Programmes

See below for the 2022 programme for the TOPRA Annual Symposium. The programme for the 2023 Symposium in Lisbon will be published in the near future.

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Veterinary Medicines Symposium 2023

23 October

  12:00 – 12:30 Registration and welcome to the Veterinary Medicines Symposium 

12:30 – 12:40 Welcome from the Working Party Chair Dr. Mel Munro and the Portuguese Direção-Geral de Alimentação e Veterinária (DGAV)/ General Directorate for Food and Veterinary Medicine representative Inês Martins de Almeida, Head of Unit of Veterinary Medicines Products 
  12:40 – 14:10

VM1: Horizontal legislation and veterinary medicine availability

Session Leader

  • Rick Clayton – Technical Director, AnimalhealthEurope, Belgium

    • This session looks at issues surrounding the availability of veterinary medicines from two different perspectives.  There will be a review of the impact of “horizontal legislation” (i.e. EU legislation that applies across all industry sectors) on the veterinary medicines sector and the potential threat to the availability of veterinary medicines that it presents. The sessionwill then hear the veterinarian’s view on how the veterinary medicines regulation influences access to medicines, or their restricted use, in the field.  

     

    12:40  Introduction

    12:45  Horizontal legislation and impact on availability: Jaume Colomer – Senior Technical Manager, AnimalhealthEurope, Belgium 

  • The impact of Regulation 2019/6 on the lives of vets
  • View from the ground on availability of veterinary medicines
  • Access to information on shortages

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    13:15  Access to medicines – views of the veterinary profession: Nancy De Briyne – Executive Director, Federation of Veterinarians of Europe (FVE), Belgium 

  • European Green Deal and Chemical Sustainability Strategy 
  • Challenges arising from ‘horizontal legislation’ in the EU
  • Impact on veterinary medicines:
              - Impact on development and manufacturing strategies
              - Impact on packaging
    •           - Impact on cost and availability of VMPs

    13:45  Panel discussion
      14:10 – 14:50 Networking break
      14:50 – 16:20

    VM2: New Initiatives in Regulatory Science

    Session Leader:

  • Raffaele Bruno – Associate Director Regulatory Affairs, Zoetis, Belgium

    • This session will firstly provide the audience with an update about the EMA’s Regulatory Science Strategy to 2025 focusing on the goals and achievements relevant to veterinary medicines. One of the key goals of the strategy is to catalyse the integration of science and technology in medicine development: in this context, the further application of the 3Rs principles has been identified as a priority. The topic will be addressed in further detail within the session, acknowledging the growing interest to find suitable alternatives to the use of animals for regulatory testing of medicines, with the Euopean Medicines Agency (EMA) advising companies about the acceptable solutions for the replacement, reduction and refinement of animal testing. Today, non-animal methodologies are successfully adopted in batch testing of vaccines, while opportunities in other areas exist that are not fully exploited.  The session will offer an overview of the potential 3Rs solutions relevant to the veterinary field from the perspective of the EMA Joint CVMP/CHMP Expert Group on 3Rs, as well as industry’s view on the implementation of such solutions in EU and global development programs.

     

    14:50  Introduction

    14:55 Regulatory Science Strategy update: Tony Humphreys– Head of Regulatory Science and Innovation Task Force, EMA, the Netherlands

  • Strategic driver for the Regulatory Science Strategy to 2025 initiative
  • Approach to implementation of the strategic goals
  • Mid-point status report with emphasis on elements of interest to the development of veterinary medicines


    • 15:15 3Rs Initiative – EMA Approach: Michael Empl – Scientific Specialist and Veterinary Secretary of the CHMP/CVMP 3Rs Working Party (3RsWP), EMA, the Netherlands

  • The 3RsWP — Past, current and future 3Rs-related activities at EMA
  • Method qualification and regulatory acceptance — Possibilities for method developers to interact with EMA
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    15:35 Access to Medicines – Views of the Veterinary Profession FVE: Corinne Phillipe – Head of Regulatory Intelligence, Policy & Communications, Boehringer Ingelheim Animal Health France, France
  • Examples of 3Rs solutions already implemented by industry
  • Challenges faced for broader adoption of NAM solutions
  • What are the perspectives & opportunities
  • Increasing regulatory acceptance

    • 15:55  Panel discussion              

     
      16:20 – 17:00 Networking break
      17:00 – 18:30

    VM3: Regulatory exchange and new/future approaches 

    Session Leader: 

  • Dr. Mel Munro - Global Lead, Regulatory Science, Knoell Animal Health, UK

    • Navigating the regulatory procedures for product life-cycle management through a continually evolving landscape requires expertise and, importantly, the latest regulatory intelligence. This session will provide practical updates and analysis from EU regulators and industry on the pressures, challenges and opportunities ahead, within the EU and UK regulatory frameworks. Labelling will be a running theme in the presentations. 

