2013 OHSUG - Using Oracle's Empirica Topics to Document Your Signal Management Process

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Using Oracle's Empirica Topics to Document Your

Signal Management Process

July 26, 2013

Rodney Lemery, MPH, PhD

Vice President, Safety andPharmacovigilance

BioPharm Systems, Inc.

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Agenda

Signal Management using Oracle Empirica

Products Detection

Use of e-Signal for data mining

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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Current Regulatory EnvironmentAs of July 2, 2012, the EMA has required among other things All validation, prioritisation, assessment, timelines, decisions, actions, plans,

reporting as well as all other key steps should be recorded and trackedsystematically. Tracking systems should be used for documentation and should

also include signals, for which the validation process conducted was notsuggestive of a new potentially causal association, or a new aspect of a knownassociation. All records need to be archived (EMA, 2012).

In June of 2002, the US Congress reauthorized (for a secondtime) the Prescription Drug User Fee Act (PDUFA III)

Specifically, FDA issued three concept papers. Each paper focused onone aspect of risk management, includingo (1) conducting premarketing risk assessment

o (2) developing and implementing risk minimization tools

o (3) performing post marketing pharmacovigilance and pharmacoepidemiologicassessments. (FDA, 2005)

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What the Industry Seeks

A systematic approach to signalmanagement

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

A system to collect and track thisapproach Standard system to document the identification,

prioritization and evaluation of signals

Capability to report this process for audit answeringand justification or risk methods (document duediligence)

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Empirica Topics Workflow Example

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Actions can be created and assigned to other users in the company

In this example, an action to review the case series is assigned

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Signals prioritized as

High or Medium are

moved into the Signal

Evaluation workflowstep for further

investigation and

signal workup

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Additional

external

documentationcan 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 alsobe attached

to the topic

to support

the

evaluationof 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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Complete auditing of the topic case

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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-marketingdata

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 CIOMSWorking Group VIII, Geneva .

Heeley E, Waller P, and Moseley J. (2005). Testing and implementing signal impactanalysis in a regulatory setting: results of a pilot study. Drug Safety28 (10), pp.901-6

Waller P, Heeley E, and Moseley J. (2005). Impact analysis of signals detectedfrom spontaneous adverse drug reaction reporting. Drug Safety28 (1), pp. 843-50

Waller P, Lee E. (1999). Responding to drug safety issues. Pharmacoepidemiologyand Drug Safety8 (7), pp. 535-52

Waller, P. (2010). An Introduction to Pharmacovigilance. Wiley-Blackwell. Oxford,UK

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Questions & Answers

2000 Alameda de las PulgasSuite 154

San Mateo, CA 94403-1270

www.biopharm.com

Rodney L. Lemery MPH, PhDVice Pres. Safety and PV

Tel (650) 292-5310

Fax (650) 292-5301

[email protected]