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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)
Tae Hyun Jung, PHD
Senior Statistical Reviewer, CDER, FDA, United States
Achieving Regulatory Approval Using R
Coline Zeballos, MSC
R Strategy Lead, Roche, Switzerland
Yes, You Can use R in Regulatory Submissions
Ning Leng, PHD
People and Product Lead, Genentech, Inc., United States
Speaker