The process of adverse event reporting typically involves several steps:
Detection: Healthcare professionals, patients, or other stakeholders identify a potential adverse event. Documentation: Detailed information about the event is recorded, including patient demographics, medical history, and specifics of the event. Submission: The report is submitted to relevant authorities, such as the FDA’s MedWatch system in the United States, the EMA’s EudraVigilance in Europe, or national pharmacovigilance centers. Analysis: The collected data are analyzed to identify patterns or trends that may indicate a safety issue. Action: Based on the analysis, regulatory actions may be taken to mitigate risks.
