<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>6</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Amaya Leunda</style></author><author><style face="normal" font="default" size="100%">Katia Pauwels</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">GMO Regulatory Aspects of Novel Investigational Vaccine Candidates</style></title><secondary-title><style face="normal" font="default" size="100%">Vaccines - the History and Future’</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">environmental risk assessment</style></keyword><keyword><style  face="normal" font="default" size="100%">European directives</style></keyword><keyword><style  face="normal" font="default" size="100%">GMO</style></keyword><keyword><style  face="normal" font="default" size="100%">novel vaccine candidates</style></keyword><keyword><style  face="normal" font="default" size="100%">regulatory challenges</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2019</style></year></dates><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;Recent scientific and technical developments create novel opportunities for&lt;br&gt;
vaccine development. Regulatory compliance has to be ensured from preclinical&lt;br&gt;
research to market authorization, whereby different legal frameworks that go&lt;br&gt;
beyond quality, efficacy or patient safety aspects need to be taken into account.&lt;br&gt;
As academia and start-ups are often focused on gathering scientific evidence,&lt;br&gt;
the regulatory maze is often regarded by applicants as challenging in the overall&lt;br&gt;
pathway to clinical translation. This is particularly true for applications concerning&lt;br&gt;
vaccine candidates containing or consisting of genetically modified organisms&lt;br&gt;
(GMOs). Active communication between applicants and competent authorities or&lt;br&gt;
advisory bodies early in the development stages facilitates a correct implementation&lt;br&gt;
of the regulatory frameworks and is of utmost importance to identify challenges&lt;br&gt;
or hurdles in order to avoid unnecessary delay in scientific review. Based on the&lt;br&gt;
state-of-play in Belgium, this chapter discusses examples of regulatory journeys of&lt;br&gt;
applications with genetically modified viral vectors and novel vaccine candidates&lt;br&gt;
that have been reviewed by GMO national competent authorities in Belgium and in&lt;br&gt;
Europe. They highlight the need of having a comprehensive view of global perspectives&lt;br&gt;
early in the development to facilitate the translation of research to clinical&lt;br&gt;
development or even market authorization.&lt;/p&gt;
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