Pharmacovigilance in the European Union : : Practical Implementation Across Member States.
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Place / Publishing House: | Wiesbaden : : Springer Fachmedien Wiesbaden GmbH,, 2017. ©2017. |
Year of Publication: | 2017 |
Edition: | 1st ed. |
Language: | English |
Online Access: | |
Physical Description: | 1 online resource (136 pages) |
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020 | |a 9783658172763 |q (electronic bk.) | ||
020 | |z 9783658172756 | ||
035 | |a (MiAaPQ)5005590983 | ||
035 | |a (Au-PeEL)EBL5590983 | ||
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040 | |a MiAaPQ |b eng |e rda |e pn |c MiAaPQ |d MiAaPQ | ||
050 | 4 | |a JF20-1177 | |
100 | 1 | |a Kaeding, Michael. | |
245 | 1 | 0 | |a Pharmacovigilance in the European Union : |b Practical Implementation Across Member States. |
250 | |a 1st ed. | ||
264 | 1 | |a Wiesbaden : |b Springer Fachmedien Wiesbaden GmbH, |c 2017. | |
264 | 4 | |c ©2017. | |
300 | |a 1 online resource (136 pages) | ||
336 | |a text |b txt |2 rdacontent | ||
337 | |a computer |b c |2 rdamedia | ||
338 | |a online resource |b cr |2 rdacarrier | ||
505 | 0 | |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. | |
505 | 8 | |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. | |
588 | |a Description based on publisher supplied metadata and other sources. | ||
590 | |a Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2024. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries. | ||
655 | 4 | |a Electronic books. | |
700 | 1 | |a Schmälter, Julia. | |
700 | 1 | |a Klika, Christoph. | |
776 | 0 | 8 | |i Print version: |a Kaeding, Michael |t Pharmacovigilance in the European Union |d Wiesbaden : Springer Fachmedien Wiesbaden GmbH,c2017 |z 9783658172756 |
797 | 2 | |a ProQuest (Firm) | |
856 | 4 | 0 | |u https://ebookcentral.proquest.com/lib/oeawat/detail.action?docID=5590983 |z Click to View |