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Guillem Wetherell Mateu on Muck Rack

Guillem Wetherell Mateu

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Articles

Analysis of a decade of post-authorisation studies for medicines approved by the EMA

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By Caroline Voltz-Girolt, Carla Torre, Bruno Sepodes, Harald Enzmann, Guillem Wetherell Mateu
| Nature Verified
Medicines are granted marketing authorisation (MA) by the European Medicines Agency (EMA) based on an assessment that they have a positive benefit–risk balance, but additional data on quality, safety or efficacy may still be needed post-authorisation in some cases. These requirements are addressed through post-authorisation study measures (PAMs), which include studies or activities requested from Marketing Authorisation Holders (MAHs) by the EMA. Enjoying our latest content?
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