With two seismic regulatory events on the horizon for European regulatory professionals, this session is an opportunity to review both the progress of the draft Regulation on veterinary medicinal products (VMPs) and the impending impact on industry and national competent authorities (NCAs) following the exit of the UK from the EU.
Chair: Gavin Hall – VMD, UK
Update on progress of the draft Regulation within the Council WP
Panel discussion on looking to the draft Regulation
The speakers above plus invited guests
BREXIT Day Zero issues
Panel Discussion on BREXIT
Streamlining processes and operations is important to facilitate the current authorisation procedures of veterinary medicinal products. This update on recent initiatives and collaborative approaches, including innovative regulatory technologies, provides some options.
Chair: Valérie Van Merris – Federal Agency for Medicines and Health Products (FAMHP), Belgium
Heads of Medicines Agencies (HMA) Regulatory Optimisation Group (ROG)
Gavin Hall – VMD, UK
Update on ISO IDMP and SPOR projects
Isabel Chicharo, Kepa Amutxastegi – European Medicines Agency
Industry viewpoint on the eSubmission roadmap, version 2.0
Patrizia Oelker – Boehringer Ingelheim Animal Health, Germany
Questions and discussion
The speakers will take questions from the floor – this is your opportunity to explore the topics more fully.
Join main symposium for Board presentation and Poster winner.
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Programme subject to change.