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 Electronic Common Technical Document (eCTD) Tutorial
Thursday, October 20, 2005

Time: 9:00-12:00 PM
Location: Montrose Metro Center II
11919 Rockville Pike
Rockville, Maryland 20852

This tutorial will provide an overview of FDA's eCTD guidance document and a comprehensive discussion on preparing the five modules of an eCTD. Emphasis will be placed on ensuring the successful submission of an application and facilitating the review process.

There is no charge for this tutorial.

  • Agenda
  • Registration form
  • Presentations (11/22/2005)
    • eCTD Guidance Overview [PPT], Gary M Gensinger, MBA, CDER
    • eCTD: Module [PPT], Bronwyn Collier, CDER
    • eCTD Tutorial Module 2: Summaries [PPT], Virginia Ventura, CDER
    • eCTD Quality/CMC Issues [PPT], Norman R. Schmuff, Ph.D., CDER
    • Guidance-Compliant eCTDs: Modules 4 and 5 [PPT] Armando Oliva, M.D., CDER
    • Ensuring a Effective Submission [PPT], Gary M Gensinger, MBA, CDER

PDF requires the free Adobe Acrobat Reader

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Date created: October 7, 2005, updated November 22, 2005
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