Workshop on immunogenicity assessment of biotechnology-derived therapeutic proteins

• Date:
  сряда, 9 March 2016, Цял ден
• Местоположение:
  European Medicines Agency, Amsterdam, the Netherlands

The 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.

Documents

Agenda - Workshop on immunogenicity assessment of biotechnology-derived therapeutic proteins

Reference Number: EMA/48362/2016

Workshop on immunogenicity assessment of biotechnology-derived therapeutic proteins - Workshop summary

Reference Number: EMA/252133/2016

Registration form - Workshop on immunogenicity assessment of biotechnology derived-therapeutic proteins with interested parties

Reference Number: EMA/55161/2016

Summary - Workshop on immunogenicity assessment of biotechnology-derived therapeutic proteins with interested parties

Reference Number: EMA/49653/2016

Presentation - Quality attributes impacting immunogenicity of therapeutic proteins (Steffen Gross)

Presentation - Immunogenicity of biological therapeutics product quality attributes (Susan Kirshner)

Presentation - Revised immunogenicity guideline: assays and methods- presentation of the draft guideline and introduction of the topics for discussion (Robin Thorpe, Meenu Wadhwa)

Presentation - Target/drug interference considerations in immunogenicity assessment (Eric Wakshull)

Presentation - Neutralising assay methodologies (Shalini Gupta)

Presentation - Challenges in assessing relative immunogenicity (Paul Chamberlain)

Presentation - Non-clinical assessment of immunogenicity (Leon van Aerts)

Presentation - Non-clinical approaches for immunogenicity assessment: predictive models (Mark Fogg)

Presentation - Summary of immunogenicity program and risk assessment (Pekka Kurki)

Presentation - Risk assessment and mitigation strategies for immune Responses to therapeutic proteins: the FDA perspective (Amy Rosenberg)

Presentation - How to integrate risk assessment and risk stratification into a risk-based approach for immunogenicity assessment (Christian Schneider)

Presentation - Tailored immunogenicity program - why? (Florian Deisenhammer)

Presentation - Immunogenicity of therapeutic antibodies (Gertjan Wolbink)

Presentation - Immunogenicity guideline pharmacovigilance (Thijs Giezen)

Presentation - Immunogenicity of biologicals: a pharmacovigilance perspective (Niels Vermeer)

Presentation - Immunogenicity guideline: basic description (Venke Skibeli)

Multimedia