Workshop on biosimilars

• 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

List of participants - Workshop on biosimilars

Reference Number: EMA/681299/2013

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

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

Presentation - Guideline on similar biological medicinal products: Overarching guideline

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

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

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

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

Presentation - Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (Hans-Karl Heim)

Presentation - Guideline on Similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues (Pekka Kurki)

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

Presentation - Nonclinical and clinical considerations

Multimedia