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Overview

*Short Course requires separate registration


Short Course Registration: 8:00AM-5:00PM


CIOMS VI (2005) states that “causality judgements based on analysis of multiple cases/aggregate data are almost always more meaningful and typically have a greater impact” (than the traditional case-based medical review).

The FDA IND safety reporting final rule reflects that position by requiring an expedited IND safety report whenever aggregate analysis indicates that events occur more frequently in the drug treatment group than in a concurrent or historic control group. Further guidance has outlined how early planning for assessment of emerging safety signals and review of aggregated safety data throughout the development program should be driven by multi-disciplinary safety management teams (SMTs). Following product launch, connection of pre-launch investigations to data sources and analytics post-market enable ongoing surveillance, signal detection, and evaluation of benefit-risk.

We will define a systematic, coordinated approach to identify, assess, and characterize safety topics of interest that enables investigators to develop clinical as well as quantitative understanding of the safety profile. We will also explore the application of appropriate statistical techniques with a safety mindset, as opposed to strict statistical inference, with the emphasis shifted from testing and confirming to exploration, learning, and medical decision-making within a quantitative framework.


Lunch is included with this Short Course.


Learning objectives

At the conclusion of this short course, participants should be able to:
  • Examine the global regulatory landscape for interdisciplinary safety evaluation
  • Develop an aggregate safety assessment planning (ASAP) process
  • Execute ongoing aggregate safety evaluation (OASE)