29 results on '"guidance"'
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2. Technical and Vocational Education and Training for Disadvantaged Youth
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UNESCO-UNEVOC International Centre for Technical and Vocational Education and Training (Germany), Alla-Mensah, Joyceline, Henderson, Holly, and McGrath, Simon
- Abstract
Due to its close links to the labour market, technical and vocational education and training (TVET) can play an important role to improve job opportunities and livelihoods for young people, and in particular for disadvantaged youth. However, this potential is not always fully realized, and relatively little research and evidence has been collected about the barriers disadvantaged youth face when accessing to and progressing through TVET. This paper maps some of the main barriers disadvantaged youth face in TVET and examines available evidence on strategies and approaches that are being used or can be used to meet the needs of disadvantaged youth. The paper discusses these barriers using a framework that looks at '4As': availability, accessibility, acceptability, and adaptability. The report is the outcome of a study conducted in collaboration with the University of Nottingham and other members of the UNEVOC Network.
- Published
- 2021
3. Towards Equity and Inclusion in Higher Education in Europe. Eurydice Report
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European Commission (Belgium), European Education and Culture Executive Agency (EACEA), Eurydice (Belgium), and Crosier, David
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This Eurydice report focuses on the topic of equity and inclusion in higher education in Europe. It analyses the current level of alignment of European higher education systems with the ten 'Principles and Guidelines agreed by all EHEA countries' as a blueprint to take forward the commitment of improving the social dimension. There are ten chapters, addressing each Principle. Each chapter opens with the full exposition of the relevant Principle and its accompanying Guidelines. Following that is a succinct explanation of how the particular Principles and Guidelines relate to equity, the methodological challenges that are addressed, and the choice of the indicators. Finally, the data collected is presented mostly in the form of maps. A scoreboard indicator at the end of each chapter summarises how the European countries perform based on the extent of implementation of the particular Guidelines. This gives the reader a clear visual picture of the current level of attention in European systems to equity and inclusion in higher education. Finally, a concluding chapter recaps the main findings of the report. The report's prime source is information on top-level regulations and policies collected from Eurydice National Units, representing 38 education systems across 36 European countries, with the academic year 2020/2021 as a reference. [This report was written with the contribution of Anita Kremo, Susanna Zellini, Elena Fiore, and Diana Antonello.]
- Published
- 2022
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4. Integrating Asylum Seekers and Refugees into Higher Education in Europe: National Policies and Measures. Eurydice Report
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European Commission, Education, Audiovisual and Culture Executive Agency (EACEA), Eurydice (Belgium), Crosier, David, and Kocanova, Daniela
- Abstract
Human history has been shaped by people moving to live in new places. The numbers of people living outside their countries of birth in today's societies are, however, much higher than in the past. In the European Union (EU) Member States, the number of people with citizenship of a non-member country on 1 January 2017 was 21.6 million, and there were 16.9 million persons with the citizenship of another EU Member State (Eurostat, 2018c). Among this broad group of migrants, asylum seekers and refugees, who have been obliged to leave their country, make up a relatively small percentage. However the rapid increase in numbers of asylum seekers entering Europe in the years 2015 and 2016 -- largely as a result of the conflict in Syria -- lead media and politicians to characterise the phenomenon as a migration or refugee crisis. This report was planned in the wake of this phenomenon. The President of the European Commission, Jean-Claude Juncker, in his State of the Union address in September 2015 stated that 'the first priority today is and must be addressing the refugee crisis' (European Commission 2015, p. 6). While there has been enormous political attention to the way in which the situation has been addressed, one of the areas of public policy that clearly has a role to play is higher education. In particular, a high proportion of refugees are aged in the typical higher education population range (18-34) and among these a considerable number have been enrolled in higher education programmes in their home country. While there is inevitably a strong potential demand for higher education among the refugee population, it cannot be taken for granted that this demand can be easily met. In many cases, there will be a need for potential students to learn the host country language and to adapt to the higher education system. This requires adequate information and guidance, as well as provision of adapted preparatory programmes. Refugees are also likely to be in need of considerable support -- both psychological and financial. Meanwhile for the host country, there will be a need to assess and recognise learning that cannot be demonstrated through certificates. This also requires system-level planning and action. The aim of this report is to assess how far national systems have developed in terms of being able to respond to the needs of asylum seekers and refugees.
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- 2019
5. Including Nonreligious Worldviews in Religious Education: The Views and Experiences of English Secondary School Teachers
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Everington, Judith
- Abstract
Although the teaching of nonreligious worldviews has been advocated in a Council of Europe Recommendation, few European countries include such a study in religious education (RE). Guidance on implementing the Recommendation recognises that inclusion is problematic, raising issues for policymakers, teacher trainers and schools. In this article, findings from a qualitative study of the views and experiences of 25 RE teachers in England are used to identify and explore a range of issues, in relation to national and international debates and research. Examples of inclusion and the models that they suggest are considered and it is argued that major obstacles, such as limited time and lack of a framework for the integration of religious and nonreligious worldviews, can be of overcome. However, it is concluded that this will require further research and curriculum development work and that international collaboration should be pursued.
