CDER SBIA Webinar: Optimizing Your Study Data Submissions to FDA: Office of Vaccines Research and Review (OVRR) Data Submission - May 8, 2018

CDER SBIA Webinar: Optimizing Your Study Data Submissions to FDA: Office of Vaccines Research and Review (OVRR) Data Submission - May 8, 2018

Tuesday, May 8, 2018

1:30pm - 2:30pm (Eastern)

Webinar Information and Registration

Join us as our FDA experts provide an overview of recent updates made to FDA’s Study Data Technical Conformance Guide.  This Study Data Technical Conformance Guide (TCG) provides specifications, recommendations, and general considerations on how to submit standardized study data using FDA-supported data standards located in the FDA Data Standards Catalog. The TCG supplements the guidance for industry Providing Regulatory Submissions in Electronic Format — Standardized Study Data and provides technical recommendations to sponsors for the submission of animal and human study data and related information in a standardized electronic format in INDs, NDAs, ANDAs, and BLAs.

Speakers:

Brenda Baldwin, Ph.D.

Primary Reviewer | Regulatory Project Manager

Division of Vaccines & Related Product Applications (DVRPA)

Office of Vaccines Research and Review (OVRR) | CBER

Dr. Baldwin will describe the preferred usage of domains and variables for vaccine clinical study data that is submitted to OVRR.

Kirk Prutzman, Ph.D. 

Primary Reviewer | Regulatory Project Manager 

DVRPA | OVRR | CBER

Dr. Prutzman will describe the reason for creation of the Study Data Standardization Plan (SDSP) CBER appendix, timeline for submission, and an overview of the appendix.

This webinar has been pre-approved by RAPS as eligible for up to 1.0 credit towards a participant’s RAC recertification upon full completion. Only live attendance will qualify for the CE. 

             (Attendance Certificates are only available for TWO WEEKS after the event)

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

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