This event has ended. Visit the official site or create your own event on Sched.
Back To Schedule
Sunday, June 26 • 8:30am - 12:00pm
#25: Signal Detection: Identifying and Managing Safety Signals

Sign up or log in to save this to your schedule, view media, leave feedback and see who's attending!

Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-16-501-L04-P; CME 3.25; IACET 3.25; RN 3.25

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

Signal detection is an essential element of the overall risk management process. This intermediate to advanced tutorial provides a concise review of current methods of drug safety signal detection for marketed products and the role of signal detection within the larger signal and risk management process. Emphasis is on practical pragmatic approaches. Outputs from quantitative signal detection will be the basis for a hands-on exercise and discussion. The tutorial also provides participants with the context to evaluate new research in the field.

Who should attend?

This tutorial is designed for members of clinical safety and pharmacovigilance organizations who oversee, manage, or perform signal detection activities. The tutorial will also benefit participants who make risk management decisions based on signal detection results.

Learning Objectives

• Identify strengths and limitations of methods for signal detection;
• Interpret outputs from automated quantitative signal detection methods (data mining results);
• Discuss how to integrate signal detection methods into the larger signal and risk management process;
• Describe emerging methods for signal detection.

avatar for James Buchanan

James Buchanan

Drug Safety Consultant, Covilance LLC
Dr. Buchanan has been in the pharmaceutical industry working in drug safety for over 30 years. He started his career at Genentech and led the drug safety departments at a number of subsequent companies, Gilead Sciences, Tularik and Nuvelo, before serving as the head of the medical... Read More →

Sunday June 26, 2016 8:30am - 12:00pm
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA