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1
Volkwein, Axel, Werner Gerber, Johannes Klette, and Georg Spescha. "Review of Approval of Flexible Rockfall Protection Systems According to ETAG 027." Geosciences 9, no. 1 (January 18, 2019): 49. http://dx.doi.org/10.3390/geosciences9010049.
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In 2009, the European Guideline for Flexible Rockfall Protection Kits European Technical Approval Guideline 027 (ETAG 027) became valid. The aim of the guideline was to approve and certify steel barriers available on the market according to a common standard. In 2018, ETAG 027 was replaced by a so-called European Assessment Document (EAD). This contribution summarizes results and experiences that were obtained through the type testing, approval and assessment procedures of 66 protection systems evaluated between 2009 and 2018. Apart from the common main task of the barriers to stop falling blocks successfully, the different test conditions and constructions of barriers result in different performance characteristics. Some of these characteristics follow certain trends, whereas others show a wide range without any trend. In such a case, this contribution helps to classify a single system compared to the others.
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Peila, D., and C. Ronco. "Technical Note: Design of rockfall net fences and the new ETAG 027 European guideline." Natural Hazards and Earth System Sciences 9, no. 4 (July 29, 2009): 1291–98. http://dx.doi.org/10.5194/nhess-9-1291-2009.
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Abstract. The need for protection against rockfall has led to the development of different types of technological solutions that are able to both prevent blocks from detaching from rock walls and to control, intercept or deviate the blocks during movement. Of the many devices that are able to intercept and stop a block, one of the most frequently used is net fence. Many different types of full-scale tests have been carried out, with different test site geometries and procedures to study their behaviour and to certify these devices. This has led to a series of data and information that are not easy to compare. The recent endorsement, by the European Organization for Technical Approvals (EOTA), of a European Technical Approval Guideline (ETAG), which defines how to test and assess the performance of a net fence, is therefore a great innovation that will change both the market and the design procedures of these devices. The most important innovations introduced by this new guideline are here presented and discussed and a net fence design procedure for protection against rockfall is provided.
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Trad, Ayman, Ali Limam, and Philippe Robit. "Real Scale Experiments on Rockfall Protection Barriers." Applied Mechanics and Materials 82 (July 2011): 734–39. http://dx.doi.org/10.4028/www.scientific.net/amm.82.734.
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In the rockfall protection barriers, the role of the net is to diffuse the efforts to the braking devices which absorb the energy and slow down the velocity of the block. An innovative braking device working by the buckling of metallic tubes is developed by quasi-static and dynamic tests. Real scale experiments on the entire structure are done and presented here. These tests are performed as the recommendations of the new Guideline for European Technical Approval concerning the falling rock protection kits, named ETAG 27.
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Serrano-Aguilar, Pedro, José Asua-Batarrita, María Teresa Molina-López, Mireia Espallargues, Joan Pons-Rafols, Sandra García-Armesto, Paloma Arriola-Bolado, et al. "The Spanish Network of Agencies for Health Technology Assessment and Services of the National Health System (RedETS)." International Journal of Technology Assessment in Health Care 35, no. 03 (2019): 176–80. http://dx.doi.org/10.1017/s0266462319000205.
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AbstractEarlier activities on health technology assessment (HTA) started in Spain around 1984, with the creation of a National Advisory Board on HTA, and the development of national and regional HTA organizations in the early 1990s. In 2012, the Spanish Health Ministry established the Spanish Network for Health Technology Assessment of the National Health System (RedETS); funded at national level and including all public HTA organizations at national and regional levels. RedETSis focused on the assessment of nondrug health technologies to inform the revision (approval and funding or disinvestment) of the Benefit Portfolio of the Spanish NHS. In parallel with European Network for Health Technology Assessment (EUnetHTA), RedETS has been setting-up and sharing common procedures and methodological guidelines to ensure effective cooperation and mutual recognition of the scientific and technical production in HTA. The output of RedETS is fifty to sixty annual reports, including the production of full HTA reports, Clinical Practice Guidelines, methodological guidance reports, relative effectiveness assessments, tools to support shared decision making between patients and healthcare professionals, and monitoring studies. The HTA assessments requested by the Regional Health Authorities are the biggest component of the annual RedETS working plan. These assessment needs are identified according to a yearly process and prioritized by a Commission composed of representatives from all Spanish regions with the aid of the PRITEC tool. The objectives of this study are to report and update the normative and organizational state of HTA in Spain; describing noteworthy advances witnessed over the past 10 years, as well as discussing existing challenges.
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Farenyuk, G. G., and O. B. Oleksiienko. "ANALYSIS CRITERIA FOR EVALUATION OF EUROPEAN EXPERIENCE FACADE SYSTEMS." Bulletin of Odessa State Academy of Civil Engineering and Architecture, no. 80 (September 3, 2020): 150–61. http://dx.doi.org/10.31650/2415-377x-2020-80-150-161.
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Abstract. Strategic problem of ensuring the update of energy profile of residential and public buildings may be solved if only recent design concept of facade thermal insulation is applied. As the design concept, facade thermal insulation appeared in reconstruction of buildings and structures. In domestic construction practice, this design concept is also widely used in new structures and that is why the system of criteria that determine the possible reduce of specific heat loss in heating of buildings should be updated, and the desired operational heat safety of buildings should be ensured. The paper deals with the development and implementation of new criteria for assessment of façade insulation systems with rendering, addresses the European experience and features the implementation of European standards in the national regulatory framework. The paper follows the previous research conducted by the State Research Institute of Building Constructions for the last fifteen years with main scientific papers being referenced and aimed at the development of methodological base for system of norms and standards that ensure the implementation of innovations in the practice of domestic construction sector. The paper covers the details of conformity assessment and suitability for use of facade thermal insulation in accordance with the methodological principles applied both in Ukraine and countries of European Community. The paper provides the analysis of the requirements set for facade thermal insulation with rendering by a national regulative document, DSTU B V.2.6-36:2008, and compares the requirements for ETICS (Exterior Thermal Insulation Composite System) set by Guideline for European Technical Approval of Exterior Thermal Insulation Composite System with Rendering (ETICS), ETAG 004.
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Laforce, Robert, Pedro Rosa-Neto, Jean-Paul Soucy, Gil D. Rabinovici, Bruno Dubois, and S. Gauthier. "Canadian Consensus Guidelines on Use of Amyloid Imaging in Canada: Update and Future Directions from the Specialized Task Force on Amyloid imaging in Canada." Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques 43, no. 4 (February 26, 2016): 503–12. http://dx.doi.org/10.1017/cjn.2015.401.
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AbstractPositron emission tomography (PET) imaging of brain amyloid beta is now clinically available in several countries including the United States and the United Kingdom, but not Canada. It has become an established technique in the field of neuroimaging of aging and dementia, with data incorporated in the new consensus guidelines for the diagnosis of Alzheimer disease and predementia Alzheimer’s disease–related conditions. At this point, there are three US Food and Drug Administration– and European Union–approved tracers. Guided by appropriate use criteria developed in 2013 by the Alzheimer’s Association and the Society of Nuclear Medicine and Molecular Imaging, the utility of amyloid imaging in medical practice is now supported by a growing body of research. In this paper, we aimed to provide an update on the 2012 Canadian consensus guidelines to dementia care practitioners on proper use of amyloid imaging. We also wished to generate momentum for the industry to submit a new drug proposal to Health Canada. A group of local, national, and international dementia experts and imaging specialists met to discuss scenarios in which amyloid PET could be used appropriately. Peer-reviewed and published literature between January 2004 and May 2015 was searched. Technical and regulatory considerations pertaining to Canada were considered. The results of a survey of current practices in Canadian dementia centers were considered. A set of specific clinical and research guidelines was agreed on that defines the types of patients and clinical circumstances in which amyloid PET could be used in Canada. Future research directions were also outlined, notably the importance of studies that would assess the pharmaco-economics of amyloid imaging.
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R. Zeltser. "Institutional environment as a precondition for improving the technological progress of construction." Ways to Improve Construction Efficiency, no. 45 (October 16, 2020): 46–56. http://dx.doi.org/10.32347/2707-501x.2020.45.46-56.
