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Note It is expected that the reference instance example included with the Implementation Guide may be updated when the HL7 Common Product Model is finalised. This probably will not impact on OIDs and code lists. See the INFORMATION PAPER Step 3 Release E2B R3 28-July-2011 for further details. The paper is available on the ICH website at www. Xsl viewer will be packaged as a. zip file and Current information on E2B R3 ICSR developments and timelin...
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What is e2b online?
e2b online is a web-based system used for electronic submission and management of adverse event reports for pharmaceuticals and medical devices.
Who is required to file e2b online?
Pharmaceutical companies, medical device manufacturers, and healthcare professionals who encounter adverse events related to their products are required to file e2b online.
How to fill out e2b online?
To fill out e2b online, users must access the e2b online platform, create an account or log in, and follow the prompts to enter the required information about the adverse event, ensuring all mandatory fields are completed.
What is the purpose of e2b online?
The purpose of e2b online is to streamline the reporting process of adverse events to regulatory authorities, ensuring patient safety and compliance with legal requirements.
What information must be reported on e2b online?
Information that must be reported on e2b online includes details about the adverse event, the patient, the product involved, and any relevant medical history or treatment details.
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