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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
Biostatistics, Center for Drug Evaluation and Research, FDA, United States
Senior Statistical Reviewer, Office of Translational Science, Office of
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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