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FDA Pre-Market Safety Assessment Program
Session Chair(s)
Vaishali Popat, MD, MPH
Branch Chief, Office of Clinical Evaluation,Office of Therapeutic Products, CBER
FDA, United States
This session describes CDER initiatives to bring consistency and improve quality of pre-market safety assessments.
Learning Objective : Describe various new drug review modernization initiatives related to pre-market safety assessment happening at CDER; Discuss the reasons for the change and their impacts on pre-market safety assessment.
Speaker(s)
The FDA Medical Queries Project: This Will Significantly Change How We Do our Safety Signal Detection
Scott Proestel, MD
FDA, United States
Senior Medical Officer, ODES, OND, CDER, FDA
The Standard Tables and Figures Visualization Project
Preeti Venkataraman, MD
FDA, United States
Physician, Biomedical Informatics & Regulatory Review Science, OND, CDER
Data Integrity Project
Vaishali Popat, MD, MPH
FDA, United States
Branch Chief, Office of Clinical Evaluation,Office of Therapeutic Products, CBER
Planning for Key Risks That are Undertaken Prior to Confirmatory Trial Initiation
Mat Soukup, PhD
FDA, United States
Deputy Director, Division of Biometrics VII, OB, OTS CDER
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