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Grazal, John G., and David S. Earl. "EU and FDA GMP regulations: overview and comparison." Quality Assurance Journal 2, no. 2 (1997): 55–60. http://dx.doi.org/10.1002/(sici)1099-1786(199706)2:2<55::aid-qaj35>3.0.co;2-x.
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He, Tian-Tian, Carolina Oi Lam Ung, Hao Hu, and Yi-Tao Wang. "Good manufacturing practice (GMP) regulation of herbal medicine in comparative research: China GMP, cGMP, WHO-GMP, PIC/S and EU-GMP." European Journal of Integrative Medicine 7, no. 1 (2015): 55–66. http://dx.doi.org/10.1016/j.eujim.2014.11.007.
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Ban, Eunmi, Dong-Jin Jang, Taek-Hyun Kwon, and Aeri Kim. "Pharmaceutical GMP Inspection: Case Study of USA and EU." Yakhak Hoeji 63, no. 1 (2019): 15–23. http://dx.doi.org/10.17480/psk.2019.63.1.15.
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Meshkovskiy, A. P., N. V. Pyatigorskaya, Z. I. Aladysheva, et al. "Responsibilities of the Marketing Authorisation Holders in Respect of GMP Compliance (Review)." Drug development & registration 9, no. 4 (2020): 164–70. http://dx.doi.org/10.33380/2305-2066-2020-9-4-164-170.
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Introduction. The article is focused on differences in quality assurance-related obligations and responsibilities between Marketing Authorisation Holders (MAHs) and manufacturing authorisation holder (manufacturers) in pharmaceutical industry. In case of outsourcing and technical agreements there is a need to differentiate responsibilities related to quality assurance between the above mentioned categories.Text. The guidelines for the pharmaceutical sector of the European Union (EU) provide guidance on the responsibilities of the MAHs in relation to the GMP rules, which are scattered throughout the various chapters of the GMP and its appendices. In addition, certain provisions on this topic are contained in the EU directives. With this in mind the European Medicines Agency (EMA) issued in January 2020 a draft Reflection paper on Good manufacturing practice and Marketing Authorisation Holders. The draft clarifies that while certain activities of an MAH may be delegated to the manufacturer, MAH retains ultimate responsibility for the performance of a medicinal product, its safety, quality and efficacy. The important obligation of MAH in this context is to facilitate GMP compliance by establishing a robust two-way communication system with national competent authorities, manufacturing sites, Qualified Persons (QPs) certifying batches before release, and other interested parties. The MAH ought to communicate to manufacturing personnel, normally through QPs, production processes and related quality control procedures, including subsequent variations, described in registration dossiers.Conclusion. A general one conclusion: in view of rapid developments in the EU GMP Guide, the Eurasian Economic Union GMP requirements ought to be updated. In respect of specific responsibilities of MAH pertaining to GMP compliance the EMA draft Reflection paper merits attention as a guidance regarding separation of obligations and responsibilities between MAH and personnel of manufacturing sights.
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Wang, Fengyi, Xuan Hu, Jing Hu, et al. "Fluorescence assay for alkaline phosphatase activity based on energy transfer from terbium to europium in lanthanide coordination polymer nanoparticles." Journal of Materials Chemistry B 6, no. 37 (2018): 6008–15. http://dx.doi.org/10.1039/c8tb01713a.
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Berezovska, I. "LEGAL FRAMEWORK OF GOOD MANUFACTURING PRACTICE (GMP) FOR VETERINARY MEDICINAL PRODUCTS IN THE EU: EXPERIENCE FOR UKRAINE." Actual Problems of International Relations, no. 137 (2018): 65–76. http://dx.doi.org/10.17721/apmv.2018.137.0.65-76.
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The article comprehensively analyzes current legislation of the European Union on Good Manufacturing Practice (GMP) for veterinary medicinal products in particular the provisions of Directives No. 91/412 and No. 2001/82, and describes GMP main elements. It is noted that as a result of EU-Ukraine Association Agreement signing a new stage in the development of Ukrainian legislation regarding the turnover of veterinary medicinal products has begun, which is characterized by the increased impact of EU law on the legal regulation of this industry. The state of the appropriate national legislation reforming was analyzed. It was proved that today the main directions of such reforming are related to the integrated introduction of Good Manufacturing Practice and to the restoration of the production of veterinary medicinal products licensing. The importance of prompt and effective completion of these reforms which will have significant consequences not only for the national pharmaceutical industry, but also for the protection of the health of animals and people in general, was underscored. It was emphasized that the scale of the obligations undertaken by Ukraine to harmonize the legislation on the circulation of veterinary medicinal products requires prompt and qualified organizational work by the Ukrainian competent authorities.
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Chimenti, Isotta, Roberto Gaetani, Elvira Forte, et al. "Serum and supplement optimization for EU GMP ‐compliance in cardiospheres cell culture." Journal of Cellular and Molecular Medicine 18, no. 4 (2014): 624–34. http://dx.doi.org/10.1111/jcmm.12210.
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Tomić, Siniša, Anita Sučić, and Adrijana Martinac. "Good Manufacturing Practice: The Role of Local Manufacturers and Competent Authorities." Archives of Industrial Hygiene and Toxicology 61, no. 4 (2010): 425–36. http://dx.doi.org/10.2478/10004-1254-61-2010-2035.
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Good Manufacturing Practice: The Role of Local Manufacturers and Competent AuthoritiesIn every country, a manufacturer of medicinal products for either human or veterinary use is required to operate in compliance with local legislation. In all EU Member States, legislation is approximated to the effect that they are committed to abide by the same standards. The candidate countries transpose the acquis into their national legislation, including the good manufacturing practice (GMP). Consequently, the local manufacturer is required to strictly comply with GMP and the manufacturing licence, including for medicinal products exclusively intended for export. A vital role is also played by national regulatory authorities, in Croatia by the Agency for Medicinal Products and Medical Devices which issues the manufacturing licence, GMP certificate, and the Certificate of a Pharmaceutical Product (CPP) and conducts laboratory control of products. GMP inspection is carried out by the Pharmaceutical Inspectorate with the Ministry of Health and Social Welfare. Both authorities are responsible only for human medicines. There are legislative issues not yet harmonised with the acquis, but as a country aspiring for the EU membership, Croatia is expected to demonstrate that its industry and competent authorities are able to conform to current requirements and thus fully adhere to the integrated European regulatory network. Hence the importance of strengthening the institutional capacity of the competent authorities, as insufficient resources may have a direct bearing on patients by limiting their access to affordable treatment.
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Sun, Jing-lin, and Bo-yang Yu. "The History and Prospects of Overseas GMP Inspection in China." Public Administration Research 11, no. 1 (2022): 24. http://dx.doi.org/10.5539/par.v11n1p24.
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Carrying out the overseas GMP (Good Manufacturing Practices) inspection is a key responsibility of the National Regulatory Agency to supervise the imported pharmaceutical products. And it&rsquo;s also an important measure to maintain the safety of the pharmaceutical products used by the public. In April 2011, China began to implement the pilot work of overseas GMP inspection. Through exploration and summary, a complete set of inspection procedures and systems have been formed. In this paper, the development history of China&#39;s overseas GMP inspection is reviewed, the inspection process and the treatment of inspection results are compared with the US FDA, the EU, WHO and so on. This paper analyzes the numbers, countries and types of products in the overseas GMP inspections, which carried out by China in the past decade, makes a statistical analysis of the observations found in the inspections, discusses the areas where the observations are concentrated, and focuses on the areas where the critical observations are concentrated. Finally, the trend of overseas GMP inspection in the future is prospected.
