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Pharmacovigilance in the European Union
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Practical Implementation across Member States
eBook
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Artikel-Nr:
9783658172763
Veröffentl:
2017
Einband:
eBook
Seiten:
124
Autor:
Michael Kaeding
eBook Typ:
PDF
eBook Format:
Reflowable eBook
Kopierschutz:
Digital Watermark [Social-DRM]
Sprache:
Englisch
Beschreibung:
This 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.
This 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.
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.