Tag: Real World Evidence

CRN Conference Group Photo

Clinical experts and patient advocates gather in Heidelberg to turn discussion into action on global rare disease research

From shared standards to local impact, the 2nd Clinical Research Networks Conference agreed concrete next steps for interoperable clinical research networks worldwide
Erdera CRN Conference verd 2_page-0002

One month to go: register now for the 2nd International Conference on Clinical Research Networks

9-10 December, Heidelberg and online — last places for in person attendance; free livestream for registered participants.
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-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
Exterior of European Medicines Agency in Amsterdam

EMA concludes pilot to support repurposing of established medicines

Accelerating evidence-driven innovation to unlock fresh indications for established therapies.
scientific paper

EMA reflection paper on Patient Experience Data (PED)

First published on 29 September, this EMA reflection paper encourages early dialogue with regulators on how patient experience data can strengthen evidence packages in medicines development and marketing authorisation.
Erdera CRN Conference verd 2_page-0002

Shaping the future of global rare disease research: Join the 2nd International Conference on Clinical Research Networks

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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