Challenges and Best Practices in Perspective
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.
KeywordsEconomic Crisis Europe Marketing
- Borg et al. (2015). European Union Pharmacovigilance Capabilities: Potential for the New Legislation. Ther Adv Drug Safety 6 (4): 120-140.Google Scholar
- 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.Google Scholar
- Douros, A. et al. (2016). Pharmakovigilanz in Deutschland. Internist 57: 616-623.Google Scholar
- 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.Google Scholar
- 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.Google Scholar
- Jadeja, M., Barrow, P. (2016). Topic 4.3: Awareness Levels. SCOPE Work Package 4 Survey Report.Google Scholar
- Jan, T., Radecka, (2015). Topic 4 Review of Reporting Forms. SCOPE Work Package 4 Survey Report.Google Scholar
- 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.Google Scholar
- Moore, N., Bégaud, B. (2010). Improving Pharmacovigilance in Europe. The BMJ 340: c1694.Google Scholar
- 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.Google Scholar
- 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.Google Scholar
- 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).Google Scholar
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