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Impact of the New Pharmaceutical Legislation on the Development and Registration of Biological Medicinal Products in the EU

Post thumbnail Impact of the New Pharmaceutical Legislation on the Development and Registration of Biological Medicinal Products in the EU

This article reviews the impact of the new pharmaceutical legislation on the development of biotech products. The authors describe in details current and new challenges that will have an impact on the development and preparation of the registration dossier of biologicals.

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    publication by

    Amanda Gibbons thumbnail
    Amanda Gibbons
    Director Biologics CMC and Regulatory Science
    She is responsible for the design and implementation of strategic development plans, particularly on Chemistry Manufacturing and Control (CMC) aspects of biological products, such as Recombinant, Gene-therapy, Vaccines and Biosimilar Medicinal Products. Her industrial experience in start-ups to large companies gives her a clear understanding of size-specific challenges faced by healthcare professionals.