The “Summary report of the Heads of Medicines Agencies” was published by the EMA Joint Big Data Task Force on 15 February 2019, offering recommendations for a path towards understanding the acceptability of evidence derived from Big Data in support of the evaluation and supervision of medicines by regulators.
EMA, among other regulators, is trying to get a deeper understanding of the data landscape. It is well known that the future benefit-risk assessment of medicines across their lifecycle will increasingly use insights derived from Big Data, coming from sources as genomics, bioanalytical ‘omics (proteomics, etc.), clinical trials, observational data, spontaneous adverse drug reactions data and social media and mobile health data.
The HARMONY Alliance is sharing this report among their Partners and Associated Members, since EMA invites stakeholders to submit feedback on the recommendations and future actions.
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Public-private partnership for Big Data in Hematology
HARMONY and HARMONY PLUS are funded through the Innovative Medicines Initiative (IMI), Europe's largest public-private initiative aiming to speed up the development of better and safer medicines for patients. Funding is received from the IMI 2 Joint Undertaking and is listed under grant agreement for HARMONY No. 116026 and grant agreement for HARMONY PLUS No. 945406. This Joint Undertaking receives support from the European Union’s Horizon 2020 Research and Innovation Programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
HARMONY Coordination Office
Institute of Biomedical Research of
Salamanca (IBSAL)
Salamanca, Spain
HARMONY Communications
European Hematology Association (EHA)
The Hague, The Netherlands
