Following the recent publication of the Data Quality Framework for EU medicine regulation, European Medicines Agency (EMA) is consulting with stakeholders to create chapters for specific domains of medicines regulation. The next chapter will concern human and veterinary Adverse Drug Reactions (ADRs) arising from all sources (e.g. spontaneous reports, medical literature, non-interventional studies and interventional clinical trials).
EMA is organising a workshop to obtain input from all stakeholders involved in ADR reporting. The aim of this workshop is to bring together experts in the field to build on their extensive experience and knowledge relating to ADR data quality.
The workshop will be held as a virtual meeting. We anticipate space for a broad representation of stakeholders; attendance will be organised through EU associations and by direct invitation.