Relevant bibliographies by topics / GMP EU

Contents

  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Conference papers
  6. Reports

Academic literature on the topic 'GMP EU'

Author: Grafiati
Published: 30 May 2022
Last updated: 31 May 2022

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Journal articles on the topic "GMP EU"

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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 (June 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 (February 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 (January 30, 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, V. V. Beregovykh, A. M. Pyatigorskiy, N. S. Nikolenko, M. M. Marshalova, and V. V. Belyaev. "Responsibilities of the Marketing Authorisation Holders in Respect of GMP Compliance (Review)." Drug development & registration 9, no. 4 (November 26, 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, Qianqian Peng, Baozhan Zheng, Juan Du, and Dan Xiao. "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, Francesco Angelini, Elena De Falco, Giuseppe Biondi Zoccai, Elisa Messina, Giacomo Frati, and Alessandro Giacomello. "Serum and supplement optimization for EU GMP ‐compliance in cardiospheres cell culture." Journal of Cellular and Molecular Medicine 18, no. 4 (January 20, 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 (December 1, 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 (March 5, 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 (December 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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Dissertations / Theses on the topic "GMP EU"

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Таран, О. І., and Олена Михайлівна Проскурня. "Реалізація нових вимог GMP на прикладі процесу "підготовка та отримання чистих середовищ" на фармацевтичному підприємстві"." Thesis, Національний фармацевтичний університет, 2015. http://repository.kpi.kharkov.ua/handle/KhPI-Press/25029.

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Vyletová, Veronika. "Pravomoc Evropské unie regulovat GMO." Master's thesis, Vysoká škola ekonomická v Praze, 2015. http://www.nusl.cz/ntk/nusl-204069.

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The thesis is devoted to legal regulation of genetically modified food and feed in the European Union. It tries to answer the question: whether and how to regulate use of GMO and the future of the regulation. Considerations are supplemented by European jurisprudence. The work also provides dispute between the European Union and the World Trade Organization concerning the adjustment of the use of genetically modified organisms. Based on available information, thesis leads to inviolable of the protection of the European consumers after the effectiveness of the Transatlantic trade and investment partnership between the European Union and the United States.
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Krug, Simone. "Die Finanzierung der GAP im Kontext des Finanzverfassungssystems der EU /." Baden-Baden : Nomos, 2008. http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&doc_number=015607340&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA.

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Krug, Simone. "Die Finanzierung der GAP im Kontext des Finanzverfassungssystems der EU." Baden-Baden Nomos, 2005. http://d-nb.info/989829707/04.

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Slotwinska, Paulina. "Genmodifierade grödor och dess konsekvenser : För människa och miljö i Sydamerika, USA och EU." Thesis, Södertörn University College, School of Life Sciences, 2007. http://urn.kb.se/resolve?urn=urn:nbn:se:sh:diva-1108.

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Uppsatsen behandlar GMO (genmodifierade grödor) och hur de påverkar människa och miljö i USA, Sydamerika (Argentina och Brasilien) och Europa. De geografiska områdena har valts då arealen över GMO-odlingar är störst i USA och Sydamerika samt för att mestadels av GMO exporteras till Europa. GMO-frågan har varit väldigt omdebatterad i Europa och andra delar av världen de senaste åren av miljöorganisationer, forskare och genteknikföretag. Syftet med denna uppsats är att undersöka för- och nackdelarna med genmodifierade grödor.

Uppsatsens undersökning utgörs av två intervjuer med sakkunniga personer med skilda uppfattningar om genmodifierade grödor. I denna del behandlas även information från olika organisationer som t.ex. SNF (Svenska naturskyddsföreningen) och gmofri.se. Undersökningen genomfördes i syfte att besvara uppsatsens frågeställningar. Hur påverkas människor och miljö av genmodifierade grödor i USA, Sydamerika och Europa? Kan genmodifierade grödor lösa problemet med världssvälten? Hur förhåller man sig till GMO i olika geografiska delar av världen och varför?

