By Elric Langton | 7th October 2021
Some of you that do use SM may well be aware hVIVO a subsidiary of Open Orphan Plc (ORPH) team are leading a consortium with HIC VAC and Wellcome Trust to develop regulatory style guidelines for the manufacture of human challenge agents. In March hVIVO ran a webinar with HIC VAC, Wellcome Trust, and IABS sharing the whitepaper, the meeting report from this was published yesterday.
The “Whitepaper” can be accessed here.
If you want to know more about the Covid-19 human challenge study trial:
The world first Covid-19 Human Challenge Trial: The Regulatory challenges. This webinar will navigate through the regulatory strategy that resulted in the approval and execution of the world’s first Covid-19 human challenge trial, in which healthy volunteers were deliberately infected with SARS-CoV-2. You will be taken step-by-step through the regulatory approach, from the manufacturing of the human challenge agent, over the Scientific Advice meetings with Regulators…