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Do Commercially Available Safety Systems Comply With E2B(R3)?


Yes, some validated systems can comply with E2B(R3). With respect to Oracle Argus Safety, the current version, 8.0.1, is able to comply with E2B(R3), Electronic Vaccine Adverse Event Reporting System (eVAERS), and Electronic Medical Device Reporting (eMDR) reporting requirements.

If a company is simply looking to meet E2B(R3) requirements, we advise waiting to upgrade until the EMA finishes testing and provides feedback to the industry. The testing should be completed by mid-2016. Nonetheless, organizations will not be able to transmit messages using the E2B(R3) format until after the audit of the new EudraVigilance, which is mid-2017.

If an organization has questions about whether a system is E2B(R3)-compliant, the software vendor or a reputable partner should easily be able to determine whether it meets regulatory requirements.

To learn about E2B(R3), the impact it is likely to have on drug safety business processes, and some ideas for how to move forward, fill out the form below or click here.

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Indy Ahluwalia

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