Uppsatsens resultat visar att miljöpåverkan är stor eftersom genmodifierade grödor är oförutsägbara och kan ge oväntade egenskaper. Det största miljöproblemet med GMO är påverkan av den biologiska mångfalden som sker p.g.a. spridning till naturliga växter. Människans påverkas då GMO kan bidra till allergiframkallning och även att människan kan få det svårare att bekämpa sjukdomar med hjälp av antibiotika. Människan påverkas även på andra områden än hälsan, exempelvis genom att människan förlorar kontroll över livsmedelsproduktionen då multinationella gentekniksföretag äger patent på 90 procent av all GMO. GMO är inte heller en lösning på svälten, man bör lösa svältens orsaker i första hand som bland annat krig. GMO som lösning på svält används som marknadsföring av genteknikföretag då det är ett faktum att det endast är dessa företag som tjänat på GMO hittills och majoriteten av GMO som odlas i perifera länder exporteras som foder till kärnländernas slaktdjur och för användning som biobränsle. Resultatet visar även att man vet för lite om genmodifierade grödors påverkan på miljö och framför allt på människan för att kommersialiseras.

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Lacková, Lucie. "Hodnocení výkonnosti systému DPH v zemích EU." Master's thesis, Vysoká škola ekonomická v Praze, 2014. http://www.nusl.cz/ntk/nusl-201563.

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The thesis assesses measurements of the VAT efficiency. It compares the tax quota, implicit tax rate and VAT revenue ratio. The first chapter deals with theoretical foundations for a flat rate consumption tax. Following chapters discuss the perquisites for VAT efficiency calculations (comparing actual VAT revenue and theoretical amount of tax base). Following chapters assess the above mentioned calculations, with special respect to VAT Revenue Ratio, which is analyzed in detail and to which is presented a comparison across the EU countries. The thesis further analyses Policy Efficiency Ratio (policy gap) and Compliance Efficiency Ratio (compliance gap). In its conclusion it summarizes the information gathered and presents a number of possible improvements.
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Jönsson, Johanna. "GMO-lagstiftningen i Sverige och EU : Frihandelns regler vs. miljö- och hälsoskydd." Thesis, Luleå tekniska universitet, Institutionen för ekonomi, teknik och samhälle, 2017. http://urn.kb.se/resolve?urn=urn:nbn:se:ltu:diva-61800.

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Syftet med denna rapport har varit att beskriva och undersöka GMO-lagstiftningen i EU och Sverige och hur denna påverkas av gällande frihandelsavtal samt kan komma att påverkas av frihandelsavtalet TTIP, mellan EU och USA. Frågan är huruvida det föreligger en risk att TTIP-avtalet, om det träder i kraft, kan leda till att mer GMO-produkter hamnar på EU:s marknad samt att den strikta lagstiftning som råder påverkas. Den rättsdogmatiska metoden har använts och material har därmed införskaffats från källor såsom doktrin, förarbeten och lagtexter. I de fall där dessa källor inte räckt till, har information hämtats från relevanta myndigheters hemsidor och nyhetsuppdateringar. Trots att EU framhållit att avtalet inte kommer att påverka EU:s syn på hälso- och miljöskyddsfrågor så råder ännu en skepticism bland konsumenter, jordbrukare och miljöorganisationer. Dessa pekar på att det ännu råder stora oklarheter kring avtalets utformning och att det kan finnas en dold agenda. Den nya politiska uppkomna situationen, med Donald Trump som USA:s nye president kan även komma att påverka utgången av TTIP. Kanske blir det inte något avtal alls alternativt att avtalet kommer modifieras om ordentligt.
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Zelenková, Jana. "Přístupy k měření chudoby se zaměřením na členské státy EU." Master's thesis, Vysoká škola ekonomická v Praze, 2014. http://www.nusl.cz/ntk/nusl-201951.

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This thesis focuses on current approaches to the measurement of poverty. The aim of the thesis is to evaluate if measuring poverty indicators and quality of life indicators used by United Nations Development Programme and Eurostat are meaningful enough. The theoretical part is an analysis of chosen indicators. The theoretical knowledge is followed by practical part, comparing poverty levels in member states of the European Union, and giving deeper insight into the analysis of sub-indicators. Furthermore, the thesis looks at informative value connected to mutual relations among the indicators. The comparison reveals that the level of human development is negatively related to aspects such as insufficient economic growth, inequality and low level of wealth redistribution. From an analytical point of view, new multi-criteria indicators are useful enough for the purpose of research on this topic, in spite of certain imperfections.
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Valová, Markéta. "Rakousko: ekonomický vývoj a integrace v rámci EU." Master's thesis, Vysoká škola ekonomická v Praze, 2008. http://www.nusl.cz/ntk/nusl-11831.

