Workshop on immunogenicity assessment of biotechnology-derived therapeutic proteins

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TitleWorkshop on immunogenicity assessment of biotechnology-derived therapeutic proteins
Date09/03/2016 - 09/03/2016
LocationEuropean Medicines Agency, London, UK
SummaryThe workshop is held to discuss the draft Committee for Medicinal Products for Human Use/Biosimilar Medicinal Products Working Party (BMWP) guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins. Participants will include experts from the BMWP, the Biostatistics Working Party (BWP), other regulatory authorities and stakeholders who provided comments on the draft guideline as well as specifically invited interested parties.

All documents

Name Language First published Last updated
Agenda - Workshop on immunogenicity assessment of biotechnology-derived therapeutic proteins (English only) 15/02/2016 09/03/2016
Workshop on immunogenicity assessment of biotechnology-derived therapeutic proteins - Workshop summary (English only) 04/07/2016  
Registration form - Workshop on immunogenicity assessment of biotechnology derived-therapeutic proteins with interested parties (English only) 27/01/2016  
Summary - Workshop on immunogenicity assessment of biotechnology-derived therapeutic proteins with interested parties (English only) 27/01/2016  
Presentation - Quality attributes impacting immunogenicity of therapeutic proteins (Steffen Gross) (English only) 17/03/2016  
Presentation - Immunogenicity of biological therapeutics product quality attributes (Susan Kirshner) (English only) 17/03/2016  
Presentation - Revised immunogenicity guideline: assays and methods- presentation of the draft guideline and introduction of the topics for discussion (Robin Thorpe, Meenu Wadhwa) (English only) 17/03/2016  
Presentation - Target/drug interference considerations in immunogenicity assessment (Eric Wakshull) (English only) 17/03/2016  
Presentation - Neutralising assay methodologies (Shalini Gupta) (English only) 17/03/2016  
Presentation - Challenges in assessing relative immunogenicity (Paul Chamberlain) (English only) 17/03/2016  
Presentation - Non-clinical assessment of immunogenicity (Leon van Aerts) (English only) 17/03/2016  
Presentation - Non-clinical approaches for immunogenicity assessment: predictive models (Mark Fogg) (English only) 17/03/2016  
Presentation - Summary of immunogenicity program and risk assessment (Pekka Kurki) (English only) 17/03/2016  
Presentation - Risk assessment and mitigation strategies for immune Responses to therapeutic proteins: the FDA perspective (Amy Rosenberg) (English only) 17/03/2016  
Presentation - How to integrate risk assessment and risk stratification into a risk-based approach for immunogenicity assessment (Christian Schneider) (English only) 17/03/2016  
Presentation - Tailored immunogenicity program - why? (Florian Deisenhammer) (English only) 17/03/2016  
Presentation - Immunogenicity of therapeutic antibodies (Gertjan Wolbink) (English only) 17/03/2016  
Presentation - Immunogenicity guideline pharmacovigilance (Thijs Giezen) (English only) 17/03/2016  
Presentation - Immunogenicity of biologicals: a pharmacovigilance perspective (Niels Vermeer) (English only) 17/03/2016  
Presentation - Immunogenicity guideline: basic description (Venke Skibeli) (English only) 17/03/2016  

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