Workshop on biosimilars
Date:
31/10/2013
Location:
European Medicines Agency, London, UK
The workshop is intended to discuss the draft guideline on similar biological medical products, the draft guideline on similar biological medical products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues, and the draft guideline on similar biological medical products containing biotechnology-derived proteins as active substance: quality issues. Registration closed.
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Agenda - Workshop on biosimilars (PDF/74.69 KB)
First published: 25/09/2013
Last updated: 12/11/2013
EMA/473908/2013 -
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List of participants - Workshop on biosimilars (PDF/143.9 KB)
First published: 12/11/2013
Last updated: 12/11/2013
EMA/681299/2013 -
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Presentation - Draft revised guideline on similar biological medicinal products: Relevant changes (Martina Weise) (PDF/234.06 KB)
First published: 12/11/2013
Last updated: 12/11/2013 -
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Presentation - EBG’s comments on the draft revised guideline on similar biological medicinal products (Karl Heinz Emmert) (PDF/1.09 MB)
First published: 12/11/2013
Last updated: 12/11/2013 -
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Presentation - Guideline on similar biological medicinal products: Overarching guideline (PDF/734.59 KB)
First published: 12/11/2013
Last updated: 12/11/2013 -
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Presentation - Guideline on similar biological medicinal products containing biotechnologically-derived proteins as active substances: quality issues (Niklas Ekman) (PDF/159.22 KB)
First published: 12/11/2013
Last updated: 12/11/2013 -
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Presentation - EGA’s perspective on the draft quality guideline (Joerg Windisch) (PDF/922.36 KB)
First published: 12/11/2013
Last updated: 12/11/2013 -
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Presentation - Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: Quality issues (PDF/656.89 KB)
First published: 12/11/2013
Last updated: 12/11/2013 -
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Presentation - Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (Niklas Ekman) (PDF/309.73 KB)
First published: 12/11/2013
Last updated: 12/11/2013 -
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Presentation - Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (Hans-Karl Heim) (PDF/117.28 KB)
First published: 12/11/2013
Last updated: 12/11/2013 -
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Presentation - Guideline on Similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues (Pekka Kurki) (PDF/360.9 KB)
First published: 12/11/2013
Last updated: 12/11/2013 -
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Presentation - EBG’s perspective on the draft guideline on the non-clinical/clinical issues (Mark McCamish) (PDF/1.18 MB)
First published: 12/11/2013
Last updated: 12/11/2013 -
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Presentation - Nonclinical and clinical considerations (PDF/571.74 KB)
First published: 12/11/2013
Last updated: 12/11/2013