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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)
Scott Proestel, MD
Principal, Bethesda Pharmaceutical Consulting, LLC, United States
The FDA Medical Queries Project: This Will Significantly Change How We Do our Safety Signal Detection
Preeti Venkataraman, MD
Physician, Biomedical Informatics & Regulatory Review Science, OND, CDER, FDA, United States
The Standard Tables and Figures Visualization Project
Vaishali Popat, MD, MPH
Branch Chief, Office of Clinical Evaluation,Office of Therapeutic Products, CBER, FDA, United States
Data Integrity Project
Mat Soukup, PhD
Deputy Director, Division of Biometrics VII, OB, OTS CDER, FDA, United States
Planning for Key Risks That are Undertaken Prior to Confirmatory Trial Initiation
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