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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 14, 9:00AM - 5:00PM

Room Number:
146B

Description:
Maximize your learning while attending the DIA 2015 51st Annual Meeting! Receive $100 off of your DIA 2015 meeting registration by registering for two half-day tutorials or one full-day tutorial. Purchases must be made at the same time in order to receive the discount.

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:
• Discuss how to utilize guidelines and regulatory requirements for clinical trials;
• Describe ways to contribute to safety analysis plans;
• Discuss the statistical safety analysis process and pitfalls that could occur;
• Identify impact of benefit-risk assessment in safety data.

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