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03899nam a22004093i 4500 |
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EBC5590983 |
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MiAaPQ |
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20231204023214.0 |
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m o d | |
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231204s2017 xx o ||||0 eng d |
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|a 9783658172763
|q (electronic bk.)
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|z 9783658172756
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|a (MiAaPQ)EBC5590983
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|a (Au-PeEL)EBL5590983
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|a (OCoLC)980869903
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|a MiAaPQ
|b eng
|e rda
|e pn
|c MiAaPQ
|d MiAaPQ
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|a JF20-1177
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|a Kaeding, Michael.
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|a Pharmacovigilance in the European Union :
|b Practical Implementation Across Member States.
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|a 1st ed.
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|a Wiesbaden :
|b Springer Fachmedien Wiesbaden GmbH,
|c 2017.
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|c ©2017.
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|a 1 online resource (136 pages)
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| 336 |
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|a text
|b txt
|2 rdacontent
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|a computer
|b c
|2 rdamedia
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|a online resource
|b cr
|2 rdacarrier
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|a Intro -- Contents -- Abbreviations -- List of Tables, Figures and Boxes -- Preface -- 1 Introduction -- 1.1 Background and Terms of Reference -- 1.2 Methodology: Selection of Countries -- 1.3 Methodology: Research Strategy -- 1.4 Summary of Evidence -- 1.5 Implementation Assessment Structure -- References -- 2 Pharmacovigilance -- 2.1 Fundamentals of Pharmacovigilance -- 2.2 Importance of Pharmacovigilance for Biologicals -- References -- 3 The EU Pharmacovigilance System -- 3.1 EU Institutions and Pharmacovigilance Actors -- 3.2 Legislative Developments -- 3.3 The Pharmacovigilance Reform: Directive 2010/84/EU and Article 102 -- References -- 4 Timely and Correct Transposition of Pharmacovigilance across Member States -- 4.1 Timely Transposition of Directive 2010/84/EU across Member States -- 4.2 Correct Transposition of Directive 2010/84/EU across Member States -- 4.2.1 Correct Transposition - Processes and Actors -- 4.2.2 Correct Transposition - Quality and Content -- References -- 5 Practical Implementation in Six Member States -- 5.1 ADR Reporting in the United Kingdom -- 5.1.1 The System -- 5.1.2 Perceived Challenges -- 5.1.3 Perceived Best Practices -- 5.2 ADR Reporting in Finland -- 5.2.1 The System -- 5.2.2 Perceived Challenges -- 5.2.3 Perceived Best Practices -- 5.3 ADR Reporting in Poland -- 5.3.1 The System -- 5.3.2 Perceived Challenges -- 5.3.3 Perceived Best Practices -- 5.4 ADR Reporting in France -- 5.4.1 The System -- 5.4.2 Perceived Challenges -- 5.4.3 Perceived Best Practices -- 5.5 ADR Reporting in Portugal -- 5.5.1 The System -- 5.5.2 Perceived Challenges -- 5.5.3 Perceived Best Practices -- 5.6 ADR Reporting in Germany -- 5.6.1 The System -- 5.6.2 Perceived Challenges -- 5.6.3 Perceived Best Practices -- References -- 6 Challenges and Best Practices in Perspective -- 6.1 Pharmacovigilance Systems -- 6.2 Major Challenges.
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|a 6.3 Comparison of Factors Contributing to Underreporting -- 6.3.1 Lack of Awareness -- 6.3.2 Complexity of ADR Reporting -- 6.3.3 Lack of Cooperation -- 6.3.4 Interconnectivity Problems -- References -- 7 Conclusions and Recommendations -- 7.1 Specific Recommendations in Relation to Article 102 -- 7.2 General Recommendations: National Healthcare Systems and Policy Options for Pharmacovigilance -- References.
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|a Description based on publisher supplied metadata and other sources.
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| 590 |
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|a Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2023. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.
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| 655 |
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|a Electronic books.
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| 700 |
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|a Schmälter, Julia.
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| 700 |
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|a Klika, Christoph.
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|i Print version:
|a Kaeding, Michael
|t Pharmacovigilance in the European Union
|d Wiesbaden : Springer Fachmedien Wiesbaden GmbH,c2017
|z 9783658172756
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| 797 |
2 |
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|a ProQuest (Firm)
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| 856 |
4 |
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|u https://ebookcentral.proquest.com/lib/matrademy/detail.action?docID=5590983
|z Click to View
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