Workshop on haemophilia registries

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Date: Trešdiena, 1 Jūlijs 2015, Visu dienu
Vieta: European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

Agenda - Workshop on haemophilia registries

Reference Number: EMA/CHMP/BPWP/190322/2015

English (EN) (113.65 KB - PDF)

Pirmo reizi publicēts: 30/04/2015 Pēdējo reizi atjaunināts: 25/06/2015

Consensus points - Workshop on haemophilia registries

Reference Number: EMA/CHMP/BPWP/380896/2015

English (EN) (83.9 KB - PDF)

Pirmo reizi publicēts: 03/08/2015 Pēdējo reizi atjaunināts: 03/08/2015

Presentation - Key points from introductory session: Setting the scene (Karri Penttila)

English (EN) (72.9 KB - PDF)

Pirmo reizi publicēts: 03/08/2015 Pēdējo reizi atjaunināts: 03/08/2015

Presentation - Key points from session 2: registries (Christine Keipert)

English (EN) (85.83 KB - PDF)

Pirmo reizi publicēts: 03/08/2015 Pēdējo reizi atjaunināts: 03/08/2015

Presentation - Key points from session 3: industry perspective (Karri Penttila)

English (EN) (72.49 KB - PDF)

Pirmo reizi publicēts: 03/08/2015 Pēdējo reizi atjaunināts: 03/08/2015

Presentation - Safety of new products: do we have enough tools in place? (Flora Peyvandi)

English (EN) (412.03 KB - PDF)

Pirmo reizi publicēts: 03/08/2015 Pēdējo reizi atjaunināts: 03/08/2015

Presentation - Focus on immunogenicity of FVIII and FIX products and general reflections on registries (H. Marijke van den Berg)

English (EN) (1.56 MB - PDF)

Pirmo reizi publicēts: 03/08/2015 Pēdējo reizi atjaunināts: 03/08/2015

Presentation - Factor VIII and factor IX development plans at the Paediatric Committee: overview (Thorsten Olski)

English (EN) (201.41 KB - PDF)

Pirmo reizi publicēts: 03/08/2015 Pēdējo reizi atjaunināts: 03/08/2015

Presentation - The UK national haemophilia database: a thumbnail sketch!(Charles RM Hay)

English (EN) (1.38 MB - PDF)

Pirmo reizi publicēts: 03/08/2015 Pēdējo reizi atjaunināts: 03/08/2015

Presentation - Haemophilia registries quantity versus quality: the current situation in Europe (Christine Keipert)

English (EN) (618.33 KB - PDF)

Pirmo reizi publicēts: 03/08/2015 Pēdējo reizi atjaunināts: 03/08/2015

Presentation - European haemophilia safety surveillance (EUHASS) (Mike Makris)

English (EN) (404.75 KB - PDF)

Pirmo reizi publicēts: 03/08/2015 Pēdējo reizi atjaunināts: 03/08/2015

Presentation - Community counts! CDC Public Health Surveillance for Bleeding Disorders (Mike Soucie)

English (EN) (304.13 KB - PDF)

Pirmo reizi publicēts: 03/08/2015 Pēdējo reizi atjaunināts: 03/08/2015

Presentation - PedNet registry (Rolf Ljung)

English (EN) (700.72 KB - PDF)

Pirmo reizi publicēts: 03/08/2015 Pēdējo reizi atjaunināts: 03/08/2015

Presentation - FranceCoag network (Roseline d'Oiron)

English (EN) (2.22 MB - PDF)

Pirmo reizi publicēts: 03/08/2015 Pēdējo reizi atjaunināts: 03/08/2015

Presentation - IPFA’s perspective on haemophilia registries usage (Franà§oise Rossi)

English (EN) (375.25 KB - PDF)

Pirmo reizi publicēts: 03/08/2015 Pēdējo reizi atjaunināts: 03/08/2015

Presentation - Medical and Regulatory Policy Plasma Protein Therapeutics Association: Industry perspectives (Mary Gustafson)

English (EN) (211.05 KB - PDF)

Pirmo reizi publicēts: 03/08/2015 Pēdējo reizi atjaunināts: 03/08/2015

Presentation - ISTH and EAHAD perspective on haemophilia registries (Flora Peyvandi)

English (EN) (686.95 KB - PDF)

Pirmo reizi publicēts: 03/08/2015 Pēdējo reizi atjaunināts: 03/08/2015

Presentation - World Federation of Hemophilia (Mark Brooker)

English (EN) (531.29 KB - PDF)

Pirmo reizi publicēts: 03/08/2015 Pēdējo reizi atjaunināts: 03/08/2015

Presentation - Haemophilia registries: patients’ perspective - European Haemophilia Consortium (EHC) (Radoslaw Kaczmarek)

English (EN) (293.16 KB - PDF)

Pirmo reizi publicēts: 03/08/2015 Pēdējo reizi atjaunināts: 03/08/2015