Career Center

Course

Title:

  Drug Approval Process
Date:   Monday, July 30, 2007  to Tuesday, July 31, 2007
Time:   8:30 AM - 5:00 PM
Location:   San Francisco
Sponsor:   Barnett International
Course details:  

 

This course provides a comprehensive approach to the preparation and submission of documents to the FDA for approval of drug products. Participants receive a foundation of knowledge about the drug approval process, submission preparation, and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring and assembly of INDs, NDAs, and post-approval documents. Information on maintaining on-going relationships with the FDA is also discussed. The course enables regulatory affairs professionals to prepare concise documents, provide the FDA with necessary information, and obtain rapid product approval.

For more information view the Course Agenda

Fee:   $1,595
     
Additional information and/or registration:   703-310-2549. Register online with Barnett Educational Services

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