Argus Safety Japan Benefits

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Argus Safety Japan Benefits

Paul Dobrowolskyj/ HSGBU Senior Sales Consultant

Key Benefits of the Argus J

• Single Global Database

• Support for Japanese and English cases and process within a Single database.

• Reduce overheads caused by running two different systems.

• Enhance compliance by improving submission monitoring.

• Fully Compliant with MHLW / PMDA Guidance and Reporting Requirements

• Queries supported in both Japanese and English

• Store and track all Documents associated with a case for Japanese

Company-specific Needs

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Argus J – Translation

• Translation Support Features

• Argus J will minimize translation data entry effort using

multiple special data entry features for global cases.

• Case Form Translation

• Provides easy to use split translation window of the

working tab

• Multilingual Capability

• Allows user to use multilingual text editor including Japan

• Auto Encoding between E and J data

• Auto encoding for all available matching E and J data

• J - Code list Item

• Web Administration of J-Specific and & Translation of

standard Code List Items

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Caseform Translation

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• English equivalent caseform tab

opens in the split window at any point

of caseform data entry task.

• Split window is available in both

vertical and horizontal for English to

Japanese and Japanese to English

translation

Multilingual Capability

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MedDRA J Events Encoding

Hiding non-Current

MedDRA J Terms

Support for

Japanese

Synonym List Displaying matching

MedDRA English

and J terms in one

window

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J &WHO Drug Dictionary Lookup

Both J and WHO drug

dictionaries are available

for searching drugs

Product Name

Formulation Code

Manufacture

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Argus J - Overview

• PMDA Tab for J-Specific Fields

• (General Tab): Capturing of Japanese Receipt Date, Follow-up

received date, and Report type custom Selection by Drug

Name and License Categories.

• (Narrative Tab): Narratives and Comments can be entered on a

per License Basis

• E2B Support - Creation of I- and J-item pair for PMDA

• Creation of separate I and J for each Japanese suspect

investigational License

• Creation of zipped E-file with unique Naming Convention

• I and J Item Files can be reviewed before Transmission

• Supports MHLW Marketed and Investigational Form 1 - 6

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Japan Receipt Date and License Category

• Japan first received

date (for reporting)

• Japan follow-up received

date:

If the follow up is significant,

this date will be used as the

reference date to schedule the

reports.

• The Correct report type is

selected with PMDA

compliance Case

Category drop-down

fields. © 2009 Oracle Corporation – Proprietary and Confidential

J Item Narrative & Comments

• Applicable

Licenses are

selectable from

the Drop-down

List

• Supports J Item

Lists to be

compliant with

PMDA.

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Periodic Safety Report Configuration

Flow

Periodic Safety Report

Configuration Cycle

•Subject of Report

•Configure •Reporting Agency •Header Information

1

Select • Ingredients • Formulation • Products

• Product Selection 2

Inclusion Criteria

Define PSR Inclusion Criteria

3

Security 5

Define User Groups to Share the Scheduled Report

Scheduling 4

•Define Assigned Date •Examination Time Period Set Up •Define Report Due Date

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© 2006 Oracle Corporation – Proprietary and Confidential