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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.
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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