The vet Regulation set out with clear drivers in key areas to reduce the development of AMR, to strengthen environmental protection, to stimulate innovation/availability, to improve the functioning of the internal market and to reduce administrative burden on all sides. Industry and regulators are turning their attention from the intense period processes of implementation Regulation 2019/6 to monitoring the impact of the new regulatory framework. The Veterinary Strategic Focus Group, on behalf of HMA, is developing metrics where the intention is to work closely with industry and veterinarians to determine ah How effectively are the new provisions are being utilised and applied, and are they addressing the objectives of the Regulation? A national competent authority perspective will be presented on progress with implementation and the metrics in development by the HMA Veterinary Strategic Focus Group, in collaboration with stakeholders, will be presented. The industry viewpoint will also be presented with an overview of the experience gained so far: the challenges, opportunities and priorities. The EU medicines agencies’ network strategy to 2028 (EMANS) was finalised earlier in March this year and will guide the network’s activities in the years ahead to meet the challenges ahead across six focus areas, including health threats such as antimicrobial resistance (within the ‘One Health Approach’). An HMA Co-Chair of the EMANS will explain how the strategy applies to veterinary medicines across the different themes, and will provide reflections from the outcome of the public consultation and on the ongoing operational implementation of the strategy via a multi-annual working plan (MAWP) at the EU and national levels. 

Topics to be included in the session: 

Measuring the success of the Regulation 

      - Where we are with implementation 
      - Network initiative to measure the impact of the Regulation
      - A NCA perspective on priorities 

Is the Regulation delivering, an industry perspective’Industry viewpoint.   

      - The Promise of Regulation 2019/6 
      - Access VetMed Analysis – Evidence and Experience 
      - Path Forward – Opportunities for Optimisation and Simplification 

EMANS to 2028: ‘Seizing opportunities in a changing medicines landscape

      - Extension of ongoing EMA/HMA strategy to 2028                                                                                                                     
      - 6 strategic focus areas 
      - 16 operational goals for the underlying multi-annual work plan (MAWP)

Session Leader:

Emily Drury Head of Department, Veterinary Surveillance & Regulatory, European Medicines Agency (EMA), The Netherlands

Speakers will include:

David Murphy Veterinary Assessment Manager,  HPRA, Ireland
Elsa Vecino MTOPRA Technical Director - Consultant, Access VetMed, Spain
Thomas Herberer Head of Department 'Veterinary Drugs',  BVL/HMA, Germany

Some hot topics in the regulatory arena will be explored in session 2, beginning with a run-down of important regulatory developments under the over-sight of the CMDv. This will include the CMDv approach to clinical trials, the latest developments in the assessment of variations, the CMDv perspective on packaging and labelling updates (QRDv9) and lessons learned through from the first SPC harmonisation procedures.  These last two topics will also be explored in more depth by industry speakers. An update will be given on the progress made by marketing authorisation holders to update packaging, and the current challenges to meet the January 2027 deadline.  A company experience will be shared from a project to harmonise the SPCs, involving a unique situation specific to 2025, which will be applicable to other companies. 

Session Leader:

 

Thomas Herberer Head of Department 'Veterinary Drugs',  BVL/HMA, Germany

Speakers will include:

Giulio Bucci Regulatory Affairs Manager, Zoetis Belgium, Belgium
Beate Gasser CMDv Vice-Chair, AGES/BASG, Austria
Erik Waterdrinker MTOPRA Regulatory Affairs Expert  Virbac, France

 

Catering
Please visit one of the catering stands as indicated on the floorplan to enjoy a cup of coffee or tea during the networking break. Various snacks will also be served during the break. Tables and seating can be found throughout the exhibition floor.

Exhibitors
Don't forget to visit our wonderful exhibitors located throughout the exhibition floor during the break.

Networking
Catch up with old colleagues and make new connections during the break. 

Poster Display
On the exhibition floor, TOPRA are delighted to present a collection of scientific posters submitted by our members – be sure to check them out during the session breaks!

The implementation of Regulation (EU) 2019/6 and associated acts on pharmacovigilance has seen a lot of movement over the last 3 years. This session will provide the latest updates and food for thought in navigating the challenges in veterinary pharmacovigilance. You will hear about the signal management processes following the conclusion of the pilot phase, and a forward-looking view on how this new process can be embedded in business as usual over the next few years. In this session we will also explore the experiences with veterinary pharmacovigilance inspections, and provide useful, practical advice based on the most common findings so far. The session will conclude with considerations on how to handle social media and mainstream media attention on veterinary medicinal products, on how this might impact on pharmacovigilance in practice and open the floor for an exchange of views how to handle the challenges arising from communication on the subject. 

