An Overview

Workingwith Argus in a

Global Community

Copyright BioPharm Systems, Inc. 2011. All rights reserved.1

Argus Overview

Argus Features

Supports all product types Drugs, devices, vaccines, biologics, and gene

therapies

Semi-Flexible configuration Allows system to be tailored to your business needs

No customization needed

Most configuration performed within the graphical user interface (GUI)

Built-in workflow Migrate cases through workflow tasks

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Argus Overview

Argus Features

Complete audit history

21 CFR Part 11 compliance

Integrated query module

Simple and complex analysis and surveillance

Reportability and submissions tracking

Both FDA and International expedited and periodic reports

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Argus Overview

Argus Features

Document Management

Attach any type of document

Interface with Documentum

Dictionary Management

MedDRA and WHODrug coding and versioning

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Argus Overview

Why Use Argus

With the changing face of FDA and International regulations surrounding product safety, the need for a more pharmacovigilance-centric business has been required in most ICH countries and will soon be required in the US

A safety system such as Argus provides a strong technical ability to mine the data with a more epidemiologic focus

Increased focus on safety is shifting expectations that pharmacovigilance is no longer centered on regulatory compliance but a duty of care through proactive safety

management this requires a system like Argus

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Argus Overview

The challenges of global safety management

Getting cases from global partners to the centre (in a a centralised model)

Reviewing/processing cases at the centre

Distributing cases back to the partners for local labelling and scientific case review

Generating and tracking global reporting deadlines

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Argus Overview

How does Argus help?

Supports fast and effective data entry from global partners

Model 1: Partners have direct access to a central Argus instance via the corporate network

Model 2: Argus Local Affiliate module allows local case entry, labelling and reporting plus central repository synchronisation

Supports fast and effective distribution of cases and appropriate reports to the global partner users

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Argus Overview

Argus main components

Case Processing

Worklist

Local Affiliate

Argus Console(Global Configuration)

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A case is the basic unit of entry in Argus and is defined by the ICH/FDA

Argus Overview

Globalized Case ProcessingModel 1

Certain case data can be entered in local language (ie. Narrative etc.)

Cases are placed into worklists (to-do lists) and assigned to global groups to keep the case process organized (ie. Notification of local labeling and reporting needs)

Central repository of global regulatory report rules allows for the tracking of submitted reports

Periodic reports are maintained in a central screen that allows for clear tracking and compliance auditing

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Argus Overview

Medical Review

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Local language can be added in many multi-language fields; i.e. Narrative

Argus Overview

Worklists

Worklists display the following information:

New cases created in the system

Cases that are currently open

To Do items like letters, reports, and other action items

Transmission status of reports

All bulk printed reports

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Argus Overview12

There are sub-menus that appear in each worklist screen allowing for further case processing from the worklist area itself

This facilitates case or report processing without having to open the detail case entry system

To access this list, simply right-click on the screen and select the desired action for the high-lighted row

Common Features

Argus Overview

Globalized Case ProcessingModel 2

Subset of case data can be entered into the LAM even in local language if required (ie. Narrative etc.)

Cases are transferred to the central repository for review and global partners are notified when local labeling or reporting is required

Local work all occurs in the LAM

Central repository of global regulatory report rules allows for the tracking of submitted reports

Periodic reports are maintained in a central screen that allows for clear tracking and compliance auditing

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Argus Overview

Local Affiliate Module

LAM allows global companies to enter the cases locally and send the cases to the central database for review

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Argus Overview

Local Affiliate Module

Local labeling can easily be performed from LAM

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Argus Overview

Reports

Many reports are available in local languages as well

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Argus Overview

Summary

Argus aides in global case processing to ensure adequate product safety profiles through

Easy Processing of SAE reports through a global workflow

Provides ability to enter into local language for relevant fields

Some reports generate in local language

Alternate case entry, labeling and reporting can be done using the Local Affiliate Module

Allows for global configuration of reporting rules

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