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Gildehaus, Franz. "Aufbau eines GMP-Radionuklidlabors." Der Nuklearmediziner 40, no. 04 (2017): 253–61. http://dx.doi.org/10.1055/s-0043-111356.
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ZusammenfassungMit der Änderung des Arzneimittelgesetzes 2009 erfolgte eine Neubewertung der Herstellung von Radiopharmaka. Seitdem unterliegt ihre Herstellung grundsätzlich dem Arzneimittelgesetz, wobei dies nicht nur für nicht-zugelassene Radiopharmaka gilt, sondern ebenso für die Herstellung von Tc-Kits aus zugelassenen Mo/Tc-Generatoren mithilfe von zugelassenen Markierungskits. Die für die Herstellung verantwortliche Person muss laut § 13 (1) entweder eine sachkundige Person sein, oder nach § 13 (2b) ein Arzt, der auch persönlich die Anwendung bei einem bestimmten Patienten vornimmt. Die Herstellung und Qualitätskontrolle von Arzneimitteln selbst unterliegt einer Reihe von Gesetzen, Verordnungen, Leitlinien und EU-Richtlinien, die aber oft nicht eindeutig oder nur eingeschränkt auf Radiopharmaka anwendbar sind. Leider erfolgt die Auslegung dieser Regelungen durch die lokalen Überwachungsbehörden innerhalb Deutschlands sehr uneinheitlich. Einer der Gründe dafür ist sicherlich die unterschiedliche Ausstattung der einzelnen Kliniken und Praxen in den verschiedenen Bundesländern. Aus Gründen einer flächendeckenden Patientenversorgung werden noch viele veraltete Einrichtungen geduldet, aber meist zieht eine Modernisierung der Räumlichkeiten auch die Anpassung der Arbeitsweise, Dokumentation und Qualitätssicherungsmaßnahmen an die bestehenden rechtlichen Rahmenbedingungen nach sich. Hierzu müssen sich die Betreiber mit den heute gültigen GMP-Anforderungen auseinandersetzen, die mit ihren vielfältigen Themen wie der baulichen Konzeption, einer personellen Weiterentwicklung, den Bedingungen einer aseptischen Arbeitsweise, der Prozessvalidierung und den Freigabekriterien für Parenteralia hohe Anforderungen stellt. Alle diese Punkte sollten dabei schon im Vorfeld mit den Fachleuten der zuständigen Überwachungsbehörde diskutiert werden, um risikobasiert die notwendigen Maßnahmen abzuschätzen. Dennoch muss eine weitgehende nationale Harmonisierung der Radiopharmaka-Herstellung und die Spezifizierung der gesetzlichen Anforderungen ein vorrangiges Ziel sein, da z. B. PET-Radiopharmaka heute zum Repertoire der modernen Nuklearmedizin gehören, auch wenn der Zugang zu innovativen Tracern für den niedergelassenen Nuklearmediziner in mehrfacher Hinsicht außerordentlich eingeschränkt ist. Die Verfügbarkeit wurde mit dem Inkrafttreten der 15. Novelle des AMG neu geregelt. Durch den Wegfall des ehemaligen § 4a Satz 1 Nr. 3 fallen Herstellung und Anwendung dieser Präparationen nun unter den Geltungsbereich des AMG und die damit verbundenen Tätigkeiten sind nach § 67 Abs. 2 bei der zuständigen Genehmigungsbehörde anzeigepflichtig. Aus der geschilderten Situation ergibt sich die Notwendigkeit, über Möglichkeiten der Eigenherstellung von Radiopharmaka unter GMP-Bedingungen auch in kleineren klinischen Einrichtungen nachzudenken.
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Souto, Eliana B., Gabriela F. Silva, João Dias-Ferreira, et al. "Nanopharmaceutics: Part I—Clinical Trials Legislation and Good Manufacturing Practices (GMP) of Nanotherapeutics in the EU." Pharmaceutics 12, no. 2 (2020): 146. http://dx.doi.org/10.3390/pharmaceutics12020146.
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The latest advances in pharmaceutical technology are leading to the development of cutting edged approaches to produce what is now known as the “Holy Grail” of medicine—nanopharmaceutics. Over the latest decade, the pharmaceutical industry has made important contributions to the scale up of these new products. To ensure their quality, efficacy, and safety for human use, clinical trials are mandatory. Yet, regulation regarding nanopharmaceuticals is still limited with a set of guidelines being recently released with respect to compliance with quality and safety. For the coming years, updates on regulatory issues about nanopharmaceuticals and their use in clinical settings are expected. The use of nanopharmaceuticals in clinical trials depends on the approval of the production methods and assurance of the quality of the final product by implementation and verification of the good manufacturing practices (GMP). This review addresses the available legislation on nanopharmaceuticals within the European Union (EU), the GMP that should be followed for their production, and the current challenges encountered in clinical trials of these new formulations. The singular properties of nanopharmaceuticals over their bulk counterparts are associated with their size, matrix composition, and surface properties. To understand their relevance, four main clinical trial guidelines, namely, for intravenous iron-based nanopharmaceuticals, liposomal-based nanopharmaceuticals, block copolymer micelle-based nanopharmaceuticals, and related to surface coating requirements, are described here.
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Migdał, W., B. Zivkovic, and Ł. Migdał. "Promotion of animal products as opportunity for further development of breeding." Biotehnologija u stocarstvu 27, no. 4 (2011): 1407–16. http://dx.doi.org/10.2298/bah1104407m.
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In order to ensure safety of meat and meat products as well as necessary repeatability of products quality throughout the food chain, raw materials producers are required to ensure appropriate condition for production (both crops and breeding). It obligates to implementation and application systems such as: Good Agriculture Practise (GAP), Good Manufacturing Practice (GMP), Good Higiene Practice (GHP), and for intermediary companies participating in raw materials trade mandatory implementation of GHP and GMP system as well as HACCP (Hazard Analysis and Critical Control Point), QACP (Quality Assurance Control Points), ISO 9001, ISO 22000. In 1987 was established ISO9000 series of standards by International Organization of Standardization for concerning quality management and quality assurance. In this system quality control is continuous and take place at every step from design through production to waste disposal. Application of management systems requires reconstruct and expansion of information flow?s channel between processing (meat processing plant) and raw materials suppliers (breeders of animal of slaugters) regarding rules of preparation and implication of feeds and drugs. Ensuring repeatability quality of producing meat products demand managing by meat processing plant or appointed to this institution, breeders audit and monitoring of livestock and crops. For proper functioning of quality management systems is necessary ensure highest quality in whole chain food, ie from farm to table. Hazard Analysis and Critical Control Point (HACCP) is quality management system, for food production process, which was imtroduce by UE Directive No. 92/46 and is valid in Poland mainly so that the producer can become a reliable supplier of food on the EU market. Adjustment of Polish law to European Union regulations require many activities including the dissemination of the principles of GMP and implementation of HACCP system in food processing (according to Directive EU 93/94/ECC in foodstuffs hygiene). HACCP system is considered as most effective and most efficient tool in ensure high standard of hygiene condition of production and food processing. Generally, HACCAP system can be described as procedures designed to identify the health hazards of food and the risk of their occurrence during all stages of food production and distribution. This is system, which controls and protects risks relevant to consumers safety and their health protect protection. HACCP protects consumer interests giving him assurance of safety and high health quality of purchased food products. The manufacturer is convinced that he did everything to provide product that is safe for human health. A characteristic property of these systems is integration of quality management and food safety, and taking over the supervision and control throughout the food chain according to the principle "from farm to fork"(from farm to fork, from stable to table).
