Veterinary Medicines Symposium programme

TUESDAY, 3 OCTOBER

Registration, lunch and exhibition

12.00


Welcome from TOPRA and opening remarks

Welcome address:

  • Professor Peter Borriello – CEO Veterinary Medicines Directorate (VMD), UK, including comments on VMD’s future post-EU exit

13.00


Session 1: Facing imminent regulatory challenges

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

  • Andrew Aguis - Veterinary and Phytosanitary Regulation Department, Ministry For Sustainable Development, The Environment And Climate Change, Malta
    Presentation (PDF)
  • Stephen Spiteri- Veterinary and Phytosanitary Regulation Department, Ministry For Sustainable Development, The Environment And Climate Change, Malta
    Presentation (PDF)

13.15


Panel discussion on looking to the draft Regulation
The speakers above plus invited guests


13.40


BREXIT Day Zero issues


14.20


Panel Discussion on BREXIT


14.40



Break

15.20


Session 2: Optimising regulatory operational procedures

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)
Presentation (PDF)
Gavin Hall – VMD, UK

  • Composition
  • Methodology
  • Timelines
  • Potential benefits.

16.00


Update on ISO IDMP and SPOR projects
Presentation (PDF)
Isabel Chicharo, Kepa Amutxastegi – European Medicines Agency

  • The business case for SPOR
  • What will SPOR deliver: RMS, OMS and P&SMS
  • SPOR timelines and benefits
  • NCA and industry involvement/impacts
  • Key messages.

16.20


Industry viewpoint on the eSubmission roadmap, version 2.0
Presentation (PDF)
Patrizia Oelker – Boehringer Ingelheim Animal Health, Germany

  • The different veterinary-relevant components of the eSubmission roadmap
  • Progress made towards reduction of administrative burden
  • Practical implications for industry
  • Further opportunities.

16.40


Questions and discussion
The speakers will take questions from the floor – this is your opportunity to explore the topics more fully.


17.00



Close of day

Join main symposium for Board presentation and Poster winner.


17.30



Dinner

19.15


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Programme subject to change.