Implementation of a French Early Access Program for orphan drug patients in nominative & cohort program

Case studies - 16 December 2020

Implementation of a French Early Access Program for orphan drug patients in nominative & cohort program

A European pharmaceutical company entrusted PharmaBlue (a BlueReg Company) as French «exploitant» with the responsibility of submitting, obtaining and implementing a French Early Access Program called “ATU” (Autorisation Temporaire d’Utilisation) for its orphan drug for patients in nominative and cohort program.

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