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ICH E2B(R3)1 ........................................................................................... 3 ...........................................................................................
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Provide personal information such as name, address, contact details, and any other information requested accurately.
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Fill in the details of the specific safety case you are reporting, including the incident description, date, time, location, and any other relevant details.
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E2BR3 Individual Case Safety refers to a standardized format used in pharmacovigilance for reporting individual safety cases related to adverse drug reactions. It ensures that relevant safety information is consistently shared among regulatory authorities and stakeholders.
Pharmaceutical companies, sponsors of clinical trials, and other stakeholders involved in drug development and distribution are required to file E2BR3 individual case safety reports to ensure compliance with regulatory requirements.
To fill out E2BR3 individual case safety reports, one must collect necessary data on the patient's details, adverse event description, drug information, and relevant medical history. The information should be entered following the specified format and guidelines provided by regulatory authorities.
The purpose of E2BR3 individual case safety reporting is to facilitate the monitoring of drug safety, identify potential risks associated with medications, and ultimately protect patient safety by ensuring timely communication of safety information.
The information that must be reported includes patient demographics, details of the adverse event, drug exposure information, medical history, outcome of the event, and any relevant lab test results.
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