The European Medicines Agency is hosting a multi-stakeholder workshop on the human medicine aspects of its draft ‘Regulatory Science Strategy to 2025’ on 18-19 November.
The draft strategy sets out working proposals on the key areas with which EMA intends to engage, in order to ensure that it has the regulatory tools to continue supporting the European medicines regulatory network and fulfil its ongoing mission in light of upcoming scientific challenges. The final strategy, expected in early 2020, will be a key contribution to the next EU Medicines Agencies Network Strategy (2020-2025) in addition to the Agency’s scientific committees’ and working parties’ workplans through to 2025.
The purpose of the workshop is to discuss the outcome of the public consultation on the draft strategy, reflect on the prioritisation of core recommendations and identify concrete actions to implement the key goals and recommendations.
An agenda of the workshop , which will be held at EMA’s premises in Amsterdam, is available. Both the plenary and breakout sessions can be followed via live broadcast on the event page.
EMA’s ‘Regulatory Science Strategy to 2025’ was released for public consultation between December 2018 and June 2019. Around 150 individuals and organisations across a broad range of stakeholder groups submitted comments which EMA has published in a partially anonymised format. The principle objective of the consultation was to allow stakeholders to engage with the proposed strategy and express their views on future priorities and where resources should be best attributed.
A second workshop with stakeholders for veterinary medicines will take place at EMA on 5-6 December, after which the strategy will be finalised. More details on this workshop will be communicated shortly. The presentations and audio recordings of both workshops will be published.
Remote participants are encouraged to submit comments by email to: [email protected] and participants are encouraged to tweet using the following hashtag: #RegScience2025.
Key priorities of EMA’s Regulatory Science Strategy to 2025
The ‘Regulatory Science Strategy to 2025’ identifies key areas where new or enhanced engagement of the network is essential and where advances in regulatory science will need to be adopted. 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.
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