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Petit, Laetitia, Galle Pagny, Fabienne Baraige, Anne-Ccile Nignol, David Zhang, and Patrick Fach. "Characterization of Genetically Modified Maize in Weakly Contaminated Seed Batches and Identification of the Origin of the Adventitious Contamination." Journal of AOAC INTERNATIONAL 90, no. 4 (2007): 1098–106. http://dx.doi.org/10.1093/jaoac/90.4.1098.
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Abstract So far, relatively few genetically modified plants (GMPs) have been planted in the European Union (EU). However, in France, seed batches weakly contaminated by unidentified GM materials have recently been detected among commercial maize seeds (14 seed batches positive out of 447 analyzed). We have developed a 3-step approach to precisely identify the genetic modifications detected in such maize seed batches. First, to isolate GMPs derived from the contaminated seed batches, 10 000 maize seeds of each batch were planted and screened by polymerase chain reaction (PCR) on 100-plant batches, then on 10-plant subbatches, and finally, plant by plant. In a second step, specific identification of the individual GMPs was performed. Finally, to determine the origin of the contamination, each individual GMP was analyzed by simple sequence repeat (SSR) markers. The results showed that all batches were contaminated by few GM seeds, having a GM content &lt;0.1%. Finally, 12 individual GMPs have been isolated from 17 plant pools that were tested positive either for P35-S and/or T-Nos. MON810 and T25 transformation events approved for cultivation in the EU were detected in 7 individual GMPs. The other seed batches were contaminated by genetically modified organisms (GMOs) that are not approved in the EU, including GA21 or the stacking MON810/T25. Presumable identification of T14 was also achieved following sequencing of 1 individual GMP. The data also showed that most of the seed batches were contaminated by several transformation events. Finally, analysis of SSR markers indicated that the contaminations were essentially due to cross-pollination in the seed production process.
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Pickova, Darina, Vladimir Ostry, Jan Malir, Jakub Toman, and Frantisek Malir. "A Review on Mycotoxins and Microfungi in Spices in the Light of the Last Five Years." Toxins 12, no. 12 (2020): 789. http://dx.doi.org/10.3390/toxins12120789.
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Spices are imported worldwide mainly from developing countries with tropical and/or subtropical climate. Local conditions, such as high temperature, heavy rainfall, and humidity, promote fungal growth leading to increased occurrence of mycotoxins in spices. Moreover, the lack of good agricultural practice (GAP), good manufacturing practice (GMP), and good hygienic practice (GHP) in developing countries are of great concern. This review summarizes recent data from a total of 56 original papers dealing with mycotoxins and microfungi in various spices in the last five years. A total of 38 kinds of spices, 17 mycotoxins, and 14 microfungi are discussed in the review. Worldwide, spices are rather overlooked in terms of mycotoxin regulations, which usually only cover aflatoxins (AFs) and ochratoxin A (OTA). In this paper, an extensive attention is devoted to the limits on mycotoxins in spices in the context of the European Union (EU) as well as other countries. As proven in this review, the incidence of AFs and OTA, as well as other mycotoxins, is relatively high in many spices; thus, the preparation of new regulation limits is advisable.
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Lim, Jieun, and Hea-Kyoung Cho. "An Analysis of the Factors Related to EU GMP Non-compliance - Focusing on Active Substance, Human Medicinal Product -." Yakhak Hoeji 65, no. 1 (2021): 46–55. http://dx.doi.org/10.17480/psk.2021.65.1.46.
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Orlov, V. A., and V. N. Shestakov. "Assessing the Correlation Between GMP Deviations and Potential Quality Defects of Medicinal Products: the Result of the Survey of Qualified Persons." Drug development & registration 9, no. 2 (2020): 151–58. http://dx.doi.org/10.33380/2305-2066-2020-9-2-151-158.
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Introduction. One of the key issues in the field of assessing the conformity of drug manufacturers with the requirements of good manufacturing practice (GMP) is a systematic methodology for classifying revealed deficiencies (deviations, non-conformities) by their level of criticality. Today the information included into regulatory documents regarding the definitions of critical, major and minor (other) deficiencies is not always sufficient for the use in GMP inspection practice, as well as in quality management systems of the pharmaceutical manufacturers. In terms to study approaches to the classification of GMP deviations applied in the practice of the Qualified persons of drug manufacturers in the Russian Federation, a survey was conducted in the form of a questionnaire. This work became a logical continuation of a previous study among employees of the pharmaceutical inspectorate of the Russian Federation.Aim. To identify the correlation between the classification of critical and major GMP deviations and potential class I and II quality defects of medicinal products.Materials and methods. The study was based on a survey of Qualified persons of drug manufacturers (56 respondents) using a questionnaire specially designed. The main hypothesis of the study is that specialists (Qualified persons) who make decisions on the classification of GMP deviations are guided by potential quality defects that may be caused by the indicated deviations. In the framework of the study, authors used the model of gradation of quality defects of the medicinal products into 3 classes (class I, II and III) according to the rate of their significance as indicated in the PIC/S and EMA guidelines. At the same time, for GMP deviations a three-level gradation system is also used: Critical, Major and Minor (Other). In designing of questionnaires for the survey, the focus was made on examples of quality defects of classes I and II and, accordingly, Critical and Major GMP deviations.Results and discussion. The results of the processing and analysis of questionnaires summarize the opinion of the majority of respondents about the direct relationship between product quality defects of the high risk (class I) and critical GMP deviations. Respondents also expressed the opinion that deviations that could trigger the occurrence of the class II quality defects in most cases will be classified as critical. The results obtained during the study also indicate the similarity of existing approaches of the classification of GMP deviations (deficiencies) between QPs of the drug manufacturers and pharmaceutical inspectors.Conclusion. The results of the study show that for the purpose of classifying (determining the criticality) of GMP deviations (deficiencies) , it is possible to use the rating system for the quality defects of medicinal products by the rate of their significance for the patient which is presented in EU regulatory documents and PIC/S guidelines. The results of the study also will facilitate the drawing of conclusions that today, not only from the position of regulatory authorities, but also for the pharmaceutical industry, there is a need to develop methodological guidelines with a focus on a risk-based classification of GMP deviations (deficiencies). These guidelines should take into account the potential impact of the mentioned GMPdeviations on the occurrence of the quality defects of medicinal products and, as a result, threats to the life and health of patients.
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Bainsal, Neeraj, Jitender Singh, Aanchal Gupta, and Kundan Singh Bora. "Relevance of Artificial Intelligence in a Retail Pharma Store: A Review." ECS Transactions 107, no. 1 (2022): 10575–83. http://dx.doi.org/10.1149/10701.10575ecst.
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Whole pharmaceutical areas needed various innovative and scientific solutions to solve the current problems related to cGMP practices, production, documentation, regulatory body requirements (USFDA, WHO, EU-GMP, PICS), quality of product, etc. To overcome such problems, different computer system software plays an important role by monitoring and maintaining the current practices of the pharma industry. Installing such software will help the pharma industry to improve their cGMP practices and fulfillment the regulatory body’s requirements. This article gives overview on different types of software used in the pharmaceutical industry and hospitals. It also covers importance and their need in the pharma industry, as well as the meaning of software used in hospitals.
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Budnikevych, Iryna, and Vadym Honchar. "REGULATORY MECHANISMS OF UKRAINIAN PHARMACEUTICAL MARKET COMPETITIVENESS IN THE CONTEXT OF EUROPEAN INTEGRATION." Three Seas Economic Journal 1, no. 3 (2020): 1–8. http://dx.doi.org/10.30525/2661-5150/2020-3-1.
