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Nupur Chowdhury - European Regulation of Medical Devices and Pharmaceuticals - 9783319353210 - V9783319353210
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European Regulation of Medical Devices and Pharmaceuticals

€ 121.99
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Description for European Regulation of Medical Devices and Pharmaceuticals Paperback. This book explores legal certainty in terms of the perceptions and expectations of regulatees in the context of medical products - specifically, pharmaceuticals and medical devices, which function in two regulatory spaces and thus form two case studies. Num Pages: 198 pages, 6 black & white illustrations, 2 black & white tables, biography. BIC Classification: KCS; LAB; LBBM; LNTM. Category: (P) Professional & Vocational. Dimension: 235 x 155 x 11. Weight in Grams: 314.

One of the primary functions of law is to ensure that the legal structure governing all social relations is predictable, coherent, consistent and applicable. Taken together, these characteristics of law are referred to as legal certainty. In traditional approaches to legal certainty, law is regarded as a hierarchical system of rules characterized by stability, clarity, uniformity, calculable enforcement, publicity and predictability. However, the current reality is that national legal systems no longer operate in isolation, but within a multilevel legal order, wherein norms created at both the international and regional level are directly applicable to national legal systems. Also, norm ... Read more

In this project the author uses multilevel regulation as a term to characterize a regulatory space in which the process of rule making, rule enforcement and rule adjudication (the regulatory lifecycle) is dispersed across more than one administrative or territorial level and amongst several different actors, both public and private. The author draws on the concept of a regulatory space, using it as a framing device to differentiate between specific aspects of policy fields. The relationship between actors in such a space is non-hierarchical and they may be independent of each other. The lack of central ordering of the regulatory lifecycle within this regulatory space is the most important feature of such a space. The implications of multilevel regulation for the notion of legal certainty have attracted limited attention from scholars and the demand for legal certainty in regulatory practice is still a puzzle. The book explores the idea of legal certainty in terms of the perceptions and expectations of regulatees in the context of medical products – specifically, pharmaceuticals and medical devices, which can be differentiated as two regulatory spaces and therefore form two case studies. As an exploratory project, the book necessarily explores new territory in terms of investigating legal certainty first in terms of regulatee perceptions and expectations and second, because it studies it in the context of multilevel regulation.

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Product Details

Format
Paperback
Publication date
2016
Publisher
Springer International Publishing AG Switzerland
Number of pages
198
Condition
New
Number of Pages
185
Place of Publication
Cham, Switzerland
ISBN
9783319353210
SKU
V9783319353210
Shipping Time
Usually ships in 15 to 20 working days
Ref
99-15

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