Post Market Surveillance & Adverse Event Reporting What is an
Post Market Surveillance & Adverse Event Reporting What is an
Post Market Surveillance & Adverse Event Reporting What is an
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<strong>Post</strong> <strong>Market</strong> <strong>Surveill<strong>an</strong>ce</strong> & <strong>Adverse</strong> <strong>Event</strong> <strong>Reporting</strong>Roles of Stakeholders according GHTF : NationalCompetent Authorities• Establ<strong>is</strong>h <strong>Adverse</strong> <strong>Event</strong> Report (AER)requirements• Establ<strong>is</strong>h <strong>an</strong>d maintain national vigil<strong>an</strong>cedatabases• Evaluate AER received• Monitor mfr. Investigation <strong>an</strong>d Field SafetyCorrective Actions• Exch<strong>an</strong>ge information between CA
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