CDER SBIA Webinar - CBER Update: 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

CDER SBIA will host this webinar, which provides an update on best practices for submitting information to FDA's Center for Biologics Evaluation and Research (CBER), Office of Vaccines Research and Review (OVRR). It includes a brief question and answer session after the presentations.

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