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Sunday, June 26 • 9:00am - 5:00pm
#40: Analysis of Safety Data from Clinical Trials

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Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 6.50 Application UAN: 0286-0000-16-503-L04-P; CME 6.50; IACET 6.50; RN 6.50

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

Learning Objectives

• 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.

avatar for Jürgen Kübler

Jürgen Kübler

Global Head, Quantitative Safety Sciences, CSL Behring GmbH
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 the University of Dortmund, Germany.
avatar for Joachim Vollmar

Joachim Vollmar

Executive Consultant, International Clinical Development Consultants LLC (ICDC)
Mr. Vollmar has been an independent consultant since 2004 and founded International Clinical Development Consultants, LLC in 2005 and Preclinical Research and Scientific Consulting Services, LLC in 2008. From 1970-1992, he was with Boehringer Mannheim as a senior statistician in clinical trials, preclinical experiments and diagnostics. From 1992-2004, he was with PRA as Managing Director, Europe, EVP Quality and Process Management, Product... Read More →

Sunday June 26, 2016 9:00am - 5:00pm
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA