Comparative Study on Law Relating to Orthopedic Implants in India, United States and European Union with Case Study

2021 ◽  
Vol 07 ◽  
Author(s):  
K.V. Ramana Murthy ◽  
Lohithasu Duppala
Keyword(s):  
United States ◽  
European Union ◽  
Clinical Investigation ◽  
Orthopedic Implants ◽  
Regulatory Requirements ◽  
Device Development ◽  
Orthopedic Device ◽  
And Performance

Background: The article provides brief discussion on the comparative regulations on orthopedic implants in India, United States and European Union. Orthopedic implants are tone of the high risk medical devices manufactured to substitute or replace a missing or damaged joint or bone or to support a damaged bone or joint and to improve the quality of life of patients. Thus, there is a need to regulate the import, manufacture, clinical investigation; sale and distribution of orthopedic implants to ensure that all orthopedic implants that were brought to market are safe, quality and performance. The orthopedic implants industry is adversely affected by lack of awareness on proper regulatory practices, lack of awareness on the current regulatory practices, separate consistent standards, separate lawful requirements, and proper guidance on quality system etc. Conclusion: The objective of this article is to harmonize the regulatory requirements at par with the internationally accepted regulations and to develop ecosystem in the country to boost the Indian orthopedic device sector, and that will make India more productive for orthopedic device development to encourage national and multinational orthopedic implants industries to manufacture their orthopedic implants in India.

scholarly journals Using Neural Networks in Order to Analyze Telework Adaptability across the European Union Countries: A Case Study of the Most Relevant Scenarios to Occur in Romania

2021 ◽  
Vol 18 (20) ◽  
pp. 10586
Author(s):  
Ana Maria Mihaela Iordache ◽  
Codruța Cornelia Dura ◽  
Cristina Coculescu ◽  
Claudia Isac ◽  
Ana Preda
Keyword(s):  
European Union ◽  
The European Union ◽  
Working From Home ◽  
Level Of Satisfaction ◽  
Final Layer ◽  
Degree Of Satisfaction ◽  
Input Variables

Our study addresses the issue of telework adoption by countries in the European Union and draws up a few feasible scenarios aimed at improving telework’s degree of adaptability in Romania. We employed the dataset from the 2020 Eurofound survey on Living, Working and COVID-19 (Round 2) in order to extract ten relevant determinants of teleworking on the basis of 24,123 valid answers provided by respondents aged 18 and over: the availability of work equipment; the degree of satisfaction with the experience of working from home; the risks related to potential contamination with SARS-CoV-2 virus; the employees’ openness to adhering to working-from-home patterns; the possibility of maintaining work–life balance objectives while teleworking; the level of satisfaction on the amount and the quality of work submitted, etc. Our methodology entailed the employment of SAS Enterprise Guide software to perform a cluster analysis resulting in a preliminary classification of the EU countries with respect to the degree that they have been able to adapt to telework. Further on, in order to refine this taxonomy, a multilayer perceptron neural network with ten input variables in the initial layer, six neurons in the intermediate layer, and three neurons in the final layer was successfully trained. The results of our research demonstrate the existence of significant disparities in terms of telework adaptability, such as: low to moderate levels of adaptability (detected in countries such as Greece, Croatia, Portugal, Spain, Lithuania, Latvia, Poland, Italy); fair levels of adaptability (encountered in France, Slovakia, the Czech Republic, Hungary, Slovenia, or Romania); and high levels of adaptability (exhibited by intensely digitalized economies such Denmark, Sweden, Finland, Germany, Ireland, the Netherlands, Belgium, etc.).

scholarly journals Quality Management in Libraries Case Study: Book Collection Retrieval in Academic Libraries

2021 ◽  
Vol 9 (2) ◽  
pp. 182
Author(s):  
Vilianty Rizki Utami ◽  
Desni Sri Hastuti Sihite
Keyword(s):  
Quality Control ◽  
Quality Management ◽  
Comprehensive Evaluation ◽  
Case Study Method ◽  
Control Data ◽  
User Expectations ◽  
And Performance ◽  
Quality Control Data

Quality management in the library is related to quality control of the library's work to meet user expectations and contributes to the continued success of the organization. However, quality control is lacking and not be the main focus in many libraries. This paper aims to explain how quality management improves work results in libraries. The research method used in this paper is qualitative research using a case study method. We conduct research in Library X that already underwent quality control in book processing activities. The data were collected through observation, and interviews for book processing activities and its quality control data during 2018-2020. The data was then analyzed document analysis. The study found that Library X could perform better by improving the quality of book processing and fixing the error just before they put the book on its shelves. Quality control gives a comprehensive evaluation in Library X either for humans, processes, and systems of book processing activities that help Library X conduct its duty to provide their user needs and expectations. Quality control and quality management also help Library X describe the library working atmosphere and can be used for giving motivation to all librarians and staff to give better service and performance for the end-users.

scholarly journals The European Union and Image Resilience during Times of Crisis: The Role of Public Diplomacy

