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

 
  March 03, 2010  
     
 
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

 
 
Organized by: Drug Information Association, Inc.
Invited Speakers:

Call contact

 
Deadline for Abstracts: Call contact
 
Registration:

Contact Information:

For detailed program information including faculty and topics, please contact:
Susan Mazak
Tel. +1-215-442-6183 

Fax: +1-215-442-6183      

Email Susan.Mazak@diahome.org

 
   
 
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