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The legislation of Ukraine on the regulation of urban planning activities establishes the legal and organizational foundations of urban planning activities, which are aimed at ensuring sustainable development of territories, taking into account State, public and private interests. In accordance with the legislative acts, a number of government decrees, orders of the Ministry of Development of Communities and Territories of Ukraine (formerly - the Ministry of Regional Development of Ukraine), state building codes (new or amended from among the current ones) have been developed. There is an urgent need to analyze the situation and further improve the legal regulation of construction, including permitting and approval procedures for the organization and management of construction in accordance with legislation and regulations, adaptation of regulatory policy to European standards as a prerequisite for improving organizational and technological processes of construction and determining their effectiveness.Based on this goal, the following set of issues is consistently considered: contractual relations in capital construction; main participants in the construction - the customer and contractor, investor, developer, etc .; conditions for concluding a contract; terms of performance of works (construction of object); calendar schedule of works; contract price and estimated cost of construction; types of contracts and their characteristics; the rights of the customer and the contractor; contracts for design and research work; methods of economic evaluation of options for the organization of technological processes of construction.Currently, work is underway to improve the legislation on the organization of construction activities, namely: architectural and construction control and supervision, permitting procedures in construction, licensing, self-regulation in urban planning, electronic systems and BIM-technology, technical regulation in construction and more. In this regard, the current guidelines will be clarified with the release of new laws and regulations.
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ФАРЕНЮК, Г. Г., and О. Б. ОЛЕКСІЄНКО. "АНАЛІЗ КРИТЕРІЇВ ОЦІНКИ ФАСАДНИХ КОНСТРУКТИВНИХ СИСТЕМ ЗІ ШТУКАТУРНИМ ШАРОМ." Наука та будівництво 26, no. 4 (February 12, 2021): 3–14. http://dx.doi.org/10.33644/scienceandconstruction.v26i4.1.
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Вирішення стратегічного завдання із забезпечення зміни енергетичного статусу житлових та громадських будівель можливе тільки при застосуванні сучасних конструктивних рішень фасадної теплоізоляції. Як конструктивна система фасадна теплоізоляція виникла при реконструкції будівель і споруд, у вітчизняній будівельній практиці. Ці конструктивні рішення широко застосовуються і у новому будівництві, що обумовлює необхідність удосконалення системи критеріїв, які визначають можливість зниження питомих тепловтрат на опалення будинків з одночасним забезпеченням необхідної теплової надійності конструкцій під час експлуатації. У статті наводиться аналіз розробки та впровадження нових критеріїв оцінки фасадних систем зі штукатурним шаром з урахуванням європейського досвіду, розглядаються особливості імплементації європейських стандартів унаціональне нормативне поле. Стаття є продовження попередніх наукових робіт, що здійснюються у ДП НДІБК на протязі останніх п’ятнадцяти років направлені на розробку методологічних основ при створенні системи норм та стандартів, що забезпечує впровадження сучасних інноваційних технічних рішень у практику вітчизняного будівництва. В статті розглянуто особливості здійснення оцінки відповідності та визначення придатності застосування конструкцій фасадної теплоізоляції згідно методологічних принципів, що існують в Україні та країнах Європейської спільноти. У статті аналізуються вимоги, що встановлюються для конструкцій фасадної теплоізоляції з опорядженням штукатурками національним нормативним документом – ДСТУ Б В.2.6-36:2008 «Конструкції зовнішніх стін із фасадною теплоізоляцією та опорядженням штукатурками», та для цих конструкцій -згідно європейській термінології ETICS (Exterior Thermal Insulation Composite System), що встановлюються настановою з європейських технічнихухвалень та визначення придатності для застосування ETAG 004 «Guideline for European technical approval of external thermal insulation compositesystems with rendering».
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Al-Abbadi, Mousa A., Helena Barroca, Beata Bode-Lesniewska, Maria Calaminici, Nancy P. Caraway, David F. Chhieng, Immacolata Cozzolino, et al. "A Proposal for the Performance, Classification, and Reporting of Lymph Node Fine-Needle Aspiration Cytopathology: The Sydney System." Acta Cytologica 64, no. 4 (2020): 306–22. http://dx.doi.org/10.1159/000506497.
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Background: The evaluation of lymph nodes (LN) by fine-needle aspiration cytology (FNAC) is routinely used in many institutions but it is not uniformly accepted mainly because of the lack of guidelines and a cytopathological diagnostic classification. A committee of cytopathologists has developed a system of performance, classification, and reporting for LN-FNAC. Methods: The committee members prepared a document that has circulated among them five times; the final text has been approved by all the participants. It is based on a review of the international literature and on the expertise of the members. The system integrates clinical and imaging data with cytopathological features and ancillary techniques. The project has received the endorsement and patronage of the International Academy of Cytology and the European Federation of the Cytology Societies. Results: Clinical, imaging, and serological data of lymphadenopathies, indications for LN-FNAC, technical procedures, and ancillary techniques are evaluated with specific recommendations. The reporting system includes two diagnostic levels. The first should provide basic diagnostic information and includes five categories: inadequate/insufficient, benign, atypical lymphoid cells of undetermined/uncertain significance, suspicious, and malignant. For each category, specific recommendations are provided. The second diagnostic level, when achievable, should produce the identification of specific benign or malignant entities and additional information by utilizing ancillary testing. Conclusion: The authors believe that the introduction of this system for performing and reporting LN-FNAC may improve the quality of the procedure, the report, and the communication between cytopathologists and the clinicians. This system may lead to a greater acceptance and utilization of LN-FNAC and to a better interdisciplinary understanding of the results of this procedure.
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Vincent, Flavien, Julien Ternacle, Tom Denimal, Mylène Shen, Bjorn Redfors, Cédric Delhaye, Matheus Simonato, et al. "Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve Stenosis." Circulation 143, no. 10 (March 9, 2021): 1043–61. http://dx.doi.org/10.1161/circulationaha.120.048048.
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After 15 years of successive randomized, controlled trials, indications for transcatheter aortic valve replacement (TAVR) are rapidly expanding. In the coming years, this procedure could become the first line treatment for patients with a symptomatic severe aortic stenosis and a tricuspid aortic valve anatomy. However, randomized, controlled trials have excluded bicuspid aortic valve (BAV), which is the most frequent congenital heart disease occurring in 1% to 2% of the total population and representing at least 25% of patients 80 years of age or older referred for aortic valve replacement. The use of a less invasive transcatheter therapy in this elderly population became rapidly attractive, and approximately 10% of patients currently undergoing TAVR have a BAV. The U.S. Food and Drug Administration and the “European Conformity” have approved TAVR for low-risk patients regardless of the aortic valve anatomy whereas international guidelines recommend surgical replacement in BAV populations. Given this progressive expansion of TAVR toward younger and lower-risk patients, heart teams are encountering BAV patients more frequently, while the ability of this therapy to treat such a challenging anatomy remains uncertain. This review will address the singularity of BAV anatomy and associated technical challenges for the TAVR procedure. We will examine and summarize available clinical evidence and highlight critical knowledge gaps regarding TAVR utilization in BAV patients. We will provide a comprehensive overview of the role of computed tomography scans in the diagnosis, and classification of BAV and TAVR procedure planning. Overall, we will offer an integrated framework for understanding the current role of TAVR in the treatment of bicuspid aortic stenosis and for guiding physicians in clinical decision-making.
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Velasco Tirado, Ana, Antonio F. Rodríguez, Celia Sevilla Sánchez, and Juan Manuel Rodríguez. "A Spanish Standard for defining Open Geographic Data." Abstracts of the ICA 1 (July 15, 2019): 1–2. http://dx.doi.org/10.5194/ica-abs-1-380-2019.
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<p><strong>Abstract.</strong> There are a wide variety of initiatives and guidelines recommending publishing government data, especially geospatial data as open data, for instance:</p><p>G8 launched in June 2013 in a meeting in Lough Erne (Ireland) the G8 Open Data Charter recognizing that Open Data improves Governance and it is an innovation engine. Geographic data where included as one of the areas of great value. The eight countries were committed to approve an action plan before 2013 October and yearly publish a report.</p><p>G20 and United Nations supports the International Open Data Charter since 2015 extending the former proposal to all the countries. Six basic principles are defined: data should be open by default, timely and comprehensive, accessible and usable, comparable and interoperable, for improved Governance and Citizen Engagement, and for inclusive development and innovation. Until now 19 national and 43 local governments has adopted the chart and 46 organisations has endorsed it.</p><p>The European Interoperability Framework v2, approved by the European Commission on March 2017 to improve the quality of European public services devotes a full section to explain what exactly Open Data is and to support it.</p><p>The United Nations Global Geographic Information Management (UN GGIM) recognizes in its Integrated Geospatial Information Framework – Part 1 Overarching Strategic Framework (July 2018) that geospatial information is a key component of the government’s open data agendas which stimulates opportunities and include government delivery systems focused on the citizen in an efficient and effective way.</p><p>But, although it seems there is a wide consensus on the positive effect of having governamental Open Data, and there is a common understanding of the theoretical meaning of Open Data (data with no barriers for use and reuse by everybody under any circumstances) there is not a common practical understanding about what Open Data is. In our opinion, the more detailed and precise technical definition of Open Data is due to the Open Knowledge International (opendefinition.org), but the problem is that there is not an Abstract Test Suite to check and verify if a dataset is published fulfilling the requirements defined in it.</p><p>By the other hand, Open Data are not yet widely implemented. The Global Open Data Index 2018 states that the National Map 1: 250,000 data are published as Open Data only in the 10 % of the countries studied. We think one of the reasons of the lack of implementation Open Geographic Data (OGD) is that there is no a standard easily verifiable technical definition of OGD.</p><p>Because of that, the Spanish Standardization Technical Committee 148 “Digital Geographic Information” decided in 2016 to define a Spanish standard on Open Geographic Data to have an objective procedure to verify and certify if a geospatial dataset is published or not as Open Data, as a tool to promote and support Open Data.</p><p>UNE 148004:2018 “Datos geográficos abiertos” (Open Geographic Data) was approved in 2018 after following the standard UNE processes, including two rounds of comments and one public information period. More than the eighty five per cent of the comments received were totally or partially accepted and we think the result reflects the consensus reached in the Spanish geographic data community around this topic.</p><p>This Spanish standard stablish a technical full and detailed definition of what exactly is Open Geographic Data (OGD) and defines a set of objective requirements to be fulfilled in order to publish a geographic dataset as Open Data. It is based in three main principles:</p><ul><li>Principle of minimizing barriers, following the idea that Open Data are data published without economic, technical and legal barriers for their use and reuse.</li><li>Principle of no-discrimination of any kind of users, field of application, social group and future use of data.</li><li>Principle of technological neutrality, which is in fact a particularization of the former one, stating that any user shall be discriminated on the basis of the technological solutions (browser, operating system, software…) he has chosen.</li></ul><p>Applying those general principles, UNE 148004:2018 defines four conceptual levels for geographic data in the way of progress towards having OGD: available, well described, under an open license and in an open format geographic data. It provides also an Abstract Test Suit for verifying and certifying, if required, Open Geographic Data.</p><p>In this communication a general approach to open geographic data, a justification for developing this standard and a brief and complete summary of its contents and prescription are given. We think this new Spanish standard will promote and support Open Data in the field of Geographic Information and we hope it will promote the progress and grow of the Spanish geospatial sector.</p>
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Patel, Veer J., and Dasharath M. Patel. "A comprehensive review on registration requirements for Drug Approval in India, South Africa and US." International Journal of Drug Regulatory Affairs 9, no. 1 (March 17, 2021): 62–71. http://dx.doi.org/10.22270/ijdra.v9i1.456.
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The drug approval process is country-specific. The regulatory framework of all the national regulatory agencies differ from one another in terms of administration and product specific guidelines for registration of drug and drug products in a particular country. Every national regulatory authority provides regulatory guidelines for drug or drug product registration and the pharmaceutical industries which rely upon these guidelines prepare drug applications along with all the required administrative, non-clinical and clinical data in the form of a technical dossier which is known as Common Technical Document. This Dossier is prepared either in an electronic format or in the paper submission format. This review focuses on the comparative study of the registration requirements for getting a drug approval in India, South Africa and United States of America. The significant differences between the technical requirements of these three markets have been discussed in detail.
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Babin, Iurii, Mykola Nazarenko, Rostyslav Nilov, and Victor Pinchuk. "RESEARCH OF THE MAIN DIFFERENCES IN THE REQUIREMENTS FOR THE CONSTRUCTION OF VEHICLES MANUFACTURED FOR MARKETS OF DIFFERENT COUNTRIES." Avtoshliakhovyk Ukrayiny, no. 4 (260) ’ 2019 (December 28, 2019): 22–29. http://dx.doi.org/10.33868/0365-8392-2019-4-260-22-29.
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Research of the main differences in the design requirements for wheeled vehicles manufactured for the markets of different countries. Review of the main legislative documents concerning the admission of RV to participation in road traffic and the state registration. Determination of the main differences RV, which were in use and were made for markets other than European, which are required pay attention to certification. Providing information and explanations for citizens wishing to purchase or have already purchased vehicles that were in use and manufactured for markets other than European, about the minimum design requirements for such vehicles, compliance with which is necessary for passing the inspection and obtaining a certificate of conformity according to the procedure for individual approval of wheeled vehicles. Definition of legislative documents about regulating the procedure for individual approval of vehicles in Ukraine. Providing information on the list of requirements (technical regulations), which must conform to the vehicle, past in usage, M1 and N1 categories for passing the procedure of individual approval of wheeled vehicles. Determination of the obligations of certification bodies in Ukraine to comply with the requirements of European standards and legislation of Ukraine during the procedure for individual approval of wheeled vehicles in Ukraine. Development and approval Technical service reports on the possibility of applying alternative technical regulations for the individual approval of completed wheeled vehicles of categories M1 and N1, which are manufactured in large series in / or for countries that are not member states of the European Union. Description of the main differences between the objects of approval that you need to pay attention to before passing certification. Keywords: RV certification, certification of cars intended for the US market, requirements for cars during certification.
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Strandberg, Kjell E. "Changes to the European Regulatory Guidelines for the Approval of Antiretroviral Agents." Drug Information Journal 33, no. 2 (April 1999): 343–45. http://dx.doi.org/10.1177/009286159903300203.
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Beukers, Thomas. "The Barroso Drama Enhancing Parliamentary Control Over the European Commission and the Member States." European Constitutional Law Review 2, no. 1 (February 2006): 21–53. http://dx.doi.org/10.1017/s1574019606000216.
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Appointment and Censure of the European Commission — Development of Rules of Constitutional Practice — Parliamentary committee hearings 2004 — Guidelines on Approval Procedure of the Commission — Framework Agreement 2005 between European Parliament and Commission — Clash between Parliament and Council on control of European Commission — Responsibility of individual Commissioners.
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Chauhan, Meenakshi K., and Shipra Malik. "REGULATORY GUIDELINES FOR APPROVAL OF BIOSIMILARS IN INDIA, EUROPE, BRAZIL AND CHINA: A COMPREHENSIVE OVERVIEW." International Journal of Pharmacy and Pharmaceutical Sciences 8, no. 10 (August 12, 2016): 7. http://dx.doi.org/10.22159/ijpps.2016v8i10.11753.
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<p>A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product (reference medicinal product). A biosimilar demonstrates similarity to the reference biological product in terms of quality characteristics, biological activity, safety and efficacy based on a comprehensive comparability exercise. EMA (European Medicines Agency) was the first to introduce the guidelines for biosimilar approval, effective from June 2006. Biosimilar guideline was released in 2010 in Brazil and 2012 in India. Recently China published its guideline for biosimilar approval in 2015.</p><p>This article summarizes the regulatory requirements for approval of biosimilars in India, Europe, Brazil, and China. These countries require comparability exercise of a biosimilar with reference biological product for generating comparative analytical, non-clinical and clinical data (usually one or two phase 1 and phase 3 comparative studies). A case study of infliximab biosimilar approval in India, Brazil and Europe has also been included.</p>
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Amaresh, K., Geetanjali Salimath, M. S. Ganachari, Revana S. Devarinti, and Uday Kumar. "A comparison of regulatory approval of clinical trial protocol with different countries." International Journal of Clinical Trials 8, no. 3 (July 22, 2021): 260. http://dx.doi.org/10.18203/2349-3259.ijct20212849.
