Continuing Education Credits are not available for the archived offering.
This program is a part of DIA's Certificate Program and is awarded the following:
Clinical Safety and Pharmacovigilance Certificate Program: 4 Elective Units
For more information go to www.diaglobal.org/certificateprograms

This archive may be purchased through June 1, 2016.
Archive duration:
Part 1: 1 hour 29 minutes
Part 2: 1 hour 31 minute
Part 3: 1 hour 26 minutes
Part 4: 1 hour 33 minutes

This training course will review approaches to the implementation of 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 US.  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.

Topics discussed will include 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.

Course Level: Beginner