Pharmacovigilance in the European Union
Practical Implementation across Member States
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Product details:
- Edition number 1st ed. 2017
- Publisher Springer Fachmedien Wiesbaden
- Date of Publication 27 February 2017
- Number of Volumes 1 pieces, Book
- ISBN 9783658172756
- Binding Paperback
- No. of pages124 pages
- Size 210x148 mm
- Weight 1906 g
- Language English
- Illustrations XIV, 124 p. 13 illus., 12 illus. in color. Illustrations, black & white 0
Categories
Long description:
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.
Table of Contents:
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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