Upstate Medical University

FDA CDER Small Business and Industry Assistance (SBIA) presents: Integrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes

The appropriate planning and conduct of integrated clinical trial safety analyses is critical to the success of drug marketing applications submitted to the FDA. As the safety analytics field is dynamic and evolving, continuous learning is required for the multiple disciplines (medical staff, statisticians, medical writers, etc.) that need to collaborate to create the necessary integrated tables, figures, and analyses.

This webinar will discuss how and when to work with FDA to improve your integrated safety analyses and obtain answers to questions you may have about your application. In addition, common mistakes seen in integrated analyses will be discussed to help you avoid making the same mistakes.


  • Pharmaceutical regulatory scientists, clinical reviewers, medical professionals, data scientists, statisticians, statistical programmers, medical writers working on integrated clinical trial safety analyses for new drug marketing applications.
  • We will not be discussing trial data for generic drug applications.


  • Importance of early planning
  • Types of issues to discuss at FDA Type C meeting for integrated safety
  • How to create integrated analysis sets for safety assessment
  • Appropriate analytical and statistical methods when combining clinical trial data from multiple studies


Common Mistakes When Pooling Clinical Trial Safety Data
Mary Nilsson
Executive Director-Statistics
Safety Analytics Working Group (FDA|PHUSE)
Eli Lilly

FDA Type C Meetings on ISS Safety Analysis Strategy and Related Data Requirements
Veronica Pei, M.D., MPH, MEd
Associate Director for Biomedical Informatics

Gregory Levin, Ph.D.
Associate Director for Statistical Science and Policy
Office of Biostatistics (OB)
Office of Translational Sciences (OTS) | CDER