Topics to be included in the session: 

Overview of the revised process for signal management within the EU 

      - Outcome and learnings from the pilot phase in the signal management implementation  
      - Practical implications of the revised process for regulators, and impact on industry  
      - Experience so far, and what to expect in the future 

Pharmacovigilance Inspections within the EU  

      - Introduction to the PhV Inspections process  
      - Practical experience with most common findings and actionable advice  
      - Interplay between national and QPPV inspections 

Handling of safety concerns arising in social media, also resulting in press attention 

      - Providing background and experience with social media interest  
      - Impact of media attention on pharmacovigilance 
      - Discussion of challenges in communication 

Session Leader:

Jana Schalansky Head of Veterinary Strategic Support Office, European Medicines Agency (EMA), The Netherlands

Speakers will include:

Camelia Mihaescu Head of Veterinary Pharmacovigilance, European Medicines Agency (EMA), The Netherlands
James Mount Pharmacovigilance Assessor, and Chair of CVMP Pharmacovigilance Working Party - Veterinary (PhVWP-V), Swedish Medical Products Agency, Sweden
Tony Simon Director, Scientific Affairs, Zoetis, Belgium

There are several on-going activities, both at EU level and at international level, to review the standards for the quality of manufacturing. At EU level the Implementing Acts for Good Manufacturing Practice of active substances and for manufactured products have introduced important changes in the legal framework. These will soon come into force. Industry experts will provide an analysis of what is new and what has changed from an operational GMP perspective, including experience with inspections. 

At the international level there are projects both within VICH and within PIC/S to develop internationally accepted GMP norms. How will these projects maintain alignment at international level and with the legal framework for human products and what will be the impact on the EU industry? 

Session Leader:

Jaume Colomer Senior Technical Manager, Animalhealth Europe, Belgium

Speakers will include:

Martin Folger Principal Fellow CMC Expert & Risk Management, Boehringer Ingelheim Vetmedica GmbH, Germany
Emmanuelle Motte Director, Regulatory Affairs, Virbac, France

Catering
Please visit one of the catering stands as indicated on the floorplan where lunch will be served. Various snacks will also be served during the break. Tables and seating can be found throughout the exhibition floor.

Exhibitors
Don't forget to visit our wonderful exhibitors located throughout the exhibition floor during the break.

Networking
Catch up with old colleagues and make new connections during the break. 

Poster Display
On the exhibition floor, TOPRA are delighted to present a collection of scientific posters submitted by our members – be sure to check them out during the session breaks!

Regulation 2019/6 paid particular attention to two classes of products that are key to disease control: immunologicals and antimicrobials.  Has this enhanced our ability to respond effectively to new disease situations? The experience gained during national emergency use of vaccines under Article 110(2) of Regulation 2019/6, and how that feeds into evaluation of MA applications that are subsequently submitted, will be explained. The final presentation in this session will review how the EMA and CVMP are implementing new provisions aimed at controlling antimicrobial resistance, restrictions on how they can be used within the context of prophylaxis. 

Speakers will include:

Ana Maria Azaceta Avila Scientific Officer, Veterinary Regulatory Affairs and Referrals Service, EMA, The Netherlands

 

This session will explore the work of the European Commission to develop a roadmap for transitioning to animal-free chemical safety assesment in the EU, and the work of the CVMP to support the qualification of non-animal methods for testing of veterinary medicinal products and promote regulatory integration of 3Rs-compliant methods. The session will discuss the implications of this shift to the veterinary medicinal products sector, the scientific and regulatory challenges, and the opportunities for innovation in safety assessment. Attendees will gain insights into the roadmap objective, milestones and timeline, alternative testing strategies, and the evolving regulatory landscape shaping the future of veterinary medicine development.

Topics to be included in the session: 

Progress in developing the EC roadmap towards phasing out of animal testing in the safety assessment of chemicals

      - How to manage change and involvement of all sectors and stakeholders, and 
      - How to measure progress, to understand benefits and obstacles.

Revision of guidance on testing requirements and implementation of 3Rs

      - Reflection paper on the current regulatory testing requirements for veterinary medicinal products and opportunities for implementation of the 3Rs 
      - This reflection paper has been revised following the public consultation in the first half of 2025 
      - What are the key challenges and opportunities for the veterinary medicinal products sector.

Session Leader:

Esther Werner Director Paul-Erhlich-Institut, Germany

Speakers will include:

 

Sarah Adler-Flindt Vice-Chair of Joint CHMP/CVMP 3Rs Working Party,  BVL, Germany
Elisabet Berggren Senior Scientist  Joint Research Centre, European Commission, Belgium