FDAnews
www.fdanews.com/articles/213554-ema-releases-its-new-real-world-evidence-capabilities-to-researchers

EMA Releases Its New Real-World Evidence Capabilities to Researchers

April 19, 2024

The European Medicines Agency (EMA) has released a document detailing how the agency’s real-world evidence (RWE) office can help with medical research.

The document, which explains how to ask EMA to run research questions through its RWE sources, comes two months after EMA and the Heads of Medicines Agencies (HMA) launched two public electronic catalogs, one for real-world data (RWD) sources and one for RWD studies.

The document, published April 10, describes how RWE can be useful in the context of regulatory decision-making, the types of studies that can be performed and how EMA can help identify the best resources to address a research question.

Read the EMA’s document on RWE here.

To read the whole story, click here.

Related Topics