Implementation and Impact of new regulations on E2B (R3), eVAERS, eMDR for Adverse Event Reporting

In 2013, the new E2B (R3) reporting guidance for transmission of Individual Case Safety Reports based on Health Level-7 (HL7) messaging protocol to outdated the existing E2B (R2) protocol.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.

Collection of adverse event information on medical devices is mandated by Medical Device Reporting (MDR) requirements. The electronic Medical Device Reporting (eMDR) provides the capability for electronic data entry and processing of medical device adverse event reports. This utilizes Health Level Seven (HL7) Individual Case Safety Report (ICSR) standard to receive medical device adverse events (MDRs).

This webinar will help to:
• Understand the concept and review the basic elements and standards required for electronic reporting through E2B (R3), eVAERS and eMDR
• Discuss on the regional specification of E2B (R3), eVAERS, eMDR
• Explain the impact of the guidelines on overall business process

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