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The purpose of the paper is to summarize and present the differences in the competitive environment of the European Union (EU) and Ukrainian pharmaceutical markets. The method of longitudinal study allowed to detect the patterns of changes and correlations for pharmaceutical products exports and imports volumes over twenty years (2001-2020). Methodology. The research is based on the definition of the pharmaceutical market as a complex socio-economic institution that fulfills the function of pricing medical products and utilizes them to ensure health care functioning. It indicates the population’s wellbeing and requires ongoing maintenance based on needs agreement of households, economic entities, and the state. The quantitative research is based on export-to-import coverage ratio calculations with the identification of pharmaceutical products fraction in the total volume of foreign trade, including the one with the EU. The results of the paper consist in the evaluation of the competitive environment of the European Union’s pharmaceutical market and statistical assessment of Ukrainian foreign trade of pharmaceutical products. They also include the definition of the European integration influence over the Ukrainian pharmaceutical market and well-reasoned recommendations about the application of the state and trade regulation mechanisms. In the paper, we defined the distinctive features of the European countries’ pharmaceutical markets and outlined their main characteristics that have connections to the transnational corporation’s activities, common market, and high concentration. Statistical data collected over 20 years indicated the dynamic development of the Ukrainian pharmaceutical market, despite its small-scale contribution to the foreign trade turnover. The dependence of Ukraine on the foreign supplies of drugs and medications is illustrated by the multiple excesses of imports over exports, especially in the trade relationships with the EU. The EU countries are the leading importers of pharmaceutical products to the Ukrainian market. However, the share of medical supplies exports from Ukraine to the EU countries is negligible. Their key exporters are post-Soviet and developing countries. The growth in Ukraine’s export potential is inextricably linked to the expansion of the competitiveness of domestic medical supplies. Practical implications consist in the development of recommendations concerning the GMP and GDP demands realization, domestic manufacturers cooperation with the leading foreign pharmaceutical companies, the penetration of transnational companies into the Ukrainian domestic pharmaceutical market based on imports of innovative technologies, the improvement of the marketing management of the pharmaceutical products exporting. The priority factor in the growth of the competitiveness of the Ukrainian pharmaceutical market is a successful combination of state and trade regulation mechanisms. The objects of these factors are the pricing policy for material resources and finished products, the introduction of innovations, tax exemptions, and export-import quotas implementation. They also include the establishment of traffic rates that depend on the market saturation with socially significant medical supplies, budget support of the prioritized subsectors of the pharmaceutical industry, and patent protection. The expected results concern the decrease in the dependence of the Ukrainian pharmaceutical market on the foreign distribution of the raw materials and finished products and strengthening the positions of the Ukrainian manufacturers in foreign markets. Value/originality. We evaluated the competitiveness of the national pharmaceutical market based on the criteria of foreign trade performance and detected the priorities of its growth, taking into consideration the synthesis of the state and trade regulation mechanisms.
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Sun, Zongbao, Yunlong Gao, Zeng Niu, et al. "Programmable-Printing Paper-Based Device with a MoS2 NP and Gmp/Eu-Cit Fluorescence Couple for Ratiometric Tetracycline Analysis in Various Natural Samples." ACS Sensors 6, no. 11 (2021): 4038–47. http://dx.doi.org/10.1021/acssensors.1c01448.
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Savchenko, L. P., and V. A. Georgiyants. "Current trends in compounding of medicines and its legislative regulation in foreign countries." Farmatsevtychnyi zhurnal, no. 4 (July 30, 2020): 6–17. http://dx.doi.org/10.32352/0367-3057.4.20.01.
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Compounding medicines preparation is part of the proper pharmaceutical supply of the population. Unfortunately, its volumes in Ukraine have been declining recently, but the spread of medicines production in privately owned pharmacies indicates the prospects of this activity type.
 The aim of the work was the analysis of the current state of medicines compounding and its legislative regulation in foreign countries, formulation of the main directions of the Ukrainian legislation reforming on this issue.
 The materials of the research were scientific publications in peer-reviewed foreign journals with using bibliosemantic method, the method of generalization and systematic data analysis.
 The analysis of publications concerning the practice of medicines preparation in foreign countries showed its volume increasing. In most countries, such activities are an integral part of pharmaceutical care and the provision of medicines to the population. Along with conventional pharmacies, the widespread medicines compounding in hospital pharmacies. The structure of drug production differs in each country. According to the Global Market Insights report for 2018, the main therapeutic areas in the structure of compounding medicines market were hormone replacement therapy, analgesia, dermatology, specialized drugs and parenteral nutrition. The regulatory framework governing the medicines compounding was reviewed in the last few years. The EU updated the PIC/S Guide and approved the second version of the EU Council Resolution on the medicines compounding. To control the spread of sterile medicines serial preparation in the United States since 2013 this activity is controlled by the FDA. Compliance with GMP requirements is a mandatory requirement for the serial preparation of sterile medicines abroad.
 Thus, the development of medicines compounding is a promising area of pharmaceutical activity. Despite the reduction in the number of compounding pharmacies, Ukrainian pharmacies are also involved in the preparation of specific medicines. A number of regulatory documents, the requirements of which are similar to international ones, regulates the quality control of compounding medicines. However, to comply with modern world trends, it is necessary to review and update this legislation.
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Matsuhama, Maki, Tomoko Takishita, Ryosuke Kuribayashi, Kazunori Takagi, Rika Wakao, and Kenichi Mikami. "Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence." Journal of Pharmacy & Pharmaceutical Sciences 19, no. 2 (2016): 290. http://dx.doi.org/10.18433/j37g80.
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Purpose. A gap analysis survey of international practices for Active Substance Master Files (ASMFs)/Drug Master Files (DMFs) of human use was conducted as a project of the ASMF/DMF working group of the International Generic Drug Regulators Pilot (IGDRP) to identify similarities and differences among ASMF/DMF procedures of 10 IGDRP members and 2 observers. Methods. We conducted a questionnaire survey and compared the following aspects: overall ASMF/DMF procedures, submission requirements for ASMFs/DMFs, assessment processes for ASMFs/DMFs, the technical requirements for active pharmaceutical ingredients (APIs), generation of assessment reports for ASMFs/DMFs, procedures for changing ASMF/DMF details, and Good Manufacturing Practice (GMP) inspection/certification of API manufacturers. Twelve organizations participated in this project: the Brazilian Health Surveillance Agency (Anvisa), the European Union (EU), Health Canada (HC), the Singapore Health Sciences Authority (HSA), the South African Medicines Control Council (MCC), the South Korean Ministry of Food and Drug Safety (MFDS), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), the Swiss Agency for Therapeutic Products (Swissmedic), the Taiwan Food and Drug Administration (TFDA), the Australian Therapeutic Goods Administration (TGA), the European Directorate for the Quality of Medicines & HealthCare (EDQM) (Observer) and the Prequalification Team (PQT) of the World Health Organization (WHO), which includes the PQT–Medicines (Observer). Results. Although there were many similarities among the participating agencies surveyed, there were also differences that should be discussed such as assessment processes of ASMFs/DMFs and Technical requirements for APIs. Conclusions. These differences revealed by this survey will be key considerations in order to facilitate the filing of ASMFs/DMFs globally and to establish a framework for sharing and utilizing information related to ASMFs/DMFs among IGDRP members in the future. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.
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Matsuhama, Maki, Tomoko Takishita, Ryosuke Kuribayashi, Kazunori Takagi, Rika Wakao, and Kenichi Mikami. "Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence." Journal of Pharmacy & Pharmaceutical Sciences 19, no. 2 (2016): 290–300. http://dx.doi.org/10.18433/jpps.v19i2.27066.
