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Overview: How it may be integrated with the recommendations of the guidance documents on CMC requirements. Areas Covered in the Session: Discussion of the elements found in the guidance document for Phase 1 material What to do at really early stages What about special IND studies? What about preclinical studies? Who Will Benefit: Regulatory Affairs personnel who coordinate activities for the CMC sections of submissions QA/QC personnel who need to plan work on early stage material R & D personnel…Find out more »
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