Workshop on biosimilar monoclonal antibodies and immunogenicity of monoclonal antibodies
Date:
24/10/2011
Location:
European Medicines Agency, London, UK
The European Medicines Agency workshop on biosimilar monoclonal antibodies is intended to discuss the draft guideline on similar biological medicinal products containing monoclonal antibodies and the guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use with stakeholders who provided comments on the two guidelines during the public consultation phase. Registration closed.
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Agenda - Workshop on biosimilar monoclonal antibodies and immunogenicity of monoclonal antibodies (PDF/142.11 KB)
First published: 24/10/2011
Last updated: 24/10/2011
EMA/838645/2011 -
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Report - Closed workshop on biosimilar monoclonal antibodies and immunogenicity of monoclonal antibodies (PDF/165.57 KB)
First published: 15/06/2012
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EMA/97951/2012 -
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List of participants: Closed workshop on biosimilar monoclonal antibodies and immunogenicity of monoclonal antibodies (PDF/110.58 KB)
First published: 15/06/2012
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EMA/362428/2012 -
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Presentation - Draft guideline on biosimilar monoclonal antibodies (PDF/1.11 MB)
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Presentation - General presentation by stakeholders (PDF/110.92 KB)
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Presentation - High-level perspective of the biosimilars industry (PDF/742.2 KB)
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Presentation - Session 1: Non-clinical issues: Introduction (PDF/234.33 KB)
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Presentation - Session 1.1: Non-clinical issues: Off-target toxicity – does it occur and how should we detect it? (PDF/342.11 KB)
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Presentation - Off-target toxicity (PDF/596.21 KB)
First published: 15/06/2012
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Presentation - Off-target toxicity – a regulator's view (PDF/90.81 KB)
First published: 15/06/2012
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Presentation - Session 1.4: Non-clinical issues: Risk-based approach - rationale and decision points (PDF/109.32 KB)
First published: 15/06/2012
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Presentation - Guideline on biosimilar monoclonal antibodies: Non-clinical issues: A risk-based approach - rationale and decision points (PDF/588.08 KB)
First published: 15/06/2012
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Presentation - Regulator's view: A risk-based approach - rationale and decision points (PDF/583.81 KB)
First published: 15/06/2012
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Presentation - Equivalence vs. non-inferiority: Introduction (PDF/239.47 KB)
First published: 15/06/2012
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Presentation - Session 2.1: Clinical issues: Could we accept non-inferiority instead of equivalence trials in specific situations? (PDF/74.47 KB)
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Presentation - Biosimilar industry perspective on clinical issues - Equivalence versus non-inferiority (PDF/602.23 KB)
First published: 15/06/2012
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Presentation - Equivalence vs. non-inferiority: Regulator‘s view (PDF/274.63 KB)
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Presentation - Session 3.1: Clinical issues: Is product / indication specific guidance necessary and meaningful? (PDF/73.36 KB)
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Presentation - Is product / indication specific guidance already necessary and meaningful? (PDF/533.13 KB)
First published: 15/06/2012
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Presentation - Is product / indication specific guidance already necessary and meaningful? (PDF/111.61 KB)
First published: 15/06/2012
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Presentation - How should antibodies against monoclonal antibody therapeutics be assessed? (PDF/468.72 KB)
First published: 15/06/2012
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Presentation - Biosimilar industry perspective on draft guideline on immunogenicity assessment of monoclonal antibodies (PDF/503.89 KB)
First published: 15/06/2012
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Presentation - Session 4.3: Immunogenicity of monoclonal antibodies: Risk-based approach – What are the risk factors? (PDF/67.63 KB)
First published: 15/06/2012
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Presentation - Immunogenicity guideline monoclonal antibodies - A risk-based approach - rationale and decision points (PDF/718.75 KB)
First published: 15/06/2012
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Presentation - Session 5.1: Pharmacovigilance: What data / studies could be deferred to the post-authorisation phase? (PDF/183.59 KB)
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Presentation - Pharmacovigilance (PDF/530.54 KB)
First published: 15/06/2012
Last updated: 15/06/2012 -
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Presentation - Pharmacovigilance (PDF/464.19 KB)
First published: 15/06/2012
Last updated: 15/06/2012