Date(s) And Time(s):
Apr 8 2010 8:30AM - Apr 9 2010 4:30PM
Drug Information Association, Inc.
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509
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
For detailed program information including faculty and topics, please contact: