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  5. Optimizing Your Study Data Submissions to FDA: Office of Vaccines Research and Review (OVRR) Data Submission - May 8, 2018
  1. CDER Small Business & Industry Assistance (SBIA)

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)

The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), welcomes you to our webinar series.

These events focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation.  The webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.

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.

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