|
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
Back
to Top
Back to Meetings
Date created: October 7, 2005, updated November 22, 2005 |
|