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COVID-19 has shown that coordinated action at EU level is necessary to effectively respond to health emergencies. While during the pandemic the EU reacted to issues as they arose, the creation of HERA is a first step to putting Europe on the front foot in addressing global health threats.
This paper outlines EFPIA and VE’s views and recommendations on a number of elements included in the Commission’s Decision establishing the Health Emergency Preparedness and Response Authority (HERA)] and in the Proposal for a Council Regulation on a framework of measures for ensuring the supply of crisis relevant medical countermeasures in the event of a public health emergency at Union leveP. EFPIA and VE, their national associations and member companies, look forward to working with HERA and all stakeholders towards the shared goal of a safer, healthier and more resilient Europe.

Various digital technologies are currently available to help biopharmaceutical and pharmaceutical manufacturers drive significant process improvements. There are numerous areas where process automation and simplification can be enabled using electronic data (eData) from key raw material suppliers. This article describes some current use cases in which the manufacturer’s analytical capabilities are enhanced using a standard eData platform, and also explores future opportunities to optimize other critical parts of the production process including logistics-related applications.