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This thesis characterizes the basic macroeconomic indicators of the economy of Austria and its economic development. Generaly I outlined the strengths of the Austrian economy, including the consequences of massive financial crisis. In the introduction I described the general characteristic and economy of Austria and all nine Federal Republics. I defined time periods the economy of Austria, which I generally characterized, with emphasis on the forecast of economic development in 2009 and 2010. The thesis also describes the preparation of Austria to join the European Union with a focus on economic co-operation of Austria and the European Community before its entry into the EU. Also, I attend to the economic development of Austria joining the EU. I deal with foreign trade of Austria with an emphasis on the commodity and territorial structure of exports and imports and the financial sector. The thesis also solves the questions of mutual cooperation of Austria and the Czech Republic.
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Marin, Joseph. "Determining Impacts of Partnership and the Euro within the European Union:: With a Focus on Accession Countries." Thesis, Boston College, 2015. http://hdl.handle.net/2345/bc-ir:104212.

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Thesis advisor: Robert Murphy
The primary goal of the European Union is to promote a high degree of competition between regions in an effort to allow for the creation of the single market. In the year 2004, the EU had allowed ten new member states to enter into the European Union. This paper looks at the potential positive or negative impact from entering into partnership with the EU. It looks at convergence between EU member states and a potential treatment effect in order to determine that this is indeed a localized phenomenon in the EU or is there a general convergence between all countries. The paper uses a fixed effects approach in order to determine the impact of partnership and use of the Euro within the EU. I find evidence of convergence and a positive benefit from partnership; however, using the Euro appears to have a negative impact on countries
Thesis (BA) — Boston College, 2015
Submitted to: Boston College. College of Arts and Sciences
Discipline: Departmental Honors
Discipline: Economics
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Books on the topic "GMP EU"

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Costa, Marios. The Accountability Gap in EU law. Abingdon, Oxon; New York, NY: Routledge, 2017. |: Routledge, 2016. http://dx.doi.org/10.4324/9781315675077.

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Bolt, W. Output gap and inflation in the EU. Amsterdam: De Nederlandsche Bank, 2000.

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Ferragina, Anna Maria. Mind the gap: Unemployment in the new eu regions. Bonn, Germany: IZA, 2005.

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Barbone, Luca. EU accession of Central and Eastern Europe: Bridging the income gap. Washington, DC: World Bank, Country Dept. II, Europe and Central Asia Division, 1997.

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Handoll, John. Protecting national interests: Bridging the gap between member states and EU policies. West Sussex [England]: J. Wiley & Sons, 1997.

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Block, Ludo. From politics to policing: The rationality gap in EU Council policy-making. The Hague, The Netherlands: Eleven International Publishing, 2011.

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Plana Casado, Maria Jose. E-FOOD: Closing the Online Enforcement Gap in the EU Platform Economy. Cham: Springer International Publishing, 2021. http://dx.doi.org/10.1007/978-3-030-79504-7.

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Stephan, Johannes. EU-integration and development prospects of CEECs: The productivity-gap and technological structural change. Halle: Institut für Wirtschaftsforschung Halle, 2001.

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Eck, Roelien Ritsema Van. Bridging the gap; research into the relationship between EU SME policies and SME consultancy firms operating in the Netherlands. Oxford: Oxford Brookes University, 1999.

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Bailey, Allen R. The EU GMP: Good manufacturing practices. International Quality Press, 1997.

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Book chapters on the topic "GMP EU"

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Le Cacheux, Jacques, and Eloi Laurent. "The EU “Beyond GDP”." In Report on the State of the European Union, 154–67. London: Palgrave Macmillan UK, 2015. http://dx.doi.org/10.1057/9781137451088_11.

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Soros, George. "Cooperative Ways to Bridge the Gap." In EU-US Relations, 159–60. London: Palgrave Macmillan UK, 2006. http://dx.doi.org/10.1057/9780230503670_30.

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Sinitsina, Irina. "The Development Gap Between the CIS and EU." In EU Eastern Neighborhood, 1–21. Berlin, Heidelberg: Springer Berlin Heidelberg, 2011. http://dx.doi.org/10.1007/978-3-642-21093-8_1.

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Escajedo San-Epifanio, Leire, Dennis Eriksson, and Alberto López-Basaguren. "GMO Opt-Out in the EU." In Encyclopedia of Food and Agricultural Ethics, 1–9. Dordrecht: Springer Netherlands, 2018. http://dx.doi.org/10.1007/978-94-007-6167-4_638-1.

