Workshop on biosimilars

EventCorporateBiosimilars

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Date: Thursday, 31 October 2013, All day
Location: 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)

First published: 25/09/2013 Last updated: 12/11/2013

List of participants - Workshop on biosimilars

Reference Number: EMA/681299/2013

English (EN) (143.9 KB - PDF)

First published: 12/11/2013 Last updated: 12/11/2013

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

English (EN) (234.06 KB - PDF)

First published: 12/11/2013 Last updated: 12/11/2013

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

English (EN) (1.09 MB - PDF)

First published: 12/11/2013 Last updated: 12/11/2013

Presentation - Guideline on similar biological medicinal products: Overarching guideline

English (EN) (734.59 KB - PDF)

First published: 12/11/2013 Last updated: 12/11/2013

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

English (EN) (159.22 KB - PDF)

First published: 12/11/2013 Last updated: 12/11/2013

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

English (EN) (922.36 KB - PDF)

First published: 12/11/2013 Last updated: 12/11/2013

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

English (EN) (656.89 KB - PDF)

First published: 12/11/2013 Last updated: 12/11/2013

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

English (EN) (309.73 KB - PDF)

First published: 12/11/2013 Last updated: 12/11/2013

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)

First published: 12/11/2013 Last updated: 12/11/2013

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)

First published: 12/11/2013 Last updated: 12/11/2013

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

English (EN) (1.18 MB - PDF)

First published: 12/11/2013 Last updated: 12/11/2013

Presentation - Nonclinical and clinical considerations

English (EN) (571.74 KB - PDF)

First published: 12/11/2013 Last updated: 12/11/2013

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