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Trk 15: Statistics [clear filter]
Sunday, June 26
 

9:00am

#40: Analysis of Safety Data from Clinical Trials
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

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

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.


Speakers
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... Read More →
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... Read More →
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... Read More →


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

9:00am

#42: Clinical Statistics for Nonstatisticians
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 6.50 Knowledge UAN: 0286-0000-16-504-L04-P; CME 6.50; IACET 6.50; RN 6.50

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

This tutorial will introduce basic statistical concepts that are fundamental to clinical research. It is designed for individuals with some exposure to statistics (either through course work or on-the-job experience) that is equivalent to an introductory statistics course. While a few formulae are included for individuals who are interested in computational details, the overall emphasis of the tutorial will be on the application of statistical concepts to clinical investigation.

Who should attend?

This tutorial is designed for professionals in the pharmaceutical industry involved in clinical research, medical affairs, medical writing, and other disciplines, who need to be familiar with statistical concepts.

Learning Objectives

• Discuss basic statistical concepts such as variability, confidence intervals, hypothesis testing, and p-values;
• Compare various study designs including techniques to avoid bias;
• Use statistical terminology with ease;
• Distinguish information needed for determining sample size.


Speakers
avatar for Michael Mosier

Michael Mosier

Director, Biostatistics, EMB Statistical Solutions, LLC
Michael Mosier, PhD is co-founder and Director of Biostatistics for EMB Statistical Solutions, a data management and statistical CRO. He has served on the editorial board of the Drug Information Journal and serves as instructor for the DIA Clinical Statistics for Nonstatisticians... Read More →


Sunday June 26, 2016 9:00am - 5:00pm
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA