Normal view MARC view ISBD view

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

By: Chowdhury, Nupur.
Material type: TextTextSeries: eBooks on Demand.Publisher: Cham : Springer International Publishing, 2014Description: 1 online resource (190 p.).ISBN: 9783319045948.Subject(s): Europe_xEconomic policy | Law | Pharmacy | Public health lawsGenre/Form: Electronic books.Additional physical formats: Print version:: European Regulation of Medical Devices and Pharmaceuticals : Regulatee Expectations of Legal CertaintyDDC classification: 337142 | 340 | 340.1 | 341.2422 LOC classification: B65HC241Online resources: Click here to view this ebook.
Contents:
""Summary""; ""Acknowledgments""; ""Abbreviations""; ""Contents""; ""Chapter 1: Introduction""; ""1.1 Introduction to the Problem""; ""1.2 Theoretical Landscape of Legal Responses""; ""1.2.1 International Constitutionalism and Global Administrative Law""; ""1.2.2 Legal Pluralism and Systems Theory""; ""1.2.3 Spotlight on an Under-Researched Issue""; ""1.3 Multilevel Regulation and Legal Certainty""; ""1.4 Research Question and Chapter Outline""; ""References""; ""Chapter 2: Conceptualizing Multilevel Regulation""; ""2.1 Introduction""
""2.2 Multilevel Governance as an Inspiration for Multilevel Regulation""""2.3 Defining Multilevel Regulation""; ""2.3.1 How Is Multilevel Regulation Different from Multilevel Governance?""; ""2.3.2 Towards a Definition of Multilevel Regulation: An Analysis of Key Features""; ""2.3.3 Multilevel Regulation: Response from Legal Scholars""; ""2.4 Conclusion""; ""References""; ""Chapter 3: Reconceptualizing Legal Certainty: From a Principle of Positive Law to Regulatee Expectations""; ""3.1 Introduction""; ""3.2 Legal Certainty: Legal Positivist Scholarship""; ""3.3 Review of WeberÂ?s Ideas""
""3.4 Empirical Understanding of Legal Certainty""""3.5 Excavating Litigant Notions of Legal Certainty: From the ECJ Case Law""; ""3.6 Conclusion""; ""References""; ""Chapter 4: Explanation of Methodological Choices""; ""4.1 Introduction""; ""4.2 Conceptualization""; ""4.3 Research Methods""; ""4.4 Operationalization of the Concepts""; ""4.5 Recruitment, Sampling and the Research Process""; ""4.5.1 Medical Device Case Study""; ""4.5.2 Pharmaceutical Case Study""; ""4.6 Analytical Strategy""; ""References""
""Chapter 5: Pilot Study of Regulatory Uncertainty in Marketing Authorization of Medical Products in Europe""""5.1 Introduction""; ""5.2 Aspects of the Regulatory System""; ""5.3 Study Results""; ""5.3.1 How Has European Regulation Shaped Product Sectors?""; ""5.3.2 How Has the European Regulations Impacted Regulatory Uncertainty in These Product Sectors?""; ""5.3.3 How Has This Shaped Compliance Strategies?""; ""5.4 Discussion and Conclusion""; ""References""; ""Chapter 6: Case Study on Medical Devices Regulation in Europe""; ""6.1 Introduction""
""6.2 History of Regulation in the Medical Device Sector""""6.3 Is the Medical Device Regulatory Space Multilevel in Nature?""; ""6.3.1 Rule Making""; ""6.3.2 Rule Application""; ""6.3.3 Rule Adjudication""; ""6.4 What Is the Regulatee Perception of Multilevelness?""; ""6.4.1 Rule Making, Rule Application and Rule Adjudication""; ""6.4.2 Regulatory Relationships""; ""6.5 What Are the Regulatee Perceptions and Expectations of Legal Certainty?""; ""6.6 Analysis and Conclusion""; ""References""; ""Chapter 7: Case Study on Pharmaceutical Regulation in Europe""; ""7.1 Introduction""
""7.2 History of Regulation in the Pharmaceutical Sector""
Summary: Comprehensive overview of the marketing authorization regulation in Medical Devices and Pharmaceutical in Europe Significant contribution to our current understanding Detailed step by step guidance on the methodology for conducting a sociolegal case study
Tags from this library: No tags from this library for this title. Log in to add tags.
Item type Current location Call number URL Status Date due Barcode
Electronic Book UT Tyler Online
Online
http://uttyler.eblib.com/patron/FullRecord.aspx?p=1730991 Available EBL1730991