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Purpose. A gap analysis survey of international practices for Active Substance Master Files (ASMFs)/Drug Master Files (DMFs) of human use was conducted as a project of the ASMF/DMF working group of the International Generic Drug Regulators Pilot (IGDRP) to identify similarities and differences among ASMF/DMF procedures of 10 IGDRP members and 2 observers. Methods. We conducted a questionnaire survey and compared the following aspects: overall ASMF/DMF procedures, submission requirements for ASMFs/DMFs, assessment processes for ASMFs/DMFs, the technical requirements for active pharmaceutical ingredients (APIs), generation of assessment reports for ASMFs/DMFs, procedures for changing ASMF/DMF details, and Good Manufacturing Practice (GMP) inspection/certification of API manufacturers. Twelve organizations participated in this project: the Brazilian Health Surveillance Agency (Anvisa), the European Union (EU), Health Canada (HC), the Singapore Health Sciences Authority (HSA), the South African Medicines Control Council (MCC), the South Korean Ministry of Food and Drug Safety (MFDS), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), the Swiss Agency for Therapeutic Products (Swissmedic), the Taiwan Food and Drug Administration (TFDA), the Australian Therapeutic Goods Administration (TGA), the European Directorate for the Quality of Medicines & HealthCare (EDQM) (Observer) and the Prequalification Team (PQT) of the World Health Organization (WHO), which includes the PQT–Medicines (Observer). Results. Although there were many similarities among the participating agencies surveyed, there were also differences that should be discussed such as assessment processes of ASMFs/DMFs and Technical requirements for APIs. Conclusions. These differences revealed by this survey will be key considerations in order to facilitate the filing of ASMFs/DMFs globally and to establish a framework for sharing and utilizing information related to ASMFs/DMFs among IGDRP members in the future. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.
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Wang, Fujen, Indra Permana, Kwowhei Lee, Dibakar Rakshit, and Parisya Premiera Rosulindo. "Improvement of Airflow Distribution and Contamination Control for a Biotech Cleanroom." Atmosphere 13, no. 2 (2022): 335. http://dx.doi.org/10.3390/atmos13020335.
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The biotech cleanroom industry presents a biological basis for living organisms or their components (bacteria or enzymes) to produce helpful medicine. However, biotech industries such as vaccine production need a clean critical environment and contamination control that is always a vital concern for the manufacturing process. This study investigates a biotech cleanroom through a comprehensive field measurement and numerical simulation. The field measurement test results conformed to the design specification to satisfactorily meet with the cleanroom standard of PIC/S and EU GMP. Furthermore, the field measurement data were used as a basic validation and boundary condition for numerical simulation. The numerical simulation results revealed that the concentration distribution in case 1 as a baseline case showed satisfactory results, with a removal efficiency of 75.2% and ventilation efficiency of 80%. However, there was still a high concentration accumulated in certain areas. The improvement strategy was analyzed through non-unidirectional flow ventilation with different face velocities and by adding one return air grille for case 2 and two return air grilles for case 3. The results revealed that case 2 presented the best results in this study, with a removal efficiency of 86.7% and ventilation efficiency of 82% when supplying air velocity at 0.2 m/s. In addition, increasing the supply air velocity to 0.3 m/s could enhance removal ventilation by around 19% and ventilation efficiency by around 5%.
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Huang, Chunyu, Ruixue Ma, Yuxin Luo, Guoyue Shi, Jingjing Deng, and Tianshu Zhou. "Stimulus Response of TPE-TS@Eu/GMP ICPs: Toward Colorimetric Sensing of an Anthrax Biomarker with Double Ratiometric Fluorescence and Its Coffee Ring Test Kit for Point-of-Use Application." Analytical Chemistry 92, no. 19 (2020): 12934–42. http://dx.doi.org/10.1021/acs.analchem.0c01570.
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Kharlamova, Ganna, Andriy Stavytskyy, Oleksandr Chernyak, Vincentas Giedraitis, and Olena Komendant. "Economic modeling of the GDP gap in Ukraine and worldwide." Problems and Perspectives in Management 17, no. 2 (2019): 493–509. http://dx.doi.org/10.21511/ppm.17(2).2019.38.
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ActualityThe concept of output gap plays an important role in traditional macroeconomic theory, applied research and monetary policy. GoalThe paper reveals analyses of the potential economic development in Ukraine and in some countries of the world under limited information. Thus, the practical goal is to consider the best modelling approach for the possibility to regulate GDP in Ukraine, as it has been experienced in other countries of the world. MethodThe research is realized with the help of economic-mathematical modelling of GDP gap based on the analysis of the production function, statistical methods of distinguishing the trend component, one-dimensional filtration, multidimensional filtration. ResultsPractical importance of the paper includes implementation of methods for estimating potential GDP and the GDP gap, in particular, the authors proposed to use an approach based on the production function for the potential growth of European countries modelling. The model reveals that for the Eurozone countries, in the short term, it is not expected that the economy will reach its potential level. The negative forecast is explained by the fact that the Eurozone has been severely affected by the debt crisis. There has been a significant increase in the gap in production volumes, which in turn led to deflation. Despite the uncertainty in the assessment of potential GDP and GDP gap for Ukraine the multidimensional method provided the best modelling result. Thus, it is disclosed that Ukraine is under the growing wave of the business cycle, but not in the synergy with the EU dynamics.
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Souto, Eliana B., Gabriela F. Silva, João Dias-Ferreira, et al. "Nanopharmaceutics: Part II—Production Scales and Clinically Compliant Production Methods." Nanomaterials 10, no. 3 (2020): 455. http://dx.doi.org/10.3390/nano10030455.
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Due the implementation of nanotechnologies in the pharmaceutical industry over the last few decades, new type of cutting-edge formulations—nanopharmaceutics—have been proposed. These comprise pharmaceutical products at the nanoscale, developed from different types of materials with the purpose to, e.g., overcome solubility problems of poorly water-soluble drugs, the pharmacokinetic and pharmacodynamic profiles of known drugs but also of new biomolecules, to modify the release profile of loaded compounds, or to decrease the risk of toxicity by providing site-specific delivery reducing the systemic distribution and thus adverse side effects. To succeed with the development of a nanopharmaceutical formulation, it is first necessary to analyze the type of drug which is to be encapsulated, select the type matrix to load it (e.g., polymers, lipids, polysaccharides, proteins, metals), followed by the production procedure. Together these elements have to be compatible with the administration route. To be launched onto the market, the selected production method has to be scaled-up, and quality assurance implemented for the product to reach clinical trials, during which in vivo performance is evaluated. Regulatory issues concerning nanopharmaceutics still require expertise for harmonizing legislation and a clear understanding of clinically compliant production methods. The first part of this study addressing “Nanopharmaceutics: Part I—Clinical trials legislation and Good Manufacturing Practices (GMP) of nanotherapeutics in the EU” has been published in Pharmaceutics. This second part complements the study with the discussion about the production scales and clinically compliant production methods of nanopharmaceutics.
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Chan, Lucas, Wendy Ingram, Nicola Hardwick, et al. "RFUSIN2 - a Clinical Grade Lentiviral Vector Co-Expressing CD80/IL-2 Manufactured Under GMP for a Phase I Clinical Trial Study of Immune Gene Therapy for Poor Prognosis Acute Myeloid Leukaemia." Blood 112, no. 11 (2008): 4630. http://dx.doi.org/10.1182/blood.v112.11.4630.4630.