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- 2019
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6. Adult Education and Lifelong Learning in Europe and Beyond: Comparative Perspectives from the 2015 Würzburg Winter School. Studies in Pedagogy, Andragogy, and Gerontagogy. Volume 67
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Egetenmeyer, Regina and Egetenmeyer, Regina
- Abstract
This volume presents comparisons of adult education and lifelong learning with a focus on educational policies, professionalization in adult education, participation in adult learning and education, quality in adult education, and educational guidance and counselling. The essays are based on comparisons discussed at the international Winter School "Comparative Studies in Adult and Lifelong Learning," held in Würzburg, Germany, February 2015. Sub-topics of lifelong learning were chosen for an in-depth comparison and analysis of the situation in various European countries and beyond. Following a preface by Bernd Käpplinger and Steffi Robak, and "Comparing Adult Education and Lifelong Learning in Europe and beyond: An Introduction" by Regina Egetenmeyer, this book contains the following essays: (1) Adult learning and education policies in Germany, Portugal and Sweden: An analysis of national reports to CONFINTEA VI (Licínio C. Lima, Paula Guimarães, and Nathalie Touma); (2) Knowledge economy and demographic change: Comparative case study of Europe and South Asia (Chetan Singai, Gaia Gioli, Eva Riemer, Kapil Dev Regmi, Sofia Mastrokoukou, and Shalini Singh); (3) Adult education and its key actors in academic professionalisation--A comparison between China, India and the European Union (Verena Liszt, Mina Toko, and Xiaojn Yan); (4) The curriculum of study programmes for adult educators--The study cases of Italy, Germany and Portugal (Vanna Boffo, Kathrin Kaleja, Khulud Sharif-Ali, and Joana Fernandes); (5) Regulations and working conditions for trainers in adult education: A comparative glance (Vanna Boffo, Kathrin Kaleja, and Joana Fernandes); (6) Academic professionalisation in adult education: Insights into study programmes in Germany, Italy and Portugal (Franziska Semrau, Nataliya G. S. Vieira, and Elisa Guida); (7) Participation and non-participation in adult education and learning: A comparative study between Portugal, Italy, Hungary, and India (Rute Ricardo, Bani Bora, Fabio Camilloni, Loretta Lizon, Mariana Cavaca, Prachi Sinha, Pratibha Kandera, and Regina Egetenmeyer); (8) Comparing Quality Management Systems and procedures in Italy and Germany (Lisa Hilbig, Sabrina Thom, and Silvia Tursi); (9) Comparative analysis of two quality management models in the U.S.A. and Germany (Peggy Everett and Christian Müller); (10) Guidance and counselling in higher education: A comparison between the career services in Germany and Italy (Maria Grasso, Nicoletta Tomei, Laura Balázs, Deepak Goswami, and Bruna da Silva Ribas); (11) A regional perspective on tutorship as a potential lifelong and adult guidance tool (Nicoletta Tomei); (12) India towards a knowledge economy: Alternatives for the global demographic challenge and inclusive development in India (Shalini Singh); and (13) The status of adult literacy and lifelong learning in Nepal (Kapil Dev Regmi).
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- 2016
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7. Designing Adult Learning Strategies: The Case of South Eastern Europe
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European Training Foundation (ETF) (Italy), Gunny, Madeleine, Viertel, Evelyn, Gunny, Madeleine, Viertel, Evelyn, and European Training Foundation (ETF) (Italy)
- Abstract
The importance of lifelong learning is generally well understood and few people today would query the need for adults to regularly update their skills in line with labour market needs, and for governments and social partners to provide an environment that supports skills acquisition and updating. However, it is clear when we look at data from the EU Member States that a great deal of lifelong learning takes place within the context of employment: it can be delivered, financed and outsourced by employers, making it directly related to the needs of the workplace. We see that access to such learning opportunities is not evenly spread across the working population. They are more likely to occur in larger companies and to be targeted at the better educated staff in middle-ranking posts. What does this imply for lifelong learning in the countries of South Eastern Europe? These countries suffer from high unemployment and low economic activity rates, so very large numbers of the active population are immediately barred from workplace learning. Moreover, those who are working are most likely to be doing so in the informal sector or in small or micro-enterprises. The purpose of this publication is to look at how lifelong learning strategies can be developed in such an environment, using recent data gathered from South Eastern Europe, and to provide guidance to those countries and others operating in a similar context. It emphasises the need for more attention to be paid to workplace learning and to exploit the potential of enterprises as providers of lifelong learning. Appended are: (1) Sweden; and (2) Accreditation: Process, Indicators, Actors and Principles. A bibliography is included. (Contains 7 tables and 14 footnotes.)
- Published
- 2006
8. European Neuroendocrine Tumor Society (ENETS) 2024 guidance paper for the management of well-differentiated small intestine neuroendocrine tumours.
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Lamarca A, Bartsch DK, Caplin M, Kos-Kudla B, Kjaer A, Partelli S, Rinke A, Janson ET, Thirlwell C, van Velthuysen MF, Vullierme MP, and Pavel M
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- Humans, Societies, Medical, Europe, Neuroendocrine Tumors therapy, Neuroendocrine Tumors pathology, Neuroendocrine Tumors diagnosis, Intestinal Neoplasms therapy, Intestinal Neoplasms pathology, Intestinal Neoplasms diagnosis, Intestine, Small pathology
- Abstract
Both the incidence and prevalence of well-differentiated neuroendocrine tumours from the small intestine (Si-NET) are gradually increasing. Most patients have non-functioning tumours with subtle GI symptoms and tumours are often discovered incidentally by endoscopy or at advanced disease stages by imaging depicting mesenteric lymph node and /or liver metastases while around 30% of the patients present with symptoms of the carcinoid syndrome. Adequate biochemical assessment and staging including functional imaging is crucial for treatment-related decision-making that should take place in an expert multidisciplinary team setting. Preferably, patients should be referred to specialised ENETS Centres of Excellence or centres of high expertise in the field. This guidance paper provides the current evidence and best knowledge for the management of Si-NET grade (G) 1-3 following 10 key questions of practical relevance for the diagnostic and therapeutic decision making., (© 2024 British Society for Neuroendocrinology.)
