Pharmacovigilance in the European Union: practical implementation across member states
Gespeichert in:
| Hauptverfasser: | , , |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Wiesbaden
Springer
[2017]
|
| Schriftenreihe: | Open
|
| Schlagworte: | |
| Online-Zugang: | DE-B1533 DE-703 DE-706 DE-29 DE-739 Volltext Inhaltsverzeichnis |
| Beschreibung: | Open Access |
| Beschreibung: | 1 Online-Ressource (XIV, 124 Seiten) Illustrationen, Diagramme |
| ISBN: | 9783658172763 |
| DOI: | 10.1007/978-3-658-17276-3 |
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Titel: Pharmacovigilance in the European Union
Autor: Kaeding, Michael
Jahr: 2017
Contents
Abbreviations .IX
List ofTables, Figures and Boxes . XI
Preface. XIII
1 Introduction. 1
1.1 Background and Terms of Reference .1
1.2 Methodology: Selection of Countries .3
1.3 Methodology: Research Strategy .5
1.4 Summary of Evidence .8
1.5 Implementation Assessment Structure .8
References. 9
2 Pharmacovigilance .'. 11
2.1 Fundamentals of Pharmacovigilance . 11
2.2 Importance of Pharmacovigilance for Biologicals . 13
References. 15
3 The EU Pharmacovigilance System . 17
3.1 EU Institutions and Pharmacovigilance Actors .21
3.2 Legislative Developments .23
3.3 The Pharmacovigilance Reform: Directive 2010/84/EU
and Article 102 .25
References. 33
4 Timely and Correct Transposition of Pharmacovigilance
across Member States .35
4.1 Timely Transposition of Directive 2010/84/EU across
Member States .35
4.2 Correct Transposition of Directive 2010/84/EU across
Member States .37
4.2.1 Correct Transposition - Processes and Actors . 37
4.2.2 Correct Transposition - Quality and Content .40
References. 42
5 Practical Implementation in Six Member States . 45
5.1 ADR Reporting in the United K ingdom .45
5.1.1 The System .45
5.1.2 Perceived Challenges .49
5.1.3 Perceived Best Practices . 53
5.2 ADR Reporting in Finland .57
5.2.1 The System . 57
5.2.2 Perceived Challenges .62
5.2.3 Perceived Best Practices .64
5.3 ADR Reporting in Poland .65
5.3.1 The System . 65
5.3.2 Perceived Challenges . 67
5.3.3 Perceived Best Practices . 71
5.4 ADR Reporting in France .73
5.4.1 The System . 73
5.4.2 Perceived Challenges . 76
5.4.3 Perceived Best Practices . 79
5.5 ADR Reporting in Portugal . 81
5.5.1 The System . 81
5.5.2 Perceived Challenges .85
5.5.3 Perceived Best Practices . 88
5.6 ADR Reporting in G erm any.90
5.6.1 The System .90
5.6.2 Perceived Challenges .94
5.6.3 Perceived Best Practices . 98
References.100
6 Challenges and Best Practices in Perspective.103
6.1 Pharmacovigilance Systems . 104
6.2 Major Challenges . 107
6.3 Comparison of Factors Contributing to Underreporting .109
6.3.1 Lack of Awareness. 109
6.3.2 Complexity of ADR Reporting . 110
6.3.3 Lack of Cooperation . Ill
6.3.4 Interconnectivity Problems . 112
References. 113
7 Conclusions and Recommendations . 115
7.1 Specific Recommendations in Relation to Article 102 . 116
7.2 General Recommendations: National Healthcare Systems and
Policy Options for Pharmacovigilance .120
References.124 |
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| series2 | Open |
| spellingShingle | Kaeding, Michael 1977- Schmälter, Julia Klika, Christoph Pharmacovigilance in the European Union practical implementation across member states Europäische Union Europäische Union (DE-588)5098525-5 gnd Political science Political economy Comparative politics European Union Pharmacy Political Science and International Relations Comparative Politics Political Economy European Union Politics Drug Safety and Pharmacovigilance Politische Wissenschaft Rechtsanwendung (DE-588)4048765-9 gnd Mitgliedsstaaten (DE-588)4170174-4 gnd Arzneimittelüberwachung (DE-588)4437717-4 gnd |
| subject_GND | (DE-588)5098525-5 (DE-588)4048765-9 (DE-588)4170174-4 (DE-588)4437717-4 (DE-588)4143413-4 |
| title | Pharmacovigilance in the European Union practical implementation across member states |
| title_auth | Pharmacovigilance in the European Union practical implementation across member states |
| title_exact_search | Pharmacovigilance in the European Union practical implementation across member states |
| title_full | Pharmacovigilance in the European Union practical implementation across member states Michael Kaeding, Julia Schmälter, Christoph Klika |
| title_fullStr | Pharmacovigilance in the European Union practical implementation across member states Michael Kaeding, Julia Schmälter, Christoph Klika |
| title_full_unstemmed | Pharmacovigilance in the European Union practical implementation across member states Michael Kaeding, Julia Schmälter, Christoph Klika |
| title_short | Pharmacovigilance in the European Union |
| title_sort | pharmacovigilance in the european union practical implementation across member states |
| title_sub | practical implementation across member states |
| topic | Europäische Union Europäische Union (DE-588)5098525-5 gnd Political science Political economy Comparative politics European Union Pharmacy Political Science and International Relations Comparative Politics Political Economy European Union Politics Drug Safety and Pharmacovigilance Politische Wissenschaft Rechtsanwendung (DE-588)4048765-9 gnd Mitgliedsstaaten (DE-588)4170174-4 gnd Arzneimittelüberwachung (DE-588)4437717-4 gnd |
| topic_facet | Europäische Union Political science Political economy Comparative politics European Union Pharmacy Political Science and International Relations Comparative Politics Political Economy European Union Politics Drug Safety and Pharmacovigilance Politische Wissenschaft Rechtsanwendung Mitgliedsstaaten Arzneimittelüberwachung Aufsatzsammlung |
| url | https://doi.org/10.1007/978-3-658-17276-3 http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=029612632&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT kaedingmichael pharmacovigilanceintheeuropeanunionpracticalimplementationacrossmemberstates AT schmalterjulia pharmacovigilanceintheeuropeanunionpracticalimplementationacrossmemberstates AT klikachristoph pharmacovigilanceintheeuropeanunionpracticalimplementationacrossmemberstates |