Getting Compliant with FDA's Regional Guidance on eVAERS Reporting Requirements

Overview

Continuing Education Credits are not available for On Demand offerings.
Broadcast time: 1 hour 3 minutes

In 2013, the ICH E2B Expert Workgroup released the new E2B (R3) reporting guidance for transmission of Individual Case Safety Reports based on Health Level-7 (HL7) messaging protocol to outdate the existing E2B (R2) protocol. A clear advantage provided by E2B (R3) over E2B (R2) is capturing of more data with increased granularity and frequency. While the ICH guideline describes the harmonized core set of ICH E2B (R3) data elements and business rules, it also includes many non-harmonized regional data elements to support electronic Vaccine Adverse Event Reporting System (eVAERS), which the FDA has adopted for electronic reporting for Vaccines.

This webinar will explore:

The regional specification of E2B R3 standard by FDA
The impact on overall business process
How to identify the most optimum solution: off-the-shelf vs. custom software
How to leverage subject matter expertise and accelerators
Preparation for a regulatory pilot

Learning objectives

At the conclusion of this webinar, participants should be able to:

Discuss the regional specifications of the E2B (R3) standard by FDA
Review the basic elements and standards required for electronic reporting through eVAERS
Explain the impact of the guidance on overall business process
Recognize the differences between off-the-shelf vs. custom software including how to identify the most optimum solution for each company
Describe how to leverage subject matter expertise and accelerators to improve the process of electronic reporting

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Getting Compliant with FDA's Regional Guidance on eVAERS Reporting Requirements

Overview

Learning objectives

Be informed and stay engaged.