Drug Information Association, Inc. , Horsham, PA
Apr 8 2010 - Apr 9 2010
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
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