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Escajedo San-Epifanio, Leire, Dennis Eriksson, and Alberto López-Basaguren. "GMO Opt-Out in the EU." In Encyclopedia of Food and Agricultural Ethics, 1468–76. Dordrecht: Springer Netherlands, 2019. http://dx.doi.org/10.1007/978-94-024-1179-9_638.

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Wesseler, Justus, and Nicholas Kalaitzandonakes. "Present and Future EU GMO Policy." In Palgrave Advances in Bioeconomy: Economics and Policies, 245–56. Cham: Springer International Publishing, 2019. http://dx.doi.org/10.1007/978-3-030-28642-2_13.

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Kritikos, Mihalis. "Developing a Regulatory Framework on GMO Releases." In EU Policy-Making on GMOs, 59–111. London: Palgrave Macmillan UK, 2017. http://dx.doi.org/10.1057/978-1-137-31446-8_3.

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Larsen, Henrik. "The Capability-Expectations Gap: A Double Reading." In Gaps in EU Foreign Policy, 23–46. London: Palgrave Macmillan UK, 2017. http://dx.doi.org/10.1057/978-1-349-95166-6_3.

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Larsen, Henrik. "The Performativity of the Capability-Expectations Gap." In Gaps in EU Foreign Policy, 47–73. London: Palgrave Macmillan UK, 2017. http://dx.doi.org/10.1057/978-1-349-95166-6_4.

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Casolari, Federico. "EU Loyalty After Lisbon: An Expectation Gap to Be Filled?" In The EU after Lisbon, 93–133. Cham: Springer International Publishing, 2014. http://dx.doi.org/10.1007/978-3-319-04591-7_5.

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Conference papers on the topic "GMP EU"

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Olavesen, KK, LB Hatlelid, RO Husteli, and LR Rødøy. "PP-023 Environmental monitoring of a robotic solution for chemotherapy compounding, placed in a eu-gmp class d classified production room." In 22nd EAHP Congress 22–24 March 2017 Cannes, France. British Medical Journal Publishing Group, 2017. http://dx.doi.org/10.1136/ejhpharm-2017-000640.470.

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Kodash, Artemii, Anna Basevich, Tatiana Bitkina, Elena Smirnova, and Irina Kaukhova. "Audit of the Production of Sterile Medicines for Compliance with the Requirements of the Draft EU GMP Annex 1 with Risk Analysis." In Proceedings of the 1st International Symposium Innovations in Life Sciences (ISILS 2019). Paris, France: Atlantis Press, 2019. http://dx.doi.org/10.2991/isils-19.2019.36.

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Fedeli, Jean-Marc, Sergio Nicoletti, Liesbet Lagae, Inigo Artundo, and Peter O'Brien. "EU pilot lines for integrated photonics." In 2017 IEEE 14th International Conference on Group IV Photonics (GFP). IEEE, 2017. http://dx.doi.org/10.1109/group4.2017.8082205.

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Mutabzija, Goran. "WESTERN BALKANS AS EU PERIPHERY: IS IT TIME FOR CHANGES?" In 4th INTERNATIONAL SCIENTIFIC CONFERENCE GEOBALCANICA 2018. Geobalcanica Society, 2018. http://dx.doi.org/10.18509/gbp.2018.34.

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STEINHÄUSLER, FRIEDRICH. "GAP ANALYSIS OF EU COUNTERTERRORISM RESEARCH INITIATIVES." In Proceedings of the 45th Session of the International Seminars on Nuclear War and Planetary Emergencies. WORLD SCIENTIFIC, 2013. http://dx.doi.org/10.1142/9789814531788_0008.

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Aleksejeva, Inese. "Comparative Analysis of GMO Risk Perception Gap between EU Consumers and Latvian Experts Involved in GMO Decision Making Process." In New Challenges of Economic and Business Development–2013. University of Latvia, 2013. http://dx.doi.org/10.22364/ncebd.2013.01.

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Aleksejeva, Inese. "Comparative Analysis of GMO Risk Perception Gap between EU Consumers and Latvian Experts Involved in GMO Decision Making Process." In New Challenges of Economic and Business Development–2013. University of Latvia, 2013. http://dx.doi.org/10.22364/ncebd.ab.2013.01.

