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Regulatory Affairs: Part I: The IND Phase, Part II: The CTD/NDA Phase
Regulatory Affairs: Part I: The IND Phase, Part II: The CTD/NDA Phase

Conference or Training Sponsor or Organizer: Drug Information Association (DIA)

Conference or Training Description: This is a modified version of two three-day courses combined into one extended four-day course. This course describes the regulatory background of the IND and NDA, and an overview of requirements and recommendations for preparing these applications for submission to the FDA.

Key Topics Overview of FDA Regulatory requirements for drug development and approval Post-approval and marketing regulatory requirements and processes Overview of the CTD format.

Conference or Training Dates: 01/21/2007

Conference or Training Location: Irvine, CA, USA

FOR FURTHER INFORMATION OR TO REGISTER FOR THIS REGULATORY CONFERENCE OR TRAINING COURSE :
Marketing Manager or visit http://www.diahome.org/product/12244/07401%20January%20Reg%20Combo%20USC.pdf

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