""Summary""; ""Acknowledgments""; ""Abbreviations""; ""Contents""; ""Chapter 1: Introduction""; ""1.1 Introduction to the Problem""; ""1.2 Theoretical Landscape of Legal Responses""; ""1.2.1 International Constitutionalism and Global Administrative Law""; ""1.2.2 Legal Pluralism and Systems Theory""; ""1.2.3 Spotlight on an Under-Researched Issue""; ""1.3 Multilevel Regulation and Legal Certainty""; ""1.4 Research Question and Chapter Outline""; ""References""; ""Chapter 2: Conceptualizing Multilevel Regulation""; ""2.1 Introduction""

""2.2 Multilevel Governance as an Inspiration for Multilevel Regulation""""2.3 Defining Multilevel Regulation""; ""2.3.1 How Is Multilevel Regulation Different from Multilevel Governance?""; ""2.3.2 Towards a Definition of Multilevel Regulation: An Analysis of Key Features""; ""2.3.3 Multilevel Regulation: Response from Legal Scholars""; ""2.4 Conclusion""; ""References""; ""Chapter 3: Reconceptualizing Legal Certainty: From a Principle of Positive Law to Regulatee Expectations""; ""3.1 Introduction""; ""3.2 Legal Certainty: Legal Positivist Scholarship""; ""3.3 Review of WeberÂ?s Ideas""

""3.4 Empirical Understanding of Legal Certainty""""3.5 Excavating Litigant Notions of Legal Certainty: From the ECJ Case Law""; ""3.6 Conclusion""; ""References""; ""Chapter 4: Explanation of Methodological Choices""; ""4.1 Introduction""; ""4.2 Conceptualization""; ""4.3 Research Methods""; ""4.4 Operationalization of the Concepts""; ""4.5 Recruitment, Sampling and the Research Process""; ""4.5.1 Medical Device Case Study""; ""4.5.2 Pharmaceutical Case Study""; ""4.6 Analytical Strategy""; ""References""

""Chapter 5: Pilot Study of Regulatory Uncertainty in Marketing Authorization of Medical Products in Europe""""5.1 Introduction""; ""5.2 Aspects of the Regulatory System""; ""5.3 Study Results""; ""5.3.1 How Has European Regulation Shaped Product Sectors?""; ""5.3.2 How Has the European Regulations Impacted Regulatory Uncertainty in These Product Sectors?""; ""5.3.3 How Has This Shaped Compliance Strategies?""; ""5.4 Discussion and Conclusion""; ""References""; ""Chapter 6: Case Study on Medical Devices Regulation in Europe""; ""6.1 Introduction""

""6.2 History of Regulation in the Medical Device Sector""""6.3 Is the Medical Device Regulatory Space Multilevel in Nature?""; ""6.3.1 Rule Making""; ""6.3.2 Rule Application""; ""6.3.3 Rule Adjudication""; ""6.4 What Is the Regulatee Perception of Multilevelness?""; ""6.4.1 Rule Making, Rule Application and Rule Adjudication""; ""6.4.2 Regulatory Relationships""; ""6.5 What Are the Regulatee Perceptions and Expectations of Legal Certainty?""; ""6.6 Analysis and Conclusion""; ""References""; ""Chapter 7: Case Study on Pharmaceutical Regulation in Europe""; ""7.1 Introduction""

""7.2 History of Regulation in the Pharmaceutical Sector""

Comprehensive overview of the marketing authorization regulation in Medical Devices and Pharmaceutical in Europe Significant contribution to our current understanding Detailed step by step guidance on the methodology for conducting a sociolegal case study

Description based upon print version of record.

There are no comments for this item.

Log in to your account to post a comment.