The report of the IHI Regulatory Science Summit is now available on the Engaging with regulators page of the IHI website. The summit, held in Brussels, Belgium on 27-28 February, brought together representatives of regulatory agencies for medicinal products and devices as well as people from the European Commission and IHI’s industry members.
Over the course of two days, the group discussed challenges and opportunities in regulatory science that could be addressed by a cross-sectoral public-private partnership like IHI. They also explored how to maximise the regulatory impact of IHI projects. The meeting focused on five key areas: rare diseases, paediatrics, real-world data / real-world evidence (RWD/RWE), artificial intelligence (AI) and regulatory sandboxes.
For each area, the report summarises the main points made during the discussions and the key takeaways in terms of the areas where IHI could make a difference.
The meeting revealed a shared ambition to transform health by identifying clear research questions that will address public health needs collectively and improve patients' lives, and provided insights into how IHI, as a cross-sectoral public-private partnership providing a unique multi-stakeholder platform, could contribute to regulatory science going forward.