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Nedomová, Lea, and Petr Doucek. "Gender Pay Gap in the Czech Economy with Accent on ICT Professionals." In Values, Competencies and Changes in Organizations. University of Maribor Press, 2021. http://dx.doi.org/10.18690/978-961-286-442-2.47.

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The subject of our article is a comparison of the level and development of the gender pay gap between selected EU countries (especially the V4 countries and other selected countries such as Austria and Slovenia) for the period 2009 - 2019. The analysis for the Czech Republic will be then supplemented by a comparison with the development of the gender pay gap in the economy and in ICT Professionals. To approximate the development of wages and GDP, we used the method of linear regression together with the method of least squares. All regression analysis calculations are performed at the 5% level of significance.
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Antonescu, Daniela. "Trends of Convergence at Regional Level in European Union (EU-28)." In International Conference Innovative Business Management & Global Entrepreneurship. LUMEN Publishing, 2020. http://dx.doi.org/10.18662/lumproc/ibmage2020/35.

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The objective regarding cohesion is achieved by means of a convergence process that assumes diminishing territorial inequalities between regions and territories. The cohesion process is not limited to the relatively poor regions, but aims also to more developed regions with the purpose of observing also the secondary effects for the entire EU (EC Report, 2013). Identifying the convergence or divergence trends is one of the intensely argued topics by both the academic and the political-decisional environment. The theoretical point of view approach regarding convergence was accompanied by models meant to mitigate the requirements of assessing over given periods the evolution of territorial inequalities (between countries or regions). Identifying a process of convergence or divergence at regional level is a widely debated issue both in the academic and political-decision making environment. Thus, in the context of favourable economic development, convergence assumes a process of closing the gap between the living standards between the poorer and richer areas beginning with the premise that the first have a swifter development as the latter. Considering this aspect, the present article analyses the trends of convergence/divergence at regional level in the context of the European Union with the help of GDP per capita and variation coefficients.
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Makrevska Disoska, Elena, Irena Kikerkova, and Katerina Toshevska- Trpchevska. "COVID-19 CHALLENGES FOR EU EXTRA AND INTRA-REGIONAL TRADE." In Economic and Business Trends Shaping the Future. Ss Cyril and Methodius University, Faculty of Economics-Skopje, 2020. http://dx.doi.org/10.47063/ebtsf.2020.0011.

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The current COVID-19 crisis will take a severe toll upon the world and the EU economy. Exports and imports between member-states account for around 30.6% of EU GDP (average value for the period 2007-2018) and some EU economies are particularly exposed to the crisis due to their strong trade and value chain linkages. The trade with the rest of the world also decreased by mid-March 2020, and Rotterdam’s traffic from China fell for 20% compared to the same period in 2019. This paper estimates the different impact of the intra- EU trade and extra-EU trade on EU GDP growth. By separating extra-EU trade flows from intra-EU trade flows and using cross-section fixed method, panel least squares for the period 2008-2018, we obtained results that confirm that trade exchange within EU has significantly higher effect on per capita economic growth in comparison with trade exchange with countries outside the EU (taking in consideration the sample of EU-27 countries, excluding Great Britain).The findings prove that the current measures proposed by the EU institutions are essential for sustaining the function of the Internal Market and for EU growth prospects. Despite all efforts to remain united against the rising global challenges under the COVID-19 crisis, the Union is growing further apart. The member-states are imposing restrains on the internal trade flows thus jeopardizing the achieved positive effects of trade liberalization. It is certain that the financial crisis from 2008 caused increased Euro scepticism. Therefore differences in national views and priorities must be taken into account in order to reach a democratic compromise within the EU that is going to be both effective and legitimate in order to confront the consequences of the COVID-19 pandemics. The solidarity among member-states is challenged once again.
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Reports on the topic "GMP EU"

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O'Donnell, Kevin, and Anne Greene. A Risk Management Solution Designed to Facilitate Risk-Based Qualification, Validation, and Change Control Activities within GMP and Pharmaceutical Regulatory Compliance Environments in the EU—Part I. Institute of Validation Technology, July 2006. http://dx.doi.org/10.1080/21506590.wp7132006agko-rmsdfrbq.

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A risk management solution is described that is designed to facilitate risk-based qualification, validation, and change control activities within GMP and regulatory compliance environments in the EU. This solution is based upon a set of pre-defined, fundamental principles and design criteria, which were considered important. It offers a documented and ready-to-use ten-step process for determining and managing, on a risk basis, the scope and extent of qualification and validation, and the likely impact of changes.
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O'Donnell, Kevin, and Anne Greene. A Risk Management Solution Designed to Facilitate Risk-Based Qualification, Validation, and Change Control Activities within GMP and Pharmaceutical Regulatory Compliance Environments in the EU—Part II. Institute of Validation Technology, July 2006. http://dx.doi.org/10.1080/21506590.wp7142006agko-rmsdii.

