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Sunday, June 18 • 9:00am - 5:00pm
#42: Analysis of Safety Data from Clinical Trials

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Component Type: Tutorial
CE: ACPE 6.50 Knowledge UAN: 0286-0000-17-509-L04-P; CME 6.50; IACET 6.50; RN 6.50

This short course 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 a case study presentation, 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.

Who should attend?

This short course is designed for regulatory affairs professionals, drug safety specialists, biostatisticians, medical writers, clinical researchers, project managers, and investigators.

Learning Objectives

At the conclusion of this course, 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


Speakers
avatar for Jürgen Kübler

Jürgen Kübler

Quantitative Scientific Consultant, QSciCon
Dr. Kübler has over 15 years of experience in the pharmaceutical industry. He has published in statistical and scientific journals, regularly gives scientific - presentations and organized various sessions at scientific conferences. He has a Masters and PhD in Statistics from th... Read More →


Sunday June 18, 2017 9:00am - 5:00pm
S405a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  • format json
  • Featured Topics Statistics
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial