This course will describe how to implement signal detection and data mining as part of your pharmacovigilance operations. The requirement for companies to perform signal detection is mandatory in Europe and highly recommended in the U.S. Many simple techniques can be applied to the generation and review of potential signals, which can also be augmented by the application of sophisticated data mining algorithms. This course will cover signal assessment, use of signal triage algorithms, compliance with FDA guidance as specified in “Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment,” March 2005, and the timing and frequency of signal detection, triage, and data mining runs.
- Describe the basic concepts and principles of signal detection
- Apply thes techniques within your company
- Apply data mining techniques to analyze large volumes of adverse event report data
- Conduct signaling analyses on real-life data
- Clinical Safety/Pharmacovigilance
- Clinical Research and Development
- Risk Management
The course will be led by one of the following instructors:
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Day 1: 8:30 a.m. – 5:00 p.m.
- Part 1: Background to Signal Detection: Regulatory requirements; approaches
to signal detection; signal detection hierarchy; layered approach to signaling;
statistical versus medical significance; signaling analyses specified by Good
Pharmacovigilance Practices; components of suggested analyses; how to characterize a
- Part 2: Signaling Examples: Signaling case study; data flow; recommended data elements to be obtained prior to analysis; typical PSUR data elements; analysis by MedDRA System Organ Class, analysis by MedDRA Preferred Term; , Age Range, Sex, Country, Time to Onset, Treatment Duration, AE Duration, Concomitant Medications, Dechallenge/Rechallenge; describe signal and relate to prior signaling exercises; define correlations found via prior signaling exercises
- Part 3: Data Mining: Definitions, principles, methodologies; challenges in adverse event databases; recommended approaches; components of suggested analyses; external data sources; data flow elements; Bayesian Confidence Propagation Neural Network (BCPNN); Multi-Item Gamma Poisson Shrinker (MGPS); Proportional Reporting Ratio (PRR); which data mining algorithm?; comparison of methods; relative timing
- Part 4: Signal Detection Process: Signal detection and pharmacovigilance
process; operational questions; sources; signal evaluation steps; signal repository
and safety profiles; Product Safety Profile (PSP); risk management planning; factors
to consider in signaling optimization; signal detection triage example; triage algorithms
used; comprehensive signaling process elements
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 7 hours (0.7 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-13-039-L01-P. Released 11/13.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.