Utilizing Chemistry, Manufacturing & Control (CMC) in Drug Development

Venue: Drug Information Association, Inc.

Location: Horsham, Pennsylvania, United States

Event Date/Time: Apr 08, 2010 End Date/Time: Apr 09, 2010
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Description

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

Venue

800 Enterprise Rd Ste 200
Horsham
Pennsylvania
United States
MORE INFO ON THIS VENUE

Types