This joint hybrid HMA/EMA workshop on Patient Registries followed on the successful disease-specific workshops held between 2017 and 2019, as well as the EMA multi-stakeholder workshop on qualification of Patient Registries held in 2024. The...
The European Medicines Agency (EMA) is hosting a workshop on supporting innovation in cardiovascular medicines and medical devices in the EU. This multi-stakeholder workshop will cover interdisciplinary discussions addressing a range of important topics including...
The 20th meeting of the industry stakeholder platform on the operation of EU pharmacovigilance aimed to inform, get feedback and foster dialogue between industry and the EU regulators. Topics included: Real World Evidence update Guidance...
This joint hybrid HMA/EMA workshop on Patient Registries follows on the successful disease-specific workshops held between 2017 and 2019, as well as the EMA multi-stakeholder workshop on qualification of Patient Registries held in 2024. The...
This guideline recommends international standards for, and promotes harmonization of, the general principles on planning, designing, analysing, and reporting of noninterventional studies that utilize fit-for-use data for safety assessment of medicines. The guideline outlines recommendations and high-level...
This joint hybrid HMA/EMA workshop on Patient Registries follows on the successful disease-specific workshops held between 2017 and 2019, as well as the EMA multi-stakeholder workshop on qualification of Patient Registries held in 2024. The event will bring...
The need for guidance on use of external controls was prioritised by the Methodology Working Party (MWP) in its consolidated 3-year workplan 2025-2027 and work has started on a “draft reflection paper on the use of external controls for evidence generation...
Randomised controlled trials are the gold standard of evidence to support causal conclusions on the benefits and risks of medicines in regulatory decision making along the lifecycle. However, in some situations, causal conclusions may be...
A third report based on studies EMA conducted using real-world data between February 2024 and February 2025 is now published. It summarises the progress made to enable the use of real-world data and establish its value in regulatory...
The User guide of the HMA-EMA Catalogues of real-world data sources (RWD) and studies has been developed for users submitting data to the Catalogues (i.e.: data holders and investigators submitting study data) to help them...
