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EMA Releases Guidance On How & When Its RWE Generation Service Can Be Used

 
• By Eliza Slawther

New EU guidance outlines the process through which scientific committees, national competent authorities and other relevant decision-makers can request real-world evidence studies for regulatory purposes.

RWE DATA FLASHDRIVE.
• Source: Alamy

Real-world evidence (RWE) can be used to inform the European Medicines Agency’s decision-making by filling in knowledge gaps in evidence submitted by pharmaceutical companies.

While companies themselves can generate RWE by conducting studies, the EMA also provides an evidence generation service based on requests from specific groups such as its own scientific committees and...

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