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Download or read book The Combination Products Handbook written by Susan Neadle and published by CRC Press. This book was released on 2023-05-16 with total page 439 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book The Group of Twenty G20 written by Andrew F. Cooper and published by Routledge. This book was released on 2013-01-04 with total page 195 pages. Available in PDF, EPUB and Kindle. Book excerpt: This work offers a concise examination of the purpose, function and practice of the Group of Twenty (G20) summit. Providing a comprehensive historical account of the G20 Finance Ministers and Central Bank Governors process, the text then moves on to outline the conditions, events and debates that led to the formation of the permanent, expanded leaders’ level forum. The historical span of the G20 Summit process is not long, but the global transformations that precipitated it are crucial when seeking to understand it. Cooper & Thakur explore a variety of major debates, including: Governance by self-selected groups versus mandated multilateral organizations the legitimacy of informal leadership the issue of the G20’s composition of both ‘solution’ countries and ‘problem’ countries the role of the emerging powers new conceptions of North-South relationships This work offers a detailed examination of the ongoing shifts in economic power and the momentum toward global institutional reform, illustrating how the G20 has moved from a crisis committee to the premier global forum over this short but intense history, and mapping out its comparative advantages and key challenges ahead.

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Download or read book Reconfiguring the Global Governance of Climate Change written by John J. Kirton and published by Routledge. This book was released on 2022-03-31 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book charts the course and causes of UN, G7 and G20 governance of climate change through the crucial period of 2015–2021. It provides a careful, comprehensive and reliable description of the individual and interactive contributions of the G7, G20 and UN summits and analyses their results. The authors explain these contributions and results by considering the impacts of causal candidates, such as a changing physical ecosystem and international political system and the actions of individual leaders of the world’s most systemically significant countries. They apply and improve an established, compact causal model, grounded in international relations theory, to guide these tasks. By developing, prescribing and implementing immediate, realistic actionable policy solutions to cope with the urgent, existential challenge of controlling climate change, this volume will appeal to scholars of international relations, global governance and global environmental governance.

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