Workshop on biosimilars

EventCorporateBiosimilars

Croatian is available via eTranslation, the European Commission's machine translation service.

Translate to Croatian | Important information about machine translation

Datum

četvrtak, 31 listopada 2013, Cijeli dan

Lokacija

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)

Prvo objavljeno: Posljednje ažuriranje:
Prikaži

List of participants - Workshop on biosimilars

Reference Number: EMA/681299/2013

English (EN) (143.9 KB - PDF)

Prvo objavljeno: Posljednje ažuriranje:
Prikaži

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

English (EN) (234.06 KB - PDF)

Prvo objavljeno: Posljednje ažuriranje:
Prikaži

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

English (EN) (1.09 MB - PDF)

Prvo objavljeno: Posljednje ažuriranje:
Prikaži

Presentation - Guideline on similar biological medicinal products: Overarching guideline

English (EN) (734.59 KB - PDF)

Prvo objavljeno: Posljednje ažuriranje:
Prikaži

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

English (EN) (159.22 KB - PDF)

Prvo objavljeno: Posljednje ažuriranje:
Prikaži

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

English (EN) (922.36 KB - PDF)

Prvo objavljeno: Posljednje ažuriranje:
Prikaži

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

English (EN) (656.89 KB - PDF)

Prvo objavljeno: Posljednje ažuriranje:
Prikaži

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

English (EN) (309.73 KB - PDF)

Prvo objavljeno: Posljednje ažuriranje:
Prikaži

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)

Prvo objavljeno: Posljednje ažuriranje:
Prikaži

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)

Prvo objavljeno: Posljednje ažuriranje:
Prikaži

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

English (EN) (1.18 MB - PDF)

Prvo objavljeno: Posljednje ažuriranje:
Prikaži

Presentation - Nonclinical and clinical considerations

English (EN) (571.74 KB - PDF)

Prvo objavljeno: Posljednje ažuriranje:
Prikaži

Multimedia

Share this page