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European regulation of medical devices and pharmaceuticals : regulatee expectations of legal certainty

Author: Nupur Chowdhury
Publisher: Cham : Springer, 2014.
Edition/Format:   eBook : Document : EnglishView all editions and formats
Database:WorldCat
Summary:
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  Read more...
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Genre/Form: Electronic books
Additional Physical Format: Print version:
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Nupur Chowdhury
ISBN: 9783319045948 3319045946 3319045938 9783319045931
OCLC Number: 879374253
Description: 1 online resource (xiii, 185 pages) : illustrations
Contents: 1. Introduction --
2. Conceptualizing Multilevel Regulation --
3. Reconceptualizing Legal Certainty: From a Principle of Positive Law to Regulatee Expectations --
4. Explanation of Methodological Choices --
5. Pilot Study of Regulatory Uncertainty in Marketing Authorization of Medical Products in Europe --
6. Case Study on Medical Devices Regulation in Europe --
7. Case Study on Pharmaceutical Regulation in Europe --
8. Case Study on Borderline Medical Products in Europe --
9. Conclusion.
Responsibility: Nupur Chowdhury.
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