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<p class="abstract">In present scenario, different countries must follow different regulatory requirements for protocol approval process of new drug application. Present study, we studied the regulatory requirements, timelines of approval and guidelines according to central drug standard control organization (CDSCO), therapeutic goods administration (TGA), food and drug administration (FDA) and European medical agency (EMA). The objective was to compare the regulatory approval of clinical trial protocol process. A comparative observational study was undertaken among the clinical trials and regulatory bodies of India (CDSCO), Australia (TGA), US (USFDA), Europe (EMA). The study specified various regulatory guidelines and safety requirements for conduct and inspection of clinical trial. Clinical trial protocol guidelines the essential documents are determined, and various timelines are being identified. And compared with the fees with other countries. Indian payments were compared with other countries. Timelines with safety reporting were compared with other 3 countries (Europe, Australia and US). The regulatory guidelines in the clinical trial different between countries. There is different timelines and requirements of clinical trial application approval process for each regulatory body. This study methodology has enabled comparisons to be made both within agencies and between different authorities and has identified differences in the timelines that applications spend in different stages of the review.</p><p> </p>
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Calvo, Begoña, Javier Martinez-Gorostiaga, and Enrique Echevarria. "The surge in biosimilars: considerations for effective pharmacovigilance and EU regulation." Therapeutic Advances in Drug Safety 9, no. 10 (August 3, 2018): 601–8. http://dx.doi.org/10.1177/2042098618790442.
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The development of biosimilars is growing rapidly, especially in Europe. They are a cost-effective alternative to original biological medicines and can help improve patient access to these therapies. The European Medicines Agency (EMA) has been the first to issue scientific guidelines related to regulatory requirements for the approval of biosimilars. These guidelines have been being updated in line with advances in analytical techniques and growing experience in the clinical use of these drugs. Given the complex nature of biological medicines, they pose a greater potential risk of immunogenicity than nonbiological medicines, and hence warrant special consideration. The risk management plan for biopharmaceuticals (innovator and biosimilar drugs) should be based on strengthening ongoing pharmacovigilance activities, especially in the post-approval period. This paper addresses regulatory issues related to the approval of biosimilars in Europe associated with safety considerations linked to the development and use of these medicines. We also discuss the issues of immunogenicity, interchangeability and traceability of biological medicines.
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Jain, Achin, M. P. Venkatesh, and Pramod T. M. Kumar. "ACTD: BRIDGE BETWEEN REGULATORY REQUIREMENTS OF DEVELOPED AND DEVELOPING COUNTRIES." International Journal of Drug Regulatory Affairs 1, no. 4 (December 6, 2013): 1–11. http://dx.doi.org/10.22270/ijdra.v1i4.6.
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Regulatory Dossier contains data which when submitted to the regulatory authority, provides for the review andultimate approval of a drug product. Once approved, an applicant may manufacture and market the drug to provide asafe, effective and low cost which benefits the society. Filing requirements in developed countries differ fromdeveloping countries which makes the approval process tedious and time consuming for the later. To make thisprocess smooth, ASEAN CTD (ACTD) was developed by Association of South East Asian Nations (ASEAN)nations. As format of ACTD resembles the format of Common Technical Document (CTD) with some differences,hence it can be used as a step. Also if both guidelines can be harmonized then differences and variation between boththe guidelines can be minimized. This article focuses on the similarities and differences in between CTD & ACTDand highlights how ACTD can be a initiating step for developing countries to meet pharmaceutical regulations ofdeveloped countries.
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Dietrich, ChristophF, and C. Jenssen. "Endoscopic ultrasound-guided sampling in gastroenterology: European society of gastrointestinal endoscopy technical guidelines." Endoscopic Ultrasound 2, no. 3 (2013): 117. http://dx.doi.org/10.4103/2303-9027.117647.
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Varela, Diego, Giacomo Benedetto, and Jose Manuel Sanchez-Santos. "Editorial statement: The first year of the European Journal of Government and Economics." European Journal of Government and Economics 1, no. 2 (December 31, 2012): 103. http://dx.doi.org/10.17979/ejge.2012.1.2.4279.
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In this editorial statement we present a balance of the first year of life of the European Journal of Government and Economics. We discuss the main developments that concern the journal’s indexation by academic databases. We also comment on the approval of a code of publication ethics and malpractice. Finally, we emphasise the dangers of excessive technical sophistication and the need to keep an integrated approach between the fields of political science and economics, according to the spirit of the journal.
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Wooden, Gemma, Matthew Blaseby, and Derk Visser. "There is no hope in inventive step." Journal of Intellectual Property Law & Practice 15, no. 1 (December 10, 2019): 2–3. http://dx.doi.org/10.1093/jiplp/jpz163.
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Abstract Guidelines for Examination in the European Patent Office, November 2019 edition The European Patent Office’s Guidelines have been updated to clarify that the approach for assessing inventive step involves determining whether a skilled person would have modified the closest prior art in an expectation of some advantage or improvement. A hope of solving the objective technical problem is insufficient for a modification of the closest prior art to be considered obvious.
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Joseph, Lincy, Mathew George, Kalpesh K. Malaviya, Kalpesh K. Malaviya, Bincy K. Chacko, and Jitendra Kumar Badjatya. "COMPARATIVE STUDY FOR GENERIC DRUG APPROVAL PROCESS AND THEIR REGISTRATION AS PER CTD IN EUROPE, USA AND BRAZIL." International Journal of Drug Regulatory Affairs 4, no. 2 (June 6, 2016): 1–9. http://dx.doi.org/10.22270/ijdra.v4i2.14.
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This aims to compare the generic drug approval and registration process in the regulatory market of Europe, USA andBrazil. Based on the information collected from various sources such as regulatory sites, Government websites,discussion with regulatory agent, interviewing pharma professionals and literature survey from various journals, aclear picture on the generic drug approval and registration process of each country was drawn. The differentauthorities’ viz. European Medicines Evaluation Agency (EMEA) of Europe, Food Drug Administration (FDA) ofUSA and National Health Surveillance Agency (ANVISA) of Brazil carried out the generic drug approval andregistration process in the respective countries. After analysing the various requirements for the generic drug approvalin the above stated countries, it was concluded that the regulatory guidelines of Europe and Brazil was not welldefined. But FDA gives very much well defined requirements.
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Jarabek, Annie M., and William H. Farland. "The U.S. Environmental Protection Agency's Risk Assessment Guidelines." Toxicology and Industrial Health 6, no. 5 (October 1990): 199–216. http://dx.doi.org/10.1177/074823379000600516.
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This paper has been reviewed by the Office of Health and Environmental Assessment, U.S. Environmental Protection Agency, and approved for publication. Approval does not signify that the contents necessarily reflect the views and policies of the Agency, nor does mention of trade names or commercial products constitute endorsement or recommendation for use. In 1983, the U.S. National Academy of Sciences (U.S. NAS) proposed a framework for the processes of risk assessment and risk management in government agencies (U.S. NAS, 1983). Using the U.S. NAS scheme as an organizing principle, the U.S. Environmental Protection Agency (U.S. EPA) published guidelines pertaining to risk assessment in five areas: estimating exposures, chemical mixtures, mutagenicity, suspect developmental toxicity and carcinogenicity. These guidelines were developed to promote high technical quality and consistent practice of risk assessment Agencywide. This paper will discuss the historical development of the guidelines and their role in the work performed by the Agency. Each of the five (5) guidelines is outlined and anticipated revisions discussed. Related assessment activities and new subject areas are also presented.
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Spiegel, Lauren L., Jill L. Ostrem, and Ian O. Bledsoe. "FDA Approvals and Consensus Guidelines for Botulinum Toxins in the Treatment of Dystonia." Toxins 12, no. 5 (May 17, 2020): 332. http://dx.doi.org/10.3390/toxins12050332.
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In 2016, the American Academy of Neurology (AAN) published practice guidelines for botulinum toxin (BoNT) in the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache. This article, focusing on dystonia, provides context for these guidelines through literature review. Studies that led to Food and Drug Administration (FDA) approval of each toxin for dystonia indications are reviewed, in addition to several studies highlighted by the AAN guidelines. The AAN guidelines for the use of BoNT in dystonia are compared with those of the European Federation of the Neurological Societies (EFNS), and common off-label uses for BoNT in dystonia are discussed. Toxins not currently FDA-approved for the treatment of dystonia are additionally reviewed. In the future, additional toxins may become FDA-approved for the treatment of dystonia given expanding research in this area.
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Adamina, Michel, Stefanos Bonovas, Tim Raine, Antonino Spinelli, Janindra Warusavitarne, Alessandro Armuzzi, Oliver Bachmann, et al. "ECCO Guidelines on Therapeutics in Crohn’s Disease: Surgical Treatment." Journal of Crohn's and Colitis 14, no. 2 (November 19, 2019): 155–68. http://dx.doi.org/10.1093/ecco-jcc/jjz187.
