000 03424nam a22005055i 4500
001 978-3-658-17276-3
003 DE-He213
005 20190313085150.0
007 cr nn 008mamaa
008 170220s2017 gw | s |||| 0|eng d
020 _a9783658172763
_9978-3-658-17276-3
024 7 _a10.1007/978-3-658-17276-3
_2doi
050 4 _aJA71-80
072 7 _aJPB
_2bicssc
072 7 _aPOL000000
_2bisacsh
082 0 4 _a320
_223
100 1 _aKaeding, Michael.
_eauthor.
245 1 0 _aPharmacovigilance in the European Union
_h[electronic resource] :
_bPractical Implementation across Member States /
_cby Michael Kaeding, Julia Schmälter, Christoph Klika.
264 1 _aWiesbaden :
_bSpringer Fachmedien Wiesbaden :
_bImprint: Springer,
_c2017.
300 _aXIV, 124 p. 13 illus., 12 illus. in color.
_bonline resource.
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _atext file
_bPDF
_2rda
506 0 _aOpen Access
520 _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.
650 0 _aPolitical science.
650 0 _aPolitical economy.
650 0 _aComparative politics.
650 0 _aEuropean Union.
650 0 _aPharmacy.
650 1 4 _aPolitical Science and International Relations.
650 2 4 _aComparative Politics.
650 2 4 _aPolitical Economy.
650 2 4 _aEuropean Union Politics.
650 2 4 _aDrug Safety and Pharmacovigilance.
700 1 _aSchmälter, Julia.
_eauthor.
700 1 _aKlika, Christoph.
_eauthor.
710 2 _aSpringerLink (Online service)
773 0 _tSpringer eBooks
776 0 8 _iPrinted edition:
_z9783658172756
856 4 0 _uhttp://dx.doi.org/10.1007/978-3-658-17276-3
912 _aZDB-2-POS
999 _c48586
_d48586