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Hilton Baltimore Inner Harbor

2025 年 01 月 26 日 1:00 下午 - 2025 年 01 月 26 日 4:00 下午

401 W Pratt Street, Baltimore, MD 21201, USA

Short Course: Introduction to Statistics in Drug Safety

This is a In-Person Pre-Conference Short Course in conjunction with the Global Pharmacovigilance and Risk Management Strategies Conference

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概览

*Short Courses require an additional registration fee. You do not need to be registered for the forum to attend*

 

This (mainly) formula-free half-day course will introduce a systematic approach for evaluating and assessing adverse events and other safety information, guided by medical judgment, which enables investigators to develop clinical as well as statistical understanding of the safety profile.

Registration for Live Short Course will be accepted onsite, or until capacity has been reached. Register prior to guarantee your seat.

学习目标

Upon completing this course, attendees will be able to:
  • Define denominators and numerators, variability, confidence intervals, p-values, and significance
  • Describe how to interpret measures of risk: risk ratios, odds ratios, and hazard ratios – when, why, and what to look for
  • Describe how the concept of estimands can be applied to safety analyses
  • Identify common abuses of statistics in PV
  • Examine accumulating safety data combined across multiple studies
  • Describe how to leverage the scientific expertise and medical judgment of multidisciplinary teams
  • Discuss how to consistently and authoritatively communicate the safety story
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