Module 5 Presentations

05/07/2024

From 1 st January 2021: SUSAR submissions to the MHRA

Report a SUSAR to the MHRA in one of the following ways:

• Using ICSR Submissions which replaces the EudraVigilance website (EVWB). The ICSR Submissions route is used to submit single reports. •Using the MHRA Getaway which replaces the Eudravigilance Gateway. The Gateway route is used to submit bulk reports. To gain access to the MHRA Gateway you need to register to another portal called MHRA Submissions.

The Organisation for Professionals in Regulatory Affairs

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Sponsor’s responsibilities from 1 st January 2021 If your trial is being conducted in the UK and in the European Union

DUAL REPORTING

Secure e-transmission of ICSRs via EVWEB EudraVigilance - Pharmacovigilance in EEA (europa.eu) EudraVigilance Gateway | European Medicines Agency (europa.eu)

MHRA

The Organisation for Professionals in Regulatory Affairs

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