October 9 - 12, 2012
Building 10 & Natcher Conference Center
- General Schedule of Events
- Opening Plenary Session
- Concurrent Symposia Sessions
- National Graduate Student Research Conference
- FARE Award Ceremony
- Poster Sessions
- Special Exhibits on Resources for Intramural Research
- TSA Research Festival Exhibit Show
- Research Festival Committees
- Past Research Festivals
2011 program
Download the 2011 Research Festival Program Book
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The Electronic Common Technical Document: One Organization's Experience
| Thursday, October 11, 2012 — Poster Session IV | |||
|---|---|---|---|
2:00 p.m. – 4:00 p.m. |
Natcher Conference Center, Building 45 |
NIAID |
RSCHSUPP-4 |
Authors
- L.H. Giambarresi
- S.C. Garrand
- M.A. Chakrabarti
- V.S. Eccard
- A.L. Gonzalez-Rodriguez
- T.B. Harvey
- J.M. Hertsch
- L.M. Lacuesta
- M.J. Buehn
Abstract
Preparation and submission of Investigational New Drug applications, Master Files, and Investigational Device Exemption applications has traditionally been accomplished in hard copy paper format. Creating these applications in the electronic Common Technical Document (eCTD) format allows for the standardized presentation of all required technical, regulatory, and administrative information; reduces publication and delivery costs; and simplifies the Food and Drug Administration (FDA) review process. Here we describe the Regulatory Compliance and Human Subject Protection Program’s experience in transitioning from paper documents to an eCTD program for regulatory applications.
