EMA is hosting a workshop on Wednesday, 24 October to gather insight from stakeholders on the key areas in human medicines to be covered in its ‘Regulatory Science Strategy to 2025’, a proposed new high-level plan for advancing its engagement with regulatory science.
The workshop will offer an opportunity to reflect on the scientific and technological advances in the pharmaceutical arena, the challenges that the Agency’s scientific committees and working parties will face in the future and to look at initial proposals to address them. It will also 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 will include patients, healthcare professionals and academia, as well as representatives of health technology assessment (HTA) bodies, payer organisations, trade associations and regulators. The workshop will kick off discussions on how to best reshape the regulatory environment so that EMA, working as part of the European medicines regulatory network, can support advances coming through research and development pipelines in the coming years.
The ‘Regulatory Science Strategy to 2025’ will identify key areas where new or enhanced engagement of the network is essential and where advances in regulatory science will need to be adopted.
The strategy will help shape the vision for the next EU Medicines Agencies Network Strategy (2020–2025). It will seek to offer informed guidance on modern product development, facilitate the optimisation of regulatory tools to improve the various processes and critically assess the benefits and risks of innovative therapies and diagnostics based on new technologies.
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; advancing patient-centred access to medicines in partnership with healthcare systems; addressing emerging health threats and availability/therapeutic challenges; enabling and leveraging research and innovation in regulatory science.
