Products Used in Early Phase IND Studies

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 who will contribute data to CMC sections Project managers for product development studies Quality systems auditors