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Managing Expedited Reporting in Argus Safety

This Argus Standard Edition 8 Managing Expedited Reporting training is recommended for pharmacovigilance professionals who will be involved with expedited regulatory reporting activities.

Required Prerequisites:

  • Experience with pharmacovigilance concepts and terminiologies
  • Argus Standard Edition Jumpstart – Online Course
  • Argus Standard Edition Processing Safety Cases
Course Content:


Overview of Regulatory Reports

Overview of Expedited regulatory reporting
Regulatory reports available in Argus Safety
Report delivery methods
Examining the reports in worklists
Examining expedited reporting activities
Scheduling Expedited Regulatory Reports

Overview of scheduling expedited regulatory reports
Viewing a list of expedited reports due soon
Scheduling expedited regulatory reports
Generating Expedited Regulatory Reports

Overview of generating regulatory reports
Generating regulatory reports
Transmitting Expedited Regulatory Reports

Overview of transmitting regulatory reports
Transmitting regulatory reports.
Tracking Expedited Regulatory Reports

Overview of tracking regulatory reports
Tracking Regulatory Reports
Schedule Expedited Regulatory Reports through Reporting Rules

Overview of Expedited reporting rules
Configure Expedited Reporting Rule
Auto-Schedule expedited reports
Performing Bulk Reporting

Overview of bulk reporting
AG Services
Auto-Generate expedited reports
Auto-Distribute expedited reports
Force-Distribute expedited reports
Batch Report Generation
Importing E2B Reports

Overview of importing E2B reports
Import pending E2B reports
Accept or Reject E2B report
Differences report
Auto-Accept incoming E2B reports
E2B(R3)

ICH-ICSR Data Element Structure
Case Form Changes
Null Flavors
Amendments to Case and Amendment Reports
Database and Common Profile Switch Changes
Configuring E2B R3 Destination
Transmission and Acknowledgement of E2B(R3) reports
MedWatch Updates

Argus Console Changes
Case Form Changes
MedWatch 3500 A Drug Report Changes
MedWatch 3500 A Device Report Changes
eVAERS

Argus Console Changes
Case Form Changes
Configure eVAERS Destination
Transmission and Acknowledgement of eVAERS reports
Monitoring Regulatory Compliance

Overview of monitoring compliance
Monitor E2B status and compliance
Dashboards features
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