Risk assessment guideline focus group meeting

• Date:
  Wednesday, 19 September 2018, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

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

Draft Reference Number: EMA/459760/2018

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)

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)

Presentation - Use of EMA’s risk assessment guideline - Danish experience (Lis Alban)

Presentation - Risk assessment of AMR: discussion and further thoughts (Johanne Ellis-Iversen)

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)

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)

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)