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Abstract Patient derived primary AML blasts cells can be efficiently modified (40–100%) to coexpress CD80 and IL-2 following a single round of transduction using a self-inactivating lentiviral vector. This modification produces significant immune stimulation as measured by proliferation, cytokine release and NK and T-cell cytolytic activity against AML in both autologous and allogeneic settings in vitro. In mouse models of leukaemia, CD80/IL-2 modified leukaemic cells result in rejection of previously established leukaemia and the longer survival of the vaccinated animals. Following regulatory approval in the UK, we have initiated a Phase I clinical study using Lentivirus Transduced AML cells expressing CD80 and IL-2 for the potential enhancement of Graft versus Leukaemia effect in poor prognosis AML. The UK regulatory approved vector, RFUSIN2, is a self-inactivating lentivirus vector, which becomes immobile following vector integration. RFUSIN2 encodes CD80 and IL-2 as a fusion protein, which is endogenously cleaved to generate biologically active CD80 that is membrane anchored and IL-2 which is secreted. Here we describe our in-house manufacturing of RFUSIN2 under EU compliant GMP conditions, which resulted in the production of &gt;3x1010 concentrated infectious particles. Extensive safety characterisation of this vector has been carried out. The vector supernatant batch is free of viral contaminants including: Porcine and bovine viruses, other retroviruses, HepA/B/C, HIV-I/II, EBV, and CMV; it is also free of other contaminants including mycoplasma, yeast, fungus and bacteria. RFUSIN2 supernatant is absent of any replication competent lentivirus (RCL) or partial recombinants and is unable to mobilise or to achieve secondary transfer.We present a summary of the protocol for the generation of the autologous AML cell vaccine. The clinical protocol, encompassing the treatment schedule, cohorts, study end points and analytical assays are described.
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Berstad, Maria E. B., Lawrence H. Cheung, and Anette Weyergang. "Production of Recombinant Gelonin Using an Automated Liquid Chromatography System." Toxins 12, no. 8 (2020): 519. http://dx.doi.org/10.3390/toxins12080519.
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Advances in recombinant DNA technology have opened up new possibilities of exploiting toxic proteins for therapeutic purposes. Bringing forth these protein toxins from the bench to the bedside strongly depends on the availability of production methods that are reproducible, scalable and comply with good manufacturing practice (GMP). The type I ribosome-inhibiting protein, gelonin, has great potential as an anticancer drug, but is sequestrated in endosomes and lysosomes. This can be overcome by combination with photochemical internalization (PCI), a method for endosomal drug release. The combination of gelonin-based drugs and PCI represents a tumor-targeted therapy with high precision and efficiency. The aim of this study was to produce recombinant gelonin (rGel) at high purity and quantity using an automated liquid chromatography system. The expression and purification process was documented as highly efficient (4.4 mg gelonin per litre induced culture) and reproducible with minimal loss of target protein (~50% overall yield compared to after initial immobilized metal affinity chromatography (IMAC)). The endotoxin level of 0.05–0.09 EU/mg was compatible with current standards for parenteral drug administration. The automated system provided a consistent output with minimal human intervention and close monitoring of each purification step enabled optimization of both yield and purity of the product. rGel was shown to have equivalent biological activity and cytotoxicity, both with and without PCI-mediated delivery, as rGelref produced without an automated system. This study presents a highly refined and automated manufacturing procedure for recombinant gelonin at a quantity and quality sufficient for preclinical evaluation. The methods established in this report are in compliance with high quality standards and compose a solid platform for preclinical development of gelonin-based drugs.
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Kobzar, Serhii, Olexandr Topal, Liudmyla Haponych, and Iryna Golenko. "Investigation of the co-firing of natural gas and RDF in a model combustion chamber**." Proceedings of the NTUU “Igor Sikorsky KPI”. Series: Chemical engineering, ecology and resource saving, no. 4 (December 24, 2021): 67–73. http://dx.doi.org/10.20535/2617-9741.4.2021.248946.
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The production and utilization of fuel derived from municipal solid waste (RDF/SFR) is an effective method for saving organic fuel and decreasing emissions of harmful substances and greenhouse gases at landfill and refuse dumps. Ukraine has a potential for the production of 1.5–2 million tons of RDF/SFR with a calorific value of 10–25 MJ/kg annually. In the case of involving these fuels to power sector, about 2500 GW-h of electricity and 4500 GW-h of heat can be produced annually. One of the promising variants to involve RDF/SFR to power sector is their combustion, including co-firing with natural gas, aimed at the production of heat and electricity, in particular, using the existing boilers of small and middle steam capacity in compliance with stringent ecological requirements (Directive 2010/75/EU etc.).
 For performing this investigation, we chose a GMP-16 gas-and-oil-fired burner, mounted into a cylindrical combustion chamber. The gas-and-oil-fired hot-water boilers of KVGM grade, designed for heating and hot water supply, are equipped with burners of this type. In computer modeling, we determined the influence of RDF additions on the co-firing with natural gas for a given geometry of the combustion chamber components (with a burner of 18.6 MW heat output). We obtained calculated dependences of temperatures, velocities, distributions of gas component concentrations, carbon remained in the solid phase, as well as the concentrations of nitrogen oxides and carbon monoxide over the combustion chamber. According to preliminary assessments, we established that additions of up to 20% RDF/SFR (by heat at input) in their co-firing with natural gas will not change substantially the technical and ecological parameters in operation of the combustion chamber.
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Sim, Min-Seok. "A Study on the Legislative measures of GMOs Regulatory and Labeling System - Comparative analysis of GMOs Regulatory and Labeling System in USA, EU, Japan -." Journal of Comparative Law 21, no. 1 (2021): 181–214. http://dx.doi.org/10.56006/jcl.2021.21.1.5.
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Turner, Ralph J., and Irwin J. Kerber. "A theory of eu-estrogenemia." Menopause 24, no. 9 (2017): 1086–97. http://dx.doi.org/10.1097/gme.0000000000000895.
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Chae, Hyung-bok. "EU Genetically Modified Organism (GMO) Legal Systeme and Food Safety - Focused on the Decision-making System for Approval of GM Food Safety -." Inha Law Review : The Institute of Legal Studies Inha University 24, no. 2 (2021): 233–73. http://dx.doi.org/10.22789/ihlr.2021.06.24.2.7.
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Mönch, Axel. "EU-Länder bremsen GAP." agrarzeitung 76, no. 21 (2021): 1. http://dx.doi.org/10.51202/1869-9707-2021-21-001.
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Williams, Brent, Bertrand Routy, Neal denHollander, et al. "NK-92 Therapy Is Well Tolerated, Has Minimal Toxicity and Shows Efficacy in a Phase I Trial of Patients with Relapsed/Refractory Hematological Malignancies Relapsing after Autologous Stem Cell Transplantation." Blood 126, no. 23 (2015): 4297. http://dx.doi.org/10.1182/blood.v126.23.4297.4297.
