Workshop on biosimilars

EventCorporateBiosimilars

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Datums

Ceturtdiena, 31 Oktobris 2013, Visu dienu

Atrašanās vieta

European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

Agenda - Workshop on biosimilars

Reference Number: EMA/473908/2013

English (EN) (74.69 KB - PDF)

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List of participants - Workshop on biosimilars

Reference Number: EMA/681299/2013

English (EN) (143.9 KB - PDF)

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Presentation - Draft revised guideline on similar biological medicinal products: Relevant changes (Martina Weise)

English (EN) (234.06 KB - PDF)

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Presentation - EBG’s comments on the draft revised guideline on similar biological medicinal products (Karl Heinz Emmert)

English (EN) (1.09 MB - PDF)

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Presentation - Guideline on similar biological medicinal products: Overarching guideline

English (EN) (734.59 KB - PDF)

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Presentation - Guideline on similar biological medicinal products containing biotechnologically-derived proteins as active substances: quality issues (Niklas Ekman)

English (EN) (159.22 KB - PDF)

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Presentation - EGA’s perspective on the draft quality guideline (Joerg Windisch)

English (EN) (922.36 KB - PDF)

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Presentation - Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: Quality issues

English (EN) (656.89 KB - PDF)

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Presentation - Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (Niklas Ekman)

English (EN) (309.73 KB - PDF)

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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)

English (EN) (117.28 KB - PDF)

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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)

English (EN) (360.9 KB - PDF)

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Presentation - EBG’s perspective on the draft guideline on the non-clinical/clinical issues (Mark McCamish)

English (EN) (1.18 MB - PDF)

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Presentation - Nonclinical and clinical considerations

English (EN) (571.74 KB - PDF)

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