Argus Safety Japan Benefits

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Argus Safety Japan Benefits

  1. 1. <Insert Picture Here>Argus Safety Japan BenefitsPaul Dobrowolskyj/ HSGBU Senior Sales Consultant
  2. 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 JapaneseCompany-specific Needs© 2009 Oracle Corporation – Proprietary and Confidential
  3. 3. Argus J – Translation• Translation Support Features• Argus J will minimize translation data entry effort usingmultiple special data entry features for global cases.• Case Form Translation• Provides easy to use split translation window of theworking 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 ofstandard Code List Items© 2009 Oracle Corporation – Proprietary and Confidential
  4. 4. Caseform Translation© 2009 Oracle Corporation – Proprietary and Confidential• English equivalent caseform tabopens in the split window at any pointof caseform data entry task.• Split window is available in bothvertical and horizontal for English toJapanese and Japanese to Englishtranslation
  5. 5. Multilingual Capability© 2009 Oracle Corporation – Proprietary and Confidential
  6. 6. MedDRA J Events EncodingHiding non-CurrentMedDRA J TermsSupport forJapaneseSynonym ListDisplaying matchingMedDRA Englishand J terms in onewindow© 2009 Oracle Corporation – Proprietary and Confidential
  7. 7. J &WHO Drug Dictionary LookupBoth J and WHO drugdictionaries are availablefor searching drugsProduct Name Formulation Code Manufacture© 2009 Oracle Corporation – Proprietary and Confidential
  8. 8. Argus J - Overview• PMDA Tab for J-Specific Fields• (General Tab): Capturing of Japanese Receipt Date, Follow-upreceived date, and Report type custom Selection by DrugName and License Categories.• (Narrative Tab): Narratives and Comments can be entered on aper License Basis• E2B Support - Creation of I- and J-item pair for PMDA• Creation of separate I and J for each Japanese suspectinvestigational 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. 9. Japan Receipt Date and License Category• Japan first receiveddate (for reporting)• Japan follow-up receiveddate:If the follow up is significant,this date will be used as thereference date to schedule thereports.• The Correct report type isselected with PMDAcompliance CaseCategory drop-downfields.© 2009 Oracle Corporation – Proprietary and Confidential
  10. 10. J Item Narrative & Comments• ApplicableLicenses areselectable fromthe Drop-downList• Supports J ItemLists to becompliant withPMDA.© 2009 Oracle Corporation – Proprietary and Confidential
  11. 11. Periodic Safety Report ConfigurationFlowPeriodic Safety ReportConfiguration Cycle•Subject of Report•Configure•Reporting Agency•Header Information1Select• Ingredients• Formulation• Products• Product Selection2Inclusion CriteriaDefinePSR Inclusion Criteria3Security5Define User Groupsto Share the Scheduled ReportScheduling 4•Define Assigned Date•Examination Time Period Set Up•Define Report Due Date© 2009 Oracle Corporation – Proprietary and Confidential
  12. 12. © 2006 Oracle Corporation – Proprietary and Confidential

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