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Case study 8
The main product receives negative feedback from European Medicines Agency. What can the company do?
Company H received tough challenges in the Day 120 feedback in registering its key products through EMA. The Company’s global management interpreted the feedback as ‘hopeless’. However, the local team contacted EMA staff and negotiated an olive branch, using a particular set of data that had not been reviewed. The Company managed to get approval for the product.