GMO Regulatory Aspects of Novel Investigational Vaccine Candidates

Last updated on 14-1-2022 by Amaya Leunda Casi

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Scientific book or chapter



Recent scientific and technical developments create novel opportunities for vaccine development. Regulatory compliance has to be ensured from preclinical research to market authorization, whereby different legal frameworks that go beyond quality, efficacy or patient safety aspects need to be taken into account. As academia and start-ups are often focused on gathering scientific evidence, the regulatory maze is often regarded by applicants as challenging in the overall pathway to clinical translation. This is particularly true for applications concerning vaccine candidates containing …

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