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Abstract Background Autologous NK cell adoptive immunotherapy has potential to treat a variety of malignancies, but is limited by patient-specific variations in numbers and quality of expanded cells. In contrast, allogeneic NK cell lines can overcome many of these limitations. The NK line, NK-92 can be manufactured under Good Manufacturing Practice (GMP) compliant conditions, and infused into patients, as demonstrated in two prior phase I trials for solid tumours. Here, we report the findings of a phase I trial of NK-92 with the highest cell dosing regimen tested to date, in patients with relapsed/refractory hematological malignancies. Methods We conducted a single-center, non-randomized, non-blinded, open-label, Phase I dose-escalation trial of irradiated NK-92 cells in adults with refractory hematological malignancies who relapsed after autologous stem cell transplantation. The objectives were to determine, safety, feasibility and evidence of activity against refractory hematological malignancies. Inclusion criteria included measurable disease, adequate organ function and ECOG performance status of < 2. Exclusion criteria were pregnancy, concurrent treatment within 28 days with other experimental therapy, known HIV, HBV or HCV infection and malignant CNS disease. Patients were treated at one of three dose levels (1x109 cells/m2, 3x109 cells/m2 and 5x109 cells/m2), given on day 1, 3 and 5 for a planned total of six monthly cycles. NK-92 cells were obtained from Conkwest, and a frozen working cell bank was established at Princess Margaret Cancer Centre and stored in liquid nitrogen. Clinical-grade NK-92 cells were then manufactured under GMP conditions by expanding a cryopreserved vial of NK-92 in Vuelife culture bags using GM1 medium. Release criteria of NK-92 for infusion included negative mycoplasma testing, day 7 culture sterility, endotoxin <0.05 EU/mL, and additionally, a negative stat gram stain and cell viability of >70%. The final NK-92 cell product was resuspended in GM2 medium (Plasma-Lyte-A medium), irradiated with 10 Gy and infused fresh intravenously over one hour. Results Twelve patients with hematological malignancies who relapsed after undergoing stem cell transplantation for relapsed/refractory disease were enrolled with the following diagnoses: multiple myeloma (5), diffuse large B-cell lymphoma (4), Hodgkin lymphoma (2) and mantle cell lymphoma (1). There were 9 males and 3 females and median age was 60 (range: 42-67) years. Patients had received 2-5 chemotherapy regimens before autologous stem cell transplantation and some also received additional chemotherapy after autotransplant and prior to receiving NK-92 infusions. The number of cycles of NK-92 administered ranged from 1-6, with 10 patients coming off study because of disease progression, and one patient proceeding to allogeneic stem cell transplantation. The only toxicity was infusion-related fever and chills (grade II) in one patient, and none had evidence of cytokine release syndrome. A patient with relapsed, refractory Hodgkin lymphoma had a complete response and remains in remission more than five years after NK-92 therapy. An additional three patients experienced transient responses. There were no significant alterations in hemoglobin, platelets, white cell count, creatinine or liver function tests in patients receiving NK-92 infusions. While six patients developed anti-HLA antibodies, none developed a T-cell immune response as determined by the mixed lymphocyte response of patient lymphocytes against NK-92. Conclusion NK-92 can be administered after autologous stem cell transplantation at very high doses with virtually no toxicity to patients with relapsed/refractory hematological malignancies. This is the first trial of NK-92 which includes patients with multiple myeloma. Surprisingly, most patients did not mount cellular immune responses against NK-92, despite receiving very large numbers of NK cells, up to a total of 150x109 cells. We conclude that high dose NK-92 therapy is safe and has the potential to induce long term survival in select patients. We propose that NK-92 can serve as a standardized off-the-shelf cellular treatment for malignancies and could provide a platform for gene-modified targeted cell therapy. Disclosures Keating: Conkwest: Other: Research funding unrelated to clinical trial.
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Mucha-Leszko, Bogumiła. "Causes of the European Union's Decreasing Position in the Global Economy in 2000-2016." Zeszyty Naukowe SGGW w Warszawie - Problemy Rolnictwa Światowego 18(33), no. 1 (2018): 159–75. http://dx.doi.org/10.22630/prs.2018.18.1.15.
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The subject of the paper is an analysis of the economic results of the main factors affecting GDP growth in the European Union in 2000-2016. The aim is to evaluate the global position of the EU as well as to identify the main factors affecting growth of the EU’s economic potential and effectiveness. The analysis also includes the long-term development gap in the EU-15/EU-28 versus the U.S.A. Quantitative and qualitative criteria were used in the assessment. Quantitative criteria include: growth rates of GDP, investments and exports, the EU’s share in global GDP, and global exports of goods and services. The qualitative criteria are: labour productivity and total factor productivity TFP. The results of the study are as follows: 1) evaluation of the EU position in the global economy (quantitative indicators) show a decline in the EU's share in global GDP, and trade and FDI were not greater than in the U.S.A.; 2) pertaining to the qualitative criteria the United States ranks better; 3) factors contributing the most to the weakening of the global economic position of the EU are: lower investment in the ICT sector compared to the U.S., differentiation of EU members in terms of their ability to grow, socio-economic divergence and a crisis in the eurozone.
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Turner, Ralph J., and Irwin J. Kerber. "Renal stones, timing hypothesis, and eu-estrogenemia." Menopause: The Journal of The North American Menopause Society 19, no. 1 (2012): 104–8. http://dx.doi.org/10.1097/gme.0b013e318221be9b.
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Sanchez, Jesus. "The Generational Digital Gap within Dual Vocational Education and Training Teachers." European Journal of Educational Research 9, no. 4 (2020): 1557–67. http://dx.doi.org/10.12973/eu-jer.9.4.1557.
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Harpaz, Guy. "Mind The Gap: Narrowing the Legitimacy Gap in EU–Israeli Relations." European Foreign Affairs Review 13, Issue 1 (2008): 117–37. http://dx.doi.org/10.54648/eerr2008006.
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Abstract. The EU strives to export its normative acquis to other parts of the world, promoting extraterritorial ‘Europeanization’. Such attempts are particularly evident in the Middle East and North Africa. In order to serve there as a civilian, normative power, the EU should rely on its economic forte and equip itself with legitimacy. However, such legitimacy is lacking, from an Israeli perspective, thereby making it difficult for the EU to position itself as a normative power in this part of the world. The article identifies and analyses concrete measures that can reduce the legitimacy deficit of the EU in the eyes of Israelis, thereby paving the way for its more constructive, normative contribution to the Middle East. Although the analysis is conducted through the prism of EU–Israel relations, some of its findings may be found to be applicable mutatis mutandis to other countries that face normative pressures from the EU.
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Vladušić, Ljubiša, Aleksandar Živković, and Nemanja Pantić. "Macroeconomic analysis of GDP and employment in EU countries." Ekonomika 66, no. 1 (2020): 65–76. http://dx.doi.org/10.5937/ekonomika2001065v.
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Monnier, Jean-Marie. "Crises économiques et décisions financières et fiscales." Gestion & Finances Publiques, no. 1 (January 2022): 24–31. http://dx.doi.org/10.3166/gfp.2022.1.004.
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Quatre épisodes de crise ont eu un impact particulièrement important sur l’activité économique depuis les années 1980. Trois de ces crises présentent une dimension financière importante, la quatrième est atypique. Elles ont cependant toutes eu un coût budgétaire élevé. L’article se concentre sur la gestion de la contrainte budgétaire et son impact sur la dette publique du fait de ces quatre crises et montre un impact cumulatif.
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Gnap, Jozef, Vladimír Konečný, and Pavol Varjan. "Istraživanje odnosa između izvedbe prijevoza tereta i BDP-a u Slovačkoj i EU državama." Naše more 65, no. 1 (2018): 32–39. http://dx.doi.org/10.17818/nm/2018/1.5.
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Rahmah C.P, Rr Nurul, Ridwan Stanley Sinaga, Adi Fadhilah Nurul Rahman, et al. "Keserasian Dua Dunia yang Berbeda: Relasi ASEAN-EU dalam Kerja sama Multilateral." Indonesian Perspective 3, no. 2 (2019): 127. http://dx.doi.org/10.14710/ip.v3i2.22348.
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Cooperation could be done by integrated cooperation between states member and inter regional organization equally, like ASEAN and EU (Eropean Union) cooperation. Popular speculations between this two organizations are mostly partial, biased in gap between EU contribution to ASEAN rather than vice versa. In this paper, we challenge capability of ASEAN as a regional organization with most of the member states are developing and third world country comparing to EU which 26 of members states has highest GDP all around the world. This paper also discuss about ASEAN as an organization that have eperiences in several humanitarian violation cases, comparing with EU as a ‘safe heaven’ in human rights. Through ecleckticism theory, we would see how liberalism and realism played a role in seeing such phenomenon, and how to see between those two theories. This paper argEUs that there are mutuliasm cooperations between EU and ASEAN, start with EU contribution on ASEAN structures, the critics about ASEAN as ‘imitation community’, and also being partner with ASEAN in investments. ASEAN is also seen as a ‘teacher’ for EU in pragmatism and normative power to improve EU capability as inclusive community.Keywords: trade, hegemony, multilateral, EU, ASEAN
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Rojewski, Markus, Natalie Fekete, Daniel Fuerst, et al. "GMP-Grade Large-Scale Expansion of Bone-Marrow- (BM) Derived Human Mesenchymal Stem/Stroma Cells (MSC): Comparison of Efficacy of Different Expansion Systems and Role of Cytokines/Chemokines." Blood 116, no. 21 (2010): 337. http://dx.doi.org/10.1182/blood.v116.21.337.337.
