Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation

• Date:
  Friday, 12 October 2018, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

This meeting will allow a direct exchange of views between the Agency's working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental approaches for dose optimisation and evaluating the consequences on withdrawal periods, target animal safety, and environmental risk assessment, with the objective of improving the SPC of veterinary antibiotics authorised in the European Union.

Documents

Draft agenda - Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation

Draft Reference Number: EMA/517715/2018

Presentation - Focus group meeting the pilot project on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation: overview (Johan Schefferlie)

Presentation - Industry view on the draft RP on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation - EMA/CVMP/849775/2017 (Hilde Moyaert)

Presentation - Pilot project on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation: industry view (Elsa Vecino)

Presentation - Focus group meeting the pilot project on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation: PK/PD approach for dose optimisation (Damien Bouchard, Pascal Sanders)

Presentation - Focus group meeting the pilot project on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation: target animal safety (Helen Jukes)

Presentation - Focus group meeting the pilot project on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation: environmental risk assessment (Johan Schefferlie)

Presentation - Focus group meeting the pilot project on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation: dose dependent withdrawal periods (Peter Hekman)