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Agenda
Prioritization Evaluation
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Signal Management
The process of identifying, prioritizing and evaluating determined signals in a data population
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In June of 2002, the US Congress reauthorized (for a second time) the Prescription Drug User Fee Act (PDUFA III)
Specifically, FDA issued three concept papers. Each paper focused on one aspect of risk management, including
o (1) conducting premarketing risk assessment o (2) developing and implementing risk minimization tools o (3) performing post marketing pharmacovigilance and pharmacoepidemiologic assessments. (FDA, 2005)
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Signals prioritized as High or Medium are moved into the Signal Evaluation workflow step for further investigation and signal workup
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Additional external documentation can also be attached to the topic to support the prioritization of the signal
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Using e-Signal, we can drill down into the case series that makes up the signal of interest
The case series can be attached to the topic of interest for historical identification
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Additional external documentati on can also be attached to the topic to support the evaluation of the signal
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Using the default abilities of e-Topics, we can run reports documenting our signal management process at the request of a regulatory authority or equivalent
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Summary
Using existing literature and Empirica Suite can be configured to provide a systematic method for signal management in a single solution that accomplishes the following: Ability to identify potential issues in clinical and post-marketing data Standard prioritization questions Standard evaluation methods to feed risk management Pre-defined workflow for these processes Capability to report this process for audit answering and justification or risk methods (document due diligence)
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References
Bennett Levitan, B., Yee, C. L., Russo,L., Bayney, R., Thomas, A. P. and Klincewicz, S. L.. (2008). A Model for Decision Support in Signal Triage. Drug Safety. 31 (9), pp. 727-735 Council for International Organizations of Medical Sciences (CIOMS). (2010). Practical Aspects of Signal Detection in Pharmacovigilance. Report of CIOMS Working Group VIII, Geneva . Heeley E, Waller P, and Moseley J. (2005). Testing and implementing signal impact analysis in a regulatory setting: results of a pilot study. Drug Safety 28 (10), pp. 901-6 Waller P, Heeley E, and Moseley J. (2005). Impact analysis of signals detected from spontaneous adverse drug reaction reporting. Drug Safety 28 (1), pp. 843-50 Waller P, Lee E. (1999). Responding to drug safety issues. Pharmacoepidemiology and Drug Safety 8 (7), pp. 535-52 Waller, P. (2010). An Introduction to Pharmacovigilance. Wiley-Blackwell. Oxford, UK
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