Characteristics, Quality and Contribution to Signal Detection of Spontaneous Reports of Adverse Drug Reactions Via the WEB-RADR Mobile Application: A Descriptive Cross-Sectional Study

Author:

Oosterhuis Ingrid,Taavola HenricORCID,Tregunno Philip M.,Mas Petar,Gama Sara,Newbould Victoria,Caster Ola,Härmark Linda

Funder

Innovative Medicine Initiative Joint Undertaking

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Toxicology

Reference23 articles.

1. Council for International Organizations of Medical Sciences. Practical aspects of signal detection in pharmacovigilance: report of CIOMS Working Group VIII. Geneva: Council for International Organizations of Medical Sciences; 2010.

2. Ishiguro C, Hall M, Neyarapally GA, Dal Pan G. Post-market drug safety evidence sources: an analysis of FDA drug safety communications. Pharmacoepidemiol Drug Saf. 2012;21(10):1134–6. https://doi.org/10.1002/pds.3317 .

3. Pacurariu AC, Coloma PM, van Haren A, Genov G, Sturkenboom MCJM, Straus SMJM. A description of signals during the first 18 months of the EMA Pharmacovigilance Risk Assessment Committee. Drug Saf. 2014;37(12):1059–66. https://doi.org/10.1007/s40264-014-0240-1 .

4. Raine JM. Risk management: a European regulatory view. In: Mann RD, Andrews EB, editors. Pharmacovigilance. 2nd ed. Chichester: Wiley; 2007. p. 553–8.

5. Mann RD, Andrews EB. Introduction. In: Mann RD, Andrews EB, editors. Pharmacovigilance. 2nd ed. Chichester: Wiley; 2007. p. 1–11.

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