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- 2024
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9. International surgical guidance for COVID-19: Validation using an international Delphi process - Cross-sectional study.
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AJ, Beamish, C, Brown, T, Abdelrahman, Harper E, Ryan, Rl, Harries, RJ, Egan, and Welsh Surgical Research Initiative (WSRI) Collaborative
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CONSENSUS (Social sciences) ,VIRAL pneumonia ,OPERATIVE surgery ,CROSS-sectional method ,COVID-19 ,MEDICAL protocols ,EPIDEMICS ,DELPHI method - Abstract
Background: International professional bodies have been quick to disseminate initial guidance documents during the COVID-19 pandemic. In the absence of firm evidence, these have been developed by expert committees, limited in participant number. This study aimed to validate international COVID-19 surgical guidance using a rapid Delphi consensus exercise.Methods: Delphi statements were directly mapped to guidance from surgical professional bodies in the US and Europe (SAGES/EAES), the UK (Joint RCS), and Australasia (RACS), to validate content against international consensus. Agreement from ≥70% participants was determined as consensus agreement.Results: The Delphi exercise was completed by 339 individuals from 41 countries and 52 statements were mapped to the guidance, 47 (90.4%) reaching consensus agreement. Of these, 27 statements were mapped to SAGES/EAES guidance, 21 to the Joint RCS document, and 33 to the RACS document. Within the SAGES/EAES document, 92.9% of items reached consensus agreement (median 89.0%, range 60.5-99.2%), 90.4% within the Joint RCS document (87.6%, 63.4-97.9%), and 90.9% within the RACS document (85.5%, 18.7-98.8%). Statements lacking consensus related to the surgical approach (open vs. laparoscopic), dual consultant operating, separate instrument decontamination, and stoma formation rather than anastomosis.Conclusion: Initial surgical COVID-19 guidance from the US, Europe and Australasia was widely supported by an international expert community, although a small number of contentious areas emerged. These findings should be addressed in future guidance iterations, and should stimulate urgent investigation of non-consensus areas. [ABSTRACT FROM AUTHOR]- Published
- 2020
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10. FACTORES Y ELEMENTOS DE CALIDAD PERCIBIDOS POR EL PROFESORADO PARTICIPANTE EN EL PLAN DE ACCIÓN TUTORIAL DE UNIVERSIDADES EUROPEAS.
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Martín Romera, Ana, Berrios Aguayo, Beatriz, and Pantoja Vallejo, Antonio
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UNIVERSITIES & colleges ,COLLEGE teachers ,COLLEGE students ,TUTORS & tutoring ,SWOT analysis - Abstract
Copyright of Educación XX1 is the property of Editorial UNED and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2020
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- View/download PDF
11. Health and nutrition claims - guidance, regulation and self-regulation.
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Walker, M. J.
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FOOD labeling laws , *ADVERTISING , *DIETARY supplements , *FRAUD , *NUTRITION , *ORGANIC foods , *PUBLIC health , *ADULT education workshops - Abstract
The law on nutrition and, especially, health claims on food is complex and evolving. There is a widely felt need for guidance and dialogue between stakeholders. A well-attended seminar was organised in September 2016 that brought together regulators, enforcement practitioners and the trade and appeared to go some way to addressing this need. It was generally agreed that several next steps are desirable: to run the seminar again ( e.g. in the north of England); to develop a multiple stakeholder forum in order to arrive at correct interpretation and shorten the decision-making process in difficult cases; to introduce an 'improvement notice' option for UK implementation of Regulation 1924/2006; and to develop a checklist for use in examining labels and advertisements. This paper offers an illustration of how this might be commenced; readers are invited to comment. More guidance on priorities and analytical methods is needed for food and food supplements for which health claims are made. The US and European Union regulatory and enforcement attitudes to health claims have developed in quite different directions. With the withdrawal of the UK from the European Union, it will be interesting to see what challenges there are ahead for the protection of consumers and responsible businesses from food health fraud. [ABSTRACT FROM AUTHOR]
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- 2017
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12. US-guided peripheral vascular interventions, comments on the EFSUMB guidelines.
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Dietrich, Christoph Frank, Horn, Rudolf, Morf, Susanne, Chiorean, Liliana, Yi Dong, Xin Wu Cui, Atkinson, Nathan, Jenssen, Christian, Dietrich, Christoph Frank Frank, Dong, Yi, and Cui, Xin Wu
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ARTERIAL diseases , *DIAGNOSTIC ultrasonic imaging , *ULTRASONIC imaging , *ARTERIAL puncture , *VENOUS puncture , *INTRAVENOUS catheterization , *MEDICAL protocols , *MEDICAL societies - Abstract
Peripheral venous as well as arterial punctures have traditionally been performed on the basis of designated anatomical landmarks. However, due to patients' individual anatomy and vessel pathology and depending on individual operators' skill, this landmark approach is associated with a significant failure rate and complication risk. This review comments on the evidence-based recommendations on ultrasound (US)-guided vascular access which have been published recently within the framework of Guidelines on Interventional Ultrasound (INVUS) of the European Federation of Societies for US in Medicine and Biology (EFSUMB) from a clinical practice point of view. Part 1 of the review had its focus on general aspects of US- guidance and on central venous access, whereas part 2 refers to peripheral vascular access. [ABSTRACT FROM AUTHOR]
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- 2016
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13. Guidance on using real-world evidence from Western Europe in Central and Eastern European health policy decision making.
