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CIOMS VI (2005) states that “causality judgments 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.

This short course will provide 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. Focus will target 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.

The goal is to empower the broader cross-disciplinary, cross-regional community to discover and promote practical quantitative solutions for safety evaluation during throughout the product life-cycle. Audience participation will be highly encouraged. This short course will present the work that has been done by the DIA-ASA Interdisciplinary Safety Evaluation scientific working group, TransCelerate, and ICH.

An additional registration fee is required for all preconference short courses.

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Who should attend?

This short course is designed for individuals from industry and regulatory agencies who practice in the areas of patient safety and pharmacovigilance. Specifically, individuals who routinely evaluate information and perform tasks such as signal detection, signal evaluation, benefit-risk assessment to determine the safety of products in development and on-market are the target for this proposed short course.

Learning objectives

At the conclusion of this 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), including: Blinded vs. unblinded analyses, static vs. dynamic assessments, and visual analytic methods, integration of data sources and analysis methods.

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