Focus group with invited stakeholders on field efficacy trials in the context of an EU authorisation for veterinary vaccines
Date:
22/06/2017 to 23/06/2017
Location:
European Medicines Agency, London, UK
The Agency organised a focus group meeting with invited stakeholders on field efficacy trials in the context of an EU authorisation for veterinary vaccines.The scope of the meeting was to explore the specific challenges faced by industry in performing field trials to support efficacy claims in the context of an EU authorisation for veterinary vaccines and how these challenges might be overcome whilst still obtaining adequate assurances of the expected efficacy of a vaccine under field conditions. The focus group meeting was within the scope of the HMA Network Strategy on availability for veterinary vaccines that aims to increase their availability by ensuring efficient and effective cooperation between all stakeholders.
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Programme – Focus group with invited stakeholders on field efficacy trials in the context of an EU authorisation for veterinary vaccines (PDF/100.91 KB)
Draft
First published: 06/06/2017
Last updated: 16/11/2017
EMA/159266/2017 -
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Report on the Focus Group meeting with invited stakeholders on field efficacy trials in the context of an EU authorisation for veterinary vaccines (PDF/147.27 KB)
First published: 16/11/2017
Last updated: 16/11/2017
EMA/405642/2017 -
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Recommendations from the Joint EMA/HMA Steering Group on veterinary vaccine availability to CVMP based on the outcome of the Focus Group meeting with invited stakeholders on field efficacy trials in the context of an EU ... (PDF/77.72 KB)
First published: 16/11/2017
Last updated: 16/11/2017
EMA/548726/2017 -
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Concept note – Focus group with invited stakeholders on field efficacy trials in the context of an EU authorisation for veterinary vaccines (PDF/105.7 KB)
First published: 06/06/2017
Last updated: 06/06/2017
EMA/52857/2017 -
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Presentation - Setting the scene: Steering Group introduction to focus group and objectives (J. Orand and F. Ioannou) (PDF/121.88 KB)
First published: 16/11/2017
Last updated: 16/11/2017 -
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Presentation - Field efficacy trials for vaccines for food-producing animals-challenges faced by industry (F. Descamps) (PDF/401.24 KB)
First published: 16/11/2017
Last updated: 16/11/2017 -
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Presentation - Challenges in performing field trials to support efficacy - companion animal vaccines (K. Hellmann) (PDF/516.28 KB)
First published: 16/11/2017
Last updated: 16/11/2017 -
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Presentation - Field efficacy trials versus laboratory challenge experiments (E. Thiry) (PDF/199.6 KB)
First published: 16/11/2017
Last updated: 16/11/2017 -
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Presentation - Summary of interim results from analysis of field efficacy data for centrally authorised products (M. Ilott) (PDF/175.13 KB)
First published: 16/11/2017
Last updated: 16/11/2017 -
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Presentation - An overview of US efficacy requirements to support licensing veterinary vaccines (P. Hauer) (PDF/131.11 KB)
First published: 16/11/2017
Last updated: 16/11/2017 -
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Presentation - When can field trials contribute practically to understanding of efficacy (and when do they not) (J. Wood) (PDF/122.25 KB)
First published: 16/11/2017
Last updated: 16/11/2017 -
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Presentation - Alternatives provided by recent system modelling in animal health for the upscaling of vaccine efficacy (H. Thulke) (PDF/847.64 KB)
First published: 16/11/2017
Last updated: 16/11/2017