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Abstract This article is the second in a series of two publications relating to the European Crohn’s and Colitis Organisation [ECCO] evidence-based consensus on the management of Crohn’s disease. The first article covers medical management; the present article addresses surgical management, including preoperative aspects and drug management before surgery. It also provides technical advice for a variety of common clinical situations. Both articles together represent the evidence-based recommendations of the ECCO for Crohn’s disease and an update of previous guidelines.
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Weise, Martina, Pekka Kurki, Elena Wolff-Holz, Marie-Christine Bielsky, and Christian K. Schneider. "Biosimilars: the science of extrapolation." Blood 124, no. 22 (November 20, 2014): 3191–96. http://dx.doi.org/10.1182/blood-2014-06-583617.
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Abstract Despite the establishment of a specific approval pathway, the issuance of detailed scientific guidelines for the development of similar biological medicinal products (so-called “biosimilars”) and the approval of several biosimilars in the European Union, acceptance of biosimilars in the medical community continues to be low. This is especially true in therapeutic indications for which no specific clinical trials with the biosimilar have been performed and that have been licensed based on extrapolation of efficacy and safety data from other indications. This article addresses the concerns frequently raised in the medical community about the use of biosimilars in such extrapolated indications and explains the underlying scientific and regulatory decision making including some real-life examples from recently licensed biosimilars.
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Vila Wagner, Marcel, and Thomas Schanze. "Comparison of approval procedures for medical devices in Europe and the USA." Current Directions in Biomedical Engineering 5, no. 1 (September 1, 2019): 605–8. http://dx.doi.org/10.1515/cdbme-2019-0152.
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AbstractImportant achievements such as the discovery of penicillin increased life expectancy in the 19th century. At the beginning of the 20th century, the influence of technical equipment and biomedical research led to a further leap in life expectancy. The use of computer devices with sophisticated software also improved the quality of life. This is linked to the fact that all these achievements have now led to the emergence of one of the largest import and export markets in the USA, alongside the european union (EU), which is an association of European states. In order to guarantee a uniform quality of this abundance of different products and therapies, there are worldwide corresponding regulations, to which all manufacturers must adhere. The entry into force of these regulations, with the associated approval and testing obligations for each individual medical device, ensures that a consistently high quality of products is used on patients. Of course, high quality as well as high functionality and safety levels of medical products are a must. However, the implementation of these regulations is realized differently in the various markets, as there is no global harmonization. This work focuses on approval procedures for medical devices in Europe (EU) and the USA and compares significant differences in the approval procedures, which are shown as a graphical comparison. An example is an approval of medical devices by the U.S. Food and Drug Administration (FDA), which is an US government agency. In Europe (EU) there is a manufacturer’s declaration of conformity for the approval.
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Palmeri, S., J. Bergh, L. Bergmann, S. W. Hansen, J. M. Moraleda, M. Marty, J. H. Schellens, et al. "The European Medicines Agency (EMEA) guideline on oncology drug development." Journal of Clinical Oncology 25, no. 18_suppl (June 20, 2007): 6636. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.6636.
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6636 Background: The scientific assessment and positive opinion of the EMEA is mandatory for the approval of new oncology drugs in the European Union. One of the tasks of the EMEA is to provide guidance on the conduct of the various tests and trials necessary for approval. The EMEA has recently revised its guideline on the clinical development of new anticancer drugs. The revised version includes specific guidance on the development of non-cytotoxic (i.e., cytostatic) agents ( http://www.emea.europa.eu/pdfs/human/ewp/020595en.pdf ). Specific guidance is given about methodological issues using progression-free survival (PFS) as primary endpoint in confirmatory trials for registration ( http://www.emea.europa.eu/pdfs/human/ewp/26757506en.pdf ). Methods: The key elements of the revised guideline are described with particular reference to requirements for approval. Results: The early stages of clinical drug development have to be tailored according to the assumed pharmacology of the individual compound as defined in non-clinical studies. The integration of information from exploratory (phase I-II) and confirmatory (phase III) studies is of primary importance. In general, phase III trials should be designed with the aim of establishing the benefit risk balance of the drug, in a well-characterized target population. These studies should be randomized controlled and, where possible, blinded or include blinded evaluation. Acceptable primary endpoints include overall survival (OS) and PFS or disease-free survival (DFS). It is acknowledged that there are situations where PFS can be considered as a primary endpoint that measures clinical benefit. Adherence to protocol-defined schedules for tumor assessments, typically by imaging techniques, is important and deviations should be reported. Independent, blinded review and confirmation of best tumor response and progression should be undertaken if PFS is the primary endpoint. Conclusions: The current revision of the EMEA guideline provides useful clinical regulatory guidance for the development of cytostatic agents. When recommended guidelines are considered suboptimal, sponsors are encouraged to seek regulatory scientific advice. No significant financial relationships to disclose.
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Dillo, Ingrid, and Lisa De Leeuw. "Ten Years Back, Five Years Forward: The Data Seal of Approval." International Journal of Digital Curation 10, no. 1 (May 9, 2015): 230–39. http://dx.doi.org/10.2218/ijdc.v10i1.363.
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If we want to share data, the long-term storage of those data in a trustworthy digital archive is an essential condition. Trust is the basis of storing and sharing data. That trust must be present in the various stakeholders involved. Certification of digital archives can make an important contribution to the confidence of these stakeholders in the digital archives.Ten years ago DANS was assigned the task of developing a Seal of Approval for digital data to ensure that archived data can still be found, understood and used in the future. In 2009 this Data Seal of Approval (DSA) was transferred to an international body, the DSA Board, which has managed and further developed the guidelines and the peer review process ever since.The objectives of the DSA are to safeguard data, ensure high quality and guide reliable management of data for the future without requiring implementation of new standards, regulations or heavy investments. The DSA contains 16 guidelines for applying and verifying quality aspects concerning the creation, storage, use and reuse of digital data.Based on feedback from data archives that applied for a DSA and different case studies we have gained some insight into the benefits of DSA. Still, the impact of having the Seal is not easy to measure. Seal holders usually refer to qualitative benefits in the form of increased awareness of the value of their repositories to their communities, funders and publishers.Ten years down the line we can safely state that the Data Seal of Approval has proven its added value. If we try to look five years into the future, what can we expect? There are different developments: a growing interest in DSA among European research infrastructures, the collaboration between DSA and the ISCU World Data System under the umbrella of the RDA (Research Data Alliance) and the European Commission is showing a growing interest in certification services.The success of DSA also provides the challenge to further professionalize the DSA organization in the coming years, this to enable its community to continue to grow. All in all there are promising developments for a bright future for the Data Seal of Approval.
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Peddle, Monica. "Participant perceptions of virtual simulation to develop non-technical skills in health professionals." Journal of Research in Nursing 24, no. 3-4 (June 2019): 167–80. http://dx.doi.org/10.1177/1744987119835873.
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Background Research has identified that virtual simulations may be effective in developing non-technical skills including communication, teamwork and decision making. However, little is known about how participants perceive learning non-technical skills via engagement in virtual simulation. Aims The aim of this research was to investigate participant perceptions and the learning experiences when engaging in virtual simulations focused on developing non-technical skills. Method A descriptive exploratory approach was used. An online voluntary survey collected qualitative extended responses from participants after each virtual simulation. Ethics approval was obtained for the research and guidelines adhered to throughout the study. Results A total of 675 responses were obtained. Participants perceive that engaging with the virtual simulation made them aware of non-technical skills including communication, teamwork, decision making, critical thinking and problem solving, and, to a lesser extent, situational awareness. Additional categories of learning, clinical practice and limitations were identified. Conclusions Engaging in virtual simulation can develop awareness of non-technical skills, as well as confidence and vigilance in practice and mindfulness of a person-centred approach to healthcare. Engaging in virtual simulation may support change in the professional performance of the participants through role modelling and learning through error.
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do Monte, Maria Helena F. Marecos, Andreas N. Angelakis, and Takashi Asano. "Necessity and basis for establishment of European guidelines for reclaimed wastewater in the Mediterranean region." Water Science and Technology 33, no. 10-11 (May 1, 1996): 303–16. http://dx.doi.org/10.2166/wst.1996.0688.
