Workshop: advancing regulatory science to 2025 for veterinary medicines
EMA is holding a workshop on Thursday, 6 December 2018 in London to gather views from a wide range of stakeholders concerning key areas in veterinary medicines to be covered in the Agency’s Regulatory Science Strategy to 2025.
Innovation in veterinary medicines has made significant progress over the last few years. In addition, the upcoming veterinary legislation will have a major impact on the development and regulation of medicines for animals.
To keep pace with these advances and ensure the sound assessment of ground-breaking, more complex therapies, regulators need to have optimal tools to improve ‘regulatory science’ – a range of scientific disciplines that are applied to the quality, safety and efficacy assessment of medicines and that inform regulatory decision-making throughout the lifecycle of a medicine.
Therefore, EMA is developing a ‘Regulatory Science to 2025’ strategy, a strategic plan for advancing regulatory science over the next five to ten years, covering both human and veterinary medicines.
The workshop will bring together veterinarians, representatives from the veterinary pharmaceutical industry, academia, trade associations and regulators. The participants will have the opportunity to reflect on the scientific and technological advances in the area of veterinary medicines, as well as the challenges that EMA’s scientific committees and working parties will face in the future. The workshop will also facilitate discussions on ways to address emerging health threats like antimicrobial resistance and the availability of medicines. In addition, it will highlight areas relevant to various stakeholder groups in advance of a six-month public consultation on the proposed strategy to be launched in December 2018.
Participants are encouraged to tweet using the following hashtag: #RegScience2025.
Key priorities of the Regulatory Science Strategy to 2025
The ‘Regulatory Science Strategy to 2025’ aims to identify key areas where new or enhanced engagement of the network is essential and where advances in regulatory science will need to be adopted. It will help shape the vision for the next EU Medicines Agencies Network Strategy (2020–2025).
The five key goals of the strategy include:
- catalysing the integration of science and technology in medicine development;
- driving collaborative evidence generation;
- improving the scientific quality of evaluations;
- addressing emerging health threats and availability/therapeutic challenges;
- enabling and leveraging research and innovation in regulatory science.