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Study Data Submissions: Office of Vaccines Research and Review (OVRR) Data Submission – May 8, 2018

Study Data Submissions: Office of Vaccines Research and Review (OVRR) Data Submission – May 8, 2018

Providing Clinical Study Data to the Office of Vaccines (2of4) Tech Conformance – Jul. 13, 2017

Providing Clinical Study Data to the Office of Vaccines (2of4) Tech Conformance – Jul. 13, 2017

Biologics Quality Bioresearch and Study Data Submissions (3of4) Technical Conformance– Jul. 13, 2017

Biologics Quality Bioresearch and Study Data Submissions (3of4) Technical Conformance– Jul. 13, 2017

SEND for CBER, What You Need to Know

SEND for CBER, What You Need to Know

Preparing Vaccine Studies for Regulatory Submissions

Preparing Vaccine Studies for Regulatory Submissions

Study Data Standards Update for CBER: Your Guide to a Successful Submission

Study Data Standards Update for CBER: Your Guide to a Successful Submission

Panel Questions and Discussion (4of4) Study Data Technical Conformance Webinar – Jul. 13, 2017

Panel Questions and Discussion (4of4) Study Data Technical Conformance Webinar – Jul. 13, 2017

Most Common Issues with CDISC-SEND Data in FDA Toxicology Review – Sep. 12, 2019

Most Common Issues with CDISC-SEND Data in FDA Toxicology Review – Sep. 12, 2019

Learn About ClinicalTrials.gov Modernization and How to Provide Input – Mar. 6, 2020

Learn About ClinicalTrials.gov Modernization and How to Provide Input – Mar. 6, 2020

FDA Study Data Technical Conformance Guide v4.4 - Nov 22, 2019

FDA Study Data Technical Conformance Guide v4.4 - Nov 22, 2019

FDA Study Data Technical Conformance Guide version 4.2 – Nov. 27, 2018

FDA Study Data Technical Conformance Guide version 4.2 – Nov. 27, 2018

DMF Workshop: GDUFA III Enhancements and Structured Data Submissions – Session 3

DMF Workshop: GDUFA III Enhancements and Structured Data Submissions – Session 3

FDA | NIH: Regulatory Do’s and Don’ts: Tips from FDA – CBER Segment

FDA | NIH: Regulatory Do’s and Don’ts: Tips from FDA – CBER Segment

Optimizing Your Study Data Submissions to FDA: Study Data TCG – Nov. 8, 2017

Optimizing Your Study Data Submissions to FDA: Study Data TCG – Nov. 8, 2017

Updates to the Study Data Technical Conformance Guide (1of4) Technical Conformance– Jul. 13, 2017

Updates to the Study Data Technical Conformance Guide (1of4) Technical Conformance– Jul. 13, 2017

179th Meeting of Vaccines and Related Biological Products Advisory Committee - Day 1

179th Meeting of Vaccines and Related Biological Products Advisory Committee - Day 1

DMF Workshop: GDUFA III Enhancements and Structured Data Submissions – Session 4 and Closing Remarks

DMF Workshop: GDUFA III Enhancements and Structured Data Submissions – Session 4 and Closing Remarks

Webinar: The NCHS Data Linkage Program

Webinar: The NCHS Data Linkage Program

Reporting NHSN Weekly COVID-19 Vaccination Data for Long-term Care Facilities

Reporting NHSN Weekly COVID-19 Vaccination Data for Long-term Care Facilities

Updates to Weekly COVID-19 Vaccination Data Reporting: Healthcare Personnel Safety Component

Updates to Weekly COVID-19 Vaccination Data Reporting: Healthcare Personnel Safety Component

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