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The use of reclaimed wastewater for irrigation contributes to water conservation and, therefore, is an important component of a sound policy for water resources management in the Mediterranean region. With the exception of France and Germany, European Mediterranean countries have not established guidelines for the use of reclaimed wastewater for irrigation. The existence of such guidelines means an important step in the planning and implementation of safe use of reclaimed wastewater for irrigation, because it contributes to a sustainable development of landscape and agricultural irrigation. Guidelines for reclaimed wastewater use for irrigation must clearly define what is allowed and what is forbidden to execute. This can be defined in great detail or in a broad manner, but must take into account some important specific local conditions, such as the quality of reclaimed wastewater, soil, climate, relevant crops and agricultural practices. Consequently, experimentation means a key-support to establishing guidelines. The experience from a research project with different type of reclaimed wastewater, crops and irrigation methods carried out for several years in the climatic Mediterranean region of Portugal brings some contribution to the technical content of possible European guidelines. Other aspects to be included in the proposed guidelines, such as monitoring and institutional management are also presented.
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Nugraheni, Fitri, Vendie Abma, and Sigit Yasien. "Scheduling of Application for Siteplan Authorization Permit Case of Licensing Process at Investment and Integrated Licensing Services Office in Sleman Regency." Applied Research on Civil Engineering and Environment (ARCEE) 1, no. 02 (February 5, 2020): 29–39. http://dx.doi.org/10.32722/arcee.v1i02.2680.
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The permit process must comply with laws and regulations. The permit functions as controlling and supervising tool from the government of activities in certain cases based on the guidelines that must be implemented. The permit also functions as a disciplinarian and regulator in accordance with the law in the administration of government. In the process, several constrains or obstacles often occur in terms of the period of the process as well as technical and non-technical constrains. In this research, an analysis of the scheduling of the site plan permit approval process is based on field data related to the site plan permit approval process with the PERT method. The data used are primary data in the form of interviews and filling in the form of questions and secondary data in the form of a site plan approval process flow. The data that has been collected is then processed and analyzed in several stages. First, calculate the expected time period (te) using interview data and the results of filling in the expected time period (te), so that the expected time period for each activity will be found in accordance with the site plan approval process flow. Second, determine the dependency relationship between activities. In this stage, the relationship between each activity is determined. Third, create a network by changing the existing site authorization process flow into a form of network planning. The results of the schedule using the PERT method are a period of 38 days with alternatives that can be done to reach the time (Tx) of 18 working days in accordance with the Regent Regulations. In addition, the probability of the overall activity being completed is 0.8531 or 85.31%.
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Rumin, Judith, Raimundo Gonçalves de Oliveira Junior, Jean-Baptiste Bérard, and Laurent Picot. "Improving Microalgae Research and Marketing in the European Atlantic Area: Analysis of Major Gaps and Barriers Limiting Sector Development." Marine Drugs 19, no. 6 (May 30, 2021): 319. http://dx.doi.org/10.3390/md19060319.
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Microalgae and cyanobacteria represent a diverse renewable resource with significant potential for the industrial production of goods and services with high added value. However, scientific, technical/technological, legislative and market gaps and barriers still limit the growth of these markets in Europe and the number of exploited species. We conducted an in-depth survey of European microalgae researchers, experts and stakeholders to identify these limitations and to discuss strategies, recommendations and guidelines to overcome these barriers. Here, we present the findings of this study which detail the main promising markets for microalgae and cyanobacteria in the coming decades, an updated SWOT analysis of the sector, the current opportunities, limitations, risks and threats for microalgae research and market sectors in Europe, a traffic light analysis for a quick assessment of market opportunities for each microalgae sector and detailed recommendations/guidelines for overcoming the scientific, technical/technological, legislative and market gaps and barriers.
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Brown, Kerry A., Maria Hermoso, Lada Timotijevic, Julie Barnett, Inger Therese L. Lillegaard, Irena Řehůřková, Ainhoa Larrañaga, et al. "Consumer involvement in dietary guideline development: opinions from European stakeholders." Public Health Nutrition 16, no. 5 (November 27, 2012): 769–76. http://dx.doi.org/10.1017/s1368980012005125.
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AbstractObjectiveThe involvement of consumers in the development of dietary guidelines has been promoted by national and international bodies. Yet, few best practice guidelines have been established to assist with such involvement.DesignQualitative semi-structured interviews explored stakeholders’ beliefs about consumer involvement in dietary guideline development.SettingInterviews were conducted in six European countries: the Czech Republic, Germany, Norway, Serbia, Spain and the UK.SubjectsSeventy-seven stakeholders were interviewed. Stakeholders were grouped as government, scientific advisory body, professional and academic, industry or non-government organisations. Response rate ranged from 45 % to 95 %.ResultsThematic analysis was conducted with the assistance of NVivo qualitative software. Analysis identified two main themes: (i) type of consumer involvement and (ii) pros and cons of consumer involvement. Direct consumer involvement (e.g. consumer organisations) in the decision-making process was discussed as a facilitator to guideline communication towards the end of the process. Indirect consumer involvement (e.g. consumer research data) was considered at both the beginning and the end of the process. Cons to consumer involvement included the effect of vested interests on objectivity; consumer disinterest; and complications in terms of time, finance and technical understanding. Pros related to increased credibility and trust in the process.ConclusionsStakeholders acknowledged benefits to consumer involvement during the development of dietary guidelines, but remained unclear on the advantage of direct contributions to the scientific content of guidelines. In the absence of established best practice, clarity on the type and reasons for consumer involvement would benefit all actors.
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Taylor, A. C., and T. D. Fletcher. "Triple-bottom-line assessment of urban stormwater projects." Water Science and Technology 54, no. 6-7 (September 1, 2006): 459–66. http://dx.doi.org/10.2166/wst.2006.598.
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New guidelines have been developed and trialled in Australia to assist urban stormwater managers to assess options for projects that aim to improve urban waterway health. These guidelines help users to examine the financial, ecological and social dimensions of projects (i.e. the so-called “triple-bottom-line”). Features of the assessment process described in the guidelines include use of multi criteria analysis, input from technical experts as well as non-technical stakeholders, and provision of three alternative levels of assessment to suit stormwater managers with differing needs and resources. This paper firstly provides a background to the new guidelines and triple-bottom-line assessment. The assessment methodology promoted in the new guidelines is then briefly summarised. This methodology is compared and contrasted with European guidelines from the “SWARD” project that have been primarily developed for assessing the relative sustainability of options involving urban water supply and sewerage assets. Finally, the paper discusses how assessment methodologies that evaluate the financial, ecological and social dimensions of projects can, under some circumstances, be used to evaluate the relative progress of options for urban water management on a journey towards the widely pursued, but vaguely defined goal of “sustainable development”.
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Prorok, Vesna, Neven Šerić, and Ivan Peronja. "Analysis of Overall and Pure Technical Efficiency of Tourism in Europe." Transactions on Maritime Science 8, no. 2 (October 21, 2019): 219–29. http://dx.doi.org/10.7225/toms.v08.n02.007.
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The aim of this paper is to assess the overall and pure technical efficiency of tourism in European countries in 2017 using the output-oriented Charnes, Cooper and Rhodes (1978, 1979), and Banker, Charnes and Cooper (1984) data envelopment analysis methodology. The countries were divided into two groups: European Union countries and non-European counties. We identified two input and two output variables for each group. Input variables were identified using the principal component analysis method, starting from fourteen pillars that measure the performance of countries in the field of travel and tourism, and are published in the regular reports of the World Economic Forum. Then, two output variables were defined (the total (direct and indirect) contribution of travel and tourism to gross domestic product, and the direct contribution of tourism to employment growth rate), to determine the relative efficiency of decision-making units within the formed homogeneous groups of countries, among which the group of Western Balkan countries was singled out. This analysis enabled us, based on relatively scarce potential, to propose guidelines for a tourism development strategy for the entire Western Balkans region.
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Lachenmeier, Dirk W., and Stephan G. Walch. "Evidence for side effects of cannabidiol (CBD) products and their non-conformity on the European food market – response to the European Industrial Hemp Association." F1000Research 9 (August 26, 2020): 1051. http://dx.doi.org/10.12688/f1000research.26045.1.
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An interesting and valuable discussion has arisen from our recent article (Lachenmeier et al., 2020) and we are pleased to have the opportunity to expand on the various points we made. Equally important, we wish to correct several important misunderstandings that were made by Kruse and Beitzke (2020) on behalf of the European Industrial Hemp Association (EIHA) that possibly contributed to their concerns about the validity of our data, toxicological assessment and conclusions regarding regulatory status of cannabidiol (CBD) products. First and foremost, our study did only assess the risk of psychotropic Δ9-tetrahydrocannabinol (THC) without inclusion of non-psychotropic Δ9-tetrahydrocannabinolic acid (THCA). Secondly, as this article will discuss in more detail, there is ample evidence for side effects of CBD products, not only in paediatric patients, but also in adult users of over-the-counter CBD products (including inadvertent “high” effects). Thirdly, the exposure and risk assessment was conducted using up-to-date guidelines according to the European Food Safety Authority (EFSA) and the German Federal Institute for Risk Assessment (BfR). And finally, the current legal situation in the European Union, without approval of any hemp extract-containing product according to the Novel Food regulation, actually allows blanket statements that all such products are illegal on the market, and this indeed would imply a general ban on the use and marketing of such products as food or food ingredients until such an approval has been granted. We hope that this reassures the F1000Research readership regarding the validity of our results and conclusions. We are pleased, though, that the EIHA has acknowledged the fact that there are non-compliant CBD products available, but according to our data these are a substantial fraction of the market.
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Lachenmeier, Dirk W., and Stephan G. Walch. "Evidence for adverse effects of cannabidiol (CBD) products and their non-conformity on the European food market – response to the European Industrial Hemp Association." F1000Research 9 (August 16, 2021): 1051. http://dx.doi.org/10.12688/f1000research.26045.2.
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An interesting and valuable discussion has arisen from our recent article (Lachenmeier et al., 2020) and we are pleased to have the opportunity to expand on the various points we made. Equally important, we wish to correct several important misunderstandings that were made by Kruse and Beitzke (2020) on behalf of the European Industrial Hemp Association (EIHA) that possibly contributed to their concerns about the validity of our data, toxicological assessment and conclusions regarding regulatory status of cannabidiol (CBD) products. First and foremost, our study did only assess the risk of psychotropic Δ9-tetrahydrocannabinol (THC) without inclusion of non-psychotropic Δ9-tetrahydrocannabinolic acid (THCA). Secondly, as this article will discuss in more detail, there is ample evidence for adverse effects of CBD products, not only in paediatric patients, but also in adult users of over-the-counter CBD products (including inadvertent “high” effects). Thirdly, the exposure and risk assessment was conducted using up-to-date guidelines according to the European Food Safety Authority (EFSA) and the German Federal Institute for Risk Assessment (BfR). And finally, the current legal situation in the European Union, without approval of any hemp extract-containing product according to the Novel Food regulation, actually allows blanket statements that all such products are illegal on the market, and this indeed would imply a general ban on the use and marketing of such products as food or food ingredients until such an approval has been granted. We hope that this reassures the F1000Research readership regarding the validity of our results and conclusions. We are pleased, though, that the EIHA has acknowledged the fact that there are non-compliant CBD products available, but according to our data these are a substantial fraction of the market.
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Ignalewski, Wojciech, and Magdalena Kaup. "Conceptual ship design intendent for European inland waterway shipping." WUT Journal of Transportation Engineering 121 (June 1, 2018): 85–93. http://dx.doi.org/10.5604/01.3001.0014.4569.
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The article presents the stages of conceptual design of inland vessels intended for navigation on international waterways of the European Union, which, connection with the Directive of the European Parliament and of the Council (EU) 2016/1629 of 14 September 2016 laying down technical requirements for inland waterway vessels, they form the basis for the development of new concepts of inland watercraft. It presents, among others, block diagram of the course of the design process, the axiomatic model of the inland ship and the use of innovative materials in the construction of inland waterway vessels. The purpose of the article was to explain and organize the basic principles of construction and design of inland vessels in accordance with modern requirements and guidelines.
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Kondratyeva, E. I., E. L. Amelina, M. Yu Chernukha, V. D. Sherman, S. A. Krasovskiy, N. Yu Kashirskaya, O. I. Simonova, et al. "Review of clinical guidelines “Cystic fibrosis”, 2020." PULMONOLOGIYA 31, no. 2 (April 11, 2021): 135–46. http://dx.doi.org/10.18093/0869-0189-2021-31-2-135-146.
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The aim of the experts who provide health care for patients with cystic fibrosis (CF) has been to develop clinical guidelines on cystic fibrosis for children and adults.Methods. The 2020 Clinical Guidelines were based on the European consensus documents on cystic fibrosis and the national consensus “Cystic fibrosis: definition, diagnostic criteria, therapy” (2016, 2019). When creating clinical guidelines, the experts were guided by Article 2 of the Federal Law No.323-FL “On the basics of health care in the Russian Federation” as of November 21st, 2011, and the regulatory legal documents governing the development and approval of clinical guidelines (https://rosmedex.ru/kr/).Results. The clinical guidelines were approved by the Federal State Budgetary Institution “Centre for Expertise and Quality Control of Medical Care” of the Russian Ministry of Health in August 2020. Standards of medical care for children and adults with cystic fibrosis were prepared based on these guidelines. The diagnostic algorithms have been expanded with a three-stage DNA diagnostic strategy, functional assays of CFTR channel, laboratory and instrumental diagnostic tools for assessing disorders of respiratory and other systems, diagnosis of the microbial inflammatory process, microbiological monitoring, and therapeutic approaches. The antibiotic therapy with dosages and courses is described in detail. The updated document should describe a unified tactic for the management of Russian CF patients.Conclusion. Unified clinical guidelines for children and adults should develop unified tactics for the diagnosis, therapy, and follow-up of CF patients in the Russian Federation and ensure continuity between health care services for children and adults.
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Chegu, Sadhika, and Maddi V. Nagabhushanam. "A Comprehensive Study on Regulation of Herbal Drugs in India, US and European Union." International Journal of Drug Regulatory Affairs 9, no. 1 (March 19, 2021): 78–86. http://dx.doi.org/10.22270/ijdra.v9i1.458.
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The current investigation surveys the guidelines of natural medications in the India US and Europe and illuminates issues identified with their clinical preliminaries. Natural medications have been utilized for quite a while in various frameworks of wellbeing like Ayurveda, Yunani, Sidha and Homeopathy for treating number of infections. It is an exceptionally hard to perform clinical investigation on Hm’s medications in light of the fact that these medications are an unpredictable mix of dynamic fixings. It is subsequently hard to distinguish the fixing which is answerable for the remedial impact among different elements of Hm’s medications. The normalization of Hm’s medications is likewise a troublesome assignment. Notwithstanding every one of these issues are existing public interest has expanded towards natural medications in last two thirty years in light of their long history of treating the illness securely. The laws and guidelines for natural medications are distinctive in various nations. The WHO has expressed that every nation ought to have a framework to control Hm’s medications in their region. In Europe, the Committee on Herbal Medicinal Products (HMPC) was established in accordance with Regulation (EC) No 726/2004 and Directive 2004/24/EC, which introduced a simplified registration procedure for traditional herbal medicinal products in EU Member States. The primary obligation of HMPC is to assess and give approval for natural medications based on their wellbeing and adequacy. In US spices are delegated dietary enhancements after the presentation of the Dietary Supplement Health and Education Act (DSHEA) in1994. In US natural medications are sorted into two kinds, first is OTC Hm’s medications and medications which required NDA endorsement. In India the Department of AYUSH has made rules for quality improvement of natural substances. The current investigation audits the guidelines of herbal medications (Hm’s) in the India US and Europe illuminates issues identified with their clinical preliminaries.
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Andreev, A. L. "Humanitarian Contexts of Technical Education in Russia." Vysshee Obrazovanie v Rossii = Higher Education in Russia 30, no. 4 (May 4, 2021): 62–72. http://dx.doi.org/10.31992/0869-3617-2021-30-4-62-72.