    17:00  Introduction

    17:05  CMDv update: Beate Gasser – CMDv Vice-Chair, Bundesamt für Sicherheit im Gesundheitswesen (BASG)/ Austrian Federal Office for Safety in Health Care and Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH (AGES)/ Austrian Agency for Health and Food Safety, Austria  

  • SPC harmonisation exercise, update on procedural aspects and planned work for 2023-2024 
  • 5-year exercise to align authorised products with QRD product information template v.9; CMDv guidance and industry survey of progress so far 
  • Database challenges for national competent authorities (UPD and CTS), including technical grouping and consequential VNRAs 

    • 17:25 Possibilities to Simplify Regulatory Approaches: Patrizia Oelker – RA EU Senior Expert, Boehringer Ingelheim Vetmedica, Germany 

  • Overview of AnimalhealthEurope’s internal survey on opportunities for simplification within existing legal framework 
  • Proposals on what could be simplified and how, based on experience so far 

    • 17:45 New UK legislation: Gavin Hall - Director of Authorisations & Deputy CEO at Veterinary Medicines Directorate (VMD) and Donal Murphy - Head of International and Regulatory Affairs, NOAH Ltd, UK  

  • GB Veterinary Medicines Regulations, direction of travel, differences with Regulation 2019/6 and opportunities (Gavin Hall) 
  • Reflections on potential impacts on industry: Donal Murphy 

    • 18:05  Panel discussion

     

     

    24 October

      All times WEST (GMT+1)
      9:00

    		 Welcome to the second day of the Veterinary Medicines Symposium from the chair, Dr. Mel Munro
      9:05 – 10:30

    VM4: Living with Post Authorisation Obligations – progress, challenges and future opportunities                                                                                                     

    Session Leader: 

  • Dr. João Duarte da Silva - Senior Officer, Veterinary Medicines Unit, Direção-Geral de Alimentação e Veterinária (DGAV)/ General Directorate for Food and Veterinary Medicine, Portugal 

    • Following the implementation of the Veterinary Medicinal Products Regulation in January 2022, significant changes were implemented in our regulatory network  including pharmacovigilance data and signal manegent, the European Medicines Agency (EMA), together with the regulatory authorities in the Member States and marketing authorisation holders are responsible for detecting and managing safety signals. In this session we introduce the Industry view on Post Authorisation Obligations focusing on the safety data and signal detection and management.

    We also approach the perspective of national competent authority with the contribution of the Head of Unit of Veterinary Medicines Products, DGAV, Portugal that will share the views of the NCAs on UPD Sales data and incidence calculation (EVVET) Data quality  of the UPD and also a report of the current state of the assesement and approval of variation G1/18 for the aligned with QRD and also the Legal obligations regarding article 5.6 of the Regulation. The final theme of this session is related to the availability of veterinary medicines issue from the perspectives of the industry and challenges that can emerge.
     

    9:05  Introduction

    9:10  PhV safety data and signal detection: Kathrin Schirmann - Scientific Officer, Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)/The Federal Office of Consumer Protection and Food Safety, Germany

  • Safety data and signal management including signal detection.
  • EVVet data warehouse

    •           - Current state
              - Upcoming system developments

  • Variations requiring assessment (VRA) related to signal management.
     

    • 9:30  Progress with Post-Authorisation Obligations from 2019/6 from an NCA perspective: Inês Martins de Almeida - Head of Unit of Veterinary Medicines Products, Direção-Geral de Alimentação e Veterinária (DGAV)/ General Directorate for Food and Veterinary Medicine, Portugal

  • Status of UPD, data quality and plans for new functionalities.
  • VRA G.I.18 alignment with QRD V. 9 NCA perspective.
  • Avaiability of VMPs in Portugal –UPD, National platforms, and electronic prescription platform (PEMV).

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    9:50 Industry view on Post Authorisation Obligations: Dr. Magali Quetin - Head of Global Pharmacovigilance EU & QPPV, Boehringer Ingelheim Vetmedica GmbH, Germany

  • Signal management 
  • PhV Inspections 
  • OPAD 

    •           - Reporting availability
              - Reporting volume of sales 

    10:10  Panel discussion

     
      10:30 – 11:00   Networking break
       11:00 – 11:45 

    TOPRA Annual Lecture - Opportunities and challenges for healthcare in the future

    Speaker:

  • Dr Miguel Forte - Managing Director, mC4Tx and President-Elect ISCT, Belgium

    •  
       11:45 – 12:30 TOPRA Annual Review
       12:30 – 13:30   Lunch break
      13:30 – 15:00 

    VM5: Digital Innovation to Support Animal and Public Health

    Session Leader: 
  • Jana Schalansky – Head of Veterinary Strategic Support at Veterinary Medicines Division (EMA), the Netherlands

    • Following the implementation of the Veterinary Medicinal Products Regulation in January 2022, regulators collect and exchange more data in the area of veterinary medicines, including pharmacovigilance and soon also antimicrobials sales and use. This creates a need to examine how to transform and use these data, with the aid of innovative digital methodologies, to support veterinary regulatory activities to foster animal and public health. The session will provide updates on the progress in the domain of human medicinal products, what can be learned and potentially leveraged for the veterinary domain, and the progress made so far. Finally, the session will provide a practical example to encourage a discussion on the challenges and opportunities arising from emerging technologies.  

    13:30  Introduction

    13:35  Big Data – Human progress and direction: Ricardo Carapeto García - Head of Area of Environmental Risks, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)/ Spanish Agency of Medicines and Medical Products, Spain

  • Progress made in human domain
  • Real World Evidence impact on registration
  • DARWIN EU    

     

    13:55  Big Data – Veterinary progress & opportunities: Ilaria Del Seppia - Chair of the EU Vet Big Data Hub, Data Scientist - Veterinary Division at European Medicines Agency (EMA), the Netherlands

  • Progress made in veterinary domain 
  • Veterinary Big Data strategy, workplan and data landscape analysis
  • Drivers and opportunities for future application of big data in the veterinary domain
     

    • 14:15  Innovation in Veterinary Medicine – practical approaches to using Big Data: Dr Jade Bokma - Postdoctoral researcher, Faculty of Veterinary Medicine at Universiteit Gent, Belgium 

  • Introduction DECIDE and example of one specific deliverable
  • Objectives, methods, progress
  • Potential future uses

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    14:35  Panel discussion            
      15:00 Closing of the Veterinary Medicines Symposium by Working Party Chair, Dr. Mel Munro

     

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