Joint EMA / European Directorate for the Quality of Medicines and Healthcare workshop on characterisation of new clotting-factor concentrates with respect to potency assays used for labelling and testing of post-infusion samples

• Date:
  Thursday, 28 November 2013, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The purpose of this workshop is to provide an overview of the current knowledge of the characterisation of new factor-VIII (FVIII) and factor-IX (FIX) concentrates with respect to potency assays and testing of post-infusion material. This overview will allow both the European Medicines Agency and the European Directorate for the Quality of Medicines and Healthcare to gather information on the new coagulation factors and help to guide future discussion on potency assays. Invitations have been sent to companies developing new FVIII and FIX products. Other invited participants are listed in the draft programme. Registration open until 31/10/2013. Places limited.

Documents

Workshop report - Joint European Medicines Agency / European Directorate for the Quality of Medicines and Healthcare workshop on characterisation of new clotting-factor concentrates (factor VIII and factor IX) with respe...

Reference Number: EMA/135928/2014 Summary:

Workshop report: Characterisation of new clotting factor concentrates (FVIII, FIX) with respect to potency assays used for labelling and testing of post infusion samples - 28-29 November 2013

Outcome of the workshop - Joint European Medicines Agency / European Directorate for the Quality of Medicines and Healthcare workshop on characterisation of new clotting factor concentrates (factor VIII and factor IX) wi...

Reference Number: EMA/789960/2013

Agenda - Joint European Medicines Agency / European Directorate for the Quality of Medicines and Healthcare workshop on characterisation of new clotting factor concentrates (factor VIII and factor IX) with respect to pot...

Reference Number: EMA/439957/2013