Michael Kaeding

Pharmacovigilance in the European Union Michael Kaeding

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 work was published by Saint Philip Street Press pursuant to a Creative Commons license permitting commercial use. All rights not granted by the work's license are retained by the author or authors.