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EU Drug Safety

Pharmacovigilance in the European Union

The implementation assessment “Pharmacovigilance in the European Union: Practical implementation across Member States” was commissioned by AbbVie, directed by Dr Michael Kaeding, managed by Julia Schmälter, and written by the aforementioned in collaboration with Christoph Klika. The book presents the results of an in-depth comparative study assessing the implementation of the EU Pharmacovigilance Directive (2010/84/EU) 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 key stakeholders in Germany, Poland, Portugal, France, Finland and the UK over the course of ten months, 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 drug safety at the national level. You can access and download the book for free here.

Key Messages

Key messages on the recommendations