Drug Information Association, Inc, Horsham, PA USA
Sep 19 2011 8:30AM - Sep 20 2011 4:30PM
Navigate the CMC Compliance Maze Arm yourself with the tools to write or assemble CMC sections of regulatory submission, to prepare for CMC meetings with FDA, and to avoid non-compliance. WHAT YOU WILL LEARN
• FDA's regulatory expectations and the regulatory framework
• Structure of CMC sections of INDs/NDAs/CTDs/DMFs
• Regulatory documents affected by CMC
• Labels required for INDs and NDAs
• How to comprehend and construct a stability protocol Event Code:
11432
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