Healthcare is a major component of the contemporary welfare state, and thus ensuring public health through product safety is a substantive public concern.
- European Union
- Member State
- European Union Member State
- Social Health Insurance
- Pharmacovigilance System
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.
Andrews, E., Moore, N. (2014). Mann’s Pharmacovigilance. Wiley-Blackwell, Oxford.
Belton, K. J. and the European Pharmacovigilance Group (1997). Attitude Survey of Adverse Drug-Reaction Reporting by Health Care Professionals across the European Union. European Journal of Pharmacology 52: 423-427.
Borg, J. J., Tanti, A., Kouvelas, D., Lungu, C., Prozynski, M., Serracino-Inglott, A., Aislaitner, G. (2015). European Union Pharmacovigilance Capabilities: Potential for the New Legislation. Therapeutic Advances in Drug Safety 6 (4): 120-140.
Burau, V., Blank, R. H. (2006). Comparing Health Policy: An Assessment of Typologies of Health Systems. Journal of Comparative Policy Analysis 8 (1): 63–76.
Cabiedes, L., Guillén, A. (2001). Adopting and Adapting Managed Competition: Health Care Reform in Southern Europe. Social Science and Medicine 52: 1205-1217.
Calvo, B., Zuňiga, L. (2014). EU’s New Pharmacovigilance Legislation: Considerations for Biosimilars. Drug Safety 37: 9-18.
Drozd, M., Szkultecka-Dębek, M., Baran-Lewandowska, I. (2014). Biosimilar Drugs – Automatic Substitution Regulations Review. Polish ISPOR Chapter’s Therapeutic Programmes and Pharmaceutical Care (TPPC) Task Force Report. Journal of Health Policy 1: 52-57.
Dubois, C.-A., McKee, M. (2004). Health and Health Care in the Candidate Countries of the European Union: Common Challenges, Different Circumstances, Diverse Policies. McKee, M., MacLehose, L., Nolte, E. (eds) (2004). Health Policy and European Union Enlargement. Maidenhead: Open University Press: 43-63.
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.
Guillén, A. M., Matsaganis, M. (2000). Testing the ‘Social Dumping’ Hypothesis in Southern Europe: Welfare Policies in Greece and Spain During the Last 20 Years. Journal of European Social Policy 10 (2): 120-145.
Moran, M. (1999) Governing the Health Care State: A Comparative Study of the United Kingdom, the United States and Germany. Manchester: Manchester University Press.
SCOPE (2016). Work Package 4 – ADR Collection.
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).
Wendt, C., Frisina, L., Rothgang, H. (2009). Healthcare System Types: A Conceptual Framework for Comparison. Social Policy and Administration 43 (1): 70-90.
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). Introduction. In: Pharmacovigilance in the European Union. Springer, Wiesbaden. https://doi.org/10.1007/978-3-658-17276-3_1
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)