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

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