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Data: 20/02/2013
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).
We especially appreciate receiving résumés from the disability protected class, as defined by Law 68/99, which meet the requisites illustrated above.
Per ulteriori informazioni potete consultare il seguente link.
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