Pediatric Drug Safety Surveillance in FDA-AERS: A Description of Adverse Events from GRiP Project

• Sandra de Bie ,

  Contributed equally to this work with: Sandra de Bie, Carmen Ferrajolo

  Affiliations Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands, Medicines Evaluation Board, Utrecht, the Netherlands

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• Carmen Ferrajolo ,

  Contributed equally to this work with: Sandra de Bie, Carmen Ferrajolo

  * E-mail: c.ferrajolo@erasmusmc.nl

  Affiliations Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands, Experimental Medicine Department, Pharmacology Section, Campania Regional Center of Pharmacovigilance and Pharmacoepidemiology, Second University of Naples, Naples, Italy

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• Sabine M. J. M. Straus,

  Affiliations Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands, Medicines Evaluation Board, Utrecht, the Netherlands

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• Katia M. C. Verhamme,

  Affiliation Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands

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• Jan Bonhoeffer,

  Affiliations Brighton Collaboration Foundation, Basel, Switzerland, University Children’s Hospital Basel, University of Basel, Basel, Switzerland

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• Ian C. K. Wong,

  Affiliation Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, University of Hong Kong, Hong Kong, China

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• Miriam C. J. M. Sturkenboom,

  Affiliations Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands, Department of Epidemiology, Erasmus University Medical Center, Rotterdam, the Netherlands

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• GRiP network

  ¶Membership of the GRiP network is provided in the Acknowledgments.

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