Friday, January 24, 2014

Free Webinar by FDA on the final guidance for industry Electronic Source Data in Clinical Investigations

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.




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.

Webinar Access link: https://collaboration.fda.gov/guidancewebinars

SPEAKERS:
        Leonard V. Sacks, MD
        Associate Director
        Office of Medical Policy
        Center for Drug Evaluation and Research
        Food and Drug Administration

        Ron Fitzmartin, PhD, MBA
        Office of Strategic Programs
        Center for Drug Evaluation and Research
        Food and Drug Administration

        Jonathan S. Helfgott, MS
        Associate Director for Risk Science (Acting)
        Office of Scientific Investigations
        Center for Drug Evaluation and Research
        Food and Drug Administration

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