Proactively managing the risk of marketed drugs: experience with the EMA Pharmacovigilance Risk Assessment Committee

Author:

Arlett Peter,Portier Geraldine,de Lisa Roberto,Blake Kevin,Wathion Noel,Dogne Jean-Michel,Spooner Almath,Raine June,Rasi Guido

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmacology,General Medicine

Reference8 articles.

1. Mullard, A. Unleashing the Mini-Sentinel. Nature Rev. Drug Discov. 11, 255–257 (2012).

2. European Medicines Agency. EMA recommends 81 medicines for marketing authorisation in 2013. European Medicines Agency [online] , (2014).

3. Eichler, H. G. et al. Adaptive licensing: taking the next step in the evolution of drug approval. Clin. Pharmacol. Ther. 91, 426–437 (2012).

4. Prieto, L. et al. Evaluation of the effectiveness of risk minimization measures. Pharmacoepidemiol. Drug Saf. 21, 896–899 (2012).

5. International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline Periodic Benefit-Risk Evaluation Report (PBRER) E2C (R2). ICH [online] , (2012).

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