DIA/FDA Biostatistics Industry and Regulator Forum

DIA Your Way! Join us virtually from the comfort of your home/office April 6-8 or watch later at a time that works for you. This event provides access to the materials for a full two months!

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Session 6: DIA Data Science and Statistics Community Meeting Discussion: Yes, You Can Use R in Regulatory Submissions

Session Chair(s)

Elena Rantou, PhD

Lead Mathematical Statistician, OB, Office of Translational Sciences, CDER

FDA, United States

Brenda Crowe, PhD

Associate Vice President, Statistics

Eli Lilly and Company, United States

This session will highlight how R programming language is used in the process of submitting drug applications to the FDA from industry perspective along with the process of regulating and approving drugs at the FDA. A panel discussion with a question-and-answer format will follow.

Learning Objective :

Recognize the process of the FDA statistical review of drug applications submitted using R language

Discuss the preparation of a regulatory drug application using R language

Identify different cases / examples where R can be used for regulatory submissions

Speaker(s)

Achieving Regulatory Approval Using R

Tae Hyun Jung, PhD

U.S. Food and Drug Administration, United States

Senior Statistical Reviewer

Yes, You Can use R in Regulatory Submissions

Coline Zeballos, MSc

Roche, Switzerland

R Strategy Lead

Speaker

Ning Leng, PhD

Genentech, Inc., United States

People and Product Lead

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