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Abstract Abstract 337 Background: MSC cells can differentiate into different tissues and exhibit non-HLA-restricted immunosuppressive properties. They are promising candidates for cellular therapy. Therapeutic use requires large-scale GMP-grade expansion of MSC. Several protocols have been published. Here we systematically compare different expansion procedures with particular emphasis on role of cytokines/chemokines in the expansion medium. Materials and Methods: Bone marrow (BM) was obtained by aspiration from the iliac crest of healthy donors after informed consent and IRB approval. BM aspirate (anticoagulated with heparin (500 U/ml)) was incubated without manipulation in 5-chamber stacks (CellStacks; Corning) in a medium free of animal components (α-MEM (Lonza) with 10% human platelet lysate (hPL)). In the single-step protocol 1.2×104 MNC/ cm2 were seeded. Non-adherent cells were washed off after 72–96 hrs. Partial medium exchange (40%) was performed twice a week (wk). After 11 days MSC were harvested by incubation with recombinant trypsin (TrypZean, Lonza). In the two-step protocol 5×104 leukocytes/cm2 were seeded in 2-chamber stacks. Non-adherent cells were removed after 72–96 hours and complete medium exchange was performed twice/wk. Cells were harvested after 10 days and the harvest was seeded in a 2nd culture at a density of 0.4×104 MSC/cm2. This 2nd culture was harvested after 5 days. Cytokines/chemokines in hPL and in culture medium during the course of expansion was measured by Milliplex MAP Kit (Millipore Corp). Surface marker expression was measured on FACSAria and FACScan. Results: Higher number of MSC could be achieved in cultures with hPL compared to fetal calf serum. hPL was equally effective in supporting MSC proliferation if prepared from apheresis platelet concentrates (PC), buffy coat-derived pooled PC in plasma or pooled PC in additive solution. hPL contained large amounts of PDGF-AB/BB (790 ng/ml; mean of 3 batches of hPL from buffy coat-derived pooled PC), PDGF-AA (266 ng/ml), RANTES (2706 ng/ml), sCD40L (27 ng/ml), GRO (11 ng/ml), sVCAM (2511 ng/ml), sICAM (188 ng/ml). During culture, sCD40L declined rapidly to very low levels. Concentration of PDGF-AA, RANTES and sICAM remained almost stable. In contrast, PDGF-AB/BB declined to low levels (<0.007 ng/ml) in MSC expansion culture whereas concentration remained stable under the same conditions in the absence of MSC. Decline was associated with MSC numbers in the expansion. BM samples from healthy donors (n=4) were split in order to perform paired comparison of single-step vs. two-step expansion protocol. In the single-step protocol 16.3×103±5.8×103 MSC/μl BM seeded were harvested after 11±0 days. In the two-step protocol 12.0×103±4.4×103 MSC/μl BM were harvested after 10 days at the end of passage 0 and 104.0×103±60.4×103 after 5±1 days at the end of passage 1. The overall consumption of medium in the single-step protocol was substantially higher than in the two-step protocol. Phenotype of MSC from the two culture systems did not significantly differ regarding standard markers (positive for CD73, CD90, CD105, HLA-class I; neg. for CD45, CD3, CD34, HLA-DR). However, in passaging experiments we could demonstrate that proportion of MSC positive for CD49a, CD71, CCR4/CD194, CD349 and MSCA-1 decreased whereas proportion of cells positive for c-kit/CD117, CCR3/CD193, CXCR4 and CD200 increased. Conclusion: hPL-based system allows efficient expansion of MSC up to a total number >1×109 MSC from a 15 ml BM aspirate in 2–3 wks with only one passaging step. hPL is a rich source of cytokines, some of which (PDGF-AB/BB) seem to be consumed during expansion and arrive at very low concentrations at the end of the expansion culture. A two-step system provides higher number of MSC per BM cells seeded and requires less medium/culture vessels. Phenotype and differentiation capacity does not differ between single- or two-step culture. However, further passaging goes along with substantial changes of the phenotype. Previous conflicting results regarding chemokine expression of MSC might be due to differences in ex-vivo culture period. Given that chemokine receptor expression affects in-vivo behaviour of cells, MSC harvested after initial expansion (passage 0 or 1) substantially differ from older cells, emphasizing the need to highly standardize all parameters of expansion. (Supported by EU 7th Framework Programme, Projects CASCADE and REBORNE). Disclosures: Fekete: Institute of Clinical Transfusion Medicine and Immunogenetics: Employment. Fuerst:Institute of Clinical Transfusion Medicine and Immunogenetics: Employment. Schrezenmeier:Institute of Clinical Transfusion Medicine and Immunogenetics: Employment.
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Mucha-Leszko, Bogumiła, and Katarzyna Twarowska. "The European Union As A Global Economic Power." Comparative Economic Research. Central and Eastern Europe 19, no. 3 (2016): 27–44. http://dx.doi.org/10.1515/cer-2016-0019.
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The aim of this study is to evaluate the EU economic position in 1995–2014 as well as the prospective growth potential in the global dimension up to 2025. The subject of the research is real and projected data including: GDP growth rate, main growth factors (labour, labour productivity and Total Factor Productivity), and their input to GDP growth, as well as data showing public debts and budget deficits. The analysis was conducted for the years 1995–2014 and 2015–2025. The authors' basic conclusions are: 1) the technological and economic gap between the European Union and the United States has been deepening; 2) the increasing polarisation of world economic powers and low GDP growth in the European Union limit the EU’s chances of maintaining the position as the second centre in the world economy; 3) improving the situation in public finances in the European Union as compared to the US is a factor which could raise GDP growth rates in European countries, however, there are countries whose future is in doubt due to the dramatically poor state of public finances, such as Greece, Italy, Portugal or Ireland; 4) economic growth forecasts indicate a deepening of the economic gap between the largest EU countries and the US.
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Olczyk, Magdalena, and Marta Kuc-Czarnecka. "DIGITAL TRANSFORMATION AND ECONOMIC GROWTH – DESI IMPROVEMENT AND IMPLEMENTATION." Technological and Economic Development of Economy 28, no. 3 (2022): 775–803. http://dx.doi.org/10.3846/tede.2022.16766.
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The paper aims to improve the methodology of the Digital Economic and Society Index (DESI), the European Commission’s newest index to assess the development of the digital economy. In particular, we investigate whether methodological changes to the structure of DESI improve its ability to capture the digital transformation of EU economies. Using the sensitivitybased analysis, we check whether the selection of weights of individual elements included in the DESI is optimal or should be improved. We also verify the importance of DESI in explaining changes in GDP per capita in EU economies. In the literature, we find that digital transformation has enabled the creation of new business models and maximized efficiency in traditional firms. Using DESI, we empirically test whether the gap between rich and poor countries in European Union can be closed or eliminated through rapid and intensive digital transformation. Our results show that the DESI – when modified by eliminating the pillars on internet services and digital public services – has the same explanatory power. Connectivity is the dimension with the largest impact on digital transformation in EU countries. We also find that DESI is a significant regressor to explain changes in GDP per capita in EU countries.
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