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Working with Argus Safety in a Global Community

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Working with Argus Safety in a Global Community

  1. 1. An OverviewWorkingwith Argus in aGlobal CommunityCopyright BioPharm Systems, Inc. 2011. All rights reserved.1
  2. 2. Argus OverviewArgus Features• Supports all product types– Drugs, devices, vaccines, biologics, and genetherapies• Semi-Flexible configuration– Allows system to be tailored to your business needs– No customization needed– Most configuration performed within the graphicaluser interface (GUI)• Built-in workflow– Migrate cases through workflow tasks2
  3. 3. Argus OverviewArgus 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 andperiodic reports3
  4. 4. Argus OverviewArgus Features• Document Management– Attach any type of document– Interface with Documentum• Dictionary Management– MedDRA and WHODrug coding andversioning4
  5. 5. Argus OverviewWhy Use Argus• With the changing face of FDA and Internationalregulations surrounding product safety, the need for amore pharmacovigilance-centric business has beenrequired in most ICH countries and will soon be requiredin the US• A safety system such as Argus provides a strongtechnical ability to mine the data with a moreepidemiologic focusIncreased focus on safety is shifting expectations thatpharmacovigilance is no longer centered on regulatorycompliance but a ‘duty of care’ through proactive safetymanagement – this requires a system like Argus5
  6. 6. Argus OverviewThe challenges of global safetymanagement• Getting cases from global partners to thecentre (in a a centralised model)• Reviewing/processing cases at the centre• Distributing cases back to the partners for locallabelling and scientific case review• Generating and tracking global reportingdeadlines6
  7. 7. Argus OverviewHow does Argus help?• Supports fast and effective data entry fromglobal partners– Model 1: Partners have direct access to a centralArgus instance via the corporate network– Model 2: Argus Local Affiliate module allows localcase entry, labelling and reporting plus centralrepository synchronisation• Supports fast and effective distribution of casesand appropriate reports to the global partnerusers7
  8. 8. Argus OverviewArgus main componentsCase ProcessingWorklistLocal AffiliateArgus Console(Global Configuration)8A case is the basic unit of entry in Argus and is defined by theICH/FDA
  9. 9. Argus OverviewGlobalized Case ProcessingModel 1• Certain case data can be entered in local language(ie. Narrative etc.)• Cases are placed into worklists (to-do lists) andassigned to global groups to keep the case processorganized (ie. Notification of local labeling andreporting needs)• Central repository of global regulatory report rulesallows for the tracking of submitted reports• Periodic reports are maintained in a central screenthat allows for clear tracking and complianceauditing9
  10. 10. Argus OverviewMedical Review10• Local language can be added in many multi-language fields; i.e. Narrative
  11. 11. Argus OverviewWorklists• Worklists display the followinginformation:– New cases created in the system– Cases that are currently open– To Do items like letters, reports,and other action items– Transmission status of reports– All bulk printed reports11
  12. 12. Argus Overview12• There are sub-menus that appear in each worklist screenallowing for further case processing from the worklist areaitself• This facilitates case or report processing without having toopen the detail case entry system• To access this list, simply right-click on the screen andselect the desired action for the high-lighted rowCommon Features
  13. 13. Argus OverviewGlobalized Case ProcessingModel 2• Subset of case data can be entered into the LAMeven in local language if required (ie. Narrative etc.)• Cases are transferred to the central repository forreview and global partners are notified when locallabeling or reporting is required• Local work all occurs in the LAM• Central repository of global regulatory report rulesallows for the tracking of submitted reports• Periodic reports are maintained in a central screenthat allows for clear tracking and complianceauditing13
  14. 14. Argus OverviewLocal Affiliate Module• LAM allows global companies to enter the caseslocally and send the cases to the central databasefor review14
  15. 15. Argus OverviewLocal Affiliate Module• Local labeling can easily be performed from LAM15
  16. 16. Argus OverviewReports• Many reports are available in local languages as well16
  17. 17. Argus OverviewSummary• Argus aides in global case processing to ensureadequate product safety profiles through– Easy Processing of SAE reports through a globalworkflow– Provides ability to enter into local language for relevantfields– Some reports generate in local language• Alternate case entry, labeling and reporting canbe done using the Local Affiliate Module• Allows for global configuration of reporting rules17

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