Tuesday, 2 October
Registration, lunch and exhibition
Welcome address: Henrik Holst, Head of Veterinary Section, MPA, Sweden
14.00 - 15.30: Session 1
The new veterinary Regulation has now reached an advanced stage of the legislative procedure and following the trilogue negotiations in the first half of 2018, delegates to the Symposium can expect to receive an update on the final text agreed between the Council and the European Parliament. This session will also host an update to another major project affecting our regulatory landscape, on e-submission and SPOR.
- Kristina Nordéus - Head of the Swedish Delegation to the European Council Working Party
- Irma van Deurzen - Managing Director, Dopharma Research, Netherlands
- Karin Gröndahl – Head of Department, Registration Office, Medical Products Agency, Sweden
- other speakers to be announced
16.00 - 17.30: Session 2
The EU Network Strategy to 2020 recognises the need to promote the availability of veterinary vaccines in general, and in particular vaccines needed to control emerging diseases. The current regulatory requirements represent a significant challenge to industry by preventing new vaccines reaching the market when they are most needed. This session will provide an update on activities intended to incentivise and facilitate the development and registration of new and novel veterinary vaccines; and the opportunity to discuss progress in an environment where there is a growing need for the rapid registration of safe and effective vaccines.
- Esther Werner - Head of Veterinary Immunologicals Assessment, Paul-Ehrlich-Institut, and Chair of the CVMP Immunological Working Party (IWP-V) at EMA
- Frédéric Descamps – Associate Director Regulatory Affairs, Biologicals in Zoetis and Vice-Chair, AnimalhHealthEurope’s Biological Working Party
- Ivo Claassen - Head of the Veterinary Medicines Division, EMA
18.15 - 19.15
Wednesday, 3 October
9.10 - 10.45: Session 3
One of the main drivers for the new veterinary legislation was the risk of antimicrobial resistance. This risk relates both to efficacious treatment of diseased animals and to public health risk from increased resistance in transmittable bacteria. EU authorities have taken innovative approaches to ensure adequate dosing and efficacy and to control risk profiles of antimicrobials. The outcome and perspectives of these initiatives will be presented. The specific legal proposals related to antimicrobials will be presented, and the future opportunities for handling of infectious diseases will be discussed.
- Helen Jukes, Head of General Assessment and Research Team at Defra and UK member of the EMA's Committee for Medicinal Products for Veterinary Use (CVMP)
- Fredrik Hultén, Clinical Assessor, Medical Products Agency, Sweden
- Johan Schefferlie - Senior Regulatory Project Manager, Medicines Evaluation Board, The Netherlands
- other speakers to be announced
11.15 - 12.45: Session 4
The development of advanced technologies in veterinary medicines requires a well-adapted and adequate regulatory framework and guidance. Projects are often initiated by SMEs with limited experience in the regulatory arena. The session provides an insight on recent experiences and discusses the challenges for both industry and regulators, to make advanced veterinary therapies available for the market.
- Regina Wolf - Head of Regulatory Affairs, Klifovet, Germany
- David John - Technical Manager, AnimalhealthEurope, Belgium
- David Mackay - former Senior Veterinary Advisor, EMA
12.45 - 13.25
13.25 - 14:50: Session 5
Brexit and Global Outlook
This session will cover two topics that will influence plans for the future:
- Brexit will create a lot of challenges to both authorities and marketing authorisation holders. The availability of veterinary medicinal products could potentially be greatly affected.
- Global registration and time to market require improved harmonisation and several initiatives will be presented.
This session will provide an update of the current activities and a forum for discussion.
- Laetitia Le Letty – CMDv Chair, French Agency for Veterinary Medicinal Products (ANSES), France
- Jean-Pierre Orand – Director, French Agency for Veterinary Medicinal Products (ANSES), France
- Lindsey Toon - Regulatory Affairs Director, Benchmark Animal Health Division, UK
Close of Veterinary Symposium