Aris Global Pharmacovigilance and Vigi flow

1. Aris G PHARMACOVIGILANCE & VIGI FLOW
AYANA R KUMAR
M Pharm, Pharmacology
DEPARTMENT OF PHARMACOLOGY 1

2. • Aris G is a leading pharmacovigilance 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.
DEPARTMENT OF PHARMACOLOGY 2

3. • Improves the case processing life cycle and
reduces data entry time.
• Automates case processing and report
distribution with flexible workflows.
• Shortens the medical review and coding process.
• Integrates with document management systems,
Business Objects and clinical systems.
DEPARTMENT OF PHARMACOLOGY 3

4. • Aris G is a comprehensive adverse event management system.
• Aris G manages reports from all potential sources.
• Aris G supports an extensive feature set that facilitates the
Entry, Classification, Coding and Assessment of adverse
event reports.
DEPARTMENT OF PHARMACOLOGY 4

5. CASE HANDLING/ WORKFLOW
• Routed is based on company SOPs and policies.
• Manage the key activities such as Data entry, Assessment,
Coding and Reporting for full compliance
• Larger case processing teams - Aris G allows a workflow
manager to assign cases to individual team members and review
the activities of each individual.
DEPARTMENT OF PHARMACOLOGY 5

6. CASE QUERYING AND ANALYSIS
• Create complex queries
• Support of the published MedDRA, SMQs
• It performs
Case review
Run batch operations
Validations
Case updates
Reporting
Users to view or represent data in the form of charts or listings
for immediate analysis
DEPARTMENT OF PHARMACOLOGY 6

7. EXPEDITED AND AGGREGATE CASE REPORTING
• Aris G provides the report to,
FDA
MedWatch
CIOMS, PSUR,ASR and other major international reporting
forms.
• Electronic exchange - Aris G supports the export and import of
E2B files with recipient-based mapping for compliance with
local deviations.
DEPARTMENT OF PHARMACOLOGY 7

8. OPEN INTEGRATION
• Aris G is an open system based on industry standard architecture. It
can be easily integrated with third-party systems such as regulatory,
clinical, document management and medical information systems
to improve collaboration between departments and eliminate
transcription errors.
DEPARTMENT OF PHARMACOLOGY 8

9. A PROVEN SOLUTION FROM THE MARKET LEADER
• Most Complete, Mature and Proven drug safety software
solution on the market today.
• Aris Global has continually refined and updated Aris G in close
collaboration with its customers, including many of the world’s
largest life science organizations.
DEPARTMENT OF PHARMACOLOGY 9

10. Aris G key features include:
• Role-based data entry forms allow for fast and efficient
processing of received adverse event data.
• Automated workflows route cases through the data entry and
assessment process. Pre-configured workflows can be
configured for each product type.
DEPARTMENT OF PHARMACOLOGY 10

11. • A MedDRA - 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.
DEPARTMENT OF PHARMACOLOGY 11

12. • Vigi Flow is an ICSR management system
• Developed and hosted by Uppsala Monitoring
Centre (UMC).
• It is compatible with the ICH-E2B standard for
electronic transmission of ICSRs.
DEPARTMENT OF PHARMACOLOGY 12

13. • Vigi flow includes
Data entry
 Assessment
 Storage
 Retrieval
 Communication with other parties
 It is web-based report management tool
 It is E2B compatible
DEPARTMENT OF PHARMACOLOGY 13

14. DEPARTMENT OF PHARMACOLOGY 14

15. SYSTEM REQUIREMENTS
• Internet via an encrypted (https) connection.
Mozilla Firefox or Internet Explorer
• It is recommended to have an Internet connection of at
least 1 Mb it/s, otherwise the system may be slow to
use.
DEPARTMENT OF PHARMACOLOGY 15

16. MAIN PARTS OF VIGI FLOW
• Create new reports
• Data entry and editing of reports
DEPARTMENT OF PHARMACOLOGY 16

17. • Communication between National and Regional centre
DEPARTMENT OF PHARMACOLOGY 17

18. • Commit reports
• Assessment page
Case narrative
Sender’s comments
Sender’s diagnosis
Imported sender’s comments and diagnosis
DEPARTMENT OF PHARMACOLOGY 18

19. Pros
• Combination of structured and free-text fields to encourage complete
data entry.
• Integrated dictionaries and terminologies ensures correct coding.
• Easy communication between national and regional centres.
• No need for local server upkeep and back-ups.
• Seamless transmission of reports to WHO/UMC.
DEPARTMENT OF PHARMACOLOGY 19

20. Cons
• Server (with national data) in another country might be against
national regulations
• Needs Internet access -at least 0.5 Mbit/s for a good experience
• Not 100% adaptable to local ideas of how it “should work
DEPARTMENT OF PHARMACOLOGY 20

21. REFERENCES
1.Pharmacovigilance Programme of India (PvPI). Indian
Pharmacopoeia commission. Page no : 27-35.
2. Aris G clinical safety and Pharmacovigilance. Page no:1-4.
3.Global provider of pharmacovigilance & regulatory services.
Forsight group of international. Page no : 2- 8.
DEPARTMENT OF PHARMACOLOGY 21

22. THANK YOU
DEPARTMENT OF PHARMACOLOGY 22