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highlight the need for patient-focused and value-adding qualification, validation, and change control programmes for manufacturing and regulating medicinal products in the EU, which are cost-effective and in-line with current regulatory requirements and guidance. To this end, a formal risk management solution was presented that seeks to demonstrate, in a practical way, how Regulators and Industry in the EU may achieve these goals. This solution represents a formal and rigorous approach to risk management, offering a scientific and practical means for determining and managing, on a risk basis, the scope and extent of qualification and validation, and the likely impact of changes. Based on a ten-step, systematic process, this approach offers a ready-to-use and documented risk management methodology for these activities. This tool is not intended for use in all situations, or to address all risk areas or concerns encountered in GMP and Regulatory Compliance environments. Rather, its use should be commensurate with the complexity and/or criticality of the issue to be addressed, and in many instances, and in-line with ICH Q9 principles, a more informal approach to risk management may be more useful, and indeed proportionate.
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Castillo Parrilla, José Antonio. The Legal Regulation of Digital Wealth: Commerce, Ownership and Inheritance of Data. Universitätsbibliothek J. C. Senckenberg, Frankfurt am Main, 2021. http://dx.doi.org/10.21248/gups.64581.

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Digital wealth and its necessary regulation have gained prominence in recent years. The European Commission has published several documents and policy proposals relating, directly or indirectly, to the data economy. A data economy can be defined as an ecosystem of different types of market players collaborating to ensure that data is accessible and usable in order to extract value from data through, for example, creating a variety of applications with great potential to improve daily life. The value of data can increase from EUR 257 billion (1.85 of EU Gross Domestic Product (GDP)) to EUR 643 billion by 2020 (3.17% of EU GDP), according to the EU Commission. The legal implications of the increasing value of the data economy are clear; hence the need to address the challenges presented by its legal regulation.
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Spiliotopoulos, Christoforos, Malgorzata Agata Kowalska, David Bernad Beltrán, and Felice Alfieri. How to Extend the Lifetime of ICT: Examples and Case Studies from the EU GPP Criteria. University of Limerick, 2021. http://dx.doi.org/10.31880/10344/10191.

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Lukasse, Leo. The use of USDA sensors as calibrated temperature recorders : In view of EU guidelines on GDP for medicinal products for human use. Wageningen: Wageningen UR Food & Biobased Research, 2016. http://dx.doi.org/10.18174/563049.

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Führ, Martin, Julian Schenten, and Silke Kleihauer. Integrating "Green Chemistry" into the Regulatory Framework of European Chemicals Policy. Sonderforschungsgruppe Institutionenanalyse, July 2019. http://dx.doi.org/10.46850/sofia.9783941627727.

