João Duarte | Vice President, Head of Global Regulatory Affairs Excellence
Ipsen

Day 2 - Wednesday 29 October @ 11:45

RealiseD - Realising clinical trials in ultra-rare diseases

RealiseD unites nearly 40 partners from academia, regulatory bodies, clinical research institutes and hospitals, patient organisations, pharmaceutical companies or European Research Infrastructures to establish new gold standards for clinical trials in rare and ultra-rare diseases. Sigmund Freud Private University and AstraZeneca lead this project, which is funded by the Innovative Health Initiative (IHI) and will run until 2029. RealiseD builds on advancements and outputs from prior and ongoing public private partnerships like EU-PEARL or Screen4Care and other relevant initiatives, such as ERICA, IDeA or ERDERA to co-create tools, methodologies and standards, to enhance innovative clinical trial designs. These will incorporate new methods like Real World Evidence and digital health technologies. Solutions will result in easy-to-use playbooks and digital tools for planning and running clinical trials.