The Combination Products Handbook PDF Download
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Author: Susan Neadle
Publisher: CRC Press
ISBN: 1000874583
Category : Medical
Languages : en
Pages : 439
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Book Description
Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.
Author: Susan Neadle
Publisher: CRC Press
ISBN: 1000874583
Category : Medical
Languages : en
Pages : 439
Get Book Here
Book Description
Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.
Author: Tamara K. Hervey
Publisher: Cambridge University Press
ISBN: 1107010497
Category : Law
Languages : en
Pages : 749
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Book Description
The first holistic and thematic study of EU health law, and its implications, through its own internal logics.
Author: Francesca Seracini
Publisher: LED Edizioni Universitarie
ISBN: 8855130153
Category : Language Arts & Disciplines
Languages : en
Pages : 166
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Book Description
This volume is a study into the norms that come into play in the translation of European Union legislation. With a focus on expressions of modality, the study adopts a corpus-based Descriptive Translation Studies approach to analyse the translation strategies used in a bilingual English/Italian parallel corpus of European Union legislation and identify the most frequent translational patterns. The book outlines the principles at the basis of the multilingual policy at the European Union and provides a detailed outline of the context in which the drafting and translation processes take place as a key to understanding the translational choices. The impact of sometimes contrasting factors such as the conventions of legal drafting at the European Union and those within the target culture, the principle of equal authenticity and the attention to the quality and readability of legislative texts is revealed in the analysis. Evidence in support of the theories concerning translation universals is also found and their implications for EU legal translation are discussed. The results lead to the formulation of several hypotheses as regards the norms governing the translation of EU legislative texts. The book also reflects on the impact that the translational choices have on the development of European Union legal language as an independent variety. This volume will be of interest to researchers and students in the fields of Legal Translation Studies and Linguistics, as well as practising translators.
Author: Jon Yorke
Publisher: Springer
ISBN: 3319329243
Category : Education
Languages : en
Pages : 296
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Book Description
This book analyses accountability and quality policies relating to learning standards and examines their implications for assessment in higher education. Whilst primarily focusing on the Australian setting, this analysis is located within a broader frame of reference that includes the United Kingdom (UK), the United States of America (US), and the Organisation for Economic Cooperation and Development (OECD). Across these settings, comparative measures of learning have been seen as a policy ‘solution’ to the problem of ‘proving quality’ in a globalised and increasingly competitive higher education market. Comparative measures of learning depend on the specification of learning standards. Learning standards attempt to articulate the capabilities expected of graduates, and students’ achievement of these is determined through the practices of assessment carried out within institutions. Quality policy, learning standards and assessment practices all intersect within the broader umbrella of accountability, with relevance to governments, higher education providers, employers, parents, and students. The findings reported in this book highlight a number of policy influences, including the rising demands for national and international comparative data on learning standards to compare quality and inform student choice in a globally competitive market.
Author: European Commission
Publisher:
ISBN:
Category : Det indre marked
Languages : en
Pages : 124
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Book Description
Author: Jekaterina Nikitina
Publisher: Key Editore
ISBN: 8827900721
Category :
Languages : en
Pages : 108
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Book Description
This book lies in the field of Genre Studies and Legal Translation Studies. It aims at filling in a gap on the language and structure of the occluded genre of written pleadings. The results contain a list of linguistic building blocks used as text-organizing patterns in this genre; they are oriented at legal practitioners who have to draft such documents and may be of use to legal translators.
Author: Sara Laviosa
Publisher: Oxford University Press
ISBN: 0190067233
Category : Language Arts & Disciplines
Languages : en
Pages : 688
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Book Description
The discipline of translation studies has gained increasing importance at the beginning of the 21st century as a result of rapid globalization and the development of computer-based translation methods. Today, changing political, economic, health, and environmental realities across the world are generating previously unknown inter-language communication challenges that can only be understood through a socially-oriented and data-driven approach. The Oxford Handbook of Translation and Social Practices draws on a wide array of case studies from all over the world to demonstrate the value of different forms of translation - written, oral, audiovisual - as social practices that are essential to achieve sustainability, accessibility, inclusion, multiculturalism, and multilingualism. Edited by Meng Ji and Sara Laviosa, this timely collection illustrates the manifold interactions between translation studies and the social and natural sciences, enabling for the first time the exchange of research resources and methods between translation and other domains' experts. Twenty-nine chapters by international scholars and professional translators apply translation studies methods to a wide range of fields, including healthcare, environmental policy, geological and cultural heritage conservation, education, tourism, comparative politics, conflict mediation, international law, commercial law, immigration, and indigenous rights. The articles engage with numerous languages, from European and Latin American contexts to Asian and Australian languages, giving unprecedented weight to the translation of indigenous languages. The Handbook highlights how translation studies generate innovative solutions to long-standing and emerging social issues, thus reformulating the scope of this discipline as a socially-oriented, empirical, and ethical research field in the 21st century.
Author: Jane Kotzmann
Publisher: Oxford University Press
ISBN: 019086351X
Category : Law
Languages : en
Pages : 289
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Book Description
A human right to higher education was included in the International Covenant on Economic Social and Cultural Rights (ICESCR), which came into force in 1976. Yet the world has changed significantly since the ICESCR was drafted. State legislation and policies have generally followed a neoliberal trajectory, shifting the perception of higher education from being a public good to being a commodity able to be bought and sold. This model has been criticized, particularly because it generally reinforces social inequality. At the same time, attaining higher education has become more important than ever before. Higher education is a prerequisite for many jobs and those who have attained higher education enjoy improved life circumstances. This book seeks to determine: Is there still a place for the human right to higher education in the current international context? In seeking to answer this question, this book compares and contrasts two general theoretical models that are used to frame higher education policy: the market-based approach and the human rights-based approach. In the process, it contributes to an understanding of the likely effectiveness of market-based versus human rights-based approaches to higher education provision in terms of teaching and learning. This understanding should enable the development of more improved, sophisticated, and ultimately successful higher education policies. This book contends that a human rights-based approach to higher education policy is more likely to enable the achievement of higher education purposes than a market-based approach. In reaching this conclusion, the book identifies and addresses some strategic considerations of relevance for advocates of a human rights-based approach in this context.
Author: Mindy J. Allport-Settle
Publisher: Pharmalogika
ISBN: 9780982147603
Category : Law
Languages : en
Pages : 686
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Book Description
This title combines all of the human and veterinary Regulations, Directives and guidance for medicinal products used by the pharmaceutical industry as their main source when manufacturing and distributing medicinal products in the European Union.
Author: Éric Poirier
Publisher: Cambridge Scholars Publishing
ISBN: 1527521427
Category : Language Arts & Disciplines
Languages : en
Pages : 254
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Book Description
The volume of economic, business, financial and institutional translation increases daily. Governments strive to produce plain and accessible information. Institutions and agencies operate in more than one language. Multinationals produce documents in multiple languages to expand their services worldwide, and large businesses and SMEs also have to adopt a multilingual approach for accessing new markets in new countries. Translation and interpreting training institutions are aware of the increasing need for training in this area. This awareness is evident in their curricula, which include subjects related to these areas of activity. Trainers and researchers are increasingly interested in knowing and researching the intricacies and aspects of this type of translation. This peer-reviewed publication, resulting from ICEBFIT 2016, echoes the voices of translation practitioners, researchers, and teachers, as well as other parties gathered to discuss new issues in institutional translation and business, finance and accounting translation, as well as, in a larger sense, specialized translation.
