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Pharmacovigilance in the European Union : Practical Implementation Across Member States.

By: Kaeding, Michael.
Contributor(s): Schm�alter, Julia | Klika, Christoph.
Material type: materialTypeLabelBookPublisher: Wiesbaden : Springer Fachmedien Wiesbaden GmbH, 2017Copyright date: �2017Edition: 1st ed.Description: 1 online resource (136 pages).Content type: text Media type: computer Carrier type: online resourceISBN: 9783658172763.Genre/Form: Electronic books.Online resources: Click to View
Contents:
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.
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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E-book E-book IUKL Library
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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.

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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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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