jueves, 23 de enero de 2014

CDER Small Business Update: Webinar on Electronic Source Data in Clinical Investigations.

The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
FDA/CDER's Small Business Assistance

On Wednesday, January 29, 2014, from 2:00PM - 3:00PM EST, FDA will present a webinar on the final guidance for industry Electronic Source Data in Clinical Investigations.
FINAL Guidance For Industry:  Electronic Source Data In Clinical Investigations (Procedural)
Information on fda.govJanuary 29 FDA Webinar
SUMMARY: The Food and Drug Administration (FDA) has announced the availability of a final guidance for industry titled “Electronic Source Data in Clinical Investigations.” This final guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations. In an effort to streamline and modernize clinical investigations this guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission.

Guidance Webinar Online-Access Instructions: To access this webinar, follow the link provided below. Audio will broadcast from your computer speakers.
After following the link, enter as a guest and provide your FULL NAME and organization (i.e. "John Smith - FDA/CBER"). The host will then allow you to enter. If you experience technical difficulties email Jeffery.Rexrode@fda.hhs.gov for assistance. Closed captioning will be provided.
Questions/Comments can be submitted live via a Q/A chat window.

The Small Business Assistance (SBA) program in the Center for Drug Evaluation and Research (CDER) provides guidance and information to regulated domestic and international small pharmaceutical business 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 SBA staff.  If you have comments or questions, please contact us Monday through Friday 8:00AM – 4:30PM.

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