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. 2019 Jul;106(1):36-39.
doi: 10.1002/cpt.1426. Epub 2019 Apr 10.

Real-World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe

Affiliations

Real-World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe

Alison Cave et al. Clin Pharmacol Ther. 2019 Jul.
No abstract available

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Conflict of interest statement

The authors declared no competing interests for this work.

References

    1. Collier, S. et al Monitoring safety in a phase III real‐world effectiveness trial: use of novel methodology in the Salford Lung Study. Pharmacoepidemiol. Drug Saf. 26, 344–352 (2017). - PMC - PubMed
    1. Mazzaglia, G. et al Study design and evaluation of risk minimization measures: a review of studies submitted to the European Medicines Agency for cardiovascular, endocrinology, and metabolic drugs. Drug Saf. 41, 191–202 (2018). - PMC - PubMed
    1. Santoro, A. , Genov, G. , Spooner, A. , Raine, J. & Arlett, P. Promoting and protecting public health: how the European Union Pharmacovigilance System Works. Drug Saf. 40, 855–869 (2017). - PMC - PubMed
    1. Goedecke, T. , Morales, D. , Pacurariu, A. & Kurz, X. Measuring the impact of medicines regulatory interventions – systematic review and methodological considerations. Br. J. Clin. Pharmacol. 84, 419–433 (2018). - PMC - PubMed
    1. Eichler, H.G. et al Data rich, information poor: can we use electronic health records to create a learning healthcare system for pharmaceuticals? Clin. Pharmacol. Ther. 105, 912–922 (2018) 10.1002/cpt.1226. - DOI - PMC - PubMed

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