Risk assessment guideline focus group meeting
The Antimicrobials Working Party of the European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) is holding a focus group meeting with stakeholders to discuss the revision of the antimicrobial veterinary medicinal product risk assessment guideline, following a public consultation on the draft revised guideline ending on 31 October 2018. The meeting will focus on topics identified during this public consultation. This guideline aims to provide guidance to marketing authorisation applicants on the data requirements and methodology to be used for assessing the risk to public health from antimicrobial resistance from use of those products in food-producing animals.
-
List item
Draft agenda - Focus group meeting on the guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals (PDF/120.56 KB)
Draft
First published: 11/09/2018
Last updated: 11/09/2018
EMA/459760/2018 -
List item
Presentation - Overview: guideline on the assessment of the risk to public health from AMR due to use of an antimicrobial VMP in food-producing animals (Helen Jukes) (PDF/319.94 KB)
First published: 13/11/2018 -
List item
Presentation - Industry view on the draft guideline on the assessment of the risk to public health from AMR due to the use of an antimicrobial VMP in livestock (Alexander Boettner) (PDF/714.41 KB)
First published: 13/11/2018 -
List item
Presentation - Use of EMA’s risk assessment guideline - Danish experience (Lis Alban) (PDF/597.08 KB)
First published: 13/11/2018 -
List item
Presentation - Risk assessment of AMR: discussion and further thoughts (Johanne Ellis-Iversen) (PDF/620.45 KB)
First published: 13/11/2018 -
List item
Presentation - Guideline on the assessment of the risk to public health from AMR due to use of an antimicrobial VMP in food-producing animals: key updates after public consultation (Helen Jukes) (PDF/288.3 KB)
First published: 13/11/2018 -
List item
Presentation - Guideline on the assessment of the risk to public health from AMR due to use of an antimicrobial VMP in food-producing animals: categorisation of risk factors, risk assessment steps and overall risk estimation (Christine Schwarz) (PDF/400.98 KB)
First published: 13/11/2018 -
List item
Presentation - Guideline on the assessment of the risk to public health from AMR due to use of an antimicrobial VMP in food-producing animals: pragmatic consequence assessment (Damien Bouchard) (PDF/380.87 KB)
First published: 13/11/2018