PDA/EMEA European Virus Safety Forum (Developments in Biologicals (Standardization))

出版者:Karger

作者:J. S., Ed. Robertson

页数:0

出版时间:2004

价格:USD 159.25

装帧:Paperback

isbn号码:9783805578738

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Viral safety is a key issue for biological and biotechnological medicinal products. This first joint PDA/EMEA European Virus Safety Forum brought together an international panel of speakers from the industry, regulatory authorities and research to present and discuss the most up-to-date scientific knowledge and regulatory aspects in the areas of virus safety of recombinant proteins, monoclonal antibodies, plasma-derived medicinal products and advanced technology medicinal products.The conference provided the opportunity to discuss new approaches in viral safety such as generic or matrix validation of virus removal and novel virus inactivation/removal technologies, and to clarify their benefits and applicability for specific product categories or technologies. This volume will further the discussion on virus safety, contribute to the development of new regulatory guidance and support harmonisation of the regulations in this field.