de Vries, Sieta T. http://orcid.org/0000-0001-6090-2434
Harrison, Judy
Revelle, Patrick
Ptaszynska-Neophytou, Alicia
Radecka, Anna
Ragunathan, Gowthamei
Tregunno, Phil
Denig, Petra http://orcid.org/0000-0002-7929-4739
Mol, Peter G. M. http://orcid.org/0000-0002-4262-3180
Funding for this research was provided by:
Innovative Medicines Initiative Joint Undertaking (115632)
Article History
First Online: 6 February 2019
Compliance with Ethical Standards
:
: This study was conducted in the context of the WEB-Recognising Adverse Drug Reactions (WEB-RADR) project. The WEB-RADR project has received support from the Innovative Medicines Initiative Joint Undertaking (ExternalRef removed) under Grant Agreement No. 115632, the resources of which comprise a financial contribution from the European Union’s Seventh Framework Programme FP7/2007-2013 and the EFPIA companies’ in kind contribution (ExternalRef removed, UK).
: Sieta T. de Vries, Petra Denig and Peter G.M. Mol have no conflicts of interest that are directly relevant to the content of this study. Alicia Ptaszynska-Neophytou, Anna Radecka, Gowthamei Ragunathan and Phil Tregunno are employees of the Medicines and Healthcare products Regulatory Agency (MHRA). The research leading to these results was conducted as part of the WEB-RADR consortium (ExternalRef removed), which is a public-private partnership coordinated by the MHRA. Judy Harrison is a consultant and Patrick Revelle is an employee of the MedDRA® Maintenance and Support Services Organization through its parent company, Northrop Grumman. The Maintenance and Support Services Organization maintains and distributes MedDRA®, a standardised international medical terminology. MedDRA® is available by a sliding-scale subscription model for commercial organisations but is provided free to regulatory authorities, non-profit organisations, direct patient care providers and educational institutions. The patient-friendly terms list referenced in the manuscript is freely and publicly available on the MedDRA® website.
: Formal ethical evaluation was not considered necessary for the study described in this report because the data were collected using the results from the MHRA’s structural work activities.