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Argus Standard Edition 8 Implementation Fundamentals New Features

This Oracle Argus Standard Edition 8 Implementation Fundamentals New Features training is designed to help you understand the implementation updates required to successfully upgrade to Argus 8. This includes updates for expedited reporting required to meet regulatory requirements via the new E2B R3 report transmission as well as eVAERS reporting features, which provide the necessary skills to configure and implement these.

Required Prerequisites:

Experience with pharmacovigilance concepts and terminologies
Experience with Oracle Argus Standard Edition

Course Content:

echnology Stack Updates

Certified Platforms
Supported Software
Changes in the Installation
Upgrade Considerations
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
Local Case Data Lock

Argus Console Changes
New Case Form Icons
Local Prospective Reportable Case
Truly Local Case Configuration
Configure Global and Japan User Privileges
Oracle B2B Gateway

Create Integration Tables in B2B Schema
B2B UI Configuration
Argus Safety Configuration
Transmission and Tracking of Reports
Oracle BIP

BI Publisher Overview
Architecture
BIP Aggregate Reporting
BIP Aggregate DSUR
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