Working with Argus Safety in a Global Community

1. An Overview
Working
with Argus in a
Global Community
Copyright BioPharm Systems, Inc. 2011. All rights reserved.
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2. 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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3. 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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4. Argus Overview
Argus Features
•Document Management
–Attach any type of document
–Interface with Documentum
•Dictionary Management
–MedDRA and WHODrugcoding and
versioning
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5. 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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6. 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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7. 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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8. Argus Overview
Argus main components
Case Processing
Worklist
Local Affiliate
Argus Console
(Global Configuration)
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A caseis the basic unit of entry in Argus and is defined by the
ICH/FDA

9. Argus Overview
Globalized Case Processing
Model 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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10. Argus Overview
Medical Review
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•Local language can be added in many multi-
language fields; i.e. Narrative

11. Argus Overview
Worklists
•Worklistsdisplay the following
information:
–New cases created in the system
–Cases that are currently open
–To Doitems like letters, reports,
and other action items
–Transmission status of reports
–All bulk printed reports
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12. Argus Overview
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•There are sub-menus that appear in each worklistscreen
allowing for further case processing from the worklistarea
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

13. Argus Overview
Globalized Case Processing
Model 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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14. 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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15. Argus Overview
Local Affiliate Module
•Local labeling can easily be performed from LAM
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16. Argus Overview
Reports
•Many reports are available in local languages as well
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17. 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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