2017 ◽  
Vol 12 (4) ◽  
pp. 257-282 ◽  
Author(s):  
Mai’a K. Davis Cross ◽  
Teresa La Porte
Keyword(s):  
United States ◽  
European Union ◽  
Public Diplomacy ◽  
The United States ◽  
The European Union ◽  
Negative Perceptions ◽  
Exogenous Factors ◽  
Shed Light

A resilient actor is one with the capacity to recover from setbacks and obstacles, whether stemming from endogenous or exogenous factors. Beyond actual recovery, this article argues that there is also an important perceptional dimension. Image resilience is the capacity on the part of actors to overcome and deal with the widespread negative perceptions that often follow on the heels of these setbacks. The article argues that the ability to cultivate image resilience rests significantly on the power of public diplomacy. Through establishing a strong image for an actor over the longer term, public diplomacy enables that actor to be more resilient during times of crisis. The European Union is a particularly good case study to shed light on this. Using original interview evidence, this article examines a specific example of how the European Union was ultimately able to strengthen its image resilience in the United States through public diplomacy.

scholarly journals The analysis of approaches to conducting bioequivalence studies and the policy of “transparency” of their results in Ukraine, the United States and the European Union

2021 ◽  
Vol 25 (1) ◽  
pp. 32-40
Author(s):  
О.S. Popov ◽  
І.V. Kravchenko ◽  
V.Ye. Dоbrоvа ◽  
K.M. Tkachenko
Keyword(s):  
United States ◽  
European Union ◽  
Generic Drugs ◽  
Low Cost ◽  
The United States ◽  
The European Union ◽  
Regulatory Requirements ◽  
Drug Registration ◽  
Pharmaceutical Manufacturers ◽  
Mandatory Requirement

Providing the population of Ukraine with quality, effective and, at the same time, economically affordable medicines is a priority task of the healthcare system. Taking into account the relatively low cost of their development generic drugs are available to the majority of the country’s population; thus, bioequivalence studies are needed to obtain data on their efficacy and safety. Ukraine is currently in the process of harmonizing domestic regulatory requirements for generic drugs and conducting bioequivalence studies with global ones. Therefore, it is important to find out the differences in approaches to the registration of generics and studies of their bioequivalence in Ukraine and other countries. Another important aspect is to provide the policy of “transparency” of bioequivalence research results, which contributes to the use of better drugs. Aim. To analyze domestic and global approaches to the organization of the bioequivalence research and provide the policy of “transparency” of their results. Materials and methods. A comparative analysis of approaches to drug registration, requirements for generic drugs and bioequivalence studies and ways to provide the policy of “transparency” of their results in Ukraine, the United States and the European Union was conducted. Results. The analysis has revealed that the methods of registration of drugs in Ukraine, the United States and the EU are the same. Approaches to providing the “transparency” of the results of bioequivalence studies differ since in Ukraine the publication of such information is not mandatory and is at the discretion of pharmaceutical manufacturers. Conclusions. Domestic regulatory requirements for assessing generic drugs are harmonized with the world ones. Today, there is a need to introduce a mandatory requirement for the publication of bioequivalence studies, and it will contribute to providing an effective “transparency” policy.

scholarly journals TOWARDS GREEN RESILIENT CITIES IN EASTERN EUROPEAN UNION COUNTRIES

2020 ◽  
Vol 12 (1) ◽  
Author(s):  
Alexandru BĂNICĂ ◽  
Marinela ISTRATE ◽  
Ionel MUNTELE
Keyword(s):  
European Union ◽  
Green Infrastructure ◽  
Urban Areas ◽  
Local Economy ◽  
Eastern European ◽  
Statistical Relationship ◽  
Environment Agency ◽  
And Performance ◽  
Green Cities

Investing in green facilities is a process of urban renewal that can transform cities by enhancing the quality of life, strengthening the local economy and reducing environmental impact. Nevertheless, greener cities are not a guarantee for improved adaptive capacity when facing current local or global challenges. In this context, we have taken into account a series of sample cities from Central and Eastern European Union. Using the green cities typology proposed by the European Environment Agency, the present approach studies the statistical relationship between indicators of green infrastructure and different proxies for the resilience capacity and performance. The results distinguish between different types of green cities, indicating which are more resilient and, respectively, which are less resilient. The statistical relationship between the indicators shows that green infrastructures are developed in new urban areas, while the natural areas diminish the flood risk and air pollution and make cities more attractive; however, in older and higher density cities, the green is sacrificed for other uses that are considered more profitable. The conclusions highlight the contradictory characteristics in the territorial distributions of cities in relation to their green infrastructure and resilience features. The present assessment contributes to promoting an integrated vision that could be used in urban planning and in more coherent strategies for sustainable cities.

scholarly journals Sharing Pandemic Vaccination Certificates through Blockchain: Case Study and Performance Evaluation

