Volume 31, Issue 2 - Medical Devices
Pharmacovigilance
Authors: Arthur Jarov, Tiziana von Bruchhausen
Abstract
The Regulatory Expert Seminar session at the 2021 Spring EMWA Conference took us on an amazing journey through marketing authorisation applications from a regulator’s and medical writer’s perspective. One of the presentations focussed on the challenges of accelerated reviews, assessments, and timelines from a regulatory affair’sperspective, in the context of marketing authorisation submissions for COVID-19 vaccines.
Tiziana von Bruchhausen (editor)
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