– Rare Needs, Big Impact: Paediatric & Orphan Medicines in the New EU Framework
The Paediatric Regulation (EC 1901/2006) came into force in 2007 with the aim to improve the health of the children in Europe by increasing the research and authorization of medicines for children. Now this legislative landscape will change due to reform of the EU pharmaceutical legislation which will include both Paediatric and Orphan medicines into the same regulation. The merger of the Orphan Regulation and the Paediatric Regulation with the legislation applicable to all medicinal products will allow for simplification and increased coherence. Additional important current themes will be EU Life Science Strategy, various ACT EU activities, Decentralized Clinical Trials, Cross-Border access to trials and ATMP products.
The targeted goal of these Nordic conferences has been to increase the attractiveness of the Nordic Region for conducting Pediatric and Orphan clinical trials. This collaborative conference is seventh in order following the 2017, 2018, 2019, 2022, 2024 and 2025 events, and it will be organized in collaboration with HUS New Children´s Hospital, FINPEDMED, University of Helsinki, the City of Helsinki and Åbo Akademi University. This year, we are expecting to have more than 100 participants joining in person from Nordic and European countries.
Since 2013, Finnish Investigators Network for Pediatric Medicines – FINPEDMED – has been facilitating Pharma-, Biotech-, and Medical Device Industry collaboration together with Icelandic, Danish, Norwegian and Swedish academic pediatric research networks to support medicine development and clinical trials in the region of Scandinavia – the northern Europe.
Moreover, many of the NORDICPEDMED national network´s legal host organizations, university hospitals, are members of the Nordic University Hospital Alliance, NUHA. The main aim of NUHA collaboration is to meet the growing demands on healthcare systems – not just in the Nordic region, but across Europe and beyond. Nordic University hospitals play a critical role in addressing also health challenges of special patient groups by conducting joint research and clinical innovation, including new medicines and medical devices, and Improving research and care pathways across borders of Nordic region.
This conference design is based on previous year´s participants´ feedback for the organizers.