PPT on Vigiflow, Argus-G and Aris For ADR Reporting
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The document outlines pharmacovigilance solutions provided by Oracle Argus, ARIS-G, and VigiFlow for managing adverse event reporting in pharmaceuticals and medical devices. It details their features such as global case processing, signal detection, and regulatory compliance, emphasizing their role in improving safety risk management and case processing efficiency. Additionally, it covers the functionality of VigiFlow as a web-based reporting tool for individual case safety reporting.
PPT on Vigiflow, Argus-G and Aris For ADR Reporting
- 1. ARGUS, ARIS-G AND VIGIFLOW Naveen K L Dept of Pharmacology Srinivas College of Pharmacy Valachil, Mangalore
- 2. • Oracle Argus is the market leading solution for processing, analysing, reporting an adverse event cases originating in Pre and Post marketed drugs, biologics, vaccines, devices and combination products. • Its an Pharmacovigilance safety database used to keep any of the PV safety database up to date with the latest regulatory requirements and validated to meet both international standard and business requirements. • The main features of Argus database includes Global case processing, Signal detection, Detailed analytics, Electronic case intake and Electronic expedited reporting in both E2B (R2) & E2B(R3) formats, Risk management periodic reporting and submission
- 4. How Does Argus Help? • Supports fast and effective data entry from global partners. Model-1: Partner have direct access to a central argues instance via corporate network. Model-2: Argus local affiliate module allows local case entry, labelling and reporting plus central repository synchronisation. • Supports fast and effective distribution of cases and appropriate reports to the global partners users.
- 5. Globalised Case Processing Model-1 Certain case data can be entered in local language Case are placed into work list and assigned to global group to keep the case process Central repository of global reports rules allows for the tracking of submitted reports Periodic reports are maintained in a central screen that allows clear tracking and compliance auditing
- 6. Globalised Case Processing Model-2 Subset of case data can be entered into a local affricate module (LAM) even in local language, if required Cases are transferred to the central repository for review and global partners are notified when local labelling or reporting is required Local work all occur in the LAM Central repository of global reports rules allows for the tracking of submitted reports Periodic reports are maintained in a central screen that allows clear tracking and compliance auditing
- 7. • Aris-G is a leading PV and clinical safety system. • Enables companies to reduce safety risk for multiple product types including drugs, devices, vaccines and combination products. • Provides international safety reports for clinical and Post marketing surveillance. • Improves the case processing life cycle and reduces data entry time. • Automates case processing and reports distribution with feasible workflow. • Shortness the medical review and coding process . • Integrates with documents management system, business objects and clinical system. • Aris-G is a comprehensive adverse event management system and manages reports from all potential sources.
- 8. Case Querying and Analysis • Creates a complex of queries and supports of the published Med- DRA;SMQ. • It performs: Case review Runs batch operation Validation Case updates Reporting Users to view or represent data in the form of charts
- 9. Key Features: • Role based data entry forms allows for fast and efficient processing of received adverse event data. • A Med-DRA browser. • Case assessment summary screen shows all key case information, while allowing the assessor to add specific case information. • Extensive regulatory and management reporting capabilities including a suite of expedited and aggregate reports, management reports.
- 10. Vigi Flow – Medical Data base • Introduction: Vigiflow is international web based report management tool for report management. It is a complete, easy management system for ICSR – Individual Case Safety Reporting. Vigiflow can be used by any authority or company as a database for report management and data analysis. Vigiflow is not primarily a tool of UMC- Uppsala monitoring Center , But the data can be transferred to UMC.
- 11. HISTORY: • Vigiflow was initiated in the year 2001 when , Swiss medic required a new Pharmacovigilant body. • Vigiflow was created with a name “ ADR Pilot”. • It was supported with primary reporting facility , 7 regional centers ,4 languages. • The first reporting was done in year 2003 at Ghana
- 13. Data flow in Vigiflow:
- 14. Creating a new report : Once we load to new report option , there are 2 sub options • Standard case : In a standard case, cases with ADR , ADE , Side effects, Drug reactions or reaction due to possible drug administration etc.. • Parent-child case : A parent-child case is filled when the child is suffering from an ADE / ADR due to the medication taken by the parent.
- 15. General Reporting: General reporting can be done by Regional centers. It consists various important sections to be filled in. Senders information : In the senders info, various mandatory sections like Fillers name , address , Designation , Fill in date , time and location .
- 16. Report Information :This contains details about the event • Patient details - Name / initials , Birth date / Age / Age group , Weight, Gender . • Tests and procedure • Relevant medical history
- 17. • Current / past drug therapy – This contains any drug treatment in the current or past times. This section must be filled with details like Drug name Indication( if any, provided in drug literature) Reaction observed
- 18. • Reaction observed – Reactions , List of coded reactions , causality assessment , Onset of reaction , End time of the reaction , Duration of the reaction, outcome of the reaction, details of any treatment given to counteract the reaction , drug ,dose .
- 19. • Drugs consumed : List of drugs given as a treatment for the reaction , drug name , dose . • Assessment given Assessment can be either be either physically or therapeutically. • Overview of the case This is a free text which includes case narrative , sender’s comment , sender’s diagnosis ( in codes a/c to Med-DRA or ICD10.
- 21. Pro’s & Con’s Pro’s • Free text fields providing complete data entry • Integrated dictionaries which helps correct coding. • Easy and constant connection between regional and national servers. Con’s • Server of a different country might give a glitch in uploading. • Needs faster internet server. • Unless the case is filled and
- 22. Thank You!