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Németh B, Kamusheva M, Mitkova Z, Petykó ZI, Zemplényi A, Dimitrova M, Tachkov K, Balkányi L, Czech M, Dawoud D, Goettsch W, Hren R, Knies S, Lorenzovici L, Maravic Z, Piniazhko O, Zerovnik S, and Kaló Z
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- Humans, Europe, Trust, Decision Making, Health Policy, Technology Assessment, Biomedical
- Abstract
Aim: Real-world data and real-world evidence (RWE) are becoming more important for healthcare decision making and health technology assessment. We aimed to propose solutions to overcome barriers preventing Central and Eastern European (CEE) countries from using RWE generated in Western Europe. Materials & methods: To achieve this, following a scoping review and a webinar, the most important barriers were selected through a survey. A workshop was held with CEE experts to discuss proposed solutions. Results: Based on survey results, we selected the nine most important barriers. Multiple solutions were proposed, for example, the need for a European consensus, and building trust in using RWE. Conclusion: Through collaboration with regional stakeholders, we proposed a list of solutions to overcome barriers on transferring RWE from Western Europe to CEE countries.
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- 2023
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14. Education systems as transition spaces.
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Tikkanen, Jenni, Bledowski, Piotr, and Felczak, Joanna
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EDUCATIONAL counseling , *CHANGE , *EDUCATION , *EDUCATIONAL equalization , *EDUCATION & society , *CROSS-cultural studies on education - Abstract
The changes that have occurred in the field of education over the course of the last couple of decades have been associated with increased demands that are not only placed on individuals from both within and beyond the education system, but also on the support they require to make successful educational choices. One central way this need is being addressed is through educational and vocational guidance provided at different stages and transition points of educational trajectories. The aim of this article is to provide a context for the research findings presented in the subsequent articles of this special issue by illustrating the ways educational trajectories are regulated through the organization of schooling and the structures of educational and vocational guidance in the eight countries that participated in the Governance of Educational Trajectories in Europe (GOETE) research project. This article presents three country clusters of education and welfare based on the comparative analysis conducted by the project. [ABSTRACT FROM PUBLISHER]
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- 2015
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15. Guidance for clinical and public health laboratories testing for influenza virus antiviral drug susceptibility in Europe
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Pozo, Francisco, Lina, Bruno, Andrade, Helena Rebelo de, Enouf, Vincent, Kossyvakis, Athanasios, Broberg, Eeva, Daniels, Rod, Lackenby, Angie, and Meijer, Adam
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- *
INFLUENZA treatment , *PUBLIC health laboratories , *PATHOLOGICAL laboratories , *ION channels , *INFLUENZA A virus , *ANTIVIRAL agents , *DISEASE susceptibility - Abstract
Abstract: Two classes of antiviral drugs are licensed in Europe for treatment and prophylaxis of influenza; the M2 ion-channel blockers amantadine and rimantadine acting against type A influenza viruses only and the neuraminidase enzyme inhibitors zanamivir and oseltamivir acting against type A and type B influenza viruses. This guidance document was developed for but not limited to the European Union (EU) and other European Economic Area (EEA) countries on how and when to test for influenza virus antiviral drug susceptibility. It is aimed at clinical and influenza surveillance laboratories carrying out antiviral drug susceptibility testing on influenza viruses from patients suspected of harbouring viruses with reduced susceptibility or for the monitoring of the emergence of such among circulating viruses, respectively. Therefore, the guidance should not be read as a directive or an algorithm for treatment. Monitoring for emergence of influenza viruses with reduced drug susceptibility in hospitalized cases is crucial for decision making on possible changes to antiviral treatment. Therefore, it is important to test for antiviral susceptibility in certain patient groups, such as patients treated with influenza antiviral drugs. It is also important to determine the frequency of viruses with natural (not related to drug use) reduced susceptibility among community and hospitalized cases, as this knowledge is essential for making empirical antiviral treatment decisions. Furthermore, testing of specimens from community influenza patients is needed to determine the frequency of viruses with reduced susceptibility and good viral fitness that are readily transmissible, as they may become dominant among circulating viruses. Phenotypic neuraminidase enzyme inhibition assays are recommended to determine the level of inhibition of the neuraminidase enzyme by antiviral drugs as a measure of drug susceptibility of the virus. Genotypic assays are recommended to identify amino acid substitutions in the neuraminidase and M2 ion-channel proteins that have been associated with reduced antiviral susceptibility previously. By 2012 all circulating seasonal influenza A(H1N1)pdm09 and A(H3N2) viruses were naturally resistant to the M2 ion-channel blockers, so priority should be given to testing for neuraminidase inhibitor susceptibility. [Copyright &y& Elsevier]
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- 2013
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16. Organización de la Orientación Universitaria en el Espacio Europeo de Educación Superior: la Unidad de Orientación de Centro.
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Villena Martínez, Ma Dolores, Muñoz-García, Antonio, Sánchez, Tamara Polo, and Rodríguez, Jorge Jiménez
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HIGHER education ,EDUCATIONAL psychology ,COLLEGE students ,COUNSELING - Abstract
Copyright of Electronic Journal of Research in Educational Psychology is the property of Editorial of the University of Almeria (Spain) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2010
17. Strategic environmental assessment and transport planning: towards a generic framework for evaluating practice and developing guidance.
