Tag: Real-World Data (RWD)

Medicine Safety studies visual

EMA publishes new guidelines for non-interventional studies

New EMA ICH M14 guidelines sets common international standards for non‑interventional real‑world data studies to strengthen medicine safety assessment.
EDERA WODC & GAM - Preview- JVDPhotography-4

ERDERA Open Session: science and advocacy align to advance rare disease research and care

Amsterdam and online, convening clinicians, scientists and advocates to share progress and the power of patient led policy to improve diagnosis and care.
EDERA WODC & GAM - Preview- JVDPhotography-1-min

ERDERA at WODC Europe 2025: wrap up and next steps

Sharing patient‑centred methods, early diagnostics, and data‑driven trial innovation to accelerate rare disease research across Europe.
Ai Exhibition

EMA opens public consultations on patient experience data and use of external controls

EMA invites feedback to strengthen how the EU generates and uses evidence that reflects what matters to patients, including in rare diseases
Ronald Cornet

“Data is the fuel of ERDERA’s mission to enhance our insights in rare diseases, to expedite diagnosis, and to find new treatments”

ERDERA interviews Ronald Cornet
Latest Developments in Good Clinical Practice

EMA Calls for Registrations in Real-World Data Catalogues

Epilepsy & Behaviour

Dravet syndrome: Insights into seizure and speech progression from registry data

Analysis of registry data offers critical insights into the progression of seizures and speech development in patients with Dravet syndrome.
European Medicines Agency (EMA)

Validation, Publication, and Maintenance of real-world data sources and studies in the HMA-EMA RWD Catalogues

ERDERA's

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