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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 and Pharmacovigilance

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 Environment As 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 tracked systematically. Tracking systems should be used for documentation and should also include signals, for which the validation process conducted was not suggestive of a new potentially causal association, or a new aspect of a known association. All records need to be archived” (EMA, 2012).

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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What the Industry Seeks

• A systematic approach to signal management 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 this approach Standard system to document the identification,

prioritization and evaluation of signals

Capability to report this process for audit answering and justification or risk methods (document due diligence)

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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 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 documentation 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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—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-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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Questions & Answers

2000 Alameda de las Pulgas Suite 154 San Mateo, CA 94403-1270 www.biopharm.com

Rodney L. Lemery MPH, PhD Vice Pres. Safety and PV Tel (650) 292-5310 Fax (650) 292-5301 rlemery@biopharm.com