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Fischer, Thomas B.
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ENVIRONMENTAL impact analysis , *TRANSPORTATION , *EVALUATION , *PLANNING - Abstract
In this paper, a generic strategic environmental assessment (SEA) framework for transport planning is introduced and tested. The framework may be used for evaluating existing practice, whilst also serving as the basis for developing context-specific guidance. Based on (a) the evidence provided by transport planning systems in northern and western European countries and (b) suggestions by various authors and guidance documents on what contributes to effective SEA, the framework revolves around assessment tasks that are allocated to four SEA tiers: policies; network plans; corridor plans; and programmes. Although the framework can be directly applied for evaluating practice, in order to support the development of guidance, existing planning and assessment practice first needs to be analysed, enabling SEA to be adapted to the underlying transport planning sys-tem. In the paper, the framework is used to identify possible core tasks of the European Union TEN-T (Trans-European Transport Network) related corridor-plan SEAs in Germany and England. [ABSTRACT FROM AUTHOR]
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- 2006
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18. The SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 11th revision, 30–31 March 2021, SCCS/1628/21.
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PERSONAL care product ingredients , *IN vivo studies , *ANIMAL experimentation , *RISK assessment , *PRODUCT safety , *SAFETY - Abstract
The "SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation, 11 th Revision" (SCCS/1628/21) contains relevant and updated information on the different aspects of testing and safety evaluation of cosmetic substances in Europe. The emphasis is on cosmetic ingredients for which a concern has been expressed for human health. Indirectly, the Guidance also provides some advice on the safety of finished products. A general aim is to improve harmonised compliance with the current cosmetic EU legislation, Regulation (EC) No 1223/2009, for which animal testing and marketing bans fully apply from 2013 onwards. This means that no in vivo testing of ingredients or finished products is allowed in Europe for the purpose of cosmetics. For this reason, the SCCS has closely followed the progress made in regard to the development and validation of alternative replacement methods, also referred to as new approach methodology (NAM). The "SCCS Notes of Guidance" are regularly revised and updated in order to incorporate progress made and experience gained over time, in particular on the use of NAMs, and the new methods and data that became available since previous revision (SCCS/1602/18) formed the basis of the current (11 th) Revision. • An updated overview of the different aspects of testing and safety evaluation of cosmetic ingredients in Europe is provided • Emphasis is on animal-free methods and experience gained for their use in safety evaluation of cosmetic ingredients • The application of next generation risk assessment using in chemico , in silico and in vitro methodology is described [ABSTRACT FROM AUTHOR]
- Published
- 2021
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19. Guidance synthesis. Medical research for and with older people in Europe: Proposed ethical guidance for good clinical practice: Ethical considerations.
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Diener, L., Hugonot-Diener, L., Alvino, S., Baeyens, J. P., Bone, M. P., Chirita, D., Husson, J. M., Maman, M., Piette, F., Tinker, A., and Von Raison, F.
- Subjects
CLINICAL trials & ethics ,OLD age ,MEDICAL research ,INFORMED consent (Medical law) ,CAREGIVERS ,PROFESSIONAL ethics ,ETHICS committees ,EXPERIMENTAL design ,ETHICS - Abstract
Introduction: In Europe the population is ageing rapidly. Older people are taking many medicinal products daily and these may not necessarily be suitable for them. Publications show that older patients are underrepresented in clinical trials, especially those over 75 years, with multiple co-morbidities, concomitant treatments and/or frailty. This document provides a summary of recommendations on ethical aspects of clinical trials with older people, who may in some cases be considered a vulnerable patient population. The EFGCP’s Geriatric Medicine Working Party (GMWP) has developed this guidance to promote such research and to support health care professionals in their efforts. Ethical, scope and context: The definition of a geriatric patient is reviewed. Frail and vulnerable patients, who are a minority of geriatric patients, should be included whenever it is relevant. The legal context is described. The process of informed consent: All adults should be presumed capable of consent, unless proven otherwise; informed consent must be sought for all older people who are able to consent. A simple, short and easy-to-understand information sheet and consent form will contribute to improving the readability and understanding of the older participant. A participant guide and the use of a simple tool to ensure decision making capacity, are recommended. Whenever older people are unable to consent, their assent should be sought systematically using adequate information, in addition to seeking the consent of their legal or authorised representative as appropriate. Ethics Committees: Research ethics committees need internal and/or external geriatric expertise to balance the benefits and risks of research in older people and to appreciate and recognise their autonomy. Design and Analyses: Design and Analyses should be adapted to the objectives with appropriate outcomes and are not different from other clinical trials. Conclusions: The absence of proper recruitment or insufficient presence of older patients in clinical development plans for new medicinal products is detrimental; there is a need to improve evidence-based knowledge, understanding and management of their conditions and treatment. The aim of this guidance is to facilitate clinical research for and with the older patient population. The long version of the guidance will be available on the EFGCP’s website: www.efgcp.be/ . [ABSTRACT FROM AUTHOR]
- Published
- 2013
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20. EBiSC best practice: How to ensure optimal generation, qualification, and distribution of iPSC lines.
