LEADER 06391 am 22006493u 450 001 9910168748003321 005 20200629152958.0 010 $a3-658-17276-2 024 7 $a10.1007/978-3-658-17276-3 035 $a(CKB)3710000001080166 035 $a(DE-He213)978-3-658-17276-3 035 $a(MiAaPQ)EBC5590983 035 $a(Au-PeEL)EBL5590983 035 $a(OCoLC)980869903 035 $a(PPN)259451126 035 $a(EXLCZ)993710000001080166 100 $a20170220d2017 u| 0 101 0 $aeng 135 $aurnn#008mamaa 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aPharmacovigilance in the European Union$b[electronic resource] $ePractical Implementation across Member States /$fby Michael Kaeding, Julia Schmälter, Christoph Klika 205 $a1st ed. 2017. 210 1$aWiesbaden :$cSpringer Fachmedien Wiesbaden :$cImprint: Springer,$d2017. 215 $a1 online resource (XIV, 124 p. 13 illus., 12 illus. in color.) 311 $a3-658-17275-4 327 $aIntro -- 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. 327 $a6.3 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. 330 $aThis book is open access under a CC BY 4.0 license. The book presents the results of an in-depth comparative study assessing the implementation of the EU Pharmacovigilance Directive in six EU Member States. By going beyond legal transposition and instead focusing on practical implementation, this study aims to close a gap in EU compliance research. Based on qualitative interviews with relevant actors in Germany, Poland, Portugal, France, Finland and the UK, the authors identify perceived challenges and best-practices, issue recommendations, and thereby contribute to a better understanding of the factors that incentivize or impede the practical implementation of EU law at the national level. Content Introduction: Background and Methodology ? Pharmacovigilance ? The EU Pharmacovigilance System ? Timely and Correct Transposition of Pharmacovigilance across Member States ? Practical Implementation in Six Member States ? Challenges and Best Practices in Perspective ? Conclusions and Recommendations The authors Dr. Michael Kaeding is Professor for European Integration and European Union Politics at the Department of Political Science of the University of Duisburg-Essen, Germany and holds an ad personam Jean Monnet Chair in "Understanding EU Decision Making and Member States´ Compliance with EU Policies". Julia Schmälter is a research assistant at the Jean Monnet Chair for European Integration and European Union Politics at the Department of Political Science at the University of Duisburg-Essen. Christoph Klika is a lecturer at the Department of Political Science at the University of Duisburg-Essen. 606 $aComparative politics 606 $aPolitical economy 606 $aEuropean Union 606 $aPharmacy 606 $aComparative Politics$3https://scigraph.springernature.com/ontologies/product-market-codes/911040 606 $aInternational Political Economy$3https://scigraph.springernature.com/ontologies/product-market-codes/912140 606 $aEuropean Union Politics$3https://scigraph.springernature.com/ontologies/product-market-codes/911140 606 $aDrug Safety and Pharmacovigilance$3https://scigraph.springernature.com/ontologies/product-market-codes/H69010 615 0$aComparative politics. 615 0$aPolitical economy. 615 0$aEuropean Union. 615 0$aPharmacy. 615 14$aComparative Politics. 615 24$aInternational Political Economy. 615 24$aEuropean Union Politics. 615 24$aDrug Safety and Pharmacovigilance. 676 $a320 700 $aKaeding$b Michael$4aut$4http://id.loc.gov/vocabulary/relators/aut$0873909 702 $aSchmälter$b Julia$4aut$4http://id.loc.gov/vocabulary/relators/aut 702 $aKlika$b Christoph$4aut$4http://id.loc.gov/vocabulary/relators/aut 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910168748003321 996 $aPharmacovigilance in the European Union$92275562 997 $aUNINA