Detailed Guidance on ICSRs in the context of COVID-19

On 21 April 2020 the EMA published the detailed guidance on ICSRs associated with medicinal products used for COVID-19 infection.

This detailed guidance document provides recommendations relevant to the processing and submission of Individual Case Safety Reports (ICSRs) associated with medicinal products used for the treatment or prevention of COVID-19 infection, taking into account the Notice to stakeholders published by the European Commission and the guidance regarding COVID-19 related terms published by the MedDRA MSSO.

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