Pharmacovigilance in the European Union

Name: Pharmacovigilance in the European Union
Author: Michael Kaeding

Practical Implementation across Member States

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Paperback, blz. | Engels

Springer Fachmedien Wiesbaden | e druk, 2017

ISBN13: 9783658172756

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Springer Fachmedien Wiesbaden e druk, 2017 9783658172756

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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.

Specificaties

ISBN13:9783658172756

Taal:Engels

Bindwijze:paperback

Uitgever:Springer Fachmedien Wiesbaden

Inhoudsopgave

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.

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Pharmacovigilance in the European Union

Practical Implementation across Member States

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