琳 張琬琳
Keyword(s):  
Twentieth Century ◽  
Music Theory ◽  
Global Scale ◽  
Musical Instruments ◽  
International Standards ◽  
The Other ◽  
Western Music ◽  
Political Issue ◽  
The World ◽  
General Society

<p>二十世紀初，在國際間崛起的各國勢力，加速了各民族內部自我整頓與反省的動力，東方音樂家學習西方音樂，也試圖以西方音樂的樂制，來整建自我民族內部的音樂紋理。</p> <p>東方音樂家欲望著西方，希冀能登上國際音樂舞臺；西方樂壇也期待從東方音樂家那裡，聽見西方人能夠「聽得懂」的「東方聲音」。在東 / 西方彼此期待、渴望之間，音樂本身被賦予極大的感官寓意，對西方人而言，帶有異國情調的音樂，尤其能夠吸引他們的目光；對於東方音樂家而言，這些「東方」的元素，卻是取自於不同民族風土的獨特聲音。</p> <p>本文聚焦臺灣近代音樂家江文也，以近年來新出版的傳記、日記和音樂作品全集，以及本論文作者近年於歐洲搜集的史料為分析佐證，探討江文也「屬於自己 / 東方的聲音」創作，如何引發西方樂壇對於「東方聲音」的想像。</p> <p>&nbsp;</p><p>The early twentieth century was a century that had the two global-scale World Wars between world powers across continents and oceans. Rising nationalism and increasing national awareness became a major political issue in general society. Eastern musicians reflected on the issue and diligently learned Western music system to get a remarkable grasp of it. Because they knew well the so-called Oriental music sounds must be rooted in the Western music theory to be able to compete among nations by international standards. On one hand, Eastern musicians desired to be seen and rival upon the world stage; on the other hand, Western musicians looked forward to hearing pure Oriental music sounds from the East. However, for Taiwanese composer Jiang, Wen-Ye, the Oriental music sounds are not the ones of a traditional and exotic concept. Traditionally, the Oriental music sounds derive its flavor from the pentatonic scale and use traditional Chinese musical instruments to play. It is under such circumstances Jiang, Wen-Ye compose beautiful musical forms that embody his love and respectful duty to the Taiwanese motherland throughout frequent international music events and competitions.</p> <p>&nbsp;</p>

scholarly journals Clinical Trial Regulations In India : Past, Present and Future

JMS SKIMS ◽  
2017 ◽  
Vol 20 (1) ◽  
pp. 5-17
Author(s):  
Haroon Rashid
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Disease Burden ◽  
International Standards ◽  
New Drugs ◽  
Safety And Efficacy ◽  
Long Time ◽  
Regulatory Bodies ◽  
Guidance Documents ◽  
Human Use

Clinical trials are the only way of establishing the safety and efficacy of any new drug before its introduction in the market for human use. Clinical trials (with safeguards) are necessary for introduction of new drugs for a country like India, considering its disease burden and emergence of new variants of disease.The regulatory bodies need to frame guidelines and regulatory approval processes on a par with international standards. Many of the new laws, guidance documents, notifications and initiatives for regulating pharmaceutical industry were in the charts for quite a long time. Indian regulatory authorities have started looking into speedy implementation and providing support in terms ofnecessary infrastructure and investment. JMS 2017; 20(1):5-17

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