Transcription of 5 – Quality (CMC) considerations
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115 Quality (CMC) considerations Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical TrialsCelia Lourenco, PhD,Manager, Clinical Group IOffice of Clinical TrialsTherapeutic Products DirectorateL1 Slide 1L1 Lourenco; : the information within this presentation is based on the presenter's expertise and experience, and represents the views of the presenter for the purposes of a training workshop3 Overview Objective in the assessment of Quality CMC framework Summary of Quality (CMC)
1 5 – Quality (CMC) considerations Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD,
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