Conferences \ BioProcessing, Biologics & Biotherapeutics Congress \ Antibody and Peptide Therapeutics \ Agenda \ Lincoln Tsang |
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EU Regulatory Landscape for Approval of BiosimilarsThursday, 21 July 2011 at 14:45 Add to Calendar ▼2011-07-21 14:45:002011-07-21 15:45:00Europe/LondonEU Regulatory Landscape for Approval of BiosimilarsSELECTBIOenquiries@selectbiosciences.com This presentation will address the regulatory framework and standards for approval biosimilar products by reference to established guidance documents and examples to illustrate the EU regulators’ attitude towards the dossier requirements. A comparative analysis will be made against the international standards for approval of biosimilars. |