In this chapter, we compare the challenges and best practices identified in the country chapters so that the in-depth analysis of selected Member States is complemented with a broader overview. In doing so, we aim to provide a better understanding of the practical implementation of the new European Union (EU) pharmacovigilance legislation across Member States.
- European Union
- Member State
- Healthcare Professional
- Regional Unit
- Batch Number
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.
Borg et al. (2015). European Union Pharmacovigilance Capabilities: Potential for the New Legislation. Ther Adv Drug Safety 6 (4): 120-140.
Dolinar, R., Reilly, M. (2014). Biosimilars Naming, Label Transparency and Authority of Choice – Survey Findings among European Physicians. Generics and Biosimilars Initiative 3 (2): 58-62.
Douros, A. et al. (2016). Pharmakovigilanz in Deutschland. Internist 57: 616-623.
European Commission Pharmaceutical Committee (2015). Overview of Member States Biennial Reports on Audits of their Pharmacovigilance Systems (2013 Reporting Year). Pharmaceutical Committee, 21 October 2015, PHARM 693.
European Commission (2016). Pharmacovigilance Related Activities of Member States and the European Medicines Agency Concerning Medicinal Products for Human Use (2012-2014), COM(2016) 498 final, Brussels, 08.08.2016.
Jadeja, M., Barrow, P. (2016). Topic 4.3: Awareness Levels. SCOPE Work Package 4 Survey Report.
Jan, T., Radecka, (2015). Topic 4 Review of Reporting Forms. SCOPE Work Package 4 Survey Report.
Klein, K., De Bruin, M. L., Broekmans, A. W., Stolk, P. (2015). Classification of Recombinant Biologics in the EU: Divergence between National Pharmacovigilance Centres. BioDrugs 29: 373-379.
Moore, N., Bégaud, B. (2010). Improving Pharmacovigilance in Europe. The BMJ 340: c1694.
Šarinić, V. M., Di Giusti, M. D., Banovac, M., Skurce, N. M., Gvozdanović, K., Krnic, D., Andrić, A., Šipić, I., Cajko, N., Sudić, D., Lovretić, N. (2016). Topic 1 Audit of National Reporting Systems, Topic 1a Medication Errors, Topic 2 Patient Reporting, Topic 5 Review of IT Systems and Special Form of Reports. SCOPE Work Package 4 Survey Report.
Vermeer, N. S., Straus, S. M. J. M., Mantel-Teeuwisse, A. K., Domergue, F., Egberts, T. C. G., Leufkens, H. G. M., De Bruin, M. L. (2013). Traceability of Biopharmaceuticals in Spontaneous Reporting Systems: A Cross-Sectional Study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance Databases. Drug Safety 36: 617-625.
Vermeer, N. S., Spierings, I., Mantel-Teeuwisse, A. K., Straus, S. M. J. M., Giezen, T. J., Leufkens, H. G. M., Egberts, T. C. G., De Bruin, M. L. (2015). Traceability of Biologicals: Present Challenges in Pharmacovigilance. Expert Opinion on Drug Safety, 14 (1).
Rights and permissions
This chapter is published under an open access license. Please check the 'Copyright Information' section either on this page or in the PDF for details of this license and what re-use is permitted. If your intended use exceeds what is permitted by the license or if you are unable to locate the licence and re-use information, please contact the Rights and Permissions team.
© 2017 The Author(s)
About this chapter
Cite this chapter
Kaeding, M., Schmälter, J., Klika, C. (2017). Challenges and Best Practices in Perspective. In: Pharmacovigilance in the European Union. Springer, Wiesbaden. https://doi.org/10.1007/978-3-658-17276-3_6
Publisher Name: Springer, Wiesbaden
Print ISBN: 978-3-658-17275-6
Online ISBN: 978-3-658-17276-3
eBook Packages: Political Science and International StudiesPolitical Science and International Studies (R0)