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Tuesday, June 16 • 4:00pm - 5:00pm
#246 SL: FDA Pre-Market Safety Assessment Program

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-633-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session describes CDER initiatives to bring consistency and improve quality of pre-market safety assessments.

Learning Objectives

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.


Vaishali Popat, MD, MPH


The FDA Medical Queries Project: This Will Significantly Change How We Do our Safety Signal Detection
Scott Proestel, MD

The Standard Tables and Figures Visualization Project
Preeti Venkataraman, MD

Data Integrity Project
Vaishali Popat, MD, MPH

Planning for Key Risks That are Undertaken Prior to Confirmatory Trial Initiation
Mat Soukup, PhD

avatar for Vaishali Popat

Vaishali Popat

Associate Directo, Biomedical Informatics & Regulatory Review Science, OND, CDER, FDA
Dr. Vaishali Popat is an Associate Director for Biomedical Informatics in the Office of New Drugs, Immediate Office. Dr. Popat is the OND lead on biomedical informatics issues in areas such as safety analytics, staff training on the use of new review tools to make the evaluation of... Read More →
avatar for Scott Proestel

Scott Proestel

Acting Associate Director, Biomedical Informatics and Regulatory Review Science,, FDA, United States
Scott Proestel, MD, is Acting Associate Director of Biomedical Informatics and Regulatory Review Science at the US FDA’s Center for Drug Evaluation and Research. He completed his internal medicine training at Johns Hopkins Hospital and obtained his medical degree from Columbia University... Read More →
avatar for Mat Soukup

Mat Soukup

Deputy Director, Division of Biometrics VII, OB, OTS CDER, FDA, United States
Following his educational endeavors in statistics at the University of Minnesota-Morris and the University of Virginia, Mat joined FDA/CDER in September 2004. His first 6 years were spent reviewing dermatology and dental products before joining the Division of Biometrics 7 as Team... Read More →
avatar for Preeti Venkataraman

Preeti Venkataraman

Physician, Biomedical Informatics & Regulatory Review Science, OND, CDER, FDA
Dr. Preeti Venkataraman is a pediatrician by training and completed her medical degree from Northeast Ohio Medical University. She joined FDA/CDER in January 2014, as first a clinical reviewer and then a Team Leader for Safety within the Division of Gastroenterology and Inborn Errors... Read More →

Tuesday June 16, 2020 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session