EMEA workshop on Monoclonal Antibodies

Event

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Date: Jeudi, 2 juillet 2009, Journée Entière
Lieu: European Medicines Agency, Amsterdam, the Netherlands

The EMEA workshop on biosimilar monoclonal antibodies (mAbs) was intended to discuss the feasibility of the scientific development and authorisation of monoclonal antibodies via the European biosimilar regulatory pathways. 159 people including health care professionals, academics, representatives from regulatory agencies in the European Union (EU), United States (US) and Canada, and 40 biopharmaceutical companies located worldwide attended the workshop. Participation was by invitation only.

Documents

Agenda - EMEA workshop on biosimilar monoclonal antibodies - Programme

Reference Number: EMEA/CHMP/BMWP/494490/2008

English (EN) (65.12 Ko - PDF)

Première publication: 01/07/2009 Dernière mise à jour: 01/07/2009

EMEA Workshop on the feasibility of Biosimilar monoclonal Antibodies - Welcome - Xavier Luria

English (EN) (54.68 Ko - PDF)

Première publication: 02/07/2009 Dernière mise à jour: 02/07/2009

Towards biosimilar monoclonal antibodies - Pros and cons - Christian K Schneider

English (EN) (2.14 Mo - PDF)

Première publication: 02/07/2009 Dernière mise à jour: 02/07/2009

Session 1 - CMC - Innovator Industry Presentation - Prof. Georg-B. Kresse

English (EN) (1.04 Mo - PDF)

Première publication: 02/07/2009 Dernière mise à jour: 02/07/2009

EGA-EBG's quality perspective on Biosimilar mAbs - Martin Schiestl

English (EN) (169.49 Ko - PDF)

Première publication: 02/07/2009 Dernière mise à jour: 02/07/2009

Session 1 - CMC - Kowid Ho

English (EN) (344.52 Ko - PDF)

Première publication: 02/07/2009 Dernière mise à jour: 02/07/2009

Session 2 - Non-Clinical Issues - Innovator Industry Presentation - Danuta Herzyk

English (EN) (152.47 Ko - PDF)

Première publication: 02/07/2009 Dernière mise à jour: 02/07/2009

EGA-EBG's Non-Clinical perspective on Biosimilar mAbs - Alexander Berghout

English (EN) (162.97 Ko - PDF)

Première publication: 02/07/2009 Dernière mise à jour: 02/07/2009

Regulator, Thinking - Non-clinical session - B. Silva Lima

English (EN) (15.1 Ko - PDF)

Première publication: 02/07/2009 Dernière mise à jour: 02/07/2009

Session 3 - Clinical Issues - Innovator Industry Presentation - Jay P. Siegel

English (EN) (303.6 Ko - PDF)

Première publication: 02/07/2009 Dernière mise à jour: 02/07/2009

Biosimilar mAbs - Clinical issues - Regulatory perspective - Christian K Schneider

English (EN) (1.7 Mo - PDF)

Première publication: 02/07/2009 Dernière mise à jour: 02/07/2009

Biosimilar mAbs - Outlook - Christian K Schneider

English (EN) (973.71 Ko - PDF)

Première publication: 02/07/2009 Dernière mise à jour: 02/07/2009