<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Nicoletta Corti</style></author><author><style face="normal" font="default" size="100%">Christopher Chiu</style></author><author><style face="normal" font="default" size="100%">Rebecca J Cox</style></author><author><style face="normal" font="default" size="100%">Clarisse Demont</style></author><author><style face="normal" font="default" size="100%">Jeanne-Marie Devaster</style></author><author><style face="normal" font="default" size="100%">Othmar G Engelhardt</style></author><author><style face="normal" font="default" size="100%">Andrew Gorringe</style></author><author><style face="normal" font="default" size="100%">Hassan, Khaole</style></author><author><style face="normal" font="default" size="100%">Marcel Hoefnagel</style></author><author><style face="normal" font="default" size="100%">Kamerling, Ingrid</style></author><author><style face="normal" font="default" size="100%">Oleg Krut</style></author><author><style face="normal" font="default" size="100%">Chelsea Lane</style></author><author><style face="normal" font="default" size="100%">Reinhard Liebers</style></author><author><style face="normal" font="default" size="100%">Catherine Luke</style></author><author><style face="normal" font="default" size="100%">Wim Van Molle</style></author><author><style face="normal" font="default" size="100%">Sandra Morel</style></author><author><style face="normal" font="default" size="100%">Neels, Pieter</style></author><author><style face="normal" font="default" size="100%">Meta Roestenberg</style></author><author><style face="normal" font="default" size="100%">Michelle Rubbrecht</style></author><author><style face="normal" font="default" size="100%">Klaas Smits, Wiep</style></author><author><style face="normal" font="default" size="100%">Daniel Stoughton</style></author><author><style face="normal" font="default" size="100%">Talaat, Kawsar</style></author><author><style face="normal" font="default" size="100%">Maria J G T Vehreschild</style></author><author><style face="normal" font="default" size="100%">Adrian Wildfire</style></author><author><style face="normal" font="default" size="100%">Meln, Irina</style></author><author><style face="normal" font="default" size="100%">Ole F Olesen</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Regulatory workshop on challenge strain development and GMP manufacture - A stakeholder meeting report.</style></title><secondary-title><style face="normal" font="default" size="100%">Biologicals</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">Clostridioides difficile</style></keyword><keyword><style  face="normal" font="default" size="100%">Humans</style></keyword><keyword><style  face="normal" font="default" size="100%">Influenza Vaccines</style></keyword><keyword><style  face="normal" font="default" size="100%">Influenza, Human</style></keyword><keyword><style  face="normal" font="default" size="100%">Viruses</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2024</style></year><pub-dates><date><style  face="normal" font="default" size="100%">2024 Feb</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">85</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;Within the Innovative Health Initiative (IHI) Inno4Vac CHIMICHURRI project, a regulatory workshop was organised on the development and manufacture of challenge agent strains for Controlled Human Infection Model (CHIM) studies. Developers are often uncertain about which GMP requirements or regulatory guidelines apply but should be guided by the 2022 technical white paper &quot;Considerations on the Principles of Development and Manufacturing Qualities of Challenge Agents for Use in Human Infection Models&quot; (published by hVIVO, Wellcome Trust, HIC-Vac consortium members). Where those recommendations cannot be met, regulators advise following the &quot;Principles of GMP&quot; until definitive guidelines are available. Sourcing wild-type virus isolates is a significant challenge for developers. Still, it is preferred over reverse genetics challenge strains for several reasons, including implications and regulations around genetically modified organisms (GMOs). Official informed consent guidelines for collecting isolates are needed, and the characterisation of these isolates still presents risks and uncertainty. Workshop topics included ethics, liability, standardised clinical endpoints, selection criteria, sharing of challenge agents, and addressing population heterogeneity concerning vaccine response and clinical course. The organisers are confident that the workshop discussions will contribute to advancing ethical, safe, and high-quality CHIM studies of influenza, RSV and C. difficile, including adequate regulatory frameworks.&lt;/p&gt;
</style></abstract></record></records></xml>