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GMP News

How to register a QPPV?

On the EMA website, the EudraVigilance registration documentation has been updated. Among other things, it is now pointed out that the EMA reserves the right to contact the previous QPPV/RP if necessary in order to validate the variation applied for.

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EMA's Reflection Paper on the Use of Real-World Data in Non-Interventional Studies

The EMA has published a draft Reflection Paper on use of real-world data in non-interventional studies to generate real-world evidence for comment.

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Real-World Evidence Provided by EMA

The use of Real-World Data (RWD) in the development, authorization and monitoring of medicinal products continues to increase. EMA's newly published document on Real-World Evidence (RWE) explains how RWE derived from analyzing RWD can be useful in the context of regulatory decisions.

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