European Regulation of Medical Devices and Pharmaceuticals Regulatee Expectations of Legal Certainty /

• Κύριος συγγραφέας: Chowdhury, Nupur (Συγγραφέας)
• Συγγραφή απο Οργανισμό/Αρχή: SpringerLink (Online service)
• Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Cham : Springer International Publishing : Imprint: Springer, 2014.
• Θέματα: Pharmacy.; Law.; Law > Philosophy.; Medical laws and legislation.; International law.; Trade.; European Economic Community literature.; European Law.; Theories of Law, Philosophy of Law, Legal History.; European Integration.; International Economic Law, Trade Law.; Medical Law.

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...

Πίνακας περιεχομένων:

• 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.