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Data: 30/05/2013
End of study. Activities after end of clinical phase
• Review (blinded/open) of database; review of listings, medical writing for the preparation of study report;
• Study results presentation/publication. Update of the IB, IMPD and other relevant document (e.g. annual safety report, IND update etc) with the study results.
End of Clinical Development:
• Preparation of all documentation summarising the Clinical studies (written summary of efficacy/safety), input to the Summary of Product Characteristics;
• Discussion with regulatory authorities along the approval process leading to the Marketing authorisation (worldwide).
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