Characterization of the Recent Postmarketing Safety Measures in Europe Focusing on Additional Pharmacovigilance Activities

Author:

Iwasaki MamiORCID,Kaneko Masayuki,Narukawa Mamoru

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Reference11 articles.

1. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP). Module V—risk management systems. London: EMA; 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf . Accessed 12 May 2016.

2. Vermeer NS, Duijnhoven RG, Straus SM, Mantel-Teeuwisse AK, Arlett PR, Egberts AC, Leufkens HG, De Bruin ML. Risk management plans as tool for proactive pharmacovigilance: a cohort study of newly approved drugs in Europe. Clin Pharmacol Ther. 2014;96:723–31.

3. Raine J, Wise L, Blackburn S, Eichler HG, Breckenridge A. European perspective on risk management and drug safety. Clin Pharmacol Ther. 2011;89:650–4.

4. Waller P. Getting to grips with the new European Union pharmacovigilance legislation. Pharmacoepidemiol Drug Saf. 2011;20:544–9.

5. European Medicines Agency. One-year report on human medicines pharmacovigilance tasks of the European Medicines Agency. London: EMA; 2014. http://ec.europa.eu/health/files/pharmacovigilance/2014_ema_oneyear_pharmacov_en.pdf . Accessed 12 May 2016.

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