Workshop on biosimilars

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TitleWorkshop on biosimilars
Date31/10/2013 - 31/10/2013
LocationEuropean Medicines Agency, London, UK
SummaryThe 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.

All documents

Name Language First published Last updated
Agenda - Workshop on biosimilars (English only) 25/09/2013 12/11/2013
List of participants - Workshop on biosimilars (English only) 12/11/2013  
Presentation - Draft revised guideline on similar biological medicinal products: Relevant changes (Martina Weise) (English only) 12/11/2013  
Presentation - EBG’s comments on the draft revised guideline on similar biological medicinal products (Karl Heinz Emmert) (English only) 12/11/2013  
Presentation - Guideline on similar biological medicinal products: Overarching guideline (English only) 12/11/2013  
Presentation - Guideline on similar biological medicinal products containing biotechnologically-derived proteins as active substances: quality issues (Niklas Ekman) (English only) 12/11/2013  
Presentation - EGA’s perspective on the draft quality guideline (Joerg Windisch) (English only) 12/11/2013  
Presentation - Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: Quality issues (English only) 12/11/2013  
Presentation - Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (Niklas Ekman) (English only) 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 only) 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 only) 12/11/2013  
Presentation - EBG’s perspective on the draft guideline on the non-clinical/clinical issues (Mark McCamish) (English only) 12/11/2013  
Presentation - Nonclinical and clinical considerations (English only) 12/11/2013  

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