1. <Insert Picture Here>
Argus Safety Japan Benefits
Paul Dobrowolskyj/ HSGBU Senior Sales Consultant

2. 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

3. 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

4. Caseform Translation
© 2009 Oracle Corporation – Proprietary and Confidential
• 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

5. Multilingual Capability
© 2009 Oracle Corporation – Proprietary and Confidential

6. MedDRA J Events Encoding
Hiding non-Current
MedDRA J Terms
Support for
Japanese
Synonym ListDisplaying matching
MedDRA English
and J terms in one
window
© 2009 Oracle Corporation – Proprietary and Confidential

7. J &WHO Drug Dictionary Lookup
Both J and WHO drug
dictionaries are available
for searching drugs
Product Name Formulation Code Manufacture
© 2009 Oracle Corporation – Proprietary and Confidential

8. 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

9. 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

10. 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

11. 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
Security5
Define User Groups
to Share the Scheduled Report
Scheduling 4
•Define Assigned Date
•Examination Time Period Set Up
•Define Report Due Date
© 2009 Oracle Corporation – Proprietary and Confidential

12. © 2006 Oracle Corporation – Proprietary and Confidential