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20 years ago a concept of “Green Chemistry” was formulated by Paul Anastas and John Warner, aiming at an ambitious agenda to “green” chemical products and processes. Today the concept, laid down in a set of 12 principles, has found support in various arenas. This diffusion was supported by enhancements of the legislative framework; not only in the European Union. Nevertheless industry actors – whilst generally supporting the idea – still see “cost and perception remain barriers to green chemistry uptake”. Thus, the questions arise how additional incentives as well as measures to address the barriers and impediments can be provided. An analysis addressing these questions has to take into account the institutional context for the relevant actors involved in the issue. And it has to reflect the problem perception of the different stakeholders. The supply chain into which the chemicals are distributed are of pivotal importance since they create the demand pull for chemicals designed in accordance with the “Green Chemistry Principles”. Consequently, the scope of this study includes all stages in a chemical’s life-cycle, including the process of designing and producing the final products to which chemical substances contribute. For each stage the most relevant legislative acts, together establishing the regulatory framework of the “chemicals policy” in the EU are analysed. In a nutshell the main elements of the study can be summarized as follows: Green Chemistry (GC) is the utilisation of a set of principles that reduces or eliminates the use or generation of hazardous substances in the design, manufacture and application of chemical products. Besides, reaction efficiency, including energy efficiency, and the use of renewable resources are other motives of Green Chemistry. Putting the GC concept in a broader market context, however, it can only prevail if in the perception of the relevant actors it is linked to tangible business cases. Therefore, the study analyses the product context in which chemistry is to be applied, as well as the substance’s entire life-cycle – in other words, the six stages in product innovation processes): 1. Substance design, 2. Production process, 3. Interaction in the supply chain, 4. Product design, 5. Use phase and 6. After use phase of the product (towards a “circular economy”). The report presents an overview to what extent the existing framework, i.e. legislation and the wider institutional context along the six stages, is setting incentives for actors to adequately address problematic substances and their potential impacts, including the learning processes intended to invoke creativity of various actors to solve challenges posed by these substances. In this respect, measured against the GC and Learning Process assessment criteria, the study identified shortcomings (“delta”) at each stage of product innovation. Some criteria are covered by the regulatory framework and to a relevant extent implemented by the actors. With respect to those criteria, there is thus no priority need for further action. Other criteria are only to a certain degree covered by the regulatory framework, due to various and often interlinked reasons. For those criteria, entry points for options to strengthen or further nuance coverage of the respective principle already exist. Most relevant are the deltas with regard to those instruments that influence the design phase; both for the chemical substance as such and for the end-product containing the substance. Due to the multi-tier supply chains, provisions fostering information, communication and cooperation of the various actors are crucial to underpin the learning processes towards the GCP. The policy options aim to tackle these shortcomings in the context of the respective stage in order to support those actors who are willing to change their attitude and their business decisions towards GC. The findings are in general coherence with the strategies to foster GC identified by the Green Chemistry & Commerce Council.
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Mahdavian, Farnaz. Germany Country Report. University of Stavanger, February 2022. http://dx.doi.org/10.31265/usps.180.

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Germany is a parliamentary democracy (The Federal Government, 2021) with two politically independent levels of 1) Federal (Bund) and 2) State (Länder or Bundesländer), and has a highly differentiated decentralized system of Government and administration (Deutsche Gesellschaft für Internationale Zusammenarbeit, 2021). The 16 states in Germany have their own government and legislations which means the federal authority has the responsibility of formulating policy, and the states are responsible for implementation (Franzke, 2020). The Federal Government supports the states in dealing with extraordinary danger and the Federal Ministry of the Interior (BMI) supports the states' operations with technology, expertise and other services (Federal Ministry of Interior, Building and Community, 2020). Due to the decentralized system of government, the Federal Government does not have the power to impose pandemic emergency measures. In the beginning of the COVID-19 pandemic, in order to slowdown the spread of coronavirus, on 16 March 2020 the federal and state governments attempted to harmonize joint guidelines, however one month later State governments started to act more independently (Franzke & Kuhlmann, 2021). In Germany, health insurance is compulsory and more than 11% of Germany’s GDP goes into healthcare spending (Federal Statistical Office, 2021). Health related policy at the federal level is the primary responsibility of the Federal Ministry of Health. This ministry supervises institutions dealing with higher level of public health including the Federal Institute for Drugs and Medical Devices (BfArM), the Paul-Ehrlich-Institute (PEI), the Robert Koch Institute (RKI) and the Federal Centre for Health Education (Federal Ministry of Health, 2020). The first German National Pandemic Plan (NPP), published in 2005, comprises two parts. Part one, updated in 2017, provides a framework for the pandemic plans of the states and the implementation plans of the municipalities, and part two, updated in 2016, is the scientific part of the National Pandemic Plan (Robert Koch Institut, 2017). The joint Federal-State working group on pandemic planning was established in 2005. A pandemic plan for German citizens abroad was published by the German Foreign Office on its website in 2005 (Robert Koch Institut, 2017). In 2007, the federal and state Governments, under the joint leadership of the Federal Ministry of the Interior and the Federal Ministry of Health, simulated influenza pandemic exercise called LÜKEX 07, and trained cross-states and cross-department crisis management (Bundesanstalt Technisches Hilfswerk, 2007b). In 2017, within the context of the G20, Germany ran a health emergency simulation exercise with representatives from WHO and the World Bank to prepare for future pandemic events (Federal Ministry of Health et al., 2017). By the beginning of the COVID-19 pandemic, on 27 February 2020, a joint crisis team of the Federal Ministry of the Interior (BMI) and the Federal Ministry of Health (BMG) was established (Die Bundesregierung, 2020a). On 4 March 2020 RKI published a Supplement to the National Pandemic Plan for COVID-19 (Robert Koch Institut, 2020d), and on 28 March 2020, a law for the protection of the population in an epidemic situation of national scope (Infektionsschutzgesetz) came into force (Bundesgesundheitsministerium, 2020b). In the first early phase of the COVID-19 pandemic in 2020, Germany managed to slow down the speed of the outbreak but was less successful in dealing with the second phase. Coronavirus-related information and measures were communicated through various platforms including TV, radio, press conferences, federal and state government official homepages, social media and applications. In mid-March 2020, the federal and state governments implemented extensive measures nationwide for pandemic containment. Step by step, social distancing and shutdowns were enforced by all Federal States, involving closing schools, day-cares and kindergartens, pubs, restaurants, shops, prayer services, borders, and imposing a curfew. To support those affected financially by the pandemic, the German Government provided large economic packages (Bundesministerium der Finanzen, 2020). These measures have adopted to the COVID-19 situation and changed over the pandemic. On 22 April 2020, the clinical trial of the corona vaccine was approved by Paul Ehrlich Institute, and in late December 2020, the distribution of vaccination in Germany and all other EU countries
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Comparing international approaches to food safety regulation of GM and Novel Foods. Food Standards Agency, August 2021. http://dx.doi.org/10.46756/sci.fsa.rdg239.

