Overview
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
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