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Steeg R, Mueller SC, Mah N, Holst B, Cabrera-Socorro A, Stacey GN, De Sousa PA, Courtney A, and Zimmermann H
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- Biological Specimen Banks ethics, Biological Specimen Banks standards, Cell Culture Techniques methods, Cell Culture Techniques standards, Cell Differentiation genetics, Cell Line, Europe, Humans, Quality Control, Biological Specimen Banks statistics & numerical data, Cellular Reprogramming genetics, Cryopreservation methods, Induced Pluripotent Stem Cells cytology, Induced Pluripotent Stem Cells metabolism
- Abstract
Disease-relevant human induced pluripotent stem cells (iPSCs) are generated worldwide for research purposes; however, without robust and practical ethical, legal, and quality standards, there is a high risk that their true potential will not be realized. Best practices for tissue procurement, iPSC reprogramming, day-to-day cultivation, quality control, and data management aligned with an ethical and legal framework must be included into daily operations to ensure their promise is maximized. Here we discuss key learning experiences from 7 years of operating the European Bank for induced Pluripotent Stem Cells (EBiSC) and recommend how to incorporate solutions into a daily management framework., (Copyright © 2021 Fraunhofer Institut fû¥r Biomedizinische Technik. Published by Elsevier Inc. All rights reserved.)
- Published
- 2021
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21. Discrepancies and similarities in the genome-informed guidance for psychiatric disorders amongst different regulatory bodies and research consortia using next generation sequencing-based clinical pharmacogenomics data.
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Kordou Z, Skokou M, Tsermpini EE, Chantratita W, Fukunaga K, Mushiroda T, Patrinos GP, and Koromina M
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- Europe, Genome, Human, High-Throughput Nucleotide Sequencing, Humans, Mental Disorders diagnosis, Pharmacogenetics, United States, United States Food and Drug Administration, Mental Disorders genetics
- Abstract
Undoubtedly, pharmacogenomics (PGx) aims in optimizing drug treatment responses whilst also improving the patients' quality of life, either via a reduction of adverse drug reactions and/or an enhancement of drug treatment efficacy. To achieve this, PGx guidance is provided by the two major regulatory bodies in a worldwide level, specifically the U.S. Food and Drug Administration (FDA) and the European Medicine Agency (EMA), and occasionally some research consortia, such as the Clinical Pharmacogenetics Implementation Consortium (CPIC) or the Dutch Pharmacogenomics Working Group (DPWG). However, so far, there is a limited number of studies focusing on the delineation of the similarities and more importantly, the discrepancies in the PGx guidance by the different regulatory bodies and consortia. Herein, we use real-life clinical PGx data to highlight such discrepancies and similarities for genome-guided interventions in psychiatric disorders, thus demonstrating the need for harmonization of the guidelines and recommendations. More precisely, we used the PharmCAT genome-informed drug treatment reports from 304 Greek individuals with psychiatric disorders in order to emphasize on the discrepancies in the PGx guidance/guidelines between FDA vs EMA and CPIC vs DPWG, respectively. For example, CYP2D6-pimozide pair is characterized as 'Testing Required' according to FDA and is accompanied by a DPWG PGx guideline, whilst no EMA or CPIC PGx guidance is found for this drug-gene pair. Moreover, discrepancies are observed regarding the type of PGx guidance for CYP2C19-doxepin pair, with 89 individuals from our study cohort requiring a dose prescribing change based on FDA, whilst only 5 individuals have to receive genome-guided treatment adjustment according to CPIC. To our knowledge, this is the first study, in which discrepancies regarding the type of PGx guidance and the number of actionable drug-gene pairs amongst FDA and EMA, as well as CPIC and DPWG, are brought to light with an emphasis on psychiatric disorders., (Copyright © 2021 Elsevier Ltd. All rights reserved.)
- Published
- 2021
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22. Current clinical practice in disabling and chronic migraine in the primary care setting: results from the European My-LIFE anamnesis survey.
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Ryvlin P, Skorobogatykh K, Negro A, Sanchez-De La Rosa R, Israel-Willner H, Sundal C, MacGregor EA, and Guerrero AL
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- Adult, Europe, Female, Humans, Male, General Practitioners, Migraine Disorders epidemiology, Migraine Disorders therapy, Practice Patterns, Physicians', Primary Health Care
- Abstract
Background: Migraine is a prevalent and disabling headache disorder that affects more than 1.04 billion individuals world-wide. It can result in reduction in quality of life, increased disability, and high socio-economic burden. Nevertheless, and despite the availability of evidence-based national and international guidelines, the management of migraine patients often remains suboptimal, especially for chronic migraine (CM) patients., Methods: My-LIFE anamnesis project surveyed 201 General practitioners (GPs) from 5 European countries (France, Germany, Italy, Spain, and the UK) with the aim of understanding chronic migraine (CM) patients' management in the primary care setting., Results: In our survey, GPs diagnosed episodic migraine (EM) more often than CM (87% vs 61%, p < 0.001). We found that many CM patients were not properly managed or referred to specialists, in contrast to guidelines recommendations. The main tools used by primary-care physicians included clinical interview, anamnesis guide, and patient diary. Tools used at the first visit differed from those used at follow-up visits. Up to 82% of GPs reported being responsible for management of patients diagnosed with disabling or CM and did not refer them to a specialist. Even when the GP had reported referring CM patients to a specialist, 97% of them were responsible for their follow-up. Moreover, the treatment prescribed, both acute and preventive, was not in accordance with local and international recommendations. GPs reported that they evaluated the efficacy of the treatment prescribed mainly through patient perception, and the frequency of follow-up visits was not clearly established in the primary care setting. These results suggest that CM is underdiagnosed and undertreated; thereby its management is suboptimal in the primary care., Conclusions: There is a need of guidance in the primary care setting to both leverage the management of CM patients and earlier referral to specialists, when appropriate.
