GESTIÓN EN SALUD PÚBLICA: CDER SBIA Webinar – Required Electronic Submissions: eCTD and Study Data

jueves, 1 de octubre de 2015

CDER SBIA Webinar – Required Electronic Submissions: eCTD and Study Data - October 8, 2015

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

CDER Small Business and Industry Assistance (CDER SBIA) Webinar –

Required Electronic Submissions: eCTD and Study Data - October 8, 2015

On October 8, 2015, 11AM EDT, FDA’s CDER and CBER will host a webinar titled "Required Electronic Submissions: eCTD and Study Data." Note that this webinar will be LIVE.

This one hour webinar will provide an overview of the final guidances and related technical specifications that implements the electronic submission requirements of section 745A(a) of the Federal Food Drug and Cosmetic Act (FD&C Act) for electronic submissions and study data contained in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs). FDA will present the electronic Common Technical Document (eCTD) and study data requirements and the timeframes on the required submission of the eCTD and study data formats within the scope of the guidance.

Webinar Information

Registration

For questions concerning the webinar, please contact CDER SBIA at:

(866)-405-5367 | (301)-796-6707

If you've never used Connect Pro, get a quick overview:

http://www.adobe.com/go/connectpro_overview

Test your connection prior to the day of the event:

https://collaboration.fda.gov/common/help/en/support/meeting_test.htm

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.