Speakers will include:

 

Rick Clayton Technical Director HealthforAnimals and AnimalhealthEurope Belgium	Thomas Heberer Head of Department 3 "Veterinary Drugs",  BVL/ HMA, Germany

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

      - 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 Support, 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 Heberer Head of Department 3 "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. 

CMDv Update 

      - Pilot on clinical trials coordination 
      - Update on variations
      - SPC harmonisation – lessons learned 

A dive into SPC harmonisation based on recent experiences

      - From the selection of the reference product to the end of procedure  
      - Harmonisation of a hybrid VMP with its reference product 
      - Discuss challenges (communication, lack of common denominators, etc.), positive discussions with RMS and potential improvements 

Session Leader:

 

Thomas Heberer Head of Department 3 "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 Office, European Medicines Agency (EMA), The Netherlands
James Mount Clinical Assessor, and Chair of CVMP Pharmacovigilance Working Party - Veterinary (PhVWP-V), Swedish Medical Products Agency, Sweden
Tony Simon Director, Scientific Affairs and Pharmacovigilance, 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? 

Industry analysis of the Implementing Acts on GMP for VMP and AS  

      - What is the impact from a company operational GMP perspective 
      - How do we ensure future alignment with human GMPs (including inspections)  
      - Prospects for global harmonisation 

Status of development of Annexes 4 and 5 as key documents to host veterinary specificities

      - Relevance of current / draft guidance e.g Annex 4, Annex 5, VICH GL 60 to host veterinary specificities 
      - How will inspectors take vet specificities into consideration for VMPs? 

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 Corporate Regulatory & Public Affairs Director Virbac, France
Virgilio Donini Ministry of Health Italy

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 put particular emphasis on two classes of products that are key to disease prevention and control: immunologicals and antimicrobials. This session will explore current experience and activities within the two areas.  The experience gained during national emergency use of vaccines under Article 110(2) of Regulation 2019/6 will be explored, and how that can feed into evaluation of MA applications (under exceptional circumstances) that are subsequently submitted. 

The industry perspective will cover the EU's regulatory preparedness for next-generation animal health innovations.  It will look at emerging technologies, their regulatory challenges, and the evolving role of regulatory affairs professionals.  The final presentation in this session will review how the EMA and CVMP are implementing new provisions aimed at preventing the further development of antimicrobial resistance.

Immunologicals:  

      - Experience gained during national emergency use of HPAI and BTV3 vaccines under Article 110(2)  of Reg. 2019/6
      - How that experience can support the evaluation of subsequent MA applications.  
      - Experience of supply in the transition from emergency use to authorised use (packaging)

Biologicals:

      - The Future is Now: Regulatory Readiness for Next-Generation Animal Health 
      - The EU Regulatory Landscape – are we set up for success? 
      - Navigating New Technologies: Benefits and Challenges 
      - The Evolving Role of Regulatory Affairs

Antimicrobials: an update on the new AMR-related procedures at CVMP

      - The CVMP’s project on dosage review and adjustment of selected veterinary antibiotics; 
      - CVMP scientific advice under Article 141(1)(i) of Regulation (EU) 2019/6 on minimising occurrence of resistance deriving from the use of antimicrobials;
      - Intentions on the next revision of the CVMP’s guideline on SPCs for antimicrobials to flag restrictions on use for products with prophylactic indications. 

Session Leader:

Anne Nallen Head of Global Regulatory Affairs CMC, Ceva Sante Animale, Ireland

Speakers will include:

Ana Maria Azaceta Avila Scientific Officer, EMA, The Netherlands
Beate Lohr Senior Director Global Regulatory  Biologicals, Elanco Animal Health GmbH, Germany
Yvonne Gall Veterinary Officer, Federal Ministry of Agriculture, Food and Regional Identity, Germany

 

This session will explore the work of the European Commission to develop a roadmap for transitioning to animal-free chemical safety assessment 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 

      - Current State of the Commission roadmap 
      - How to manage change and involvement of all sectors and stakeholders 
      - How to measure progress, to understand benefits and obstacles 

Revision of guidance on 3Rs opportunities in current testing requirements  

      - Reflection paper on the current regulatory testing requirements for veterinary medicinal products and opportunities for implementation of the 3Rs 
      - This reflection paper is currently under revision (public consultation ended June 2025)  
      - What are the key challenges and opportunities for the veterinary medicinal products sector 


Session Leader:

Esther Werner Head of Veterinary Medicines Division, Paul-Ehrlich-Institut, Germany

Speakers will include:

 

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