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McCormick Place

Jun 18, 2017 8:30 AM - Jun 22, 2017 12:45 PM

2301 South Martin Luther King Jr. Drive, Gate 4, Chicago, IL 60616

DIA 2017 Annual Meeting

FDA Session: Electronic Submissions and Data

Session Chair(s)

Ron  Fitzmartin, PhD, MBA

Ron Fitzmartin, PhD, MBA

Senior Advisor, Office of Regulatory Operations, CBER

FDA, United States

Study Data Standards are required in clinical and nonclinical studies that start after December 17, 2016. Technical rejection criteria will be added to the existing eCTD validation criteria to enforce the deadlines. This session will provide an update on these topics and others focused on eCTD and standardized study data.

Learning Objective : Discuss the status of electronic submissions, standardized data requirements, and data validation at FDA.

Speaker(s)

Weiya  Zhang, PhD

Moving Forward: Statistical Review of CDISC ADaM Standardized Data at CDER

Weiya Zhang, PhD

FDA, United States

Mathematical Statistician, OB, Office of Translational Science, CDER

Elaine  Thompson, PhD

Results from the CDISC-SEND Fit for Use Pilot: A Structured Assessment of Nonclinical Pilot Submissions to FDA

Elaine Thompson, PhD

FDA, United States

Senior Staff Fellow, OTS, OCS, CDER

Colleen  Ratliffe, MS, PMP

CDER Perspective

Colleen Ratliffe, MS, PMP

FDA, United States

Project Management Officer, Office of Strategic Programs, CDER

Ginny  Hussong

CBER Perspective

Ginny Hussong

FDA, United States

Branch Chief, Data Standards, CBER

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