EVH Regulatory Preparedness Strategy - Executive Summary

The European Vaccines Hub (EVH) serves as a coordinative platform for the development of pandemic vaccines and monoclonal antibodies (mAb). Its ambition is to support vaccine and antibody development across all stages, seamlessly leading to large-scale manufacturing and marketing authorization. To fulfill this objective the EVH will follow the Vaccines Readiness Plan (VRP), which covers the relevant aspects from pathogen selection to pre-pandemic vaccine development and stress testing of the network.

This document specifically addresses the EVH strategy for anticipation and preparation for challenges that might impede product development, manufacturing and marketing authorization in a pandemic.

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