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

• Date:
  Thursday, 22 June 2017
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

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

DraftReference Number: EMA/159266/2017

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

Reference Number: EMA/405642/2017

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 ...

Reference Number: EMA/548726/2017

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

Reference Number: EMA/52857/2017

Presentation - Setting the scene: Steering Group introduction to focus group and objectives (J. Orand and F. Ioannou)

Presentation - Field efficacy trials for vaccines for food-producing animals-challenges faced by industry (F. Descamps)

Presentation - Challenges in performing field trials to support efficacy - companion animal vaccines (K. Hellmann)

Presentation - Field efficacy trials versus laboratory challenge experiments (E. Thiry)

Presentation - Summary of interim results from analysis of field efficacy data for centrally authorised products (M. Ilott)

Presentation - An overview of US efficacy requirements to support licensing veterinary vaccines (P. Hauer)

Presentation - When can field trials contribute practically to understanding of efficacy (and when do they not) (J. Wood)

Presentation - Alternatives provided by recent system modelling in animal health for the upscaling of vaccine efficacy (H. Thulke)