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- 2021
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23. August 2020 Interim EuGMS guidance to prepare European Long-Term Care Facilities for COVID-19.
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Blain H, Rolland Y, Schols JMGA, Cherubini A, Miot S, O'Neill D, Martin FC, Guérin O, Gavazzi G, Bousquet J, Petrovic M, Gordon AL, and Benetos A
- Subjects
- Europe, Humans, Palliative Care, Pandemics, Practice Guidelines as Topic, Reverse Transcriptase Polymerase Chain Reaction, SARS-CoV-2, Social Isolation, COVID-19 diagnosis, COVID-19 prevention & control, COVID-19 therapy, COVID-19 transmission, Geriatrics methods, Geriatrics organization & administration, Long-Term Care classification, Long-Term Care methods, Skilled Nursing Facilities
- Abstract
Purpose: The European Geriatric Medicine Society (EuGMS) is launching a second interim guidance whose aim is to prevent the entrance and spread of COVID-19 into long-term care facilities (LTCFs)., Methods: The EuGMS gathered experts to propose a guide of measures to prevent COVID-19 outbreaks in LTCFs. It is based on the specific features of SARS-CoV-2 transmission in LTCFs, residents' needs, and on experiences conducted in the field., Results: Asymptomatic COVID-19 residents and staff members contribute substantially to the dissemination of COVID-19 infection in LTCFs. An infection prevention and control focal point should be set up in every LTCF for (1) supervising infection prevention and control measures aimed at keeping COVID-19 out of LTCFs, (2) RT-PCR testing of residents, staff members, and visitors with COVID-19 symptoms, even atypical, and (3) isolating subjects either infected or in contact with infected subjects. When a first LCTF resident or staff member is infected, a facility-wide RT-PCR test-retest strategy should be implemented for detecting all SARS-CoV-2 carriers. Testing should continue until no new COVID-19 cases are identified. The isolation of residents should be limited as much as possible and associated with measures aiming at limiting its negative effects on their mental and somatic health status., Conclusions: An early recognition of symptoms compatible with COVID-19 may help to diagnose COVID-19 residents and staff more promptly. Subsequently, an earlier testing for SARS-CoV-2 symptomatic and asymptomatic LTCF staff and residents will enable the implementation of appropriate infection prevention and control. The negative effects of social isolation in residents should be limited as much as possible.
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- 2020
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24. Towards defining core principles of public health emergency preparedness: scoping review and Delphi consultation among European Union country experts.
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Belfroid E, Roβkamp D, Fraser G, Swaan C, and Timen A
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- Disease Outbreaks, Europe, European Union, Humans, Public Health, Referral and Consultation, Civil Defense, Disaster Planning
- Abstract
Background: European Member States, the European Commission and its agencies work together to enhance preparedness and response for serious cross-border threats to health such as Ebola. Yet, common understanding of public health emergency preparedness across EU/EEA countries is challenging, because preparedness is a relatively new field of activity and is inherently fraught with uncertainty. A set of practical, widely accepted and easy to use recommendations for generic preparedness that bundles the activities described in separate guidance documents supports countries in preparing for any possible health threat. The aim of this consensus procedure was to identify and seek consensus from national-level preparedness experts from EU/EEA countries on key recommendations of public health emergency preparedness., Methods: To identify key recommendations and to prioritize the recommendations we started with a literature consensus procedure, followed by a modified Delphi method for consultation of public health emergency preparedness leaders of EU/EEA countries. This consisted of six consecutive steps: a questionnaire to achieve consensus on a core set of recommendations, a face-to-face consultation, preselection of prioritized recommendations, a questionnaire to achieve consensus on the prioritized set and a face-to-face consensus meeting to further prioritize recommendations., Results: As a result, EU/EEA experts selected 149 recommendations as core preparedness principles and prioritized 42. The recommendations were grouped in the seven domains: governance (57), capacity building and maintenance (11), surveillance (19), risk-assessment (16), risk- and crisis management (35), post-event evaluation (6) and implementation of lessons learned (5)., Conclusions: This prioritised set of consensus principles can provide a foundation for countries aiming to evaluate and improve their preparedness for public health emergencies. The recommendations are practical, support generic preparedness planning, and can be used by all countries irrespective of their current level of preparedness.
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- 2020
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25. The SCCS guidance on the safety assessment of nanomaterials in cosmetics.
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- Animals, Europe, Humans, Risk Assessment, Consumer Product Safety, Cosmetics chemistry, Nanostructures adverse effects
- Abstract
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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- 2020
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26. The Manchester International Consensus Group recommendations for the management of gynecological cancers in Lynch syndrome.