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The article deals with the problem of formation of social and humanitarian competen[1]cies in Russian engineering education. The author shows how different views on the relationship between man and machine, as well as between society and the technosphere, were translated into various public initiatives and analyzes the impact of these initiatives on the evolution of approaches to engineering education. Special attention is paid to the promotion of the ideology of design think[1]ing and the movement for the humanitarization of engineering education. Both gained a consider[1]able popularity in the last quarter of the twentieth century. However, in modern conditions, the relationship between technological progress and the development of human society is taking on new forms that require new answers. There are also new risks – in particular, the risk of complete de[1]humanization of technological progress and the unclear prospect of the formation of a so-called post-human civilization. Social assessment of technology and the development of value-based tech[1]nologies are possible answers. They have received a very significant support in the United States and Western Europe. In particular, several European conferences on this topic have already been held within the EU (the latest one took place in Bratislava in 2019). However, due to some features of the Russian intellectual tradition, as well as the pronounced techno-optimism of mass consciousness, the Russian academic environment has not yet shown sufficient interest to implant these approaches in technical education. The possibility of managing the current technological progress on the basis of a dialogue with civil society, which is popular in the European Union, is also not considered in Russian intellectual environments. At the same time, the leading technical universities in Russia are gradually developing a network of enthusiasts who are studying the European practice of social assessment of technology and its adaptation to Russian conditions. Such adapted practices may become the con[1]ceptual guidelines for Russian engineering education.
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Dietrich, Christoph F., Christian Pállson Nolsøe, Richard G. Barr, Annalisa Berzigotti, Peter N. Burns, Vito Cantisani, Maria Cristina Chammas, et al. "Guidelines and Good Clinical Practice Recommendations for Contrast Enhanced Ultrasound (CEUS) in the Liver – Update 2020 – WFUMB in Cooperation with EFSUMB, AFSUMB, AIUM, and FLAUS." Ultraschall in der Medizin - European Journal of Ultrasound 41, no. 05 (July 24, 2020): 562–85. http://dx.doi.org/10.1055/a-1177-0530.
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AbstractThe present, updated document describes the fourth iteration of recommendations for the hepatic use of contrast enhanced ultrasound (CEUS), first initiated in 2004 by the European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB). The previous updated editions of the guidelines reflected changes in the available contrast agents and updated the guidelines not only for hepatic but also for non-hepatic applications.The 2012 guideline requires updating as previously the differences of the contrast agents were not precisely described and the differences in contrast phases as well as handling were not clearly indicated. In addition, more evidence has been published for all contrast agents. The update also reflects the most recent developments in contrast agents, including the United States Food and Drug Administration (FDA) approval as well as the extensive Asian experience, to produce a truly international perspective.These guidelines and recommendations provide general advice on the use of ultrasound contrast agents (UCA) and are intended to create standard protocols for the use and administration of UCA in liver applications on an international basis to improve the management of patients.
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Vodusek, David B., Wolfgang Grisold, Marianne De Visser, Nils Erik Gilhus, and Guido Cavaletti. "Guidelines by the European Federation of Neurological Societies (EFNS) subcommittee for Continuing Medical Education (CME) - modification 2003. EFNS - approval of CME." European Journal of Neurology 11, no. 3 (March 2004): 145–51. http://dx.doi.org/10.1111/j.1468-1331.2004.00790.x.
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Häßler, Dustin, and Sascha Hothan. "Numerical and Experimental Analysis of Reactive Fire Protection Systems Applied to Solid Steel Rods in Tension." Journal of Structural Fire Engineering 6, no. 4 (June 17, 2015): 275–82. http://dx.doi.org/10.1260/2040-2317.6.4.275.
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The application of intumescent coatings for fire protection of steel constructions is increasing. Thanks to the relative thin thickness of the coatings, the typical visual appearance of the structures can remain essentially unchanged. In Germany, the applicability of the systems is regulated by the national as well as European technical assessments. According to the approvals, the application on steel members in tension is only allowed with limitations. Especially, the application on solid steel rods in tension is currently excluded from the approval. The paper explains the actual state of the art of the application of reactive fire protection systems applied to steel structures. Physical and technical background information are provided. Furthermore, the latest scientific results of an on-going research project funded by the German National Institute of Building Technology (DIBt) and conducted by the Federal Institute for Materials Research and Testing (BAM) will be described.
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Behrendt, C. ‑A, U. Rother, G. Rümenapf, C. Uhl, H. Görtz, and D. Böckler. "Randomized controlled trials and real-world evidence for market access and surveillance of high-risk products—The example of paclitaxel." Gefässchirurgie 25, S1 (November 27, 2020): 29–36. http://dx.doi.org/10.1007/s00772-020-00726-0.
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AbstractIn 2018 and 2020, two meta-analyses using summary-level data from randomized controlled trials reported worse mortality following the application of paclitaxel-coated stents and balloons in femoropopliteal and crural arteries. These results initiated a heated global discussion concerning the validity of this association, while various observational studies using clinical and administrative registries proved the safety of coated devices. This article aimed to summarize the development and adoption of paclitaxel-coated balloons and stents for the treatment of peripheral arterial occlusive disease in clinical practice, research, and practice guidelines. It especially focusses on the European Unionʼs medical device regulation, which has far-reaching implications for the market approval and monitoring of high-risk medical devices.
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Marzukhi, Marlyana Azyyati, Oliver Ling Hoon Leh, Nurul Shakila Khalid, and Azfarnizam Jaafar. "THE BUILDING PLAN APPROVAL PROCESS FOR RESIDENTIAL DEVELOPMENT IN ONE STOP CENTRE. CASE STUDY: SUBANG JAYA MUNICIPAL COUNCIL, SELANGOR." Journal of Surveying, Construction & Property 11, no. 2 (October 15, 2020): 40–49. http://dx.doi.org/10.22452/jscp.sp2020no1.4.
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The building plan approval involved with regulations, laws and guidelines to ensure systematic and orderly development. The growth in construction activities in Malaysia since the 1980’s has given rise to the need for more statutory controls in obtaining permissions from the relevant authorities to initiate and to construct a facility and upon its completion to occupy and use the completed facility. The understanding of building plan process is important to understand whether the development follows the building regulations. Thus, the construction failures can be limited. Nevertheless, little is known about the effectiveness of building plan process in the local authority though the enhancement of mechanism delivery system of the process known as One Stop Centre (OSC) has been established. The study was conducted to investigate the effectiveness of building plan approval process in Subang Jaya Municipal Council (MPSJ). Forty-seven (47) questionnaires survey has been distributed to respondents from the MPSJ's internal technical departments. Most of the respondents felt that the ineffectiveness of the building plan approval process was due to the incomplete documents submitted to the OSC, lack of knowledge among the Principal Submitting Person (PSP) and the incapability of staffs in handling development applications. The findings present a synthesis of results for town planners, architects, developers and government agencies to have a better understanding of how the effective and efficient building plan process can rationalize the success of property development sector in Malaysia.
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LEHMKUHL, DIRK. "On Government, Governance and Judicial Review: The Case of European Competition Policy." Journal of Public Policy 28, no. 1 (April 2008): 139–59. http://dx.doi.org/10.1017/s0143814x08000810.
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ABSTRACTFrom a traditional rationalist principal-agent framework, the development of the European Community’s competition policy could appear as a straightforward story of agency loss. However, the recent overhaul of competition policy, which the Community presented in terms of decentralisation, appears to have changed the story. We are confronted with the uncommon event of an agent (the European Commission) returning some of its powers to the principals (the member states). This paper resolves the puzzle by highlighting the role of the Commission and of European courts. It has become part of the Commission’s strategy to pursue its objectives through legally non-binding instruments such as notices or guidelines or co-operation in networks. These instruments do not need the approval of the Council of Ministers or the European Parliament. With the Commission’s promotion of new modes of governance, the link between sectoral governance (in terms of regulation specific to competition policy) and the governmental shadow of hierarchy shifted to an increasing extent to judicial review by European courts. Alongside this shift, the character of judicial review has changed in the direction of judicial control, as European courts no longer restrict themselves to review of the legality of Commission actions, but also engage in assessing the facts themselves.
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Van de Geuchte, Sofie, and Leona Van Vaerenbergh. "Text creation in a multilingual institutional setting." Cognitive space: Exploring the situational interface 5, no. 1 (January 1, 2007): 59–77. http://dx.doi.org/10.1075/ts.5.1.04van.
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Text creation is influenced by situational factors, like the context in which the text is written. In a multilingual institution, the context is especially important, because it is controlled by rules and guidelines. This paper presents a case study conducted in the European Commission and the Directorate General for Translation. The text creation and translation process were reconstructed starting from the published version in the Official Journal of the European Union back to the initial idea. The paper focuses on the impact that external processes have on internal processes. We found that text editing and translation go hand in hand and that translators are part of a cooperative system in which their input is of importance for the source text. Moreover, the impact of the institution is significant, since it determines not only the work processes, but also the linguistic form, technical medium and technical content.