European Regulation of Medical Devices and Pharmaceuticals: Regulatee Expectations of Legal Certainty
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Cham [u.a.]
Springer International Publishing
2014
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| Schlagworte: | |
| Online-Zugang: | UBG01 UPA01 Volltext Inhaltsverzeichnis Abstract |
| Beschreibung: | 1 Online-Ressource (XIII, 185 p.) Ill. |
| ISBN: | 9783319045948 |
| DOI: | 10.1007/978-3-319-04594-8 |
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Datensatz im Suchindex
| _version_ | 1804152180570062848 |
|---|---|
| adam_text | EUROPEAN REGULATION OF MEDICAL DEVICES AND PHARMACEUTICALS
/ CHOWDHURY, NUPUR
: 2014
TABLE OF CONTENTS / INHALTSVERZEICHNIS
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
DIESES SCHRIFTSTUECK WURDE MASCHINELL ERZEUGT.
EUROPEAN REGULATION OF MEDICAL DEVICES AND PHARMACEUTICALS
/ CHOWDHURY, NUPUR
: 2014
ABSTRACT / INHALTSTEXT
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 CREATION IS NO LONGER THE EXCLUSIVE PREROGATIVE OF PUBLIC
OFFICIALS OF THE STATE: PRIVATE ACTORS HAVE AN INCREASING INFLUENCE ON
NORM CREATION AS WELL. SOCIAL SCIENTISTS HAVE REFERRED TO THIS
PHENOMENON OF INTERACTING AND OVERLAPPING COMPETENCES AS MULTILEVEL
GOVERNANCE.ONLY RECENTLY HAVE LEGAL SCHOLARS FOCUSED ATTENTION ON THE
INCREASING INTERCONNECTEDNESS (AND THEREFORE THE CONCOMITANT LOSS OF
PRIMACY OF NATIONAL LEGAL ORDERS) BETWEEN THE GLOBAL, EUROPEAN AND
NATIONAL REGULATORY SPHERES THROUGH THE CONCEPT OF MULTILEVEL
REGULATION. 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
DIESES SCHRIFTSTUECK WURDE MASCHINELL ERZEUGT.
|
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| author | Chowdhury, Nupur |
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| dewey-full | 341.2422 |
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| dewey-ones | 341 - Law of nations |
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| discipline | Rechtswissenschaft |
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| spelling | Chowdhury, Nupur Verfasser (DE-588)1050935896 aut European Regulation of Medical Devices and Pharmaceuticals Regulatee Expectations of Legal Certainty Nupur Chowdhury Cham [u.a.] Springer International Publishing 2014 1 Online-Ressource (XIII, 185 p.) Ill. txt rdacontent c rdamedia cr rdacarrier Recht Wirtschaftspolitik Law Pharmacy Public health laws Europe Economic policy Öffentliches Gesundheitswesen (DE-588)4139691-1 gnd rswk-swf Recht (DE-588)4048737-4 gnd rswk-swf Medizinprodukt (DE-588)4024018-6 gnd rswk-swf Europa Europa (DE-588)4015701-5 gnd rswk-swf Europa (DE-588)4015701-5 g Öffentliches Gesundheitswesen (DE-588)4139691-1 s Recht (DE-588)4048737-4 s DE-604 Medizinprodukt (DE-588)4024018-6 s Erscheint auch als Druckausgabe 978-3-319-04593-1 https://doi.org/10.1007/978-3-319-04594-8 Verlag Volltext Springer Fremddatenuebernahme application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=027284227&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis Springer Fremddatenuebernahme application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=027284227&sequence=000003&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA Abstract |
| spellingShingle | Chowdhury, Nupur European Regulation of Medical Devices and Pharmaceuticals Regulatee Expectations of Legal Certainty Recht Wirtschaftspolitik Law Pharmacy Public health laws Europe Economic policy Öffentliches Gesundheitswesen (DE-588)4139691-1 gnd Recht (DE-588)4048737-4 gnd Medizinprodukt (DE-588)4024018-6 gnd |
| subject_GND | (DE-588)4139691-1 (DE-588)4048737-4 (DE-588)4024018-6 (DE-588)4015701-5 |
| title | European Regulation of Medical Devices and Pharmaceuticals Regulatee Expectations of Legal Certainty |
| title_auth | European Regulation of Medical Devices and Pharmaceuticals Regulatee Expectations of Legal Certainty |
| title_exact_search | European Regulation of Medical Devices and Pharmaceuticals Regulatee Expectations of Legal Certainty |
| title_full | European Regulation of Medical Devices and Pharmaceuticals Regulatee Expectations of Legal Certainty Nupur Chowdhury |
| title_fullStr | European Regulation of Medical Devices and Pharmaceuticals Regulatee Expectations of Legal Certainty Nupur Chowdhury |
| title_full_unstemmed | European Regulation of Medical Devices and Pharmaceuticals Regulatee Expectations of Legal Certainty Nupur Chowdhury |
| title_short | European Regulation of Medical Devices and Pharmaceuticals |
| title_sort | european regulation of medical devices and pharmaceuticals regulatee expectations of legal certainty |
| title_sub | Regulatee Expectations of Legal Certainty |
| topic | Recht Wirtschaftspolitik Law Pharmacy Public health laws Europe Economic policy Öffentliches Gesundheitswesen (DE-588)4139691-1 gnd Recht (DE-588)4048737-4 gnd Medizinprodukt (DE-588)4024018-6 gnd |
| topic_facet | Recht Wirtschaftspolitik Law Pharmacy Public health laws Europe Economic policy Öffentliches Gesundheitswesen Medizinprodukt Europa |
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