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The global area of genetically modified (GM) crop production has considerably increased over the past two decades, with GM crops now cultivated in about 28 countries, accounting for over 10% of the world’s arable land. A 'novel food' is any food or substance that has not been used for human consumption to a significant degree within the EU before 15 May 1997. Since then, there has been over 90 novel foods authorisations approved for use by the EU. Novel foods and genetically modified organisms (GMOs) are subject to a large variation in regulatory approaches around the world, for which many countries have specifically developed their own regulatory frameworks to control the placement of such products on their markets.
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Surveillance of Antimicrobial Resistance (AMR) in E. coli and Campylobacter from retail turkey meat and E. coli from retail lamb in 2020/21. Food Standards Agency, February 2022. http://dx.doi.org/10.46756/sci.fsa.hlo814.

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The FSA's AMR surveillance programme has been established for several years, with a particular focus on retail meats. Between 2015 and 2020, we participated in an EU-harmonised survey on AMR E. coli in retail meats, which generated AMR prevalence data in beef, pork and chicken, collected at retail in the UK. The survey confirmed that chicken, and to a lesser extent beef and pork, can be contaminated with AMR E. coli. However, there is no equivalent AMR data for lamb and turkey meat on retail sale in the UK. To address this gap in our AMR surveillance, we extended the EU survey of AMR E. coli in retail meats to include lamb and turkey meat. Testing for AMR Campylobacter has also been included for turkey meat.
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National report 2009-2019 - Rural NEET in Serbia. OST Action CA 18213: Rural NEET Youth Network: Modeling the risks underlying rural NEETs social exclusion, December 2020. http://dx.doi.org/10.15847/cisrnyn.nrrs.2020.12.

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The situation of rural Youths Neither in Employment nor in Education or Training (NEET) aged between 15 and 34 years old, over the last decade (2010-2019) in Serbia is presen-ted in this report. The main criterion for analysis was the degree of urbanisation, where the comparison was done between rural areas, towns and suburbs, cities, and the whole country. The data available on EUROSTAT and the national Statistical office of Serbia were used as main resources for statistical interpretation. The statistical procedures used in the report rely on descriptive longitudinal analysis, using graphical displays (e.g. overlay line charts) as well as the calculation of proportional abso-lute and relative changes between observed years. The analysis of the youth population in Serbia aged 15-24 years in total as well as the youth population for different degrees of urbaisation, for the period 2010-2019, showed a de-creasing trend. In the period 2014-2019 (which is with available data for the case of Serbia) it can be ob-served that the youth employment rate is increasing in all areas of urbanisation. In contrast to the employment, the level of unemployment in Serbia is constantly decreasing in the period 2014-2019. This trend is similar for all three areas of urbanisation.The decrease in the number of early school leavers is registered in the case of entire Serbia, cities, and rural areas. The only trend of increasing of early school leavers’ rate is recorded for the towns and suburbs, for the observed period 2014-2019.In the period 2010-2019, the NEET rate is declining in Serbia for all three degrees of ur-banisation. In comparison to EU countries, Serbia is still significantly above the European average, but with a tendency of reducing the gap.
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