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Crosbie EJ, Ryan NAJ, Arends MJ, Bosse T, Burn J, Cornes JM, Crawford R, Eccles D, Frayling IM, Ghaem-Maghami S, Hampel H, Kauff ND, Kitchener HC, Kitson SJ, Manchanda R, McMahon RFT, Monahan KJ, Menon U, Møller P, Möslein G, Rosenthal A, Sasieni P, Seif MW, Singh N, Skarrott P, Snowsill TM, Steele R, Tischkowitz M, and Evans DG
- Subjects
- Colorectal Neoplasms, Hereditary Nonpolyposis epidemiology, Consensus, Early Detection of Cancer, Endometrial Neoplasms epidemiology, Europe, Female, Genital Neoplasms, Female epidemiology, Humans, Mass Screening, North America, Ovarian Neoplasms epidemiology, Ovarian Neoplasms therapy, Colorectal Neoplasms, Hereditary Nonpolyposis therapy, Endometrial Neoplasms therapy, Genital Neoplasms, Female therapy
- Abstract
Purpose: There are no internationally agreed upon clinical guidelines as to which women with gynecological cancer would benefit from Lynch syndrome screening or how best to manage the risk of gynecological cancer in women with Lynch syndrome. The Manchester International Consensus Group was convened in April 2017 to address this unmet need. The aim of the Group was to develop clear and comprehensive clinical guidance regarding the management of the gynecological sequelae of Lynch syndrome based on existing evidence and expert opinion from medical professionals and patients., Methods: Stakeholders from Europe and North America worked together over a two-day workshop to achieve consensus on best practice., Results: Guidance was developed in four key areas: (1) whether women with gynecological cancer should be screened for Lynch syndrome and (2) how this should be done, (3) whether there was a role for gynecological surveillance in women at risk of Lynch syndrome, and (4) what preventive measures should be recommended for women with Lynch syndrome to reduce their risk of gynecological cancer., Conclusion: This document provides comprehensive clinical guidance that can be referenced by both patients and clinicians so that women with Lynch syndrome can expect and receive appropriate standards of care.
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- 2019
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27. Mind the Gap: From Tool to Knowledge Base.
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Mayrhofer MT and Schlünder I
- Subjects
- Europe, Humans, Translational Research, Biomedical ethics, Translational Research, Biomedical legislation & jurisprudence, Biological Specimen Banks ethics, Biological Specimen Banks legislation & jurisprudence, Knowledge Bases
- Abstract
With the ethical, legal, and societal issues (ELSI) Knowledge Base, we introduce a key element of the Biobanking and Biomolecular Resources Research Infrastructure-European Research Infrastructure Consortium (BBMRI-ERIC) Common Service ELSI, which provides ethical, legal, and societal support for researchers and biobankers involved in transnational research. In contrast to the customized support provided by the ELSI Helpdesk, the ELSI Knowledge Base will be available to the user on a self-serve basis. The information that is made available through a knowledge base comes from multiple sources, usually from several expert contributors who are well versed in the subject matter. The knowledge base provides users with a first orientation on the subject matter, as well as allowing them to explore more detailed information if desired in a self-service manner. It is crucial that the information and knowledge provided are shared in a manner that is user friendly. Long lists of links, legalistic language, and multiple links have to be avoided wherever possible. The long-term sustainability and accuracy of a knowledge base need to be ensured by placing its expert curation and technical maintenance under the responsibility of an organization rather than a research consortium. In its core, it builds on a scenario-based approach using a nonlegalistic language. In addition, the knowledge base connects to frequently asked questions, promotes contract and informed consent templates, how-to-guides, best-practice models, and scripts. The ELSI Knowledge Base is a key element of the BBMRI-ERIC Common Service ELSI, which currently serves biobanks but will be enlarged to serve the biological and medical sciences community. In contrast to the ELSI Helpdesk, which provides customized support, the ELSI Knowledge Base is available to the user on a self-serve basis. The conceptualization of the ELSI Knowledge Base builds on assessments of several ethical, legal, and societal guidance tools that favor a single sustainable knowledge base for closing the knowledge gap by providing practical hands-on guidance for researchers. Ultimately, the ELSI Knowledge Base aims at promoting practical know-how and skills for conducting responsible research.
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- 2018
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28. Heterogeneity in European research integrity guidance: relying on values or norms?
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Godecharle S, Nemery B, and Dierickx K
- Subjects
- Ethics, Research, Europe, Humans, Internationality, Trust, Biomedical Research ethics, Guidelines as Topic, Publishing ethics, Scientific Misconduct
- Abstract
Similar forms of misconduct are perceived differently throughout Europe. There are no extensive surveys on the guidance on research integrity in the different countries of Europe. Therefore, we performed a systematic content analysis of (biomedical) research integrity guidance documents from all the countries of the European Economic Area. We show that there is strong heterogeneity concerning research integrity guidance on crucial aspects, for example, the defining of research misconduct, at both an international and a national level. We also sought to explain why the guidance documents differ by distinguishing the approaches that underlie them. We distinguished a value-based and a norm-based approach, as well as different perspectives on trust. The current confusing situation concerning research integrity guidance hampers international research and possibly wastes research funds. We risk talking past each other, if we do not take the distinction between these underlying approaches into account., (© The Author(s) 2014.)
- Published
- 2014
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29. European Medicines Agency initiatives and perspectives on pharmacogenomics.
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Ehmann F, Caneva L, and Papaluca M
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- Europe, Guidelines as Topic, Humans, Pharmacovigilance, Drug Discovery trends, Pharmacogenetics trends
- Abstract
Pharmacogenomics, the study of variations of DNA and RNA characteristics as related to drug response, has become an integral part of drug development and pharmacovigilance, as reflected by the incorporation of pharmacogenomic data in EU product information. In this short review article, we describe recent European Medicines Agency initiatives intended to support further the implementation of pharmacogenomics in drug development and surveillance so that patients and the public can benefit from advances in genomic science and technology., (© 2014 The British Pharmacological Society.)
- Published
- 2014
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