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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

2009 Oracle Corporation Proprietary and Confidential

 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

2009 Oracle Corporation Proprietary and Confidential

 Caseform Translation

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

2009 Oracle Corporation Proprietary and Confidential

 Multilingual Capability

2009 Oracle Corporation Proprietary and Confidential

 MedDRA J Events Encoding

Hiding non-Current
MedDRA J Terms
Support for
Japanese
Displaying matching Synonym List
MedDRA English
and J terms in one
window

2009 Oracle Corporation Proprietary and Confidential

 J &WHO Drug Dictionary Lookup

Product Name Formulation Code Manufacture

Both J and WHO drug

dictionaries are available
for searching drugs

2009 Oracle Corporation Proprietary and Confidential

 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

2009 Oracle Corporation Proprietary and Confidential

 Japan Receipt Date and License Category

Japan follow-up received

date:
If the follow up is significant,
Japan first received this date will be used as the
date (for reporting) 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.

2009 Oracle Corporation Proprietary and Confidential

 Periodic Safety Report Configuration
Flow
2
Product Selection Select
Ingredients
1 Formulation
Products
Subject of Report

3 Inclusion Criteria
Configure
Reporting Agency
Header Information Define
PSR Inclusion Criteria

Periodic Safety Report

Configuration Cycle

Scheduling 4
5 Security
Define Assigned Date
Examination Time Period Set Up
Define User Groups Define Report Due Date
to Share the Scheduled Report

2009 Oracle Corporation Proprietary and Confidential

 2006 Oracle Corporation Proprietary and Confidential