Electronic Common Technical Document (eCTD) Tutorial,
Friday, April 22, 2005, Rockville, MD

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.

• Agenda

Presentations

• eCTD: Module 1 [PPT], Bronwyn Collier, FDA
• eCTD Guidance Overview [PPT], Gary M. Gensinger, MBA, FDA
• Ensuring a Effective Submission [PPT], Gary M. Gensinger, MBA, FDA
• Guidance-Compliant eCTDs: Module 5 [PPT], Armando Oliva, M.D., FDA
• eCTDs Quality/CMC Issues [PPT], Norman R. Schmuff, Ph.D., FDA
• Prequel 1: Template or Guidance? [PPT], Steve Wilson, DrPH, CAPT USPHS, FDA
• Guidance Compliant eCTDs Module 4: Safety [PPT], Steve Wilson, DrPH, CAPT USPHS, FDA

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Date created: April 26, 2005

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