Workshop on haemophilia registries
Date:
01/07/2015 to 02/07/2015
Location:
European Medicines Agency, London, UK
Independent, disease-based registries are a potential source of valuable safety and efficacy data on products. The European Medicines Agency (EMA) is currently embarking on a strategy for patient registries. This initiative provides an appropriate starting point to consider what regulators need from haemophilia registries. The aim is to get the best capture of data in the European Union (EU) and build on existing expertise in this area. It is proposed to work with stakeholders on this topic, commencing with this EMA workshop. Places limited. Registration open until 01/06/2015.
-
List item
Agenda - Workshop on haemophilia registries (PDF/113.65 KB)
First published: 30/04/2015
Last updated: 25/06/2015
EMA/CHMP/BPWP/190322/2015 -
List item
Consensus points - Workshop on haemophilia registries (PDF/83.9 KB)
First published: 03/08/2015
Last updated: 03/08/2015
EMA/CHMP/BPWP/380896/2015 -
List item
Presentation - Key points from introductory session: Setting the scene (Karri Penttila) (PDF/72.9 KB)
First published: 03/08/2015
Last updated: 03/08/2015 -
List item
Presentation - Key points from session 2: registries (Christine Keipert) (PDF/85.83 KB)
First published: 03/08/2015
Last updated: 03/08/2015 -
List item
Presentation - Key points from session 3: industry perspective (Karri Penttila) (PDF/72.49 KB)
First published: 03/08/2015
Last updated: 03/08/2015 -
List item
Presentation - Safety of new products: do we have enough tools in place? (Flora Peyvandi) (PDF/412.03 KB)
First published: 03/08/2015
Last updated: 03/08/2015 -
List item
Presentation - Focus on immunogenicity of FVIII and FIX products and general reflections on registries (H. Marijke van den Berg) (PDF/1.56 MB)
First published: 03/08/2015
Last updated: 03/08/2015 -
List item
Presentation - Factor VIII and factor IX development plans at the Paediatric Committee: overview (Thorsten Olski) (PDF/201.41 KB)
First published: 03/08/2015
Last updated: 03/08/2015 -
List item
Presentation - The UK national haemophilia database: a thumbnail sketch!(Charles RM Hay) (PDF/1.38 MB)
First published: 03/08/2015
Last updated: 03/08/2015 -
List item
Presentation - Haemophilia registries quantity versus quality: the current situation in Europe (Christine Keipert) (PDF/618.33 KB)
First published: 03/08/2015
Last updated: 03/08/2015 -
List item
Presentation - European haemophilia safety surveillance (EUHASS) (Mike Makris) (PDF/404.75 KB)
First published: 03/08/2015
Last updated: 03/08/2015 -
List item
Presentation - Community counts! CDC Public Health Surveillance for Bleeding Disorders (Mike Soucie) (PDF/304.13 KB)
First published: 03/08/2015
Last updated: 03/08/2015 -
List item
Presentation - PedNet registry (Rolf Ljung) (PDF/700.72 KB)
First published: 03/08/2015
Last updated: 03/08/2015 -
List item
Presentation - FranceCoag network (Roseline d'Oiron) (PDF/2.22 MB)
First published: 03/08/2015
Last updated: 03/08/2015 -
List item
Presentation - IPFA’s perspective on haemophilia registries usage (Franà§oise Rossi) (PDF/375.25 KB)
First published: 03/08/2015
Last updated: 03/08/2015 -
List item
Presentation - Medical and Regulatory Policy Plasma Protein Therapeutics Association: Industry perspectives (Mary Gustafson) (PDF/211.05 KB)
First published: 03/08/2015
Last updated: 03/08/2015 -
List item
Presentation - ISTH and EAHAD perspective on haemophilia registries (Flora Peyvandi) (PDF/686.95 KB)
First published: 03/08/2015
Last updated: 03/08/2015 -
List item
Presentation - World Federation of Hemophilia (Mark Brooker) (PDF/531.29 KB)
First published: 03/08/2015
Last updated: 03/08/2015 -
List item
Presentation - Haemophilia registries: patients’ perspective - European Haemophilia Consortium (EHC) (Radoslaw Kaczmarek) (PDF/293.16 KB)
First published: 03/08/2015
Last updated: 03/08/2015