Signal Detection and Data Mining in Pharmacovigilance Date:
Tuesday, December 07, 2010 10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes Price:
This webinar will cover the fundamentals of signal detection, and how these can be augmented by the use of data mining techniques.
In March 2005, the FDA published final guidance on "Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment." This guidance defines the FDA's views on pharmacovigilance concepts, safety signal identification, pharmacoepidemiologic assessment and interpretation of safety signals. This webinar will demonstrate how to meet FDA's requirements for detection of potential signals or trends.
Areas Covered in the seminar:
l Analysis of demographics, risk assessment, dose effects, product-product interactions, and differences from known background rates
l Strategies for incorporating all relevant data sources, including clinical trials, individual case reports, PSURs, external databases (FDA, WHO), and registries
l Understanding the risk-benefit ratio of a product and how to discover product-adverse event relationships
l Measuring the strength of the relationship of the adverse event and the drug using the Bayesian Confidence Propagation Neural Network algorithm (BCPNN)
Click here to register for this webinar
Who Will Benefit: l Drug safety and pharmacovigilance l Regulatory Affairs l Clinical development
Instructor Profile: Steve Jolley
Principal, SJ Pharma Consulting
Steve Jolley is a subject matter expert in all areas of global safety compliance and signal detection, and is a frequent speaker at leading industry events including DIA and MHRA. He has 25 years’ experience in drug safety & pharmacovigilance and has worked with over 50 clients in the US, Europe and Japan. He holds degrees in mathematics and computer science from Cambridge University, England. Steve is a featured speaker with FDA at DIA conferences and webinars on auditing, signaling and data mining. Steve began his career in the pharmaceutical industry in 1985 when he founded DLB Systems, a supplier of computer systems for clinical trials and adverse event reporting to many of the leading life science companies worldwide. DLB was acquired by eResearch Technologies in 1997; since then Steve has worked as an independent consultant. ...mo
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