European Regulation of Medical Devices and Pharmaceuticals Regulatee Expectations of Legal Certainty /
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...
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| Language: | English |
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Cham :
Springer International Publishing : Imprint: Springer,
2014.
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| Edition: | 1st ed. 2014. |
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| Online Access: | https://doi.org/10.1007/978-3-319-04594-8 |
Table of 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.