2021 ◽  
Vol 2021 ◽  
pp. 1-12
Author(s):  
José L. Hernández-Ramos ◽  
Georgios Karopoulos ◽  
Dimitris Geneiatakis ◽  
Tania Martin ◽  
Georgios Kambourakis ◽  
...  
Keyword(s):  
European Union ◽  
Performance Evaluation ◽  
Large Scale ◽  
Evaluation Criteria ◽  
Use Case ◽  
The European Union ◽  
Satisfactory Performance ◽  
And Performance ◽  
Network Response Time

During 2021, different worldwide initiatives have been established for the development of digital vaccination certificates to alleviate the restrictions associated with the COVID-19 pandemic to vaccinated individuals. Although diverse technologies can be considered for the deployment of such certificates, the use of blockchain has been suggested as a promising approach due to its decentralization and transparency features. However, the proposed solutions often lack realistic experimental evaluation that could help to determine possible practical challenges for the deployment of a blockchain platform for this purpose. To fill this gap, this work introduces a scalable, blockchain-based platform for the secure sharing of COVID-19 or other disease vaccination certificates. As an indicative use case, we emulate a large-scale deployment by considering the countries of the European Union. The platform is evaluated through extensive experiments measuring computing resource usage, network response time, and bandwidth. Based on the results, the proposed scheme shows satisfactory performance across all major evaluation criteria, suggesting that it can set the pace for real implementations. Vis-à-vis the related work, the proposed platform is novel, especially through the prism of a large-scale, full-fledged implementation and its assessment.

scholarly journals Solar Dryer for Large/Medium Scale Ripening and Drying of Dates; A Case Study of Dates Growing Area of Pakistan

2021 ◽  
Vol 64 (1) ◽  
pp. 30-37
Author(s):  
Saeeda Sultana ◽  
Syed Hussain ◽  
Muhammad Farooq ◽  
Muhammad Ehsan
Keyword(s):  
Natural Gas ◽  
Solar Thermal ◽  
Medium Scale ◽  
Solar Dryer ◽  
Lack Of Information ◽  
Sunshine Hours ◽  
And Performance ◽  
One Year

This study describe the design features and performance of the unglazed transpired solar dryer for large and medium scale drying of Dates in the Dates growing area of Pakistan. The dryer has the designed capacity to dry 500 Kg of Dates from Khalaal (70% humidity) to Tamar (25% humidity), at 55 C ± 5 C in 72 continuous hours using biomass furnace as an auxiliary heat source and it covers approximately 256 m2 areas. This is the ideal humidity condition to store Dates for one year without any further degradation. In traditional open sunshine the huge quantity of Dates are dried in over 150 h hours and requires hectare of area to spread the Dates. Moreover, the quality of Dates in the open sunshine is affected badly due to two main reasons. Firstly, the heavy dust in the area that sticks the Dates during the drying process makes them unable to eat. Secondly, the Monsoon rains in the months of July and August also destroys Dates placed in the open areas for drying. Dera Ismail (D.I.) Khan, a remote district of Khyber Pakhtoon Khawa province of Pakistan, was selected to study the performance of Dates dryer, where solar insolation is 700-750 W/m2 in the months of July and August. The Dates were dried continuously and during off sunshine hours biomass auxiliary source was used. This solar dryer, containing eight trolleys and each trolley is loaded with twelve trays, is the first in Pakistan to dry a large amount of Dates. Moreover, the unglazed transpired dryer is designed in such a way that it can withstand the dusty atmosphere of D.I. Khan and also protect the Dates from dust and rainy water during the drying period. The design does not have any adverse effect on the quality of dried Dates. In D.I. Khan around 350 days are sunny per year and solar thermal technology is economically feasible compared to other conventional energy resources with a payback period of 3 and 7.5 years compared to un-subsided and subsided cost of Natural Gas respectively. The Natural Gas is the cheapest conventional energy source in Pakistan. But solar thermal technology is yet not popular source of energy in the area due to lack of information, fear of initial capital cost and weak government policies for renewable energies. This study also incorporates the recommendations to overcome these issues regarding Solar Thermal Technology, PACS Number: 44.40.+a, 89.30.Cc, 84.60.- h, 89.30.-g.   

scholarly journals Raising compulsory automobile insurance minimum amounts: a case study from the United States

2019 ◽  
Vol 4 (2019/4) ◽  
Keyword(s):  
United States ◽  
European Union ◽  
Union Member ◽  
The United States ◽  
Automobile Insurance ◽  
The European Union ◽  
Automobile Accidents ◽  
Member States ◽  
European Union Member States

This article discusses a decision both European Union Member States and states in the United States must make: whether to raise their compulsory automobile insurance minimum amounts. The authors review a case study from the United States, the Commonwealth of Pennsylvania, and conclude a proposed increase in the compulsory minimum amounts should pass the legislator. The purpose of compulsory automobile insurance is to compensate victims of automobile accidents. Due to inflation, the minimum amounts in Pennsylvania no longer compensate adequately. Moreover, the data do not support the contention that an increase in the minimum amounts will cause large increases in premiums and uninsured rates. The authors conclude that compulsory minimum amounts should be periodically reviewed, as they are in the European Union, and that arguments about large increases in premiums and uninsured rates should be subjected to a careful review based on data.

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