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Signal Detection and Pharmacovigilance

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Course Description 

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. 

Learning Objectives 

  • 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 
Who Should Attend

  • Clinical Safety/Pharmacovigilance 
  • Clinical Research and Development 
  • Risk Management 
Instructor

The course will be led by one of the following instructors: 

Steve Jolley 

Click here for complete trainer biographies 

Course Outline 

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
    suspected signal
     
  • 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 

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. 

Click here for our seminar cancellation policy 

Accreditation Information 

ACPE LogoBarnett 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. 

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