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#40: Analysis of Safety Data from Clinical Trials

Tutorial name:
#40: Analysis of Safety Data from Clinical Trials

Day & Time:
June 15, 9:00AM - 5:00PM (Pacific Standard Time)

Room Number:

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This tutorial is a combination of theory, guidelines, practical considerations, and real-life solutions for those working in the clinical development environment (pharmaceutical, biotech industry, or CRO). The instructors, with the use of case study presentations, will provide a basic understanding of the underlying methodology and the current guidelines on safety data. Aspects of the planning of clinical trials as well as the problems and pitfalls during the analysis of safety data will be presented.

Learning Objective(s):
At the conclusion of this tutorial, participants should be able to:
• Utilize guidelines and regulatory requirements for clinical trials;
• Contribute to safety analysis plans;
• Assess statistical safety analysis and identify pitfalls in safety analysis;
• Recognize the impact of benefit-risk assessment in safety data.

Target Audience:
This tutorial is designed for drug safety specialists, biostatisticians, medical writers, clinical researchers, project managers, and investigators.