Life Sciences

What Are The Implications Of Not Complying With E2B(R3)?

e2b-r3-z

In the European Union, the use of E2B(R3), along with IDMP, is in legislation, so not complying by the deadline could have legal repercussions. Non-compliance with the FDA and MHLW’s requirements could also bring unwanted scrutiny. More importantly, if an organization does not comply by the deadlines, they will not be able to send ICSRs automatically to regulatory agencies. Nonetheless, if an organization’s safety and pharmacovigilance system does not have the ability to submit data in the new E2B(R3) format, they can still transmit the information via web-based solutions, such as EMA’s WebTrader.

Life Sciences - How Artificial Intelligence Can Enhance the Clinical Data Review and Cleaning Process
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Navigating regulatory guidelines and requirements is a challenge that all life sciences organizations must confront in order to protect the safety of patients, as well as to shield themselves from the dire consequences that can be imposed by global regulatory bodies.

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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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