Focus group with invited stakeholders on field efficacy trials in the context of an EU authorisation for veterinary vaccines

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TitleFocus group with invited stakeholders on field efficacy trials in the context of an EU authorisation for veterinary vaccines
Date22/06/2017 - 23/06/2017
LocationEuropean Medicines Agency, London, UK
SummaryThe 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.

All documents

Name Language First published Last updated
Programme – Focus group with invited stakeholders on field efficacy trials in the context of an EU authorisation for veterinary vaccines (English only) 2017-06-06 2017-11-16
Report on the Focus Group meeting with invited stakeholders on field efficacy trials in the context of an EU authorisation for veterinary vaccines (English only) 2017-11-16  
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 authorisation for veterinary vaccines (English only) 2017-11-16  
Concept note – Focus group with invited stakeholders on field efficacy trials in the context of an EU authorisation for veterinary vaccines (English only) 2017-06-06  
Presentation - Setting the scene: Steering Group introduction to focus group and objectives (J. Orand and F. Ioannou) (English only) 2017-11-16  
Presentation - Field efficacy trials for vaccines for food-producing animals-challenges faced by industry (F. Descamps) (English only) 2017-11-16  
Presentation - Challenges in performing field trials to support efficacy - companion animal vaccines (K. Hellmann) (English only) 2017-11-16  
Presentation - Field efficacy trials versus laboratory challenge experiments (E. Thiry) (English only) 2017-11-16  
Presentation - Summary of interim results from analysis of field efficacy data for centrally authorised products (M. Ilott) (English only) 2017-11-16  
Presentation - An overview of US efficacy requirements to support licensing veterinary vaccines (P. Hauer) (English only) 2017-11-16  
Presentation - When can field trials contribute practically to understanding of efficacy (and when do they not) (J. Wood) (English only) 2017-11-16  
Presentation - Alternatives provided by recent system modelling in animal health for the upscaling of vaccine efficacy (H. Thulke) (English only) 2017-11-16  

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